title: A Randomized, Double-blind, Placebo-controlled Phase II-III Multi-centre Study to Evaluate the Effect of Adjuvant Pazopanib (GW786034) Versus Placebo on Post-surgical Disease-free Survival in Patients With Stage I Non Small Cell Lung Cancer and Tumor Size Equal or Inferior to 5 cm.

summary: The aim of this study is to evaluate the efficacy and safety of pazopanib compared with placebo in patients with T < or = 5 cm, N0 (stage I according to TNM 2009) completely resected NSCLC.

ReferenceCitation: Besse B, Mazières J, Ribassin-Majed L, Barlesi F, Bennouna J, Gervais R, Moreau L, Berard H, Debieuvre D, Molinier O, Moro-Sibilot D, Souquet PJ, Jacquot S, Petit L, Lena H, Pignon JP, Lacas B, Morin F, Milleron B, Zalcman G, Soria JC; Intergroupe Francophone de Cancérologie Thoracique (IFCT). Pazopanib or placebo in completely resected stage I NSCLC patients: results of the phase II IFCT-0703 trial. Ann Oncol. 2017 May 1;28(5):1078-1083. doi: 10.1093/annonc/mdx070.

family: Besse

full_name: B. Besse

given: B.

full_name: J. Mazières

given: J.

family: Ribassin-Majed

full_name: L. Ribassin-Majed

given: L.

family: Barlesi

full_name: F. Barlesi

given: F.

family: Bennouna

full_name: J. Bennouna

family: Gervais

full_name: R. Gervais

given: R.

family: Moreau

full_name: L. Moreau

family: Berard

full_name: H. Berard

given: H.

family: Debieuvre

full_name: D. Debieuvre

given: D.

family: Molinier

full_name: O. Molinier

given: O.

full_name: D. Moro-Sibilot

full_name: P.J. Souquet

family: Jacquot

full_name: S. Jacquot

given: S.

family: Petit

full_name: L. Petit

family: Lena

full_name: H. Lena

family: Pignon

full_name: J.P. Pignon

family: Lacas

full_name: B. Lacas

full_name: F. Morin

family: Milleron

full_name: B. Milleron

full_name: G. Zalcman

given: G.

full_name: J.C. Soria

location_facility:
Annemasse - CH
Moulins - CH
Colmar - CH
Strasbourg - NHC
Centre Catalan d'Onologie
Metz - Clinique Claude Bernard
Mont de Marsan - CH
Nantes - Centre René Gauducheau
Clermont Ferrand - CHU
CHU
Toulon - HIA
Paris - hôpital Saint-Antoine
Villejuif - Institut Gustave Roussy
Béziers - CH
Montpellier - CHRU
Reims - CHU
Montpellier - Clinique Clémentville
Dax - CH
Nevers - CH
Pau - CH
Thonon les bains - CH
Caen - CHU Côte de Nacre
Paris - Saint Louis
Paris - Hopital Tenon
Bordeaux - Polyclinique Nord
Nancy - CHU
Grenoble - CHU
Lille - Hôpital Calmette
Clamart - Hôpital Percy
Vesoul - CHI
Lyon Sud
Rennes - CHU
Caen - Centre François Baclesse
Boulogne - Ambroise Paré
Mantes La Jolie - CH
Bobigny - Hôpital Avicenne
Le Mans - Centre Hospitalier
Toulouse - CHU Larrey
Orléans - CH
Marseille - Hôpital Sainte Marguerite


title: Phase III Study Evaluating the Use of Systemic Chemotherapy and Chemohyperthemia Intraperitoneal Preoperatively (CHIP) and After Maximum Resection of Peritoneal Carcinomatosis Originating With Colorectal Cancer

summary:
RATIONALE: Drugs used in chemotherapy, such as leucovorin, fluorouracil, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether systemic chemotherapy is more effective with or without intraperitoneal chemohyperthermia in treating patients with peritoneal carcinomatosis from colorectal cancer.

PURPOSE: This randomized phase III trial is studying systemic chemotherapy to see how well it works compared with or without intraperitoneal chemohyperthermia in treating patients undergoing surgery for peritoneal carcinomatosis from colorectal cancer.

status: Completed

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Quénet F, Elias D, Roca L, Goéré D, Ghouti L, Pocard M, Facy O, Arvieux C, Lorimier G, Pezet D, Marchal F, Loi V, Meeus P, Juzyna B, de Forges H, Paineau J, Glehen O; UNICANCER-GI Group and BIG Renape Group. Cytoreductive surgery plus hyperthermic intraperitoneal chemotherapy versus cytoreductive surgery alone for colorectal peritoneal metastases (PRODIGE 7): a multicentre, randomised, open-label, phase 3 trial. Lancet Oncol. 2021 Feb;22(2):256-266. doi: 10.1016/S1470-2045(20)30599-4. Epub 2021 Jan 18.

family: Quénet

full_name: François Quénet

given: François

sequence: first

family: Elias

full_name: Dominique Elias

given: Dominique

sequence: additional

family: Roca

full_name: Lise Roca

given: Lise

family: Goéré

full_name: Diane Goéré

given: Diane

family: Ghouti

full_name: Laurent Ghouti

given: Laurent

family: Pocard

full_name: Marc Pocard

given: Marc

family: Facy

full_name: Olivier Facy

given: Olivier

family: Arvieux

full_name: Catherine Arvieux

given: Catherine

family: Lorimier

full_name: Gérard Lorimier

given: Gérard

family: Pezet

full_name: Denis Pezet

given: Denis

family: Marchal

full_name: Frédéric Marchal

given: Frédéric

family: Loi

full_name: Valeria Loi

given: Valeria

family: Meeus

full_name: Pierre Meeus

given: Pierre

family: Juzyna

full_name: Beata Juzyna

given: Beata

family: de Forges

full_name: Hélène de Forges

given: Hélène

family: Paineau

full_name: Jacques Paineau

given: Jacques

family: Glehen

full_name: Olivier Glehen

family: MARIANI

full_name: Pascale MARIANI

given: Pascale

family: BRIGAND

full_name: Cécile BRIGAND

given: Cécile

family: BEREDER

full_name: Jean-Marc BEREDER

given: Jean-Marc

family: MSIKA

full_name: Simon MSIKA

given: Simon

family: PORTIER

full_name: Guillaume PORTIER

given: Guillaume

family: RAT

full_name: Patrick RAT

given: Patrick

bso_classification: Medical research

datasource: user

location_facility: Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle


title: Heparin-Induced Thrombocytopenia : Development and Validation of a Predictive Clinical Score: a Prospective Multicenter Study Under the Auspices of the French Haemostasis and Thrombosis Study Group (GEHT)in Cooperation With the French Association of Regional PharmacoVigilance Center (AFCRPV)

acronym: Score-TIH

summary:
Although Heparin-induced thrombocytopenia (HIT) is a rare complication of heparin treatment, it results in a high rate of morbidity and mortality, the cumulative rate of thrombosis recurrence, amputation and death approaching 52 % at one month if no specific treatment is initiated. It is therefore vital to diagnose HIT as early and as reliably as possible to permit appropriate management of this rare condition.

During the acute phase of HIT, clinicians and biologists can only suspect this complication with a greater or lesser degree of confidence. Clinical data are not sufficiently sensitive or specific to confirm or refute thr diagnosis of HIT.

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Tardy-Poncet B, de Maistre E, Pouplard C, Presles E, Alhenc-Gelas M, Lasne D, Horellou MH, Mouton C, Serre-Sapin A, Bauters A, Nguyen P, Mullier F, Perrin J, Le Gal G, Morange PE, Grunebaum L, Lillo-Le Louet A, Elalamy I, Gruel Y, Greinacher A, Lecompte T, Tardy B; GFHT-HIT study group. Heparin-induced thrombocytopenia: Construction of a pretest diagnostic score derived from the analysis of a prospective multinational database, with internal validation. J Thromb Haemost. 2021 Aug;19(8):1959-1972. doi: 10.1111/jth.15344. Epub 2021 Jun 14.

name: CIC 1408, Inserm U1059 SAINBIOSE F‐Crin INNOVTE Université de Lyon Saint‐Etienne France

family: Tardy‐Poncet

full_name: Brigitte Tardy‐Poncet

given: Brigitte

family: Maistre

full_name: Emmanuel Maistre

given: Emmanuel

name: Division of Hematology ‐ Hemostasis University Hospital of Tours Tours France

family: Pouplard

full_name: Claire Pouplard

given: Claire

family: Presles

full_name: Emilie Presles

given: Emilie

name: Hemostasis Unit Hopital Européen Georges PompidouAP‐HP Paris France

family: Alhenc‐Gelas

full_name: Martine Alhenc‐Gelas

given: Martine

name: Hemostasis Unit Hôpital NeckerAP‐HP Paris France

name: Université Paris Sud Paris SaclayInserm U1176 Le Kremlin‐Bicêtre France

family: Lasne

full_name: Dominique Lasne

given: Dominique

name: Hematology Laboratory Unit Hôpital Universitaire Paris‐centre Paris France

family: Horellou

full_name: Marie‐Hélène Horellou

given: Marie‐Hélène

name: Hemostasis Unit CHU Bordeaux Bordeaux France

family: Mouton

full_name: Christine Mouton

given: Christine

name: Hemostasis Unit CHU Clermont‐Ferrand Clermont‐Ferrand France

family: Serre‐Sapin

full_name: Anne Serre‐Sapin

given: Anne

family: Bauters

full_name: Anne Bauters

family: Nguyen

full_name: Philippe Nguyen

given: Philippe

name: Namur Thrombosis and Hemostasis Center Hematology Laboratory Université catholique de LouvainCHU UCL Namur Yvoir Belgium

family: Mullier

full_name: François Mullier

given: François

family: Perrin

full_name: Julien Perrin

given: Julien

name: Department of Medicine University of OttawaOttawa Hospital Research InstituteThrombosis Research Group Ottawa ON Canada

family: Le Gal

full_name: Grégoire Le Gal

given: Grégoire

name: C2VNAix Marseille UniversityINSERMINRA; Laboratory of HematologyLa Timone HospitalAssistance Publique des Hôpitaux de Marseille Marseille France

family: Morange

full_name: Pierre‐Emmanuel Morange

given: Pierre‐Emmanuel

name: Laboratory of Hematology CHU Strasbourg Strasbourg France

family: Grunebaum

full_name: Lélia Grunebaum

given: Lélia

name: Pharmacovigilance Center Georges Pompidou European HospitalAP‐HP Paris France

family: Lillo‐Le Louet

full_name: Agnès Lillo‐Le Louet

given: Agnès

name: Hematology and Thrombosis Center Tenon University HospitalINSERM UMRS 938Sorbonne University Paris France

family: Elalamy

full_name: Ismail Elalamy

given: Ismail

family: Gruel

full_name: Yves Gruel

given: Yves

name: Institut fuer Immunologie und Transfusionsmedizin Universitaetsmedizin Greifswald Greifswald Germany

family: Greinacher

full_name: Andreas Greinacher

given: Andreas

name: Department of Medicine Geneva University Hospitals, and Geneva Platelet Group (GpG)Faculty of MedicineUniversity of Geneva Geneva Switzerland

family: Lecompte

full_name: Thomas Lecompte

given: Thomas

family: Tardy

full_name: Bernard Tardy

given: Bernard

genre: journal-article

genre_raw: journal-article

title: Heparin‐induced thrombocytopenia: Construction of a pretest diagnostic score derived from the analysis of a prospective multinational database, with internal validation

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility: G.H. Pitié Salpétrière - Labo Hémostase Pavillon Laveran

location_facility: Hôpital Antoine Beclère - Laboratoire d'hématologie

location_facility: Hôpital SAINT ELOI - CHU de Montpellier - Laboratoire d'Hématologie

location_facility: Hôpital BICHAT - Service d'hématologie immunologie

location_facility: Laboratoire d'Hématologie - CHU le Bocage

location_facility: Laboratoire d'hématologie - CHU de Clermont Ferrand

location_facility: Hôpital Cardiologique - Laboratoire d'Hémostase

location_facility: Hopital Purpan - Laboratoire d'hématologie

location_facility: CHU Trousseau - CTH - Service d'Hématologie Hémostase

location_facility: CHU Cavale Blanche Laboratoire d'Hématologie

location_facility: Hôpital Necker Enfants Malades -Laboratoire d'Hématologie

location_facility: Laboratoire d'hématologie - Hôpital Louis Pradel

location_facility: HOTEL DIEU - CHU Nantes - Laboratoire d'Hématologie

location_facility: Laboratoire central d'hématologie - Hôpital R. DEBRE

location_facility: Hôpital Européen Georges Pompidou - Service Hématologie Biologique A

location_facility: ETS de Franche Conté - Laboratoire d'Immuno Hématologie

location_facility: CHU Strasbourg Hautepierre Laboratoire d'Hématologie


title: A Phase II Trial With Pemetrexed Plus Cisplatin as First Line Chemotherapy for Advanced Non - Small Cell Lung Cancer (NSCLC) Patients With Measurable Asymptomatic Brain Metastasis (GFPC 07-01/METAL).

summary:
NSCLC patients often have cerebral metastasis : 10% at diagnosis and 40% during disease management. Neurosurgery is not indicated in the majority of cases because of presence of several lesions in the brain, failure of primary tumor control or presence of extra-cerebral metastasis. Cerebral metastasis lead to death in 30 to 50% of these cases. Management of these patients in this situation is based on supportive care and whole-brain radiotherapy. The place of chemotherapy for patients with good performance status was discussed for a long time and it is now admitted. However, the place of new drugs such as pemetrexed, which is currently used as a second line treatment for NSCLC, needs to be further studied. It is known that pemetrexed when added to cisplatin for treatment of NSCLC provides a similar effectiveness when compared to other drugs associations commonly used in this indication. In addition, Cisplatin with Pemetrexed probably present a better safety profile.

The present study is based upon the hypothesis stipulating that the association cisplatin-pemetrexed will be at least as efficient as the others association currently used for treatment of NSCLC and will present a better safety profile. The primary objective of this study is overall response rate on brain metastasis according to RECIST criteria. Secondary judgment criterias are : Overall response rate, PFS after first-line CDDP plus pemetrexed, safety profile, quality of life, neurological symptoms, overall survival.

The trial will enroll up to 45 patients in this single-arm two-stage sequential phase II study with the possibility of stopping the study early because of lack of efficacy.

design_allocation: Non-Randomized

lead_sponsor: University Hospital, Brest

location_facility: Hôpital A. Mignot, Service de Pneumologie

location_facility: CHU brest, institut de cancérologie et d'hématologie

location_facility: Serv. de Pneumo-Allergo, CH de Martigues

location_facility: CHU de ROUEN, Hôpital Bois Guillaume, Serv. de Pneumo.

location_facility: Médecine 4, C.H.G. de la Fontonne Antibes

location_facility: Hôpital Pontchailloux, Service de Pneumologie.

location_facility: Centre Hospitalier Départemental, Service de Pneumologie,

location_facility: Pneumologie, Centre hôspitalier, DRAGUIGNAN

location_facility: Centre Hospitalier, Service de Pneumologie

location_facility: Centre Hôspitalier du Pays d'Aix, Service des Maladies Respiratoires

location_facility: Centre Hôspitalier, Service de Pneumo-Neuro

location_facility: Centre Hospitalier René Dubos - Pontoise, Service d'Oncologie - Hématologie Clinique

location_facility: Service Pneumologie, Pavillon 1A, CH de Lyon-Sud

intervention_type: Drug

lead_sponsor_type: academique

status_simplified: Completed


title: A Randomised, Controlled, Open-label, French Multicenter Parallel Group Study to Compare the Maintenance of Haemoglobin Level With Once Monthly Administration of C.E.R.A. (Continuous Erythropoietin Receptor Activator) Versus Epoetin Beta or Darbepoetin Alfa in Patients With Chronic Kidney Disease on Haemodialysis

summary: This 2 arm study will compare the hemoglobin maintenance with once monthly methoxy polyethylene glycol-epoetin beta (Mircera) administration versus epoetin beta or darbepoetin alfa in participants with chronic kidney disease on hemodialysis. Participants will be randomized to receive either monthly intravenous (IV) or subcutaneous (SC) methoxy polyethylene glycol-epoetin beta (at a starting dose of 120 or 200 micrograms, calculated from the last weekly dose of epoetin beta or darbepoetin alfa previously administered), or standard therapy (IV or SC epoetin beta once, twice or thrice weekly, or IV or SC darbepoetin alfa once a week or twice a week).

ReferenceCitation: Locatelli F, Choukroun G, Truman M, Wiggenhauser A, Fliser D. Once-Monthly Continuous Erythropoietin Receptor Activator (C.E.R.A.) in Patients with Hemodialysis-Dependent Chronic Kidney Disease: Pooled Data from Phase III Trials. Adv Ther. 2016 Apr;33(4):610-25. doi: 10.1007/s12325-016-0309-6. Epub 2016 Mar 10.

family: Locatelli

full_name: Francesco Locatelli

given: Francesco

family: Choukroun

full_name: Gabriel Choukroun

given: Gabriel

family: Truman

full_name: Matt Truman

given: Matt

family: Wiggenhauser

full_name: Alfons Wiggenhauser

given: Alfons

family: Fliser

full_name: Danilo Fliser

given: Danilo

journal_name: Advances in Therapy

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via page says license)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

evidence: oa repository (via OAI-PMH doi match)

host_type: repository

license: implied-oa

license_normalized: implied-oa

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: Hoffmann-La Roche

lead_sponsor_type: industriel


title: An Open Label Study to Assess the Rate of Pathological Complete Response in Patients With Primary Inflammatory HER2-positive Breast Cancer Treated With Avastin + Herceptin Based Chemotherapy

summary: This single arm study will assess the efficacy and safety of preoperative treatment with Avastin combined with Herceptin-based chemotherapy in patients with primary inflammatory HER2-positive breast cancer. Patients will be treated with a total of 8 cycles of pre-operative chemotherapy + Avastin + Herceptin. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.

ReferenceCitation: Pierga JY, Petit T, Delozier T, Ferrero JM, Campone M, Gligorov J, Lerebours F, Roché H, Bachelot T, Charafe-Jauffret E, Pavlyuk M, Kraemer S, Bidard FC, Viens P. Neoadjuvant bevacizumab, trastuzumab, and chemotherapy for primary inflammatory HER2-positive breast cancer (BEVERLY-2): an open-label, single-arm phase 2 study. Lancet Oncol. 2012 Apr;13(4):375-84. doi: 10.1016/S1470-2045(12)70049-9. Epub 2012 Feb 28.

family: Pierga

full_name: Jean-Yves Pierga

given: Jean-Yves

family: Petit

full_name: Thierry Petit

given: Thierry

family: Delozier

full_name: Thierry Delozier

family: Ferrero

full_name: Jean-Marc Ferrero

given: Jean-Marc

family: Campone

full_name: Mario Campone

given: Mario

family: Gligorov

full_name: Joseph Gligorov

given: Joseph

family: Lerebours

full_name: Florence Lerebours

given: Florence

family: Roché

full_name: Henri Roché

given: Henri

family: Bachelot

full_name: Thomas Bachelot

family: Charafe-Jauffret

full_name: Emmanuelle Charafe-Jauffret

given: Emmanuelle

family: Pavlyuk

full_name: Maria Pavlyuk

given: Maria

family: Kraemer

full_name: Sandrine Kraemer

given: Sandrine

family: Bidard

full_name: François-Clément Bidard

given: François-Clément

family: Viens

full_name: Patrice Viens

given: Patrice

journal_name: The Lancet Oncology

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier


title: Ventricular Arrhythmias Incidence According to Sleep Apnea Syndrome in ICD Patients

summary: The purpose of this study is to report the incidence of ventricular arrhythmias correlated to the SAS and to focus on the interest of diagnosing Sleep-disorders breathing in ICD patients. This diagnosis will be assessed by an ambulatory nasal pressure recording with portable multi-channel recorder associated to a complete SAS related symptoms questionnaire.This clinical trial will be the first step to gather information about the suspected sleep relation between ventricular arrhythmias and Sleep breathing disorders, in order to improve the management and treatment of such arrhythmias in next generation of defibrillators which will integrate a minute ventilation sensor able to monitor breathing.

enrollment_type: Anticipated

lead_sponsor: LivaNova

location_country: Italy Germany France Greece

location_facility:
Instituto di Cura
Hopital cardiologique
CHU Hopital la Milétrie
CHR Notre Dame de Bonsecours
Hopital Saint Joseph et saint Luc
CHU
Hopital Nord
Policlinico San Donato
CHU Charles Nicolle
Universitatsklinikum Hamburg Eppendorf
Clinique Pasteur
CHRU Brabois
Casa di Cura Montevergine
CH Montpellier
Prof. Frey Praxis Starnberg
CHU Dupuytren
Ospedale Mellini
Policlinico de Modenna
Osp. Civile
CHR Cardiologie A
Nouvelle Clinique Nantaise
CHRU Hopital de la cavale blanche
CH Pau
CHU - Hopital Michallon
CHRU Hopital Trousseau
Clinique Saint gatien
Herz-Kreislauf-Klinik Bevensen AG
Hospitale civile Guglielmo da Saliceto
Onassis Cardiac Surgery Center
Clinique Bizet

intervention_type: Device


title: Survey on Time to Lipid-lowering Drug Implementation on Dyslipidemic Patients in General Practice.

acronym: PRYSME

summary: The purpose of this observational study is to describe the time to lipid-lowering drug implementation in the management of dyslipidemic patients, according to the cardiovascular risk level.

time_perspective: Cross-Sectional

lead_sponsor: AstraZeneca


title: Comparison and Description of Coronary Patients Management With or Without Heart Failure in Cardiology Consulting

acronym: COMPAR

summary: The purpose of this observational study is to compare frequency of attainment control goals through the more represented cardiovascular factor risk, dyslipidemia, among coronary patients with or without heart failure in cardiology consulting.


title: National Prospective Survey on Women With a Diagnosis of Infiltrative Breast Cancer

acronym: CSI

summary: The purpose of this observational study is to describe radiological, clinical and histological characteristics of women with infiltrative breast cancer.


title: Evaluation of the Impact of Abdominal Fat on GERD Severity and GERD Frequency in General Practice

acronym: LINEA

summary: The purpose of this observational study is to assess the impact of abdominal fat on severity and frequency of GERD symptoms .


title: Profile of Hypertensive Patients Seen in Hospital Outpatient's Department

acronym: PROPHYL HO

summary: To evaluate (with sufficient accuracy) the profile(demographic and clinical characteristics, health care management) of hypertensive patients seen in hospital out patient's department by a cardiologist or a nephrologists.


title: Profile of Hypertensive Patients Seen in Private Cardiology Consultation

acronym: Prophyl C

summary: To evaluate (with sufficient accuracy) the profile(demographic and clinical characteristics, health care management) of hypertensive patients seen in private cardiology consultation by holding account of type of exercise of the cardiologist (private exclusive or mixed hospital and private).


publications_result: Pujol P, Mijonnet S, Karen S, et al.: Breast cancer prevention by letrozole in post menopausal BRCA1/2 mutations carriers: The Onco-03/LIBER trial. [Abstract] 32nd Annual San Antonio Breast Cancer Symposium, December 9-13, 2009, San Antonio, Texas. A-1048, 2009.

ReferenceType: background

ReferenceCitation: Pujol P, Lasset C, Berthet P, Dugast C, Delaloge S, Fricker JP, Tennevet I, Chabbert-Buffet N, This P, Baudry K, Lemonnier J, Roca L, Mijonnet S, Gesta P, Chiesa J, Dreyfus H, Vennin P, Delnatte C, Bignon YJ, Lortholary A, Prieur F, Gladieff L, Lesur A, Clough KB, Nogues C, Martin AL; French Federation of Cancer Centres (FNCLCC). Uptake of a randomized breast cancer prevention trial comparing letrozole to placebo in BRCA1/2 mutations carriers: the LIBER trial. Fam Cancer. 2012 Mar;11(1):77-84. doi: 10.1007/s10689-011-9484-4.

family: Pujol

full_name: Pascal Pujol

given: Pascal

name: On behalf the French Federation of Cancer Centres (FNCLCC)

family: Lasset

full_name: Christine Lasset

given: Christine

family: Berthet

full_name: Pascaline Berthet

given: Pascaline

family: Dugast

full_name: Catherine Dugast

given: Catherine

family: Delaloge

full_name: Suzette Delaloge

given: Suzette

family: Fricker

full_name: Jean-Pierre Fricker

given: Jean-Pierre

family: Tennevet

full_name: Isabelle Tennevet

given: Isabelle

family: Chabbert-Buffet

full_name: Nathalie Chabbert-Buffet

given: Nathalie

family: This

full_name: Pascale This

given: Pascale

family: Baudry

full_name: Karen Baudry

given: Karen

family: Lemonnier

full_name: Jerome Lemonnier

given: Jerome

family: Roca

full_name: Lise Roca

given: Lise

family: Mijonnet

full_name: Sylvie Mijonnet

given: Sylvie

family: Gesta

full_name: Paul Gesta

given: Paul

family: Chiesa

full_name: Jean Chiesa

given: Jean

family: Dreyfus

full_name: Helene Dreyfus

given: Helene

family: Vennin

full_name: Philippe Vennin

given: Philippe

family: Delnatte

full_name: Capucine Delnatte

given: Capucine

family: Bignon

full_name: Yves Jean Bignon

given: Yves Jean

family: Lortholary

full_name: Alain Lortholary

given: Alain

family: Prieur

full_name: Fabienne Prieur

given: Fabienne

family: Gladieff

full_name: Laurence Gladieff

given: Laurence

family: Lesur

full_name: Anne Lesur

given: Anne

family: Clough

full_name: Krishna B. Clough

given: Krishna B.

family: Nogues

full_name: Catherine Nogues

ipd_sharing_description: Unicancer will share de-identified individual data that underlie the results reported. A decision concerning the sharing of other study documents, including protocol and statistical analysis plan will be examined upon request.

location_facility: Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes

title: Prevention of Breast Cancer by Letrozole in Post-menopausal Women Carrying a BRCA1/BRCA2 Mutation

summary:
RATIONALE: Letrozole may prevent breast cancer in postmenopausal women with a BRCA1 or BRCA2 mutation.

PURPOSE: This randomized phase III trial is studying letrozole to see how well it works compared with a placebo in preventing breast cancer in postmenopausal women with a BRCA1 or BRCA2 mutation.


ReferenceType: result

ReferenceCitation: Zalcman G, Mazieres J, Margery J, Greillier L, Audigier-Valette C, Moro-Sibilot D, Molinier O, Corre R, Monnet I, Gounant V, Rivière F, Janicot H, Gervais R, Locher C, Milleron B, Tran Q, Lebitasy MP, Morin F, Creveuil C, Parienti JJ, Scherpereel A; French Cooperative Thoracic Intergroup (IFCT). Bevacizumab for newly diagnosed pleural mesothelioma in the Mesothelioma Avastin Cisplatin Pemetrexed Study (MAPS): a randomised, controlled, open-label, phase 3 trial. Lancet. 2016 Apr 2;387(10026):1405-1414. doi: 10.1016/S0140-6736(15)01238-6. Epub 2015 Dec 21. Erratum in: Lancet. 2016 Apr 2;387(10026):e24.

family: Zalcman

full_name: Gérard Zalcman

given: Gérard

family: Mazieres

full_name: Julien Mazieres

given: Julien

family: Margery

full_name: Jacques Margery

given: Jacques

family: Greillier

full_name: Laurent Greillier

given: Laurent

family: Audigier-Valette

full_name: Clarisse Audigier-Valette

given: Clarisse

family: Moro-Sibilot

full_name: Denis Moro-Sibilot

given: Denis

family: Molinier

full_name: Olivier Molinier

given: Olivier

family: Corre

full_name: Romain Corre

given: Romain

family: Monnet

full_name: Isabelle Monnet

given: Isabelle

family: Gounant

full_name: Valérie Gounant

given: Valérie

family: Rivière

full_name: Frédéric Rivière

given: Frédéric

family: Janicot

full_name: Henri Janicot

given: Henri

family: Gervais

full_name: Radj Gervais

given: Radj

family: Locher

full_name: Chrystèle Locher

given: Chrystèle

family: Milleron

full_name: Bernard Milleron

given: Bernard

family: Tran

full_name: Quan Tran

given: Quan

family: Lebitasy

full_name: Marie-Paule Lebitasy

given: Marie-Paule

family: Morin

full_name: Franck Morin

given: Franck

family: Creveuil

full_name: Christian Creveuil

given: Christian

family: Parienti

full_name: Jean-Jacques Parienti

given: Jean-Jacques

family: Scherpereel

full_name: Arnaud Scherpereel

given: Arnaud

journal_name: The Lancet

ReferenceCitation: Brosseau S, Danel C, Scherpereel A, Mazières J, Lantuejoul S, Margery J, Greillier L, Audigier-Valette C, Gounant V, Antoine M, Moro-Sibilot D, Rouquette I, Molinier O, Corre R, Monnet I, Langlais A, Morin F, Bergot E, Zalcman G, Levallet G. Shorter Survival in Malignant Pleural Mesothelioma Patients With High PD-L1 Expression Associated With Sarcomatoid or Biphasic Histology Subtype: A Series of 214 Cases From the Bio-MAPS Cohort. Clin Lung Cancer. 2019 Sep;20(5):e564-e575. doi: 10.1016/j.cllc.2019.04.010. Epub 2019 May 13.

family: Brosseau

full_name: Solenn Brosseau

given: Solenn

family: Danel

ReferenceCitation: Ribi K, Luo W, Colleoni M, Karlsson P, Chirgwin J, Aebi S, Jerusalem G, Neven P, Di Lauro V, Gomez HL, Ruhstaller T, Abdi E, Biganzoli L, Müller B, Barbeaux A, Graas MP, Rabaglio M, Francis PA, Foukakis T, Pagani O, Graiff C, Vorobiof D, Maibach R, Di Leo A, Gelber RD, Goldhirsch A, Coates AS, Regan MM, Bernhard J; SOLE Investigators. Quality of life under extended continuous versus intermittent adjuvant letrozole in lymph node-positive, early breast cancer patients: the SOLE randomised phase 3 trial. Br J Cancer. 2019 May;120(10):959-967. doi: 10.1038/s41416-019-0435-4. Epub 2019 Apr 10. Erratum in: Br J Cancer. 2020 Jan 16;:.

repository_institution: University of Melbourne - Minerva Access

lead_sponsor: Intergroupe Francophone de Cancerologie Thoracique

location_facility: Boujan sur Libron - Polyclinique Saint-Privat

title: A Phase II-III Randomized Trial Pemetrexed-Cisplatin Chemotherapy With or Without Bevacizumab (Avastin), 15 mg/kg, for Malignant Pleural Mesothelioma (MPM)

summary: Our hypothesis is that the addition of bevacizumab to the standard chemotherapy treatment of MPM will improve overall survival and quality of life beyond that achieved with chemotherapy alone.


title: Azithromycin (Zithromax®) 5 Days Versus Amoxicillin-Clavulanic Acid (Augmentin®): Multicentre, Randomised, Open-Label Study To Compare The Clinical Efficacy And Safety Of Azithromycin With Those Of Amoxicillin-Clavulanic Acid In Patients Presenting With An Exacerbation Of Chronic Bronchitis

summary: This study compared the clinical efficacy and safety of azithromycin with that of amoxicillin-clavulanic acid, in patients between the ages of 35 and 75 years, presenting with an exacerbation of chronic bronchitis.

lead_sponsor: Pfizer


title: Multicenter, Open, Randomized Comparative Trial To Compare Bacteriological And Clinical Efficacy Of Azithromycin Versus Amoxicillin In Children With Streptococcus Tonsillitis

summary: The primary objective was to compare the bacteriological efficacy at Day 10 of azithromycin pediatric suspension (20 mg/kg/day once daily for 3 consecutive days) versus amoxicillin pediatric suspension (50 mg/kg/day in 2 doses for 6 consecutive days) in children aged 3-15 years with Group A streptococcal acute pharyngitis/tonsillitis. Secondary objectives were assessments of bacteriological efficacy at Day 30 and clinical efficacy at Day 10 and Day 30.


acronym: PRADO

type: EudraCT Number

source: euctr

title: A Single Arm, Open Label, French Multi-centre Study to Assess the Maintenance of Hemoglobin Levels With Once Monthly Subcutaneous Administration of C.E.R.A. (Continuous Erythropoietin Receptor Activator) in Patients With Chronic Kidney Disease Not on Dialysis

summary: This single arm study will assess the efficacy and safety of monthly administration of subcutaneous methoxy polyethylene glycol-epoetin beta (Mircera) when administered for the maintenance of hemoglobin levels in participants with chronic renal anemia, not on dialysis. Participants currently receiving treatment with subcutaneous epoetin or darbepoetin alfa will receive monthly subcutaneous injections of methoxy polyethylene glycol-epoetin beta, with the starting dose (120 or 200 micrograms) calculated from the last weekly dose of epoetin beta or darbepoetin alfa previously administered.


title: Velcade®-Melphalan Association as Conditioning Regimen Before Autologous Stem-cell Transplantation in Multiple Myeloma Patients Under 65 Years

summary:
Intensification with autologous stem cell (ASCT) is currently the most effective treatment for subjects under 65 and the essential goal is to achieve complete response (CR) or very good partial response (VGPR= greater than 90% reduction of monoclonal component). However, only 50% of patients achieve this CR/VGPR even with tandem ASCT early in the course of disease.

Optimization of the conditioning regimen could improve this CR/VGPR rate. The combinaison of Velcade and HD Melphalan has never been evaluated. However, at conventional doses, Velcade potentiates the antimyeloma effect of Melphalan without inducing any common toxicity.

This study will be conducted in patients under the age of 65 with de novo multiple myeloma or in first relapse, with Salmon and Durie stage of III, II, I with one symptomatic bone lesion (radiological)and no contraindication to intensification. The primary objective will be to increase the CR/VGPR rate 3 months after autologous peripheral blood stem cell transplantation conditioned by Velcade-Melphalan from 40% to 70%. With alpha=5% and bêta=10%, 61 patients will be included.

Secondary objectives will be to assess the toxicity of the Velcade-Melphalan conditioning regimen, the progression-free survival and the overall survival after intensification. Response rates will be evaluated according to the response criteria defined by. Analysis will be performed on an intention-to-treat basis.

After conventional induction therapy and PBSC collection, patients will be offered this new conditioning regimen. they will be free to refuse this regimen, in which case they will receive standard intensification therapy by Melphalan 200 mg/m² followed by autologous stem cell transplantation.

Evaluation will occur at 3 months post intensification.

ReferenceCitation: Roussel M, Moreau P, Huynh A, Mary JY, Danho C, Caillot D, Hulin C, Fruchart C, Marit G, Pégourié B, Lenain P, Araujo C, Kolb B, Randriamalala E, Royer B, Stoppa AM, Dib M, Dorvaux V, Garderet L, Mathiot C, Avet-Loiseau H, Harousseau JL, Attal M; Intergroupe Francophone du Myélome (IFM). Bortezomib and high-dose melphalan as conditioning regimen before autologous stem cell transplantation in patients with de novo multiple myeloma: a phase 2 study of the Intergroupe Francophone du Myelome (IFM). Blood. 2010 Jan 7;115(1):32-7. doi: 10.1182/blood-2009-06-229658. Epub 2009 Nov 2.

family: Roussel

full_name: Murielle Roussel

given: Murielle

family: Moreau

full_name: Philippe Moreau

given: Philippe

family: Huynh

full_name: Anne Huynh

given: Anne

name: Unité Inserm U717, Hôpital Saint Louis, Paris;

family: Mary

full_name: Jean-Yves Mary

given: Jean-Yves

family: Danho

full_name: Clotaire Danho

given: Clotaire

family: Caillot

full_name: Denis Caillot

given: Denis

family: Hulin

full_name: Cyrille Hulin

given: Cyrille

family: Fruchart

full_name: Christophe Fruchart

given: Christophe

family: Marit

full_name: Gérald Marit

given: Gérald

family: Pégourié

full_name: Brigitte Pégourié

given: Brigitte

family: Lenain

full_name: Pascal Lenain

given: Pascal

name: Centre Hospitalier de la Côte Basque, Bayonne;

family: Araujo

full_name: Carla Araujo

given: Carla

family: Kolb

full_name: Brigitte Kolb

name: Centre Hospitalier la Mileterie, Poitiers;

family: Randriamalala

full_name: Edouard Randriamalala

given: Edouard

family: Royer

full_name: Bruno Royer

given: Bruno

family: Stoppa

full_name: Anne-Marie Stoppa

given: Anne-Marie

family: Dib

full_name: Mammoun Dib

given: Mammoun

family: Dorvaux

full_name: Véronique Dorvaux

given: Véronique

family: Garderet

full_name: Laurent Garderet

given: Laurent

family: Mathiot

full_name: Claire Mathiot

given: Claire

family: Avet-Loiseau

full_name: Hervé Avet-Loiseau

given: Hervé

family: Harousseau

full_name: Jean-Luc Harousseau

given: Jean-Luc

family: Attal

full_name: Michel Attal

given: Michel

name: for the Intergroupe Francophone du Myélome (IFM)

title: Bortezomib and high-dose melphalan as conditioning regimen before autologous stem cell transplantation in patients with de novo multiple myeloma: a phase 2 study of the Intergroupe Francophone du Myélome (IFM)

location_facility: Service of Oncohematology - Louis Pasteur Hospital

location_facility: Service of Clinical Hematology - Bocage Hospital

location_facility: Service of Clinical Hematology - Army Instruction Hospital of Percy

location_facility: Service of Clinical Hematology - Cote Basque Hospital

location_facility: Service of Clinical Hematology - Minjoz Hospital

location_facility: Service of Hematology - Paoli Calmette Institute

location_facility: Service of Hematology -Henri Becquerel Center

location_facility: Service of Clinical Hematology - Purpan hospital TSA 40031

location_facility: Service of Clinical Hematology - A. Morvan Hospital

location_facility: Service of Hematology - R.Debré Hospital

location_facility: Service of Hematology - Pontchaillou Hospital

location_facility: Service of Hematology - Jean Bernard Hospital

location_facility: Service of Hematology - Edouard Herriot Hospital

location_facility: Service of Hematology - General Hospital

location_facility: Service of Hematology - Brabois Hospital

location_facility: Service of Hematology - Hautepierre Hospital

location_facility: Service of Clinical Hematology - Archet 1 Hospital

location_facility: Service of Hematology - Claude Hurriez Hospital

location_facility: Service of Clinical Hematology - F. Baclesse Center

location_facility: Service of Hematology - A. Michallon Hospital

location_facility: Service of Blood Deseases - Saint Antoine Hospital

location_facility: Service of Onco-Hematology - Bretonneau Hospital

location_facility: Service of Blood Deseases - South Hospital

location_facility: Service of Blood Deseases - UH of Nantes

location_facility: Service of Hematology - Lyon Sud Hospital

location_facility: Service of Hematology - Léon Bérard Center

location_facility: Service of Clinical Hematology - Avicenne Hospital

location_facility: Service of Hematology - Notre Dame du Bon Secours Hospital

location_facility: Service of Clinical Hematology - UH of Clermont-Ferrand

location_facility: Service of Hematology -Gustave Roussy Institute


title: Evaluation of the Technique of Axillary Sentinel Lymph Node (SLN) Detection in Breast Cancers > 2 cm

summary:
The purpose of this study is to evaluate the quality criteria of the SLN detection technique in breast cancer patients with a tumor size (clinical measurement) greater than 2 centimeters (rate of false negatives, rate of detection).

Eligible patients will only be registered (no randomization). The estimated inclusion period is approximately 24 months. The duration of the research is 25 months (24 months for patient inclusion + 1 month for reception of results). The maximum participation duration of each patient is 1 month.

The number of patients required in this multicentric and prospective study is 240 (16 participating centers).

primary_purpose: Diagnostic

ReferenceCitation: Bonadonna G, Valagussa P, Moliterni A, Zambetti M, Brambilla C. Adjuvant cyclophosphamide, methotrexate, and fluorouracil in node-positive breast cancer: the results of 20 years of follow-up. N Engl J Med. 1995 Apr 6;332(14):901-6.

ReferenceCitation: Ivens D, Hoe AL, Podd TJ, Hamilton CR, Taylor I, Royle GT. Assessment of morbidity from complete axillary dissection. Br J Cancer. 1992 Jul;66(1):136-8.

ReferenceCitation: Ververs JM, Roumen RM, Vingerhoets AJ, Vreugdenhil G, Coebergh JW, Crommelin MA, Luiten EJ, Repelaer van Driel OJ, Schijven M, Wissing JC, Voogd AC. Risk, severity and predictors of physical and psychological morbidity after axillary lymph node dissection for breast cancer. Eur J Cancer. 2001 May;37(8):991-9.

ReferenceCitation: Kissin MW, Querci della Rovere G, Easton D, Westbury G. Risk of lymphoedema following the treatment of breast cancer. Br J Surg. 1986 Jul;73(7):580-4.

ReferenceCitation: Giuliano AE, Kirgan DM, Guenther JM, Morton DL. Lymphatic mapping and sentinel lymphadenectomy for breast cancer. Ann Surg. 1994 Sep;220(3):391-8; discussion 398-401.

ReferenceCitation: Krag DN, Weaver DL, Alex JC, Fairbank JT. Surgical resection and radiolocalization of the sentinel lymph node in breast cancer using a gamma probe. Surg Oncol. 1993 Dec;2(6):335-9; discussion 340.

ReferenceCitation: Glass EC, Essner R, Giuliano AE. Sentinel node localization in breast cancer. Semin Nucl Med. 1999 Jan;29(1):57-68. Review.

ReferenceCitation: Turner RR, Ollila DW, Krasne DL, Giuliano AE. Histopathologic validation of the sentinel lymph node hypothesis for breast carcinoma. Ann Surg. 1997 Sep;226(3):271-6; discussion 276-8.

ReferenceCitation: McMasters KM, Tuttle TM, Carlson DJ, Brown CM, Noyes RD, Glaser RL, Vennekotter DJ, Turk PS, Tate PS, Sardi A, Cerrito PB, Edwards MJ. Sentinel lymph node biopsy for breast cancer: a suitable alternative to routine axillary dissection in multi-institutional practice when optimal technique is used. J Clin Oncol. 2000 Jul;18(13):2560-6.

ReferenceCitation: Weaver DL, Krag DN, Ashikaga T, Harlow SP, O'Connell M. Pathologic analysis of sentinel and nonsentinel lymph nodes in breast carcinoma: a multicenter study. Cancer. 2000 Mar 1;88(5):1099-107.

ReferenceCitation: Tafra L, McMasters KM, Whitworth P, Edwards MJ. Credentialing issues with sentinel lymph node staging for breast cancer. Am J Surg. 2000 Oct;180(4):268-73.

ReferenceCitation: McMasters KM, Wong SL, Chao C, Woo C, Tuttle TM, Noyes RD, Carlson DJ, Laidley AL, McGlothin TQ, Ley PB, Brown CM, Glaser RL, Pennington RE, Turk PS, Simpson D, Edwards MJ; University of Louisville Breast Cancer Study Group. Defining the optimal surgeon experience for breast cancer sentinel lymph node biopsy: a model for implementation of new surgical techniques. Ann Surg. 2001 Sep;234(3):292-9; discussion 299-300.

ReferenceCitation: Orr RK, Hoehn JL, Col NF. The learning curve for sentinel node biopsy in breast cancer: practical considerations. Arch Surg. 1999 Jul;134(7):764-7. Review.

ReferenceCitation: Bedrosian I, Reynolds C, Mick R, Callans LS, Grant CS, Donohue JH, Farley DR, Heller R, Conant E, Orel SG, Lawton T, Fraker DL, Czerniecki BJ. Accuracy of sentinel lymph node biopsy in patients with large primary breast tumors. Cancer. 2000 Jun 1;88(11):2540-5.

ReferenceCitation: Chung MH, Ye W, Giuliano AE. Role for sentinel lymph node dissection in the management of large (> or = 5 cm) invasive breast cancer. Ann Surg Oncol. 2001 Oct;8(9):688-92.

ReferenceCitation: Lelievre L, Houvenaeghel G, Buttarelli M, Brenot-Rossi I, Huiart L, Tallet A, Tarpin C, Jacquemier J. Value of the sentinel lymph node procedure in patients with large size breast cancer. Ann Surg Oncol. 2007 Feb;14(2):621-6. Epub 2006 Nov 12.

ReferenceCitation: Schwartz GF, Giuliano AE, Veronesi U; Consensus Conference Committee. Proceedings of the consensus conference on the role of sentinel lymph node biopsy in carcinoma of the breast, April 19-22, 2001, Philadelphia, Pennsylvania. Cancer. 2002 May 15;94(10):2542-51. Review.

ReferenceCitation: Lyman GH, Giuliano AE, Somerfield MR, Benson AB 3rd, Bodurka DC, Burstein HJ, Cochran AJ, Cody HS 3rd, Edge SB, Galper S, Hayman JA, Kim TY, Perkins CL, Podoloff DA, Sivasubramaniam VH, Turner RR, Wahl R, Weaver DL, Wolff AC, Winer EP; American Society of Clinical Oncology. American Society of Clinical Oncology guideline recommendations for sentinel lymph node biopsy in early-stage breast cancer. J Clin Oncol. 2005 Oct 20;23(30):7703-20. Epub 2005 Sep 12.

ReferenceCitation: Edwards M, Giuliano A, Reintgen D, Tafra L. Consensus statement on guidelines for performance of sentinel lymph node biopsy for breast cancer. Am Soc Breast Surg Q. Press Release, 1998 ;Fall :3

lead_sponsor: Centre Leon Berard

location_facility:
Centre Paul Papin
Clinique des 2 Caps
CH Calais
Centre René Gauducheau
Centre Henri Becquerel
Centre Hospitalier Lyon Sud
Clinique Pasteur
CHRU Saint Etienne
Hôtel Dieu
Centre Eugène Marquis
Centre Val d'Aurelle
Centre René Huguenin
Institut Claudius Régaud
Institut Paoli Calmettes
CMCO
Clinique des Acacias
Institut Bergonié
Centre Léon Bérard
Centre Alexis Vautrin
Centre Oscar Lambret
CH Arrondissement Montreuil sur Mer
CH Boulogne sur Mer

intervention_type: Other


title: Randomized Multicenter Phase III Study in Patients With Locally Advanced Adenocarcinoma of the Pancreas: Gemcitabine With or Without Chemoradiotherapy and With or Without Erlotinib. Intergroup Study

summary:
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known which regimen of chemotherapy with or without erlotinib and/or radiation therapy is most effective in treating pancreatic cancer.

PURPOSE: This randomized phase III trial is studying giving gemcitabine together with or without capecitabine and/or radiation therapy to see how well it works compared with giving gemcitabine together with or without erlotinib in treating patients with locally advanced pancreatic cancer that cannot be removed by surgery.

ReferenceCitation: Hammel P, Huguet F, van Laethem JL, Goldstein D, Glimelius B, Artru P, Borbath I, Bouché O, Shannon J, André T, Mineur L, Chibaudel B, Bonnetain F, Louvet C; LAP07 Trial Group. Effect of Chemoradiotherapy vs Chemotherapy on Survival in Patients With Locally Advanced Pancreatic Cancer Controlled After 4 Months of Gemcitabine With or Without Erlotinib: The LAP07 Randomized Clinical Trial. JAMA. 2016 May 3;315(17):1844-53. doi: 10.1001/jama.2016.4324.

name: Department of Digestive Oncology, Beaujon Hospital (AP-HP), Clichy, France

family: Hammel

full_name: Pascal Hammel

name: Department of Radiotherapy, Tenon Hospital (AP-HP), Paris, France

family: Huguet

full_name: Florence Huguet

given: Florence

name: Department of Gastroenterology, Erasme University Hospital, Brussels, Belgium

family: van Laethem

full_name: Jean-Luc van Laethem

name: Department of Medical Oncology, Prince of Wales Hospital, Sydney, Australia5Australasian Gastrointestinal Trials Group (AGITG), Camperdown, Australia6Prince of Wales Clinical School, University of New South Wales, Sydney, Australia

family: Goldstein

full_name: David Goldstein

given: David

name: Department of Radiology, Oncology, and Radiation Science, University of Uppsala, Uppsala, Sweden

family: Glimelius

full_name: Bengt Glimelius

given: Bengt

name: Department of Gastroenterology, Jean Mermoz Hospital, Lyon, France

family: Artru

full_name: Pascal Artru

name: Department of Gastroenterology, Saint-Luc University Clinics, Brussels, Belgium

family: Borbath

full_name: Ivan Borbath

given: Ivan

name: Department of Gastroenterology, Robert Debré Hospital, Reims, France

family: Bouché

full_name: Olivier Bouché

given: Olivier

name: Australasian Gastrointestinal Trials Group (AGITG), Camperdown, Australia6Prince of Wales Clinical School, University of New South Wales, Sydney, Australia11Department of Medical Oncology, Nepean Hospital NSW, Sydney, Australia

family: Shannon

full_name: Jenny Shannon

given: Jenny

name: Department of Medical Oncology, Saint-Antoine Hospital (AP-HP), Paris, France

family: André

full_name: Thierry André

given: Thierry

name: Department of Radiotherapy and Medical Oncology, Sainte-Catherine Institute, Avignon, France

family: Mineur

full_name: Laurent Mineur

name: Department of Medical Oncology, Franco-British Hospital Institute, Levallois-Perret, France15Oncology Multidisciplinary Research Group (GERCOR), Paris, France

family: Chibaudel

full_name: Benoist Chibaudel

given: Benoist

name: Department of Methodology and Quality of Life in Oncology, Hospital Minjoz, Besançon, France

family: Bonnetain

full_name: Franck Bonnetain

given: Franck

name: Department of Medical Oncology, Institute Mutualiste Montsouris, Paris, France

family: Louvet

full_name: Christophe Louvet

journal_name: JAMA

oa_host_type: publisher

evidence: open (via free pdf)

publisher: American Medical Association (AMA)

publisher_dissemination: American Medical Association

publisher_group: American Medical Association

publisher_normalized: American Medical Association

lead_sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

location_facility: Centre Hospitalier General de Mont de Marsan

location_facility: C.H.U. de Nimes - Groupe Hospitals-Universitaire Caremeau

location_facility: Centre Hospitalier Regional Metz Thionville

location_facility: Centre de Lutte Contre le Cancer Georges-Francois Leclerc

location_facility: Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz

location_facility: Centre Hospitalier Universitaire de Bicetre

location_facility: Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes

location_facility: Centre Radiotherapie Oncologie Moyenne Garonne

location_facility: Centre Hospitalier Universitaire Henri Mondor


title: Evaluation of the Efficacy and Safety of Rosuvastatin 5 mg Versus Pravastatin 40 mg and Atorvastatin 10 mg in Subjects With Type IIa and IIb Hypercholesterolaemia

acronym: CAP-Chol

summary: The purpose of this study is to evaluate the efficacy and safety of Rosuvastatin 5 mg as an hypercholesterolemia treatment comparatively at 2 other statins: Pravastatin 40 mg and Atorvastatin 10 mg. Treatment efficacy will be evaluated by the percentage of LDL-C variation after 8 weeks of treatment.


title: Multicenter Assessment of the PDA-FIT System in Type 1 Diabetic Patients With Chronic Failure of Intensive Insulin Therapy and Conventional Care. The TELEDIAB-1 STUDY

summary:
TELEDIAB-1 is a national, multicenter, controlled, randomised trial. The Primary objective of the TELEDIAB-1 study is to demonstrate that the PDA-FIT system (PDA-Phone and/or telemonitoring) is able to improve metabolic control of chronically uncontrolled type 1 diabetic patients, despite intensive insulin therapy (multiple daily injections with basal-bolus insulin or insulin pump), as compared with conventional care.

Main judgment criteria: comparison of HbA1c means between the 3 groups at 6 months

primary_purpose: Prevention

ReferenceCitation: Charpentier G, Benhamou PY, Dardari D, Clergeot A, Franc S, Schaepelynck-Belicar P, Catargi B, Melki V, Chaillous L, Farret A, Bosson JL, Penfornis A; TeleDiab Study Group. The Diabeo software enabling individualized insulin dose adjustments combined with telemedicine support improves HbA1c in poorly controlled type 1 diabetic patients: a 6-month, randomized, open-label, parallel-group, multicenter trial (TeleDiab 1 Study). Diabetes Care. 2011 Mar;34(3):533-9. doi: 10.2337/dc10-1259. Epub 2011 Jan 25.

family: Charpentier

full_name: G. Charpentier

given: G.

family: Benhamou

full_name: P.-Y. Benhamou

family: Dardari

full_name: D. Dardari

given: D.

family: Clergeot

full_name: A. Clergeot

given: A.

family: Franc

full_name: S. Franc

given: S.

family: Schaepelynck-Belicar

full_name: P. Schaepelynck-Belicar

given: P.

family: Catargi

full_name: B. Catargi

given: B.

family: Melki

full_name: V. Melki

given: V.

family: Chaillous

full_name: L. Chaillous

given: L.

family: Farret

full_name: A. Farret

family: Bosson

full_name: J.-L. Bosson

family: Penfornis

full_name: A. Penfornis

journal_name: Diabetes Care

oa_colors: green other

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

publisher: American Diabetes Association

publisher_dissemination: American Diabetes Association

publisher_group: American Diabetes Association

publisher_normalized: American Diabetes Association

title: The Diabeo Software Enabling Individualized Insulin Dose Adjustments Combined With Telemedicine Support Improves HbA1c in Poorly Controlled Type 1 Diabetic Patients: A 6-month, randomized, open-label, parallel-group, multicenter trial (TeleDiab 1 Study)

lead_sponsor: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

location_facility: Centre Hospitalier de Belfort Montbéliard


title: Chemotherapy With FOLFIRI Plus Bevacizumab (AvastinR) in Patients With Metastatic Colorectal Cancer Bearing Genotype UGT1A1*1/UGT1A1*1 or UGT1A1*1/UGT1A1*1/UGT1A1*28: Prospective, Phase II, Multicenter Study

summary:
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving combination chemotherapy together with bevacizumab may kill more tumor cells.

PURPOSE: This phase II trial is studying the side effects of giving combination chemotherapy together with bevacizumab and to see how well it works in treating patients with metastatic colorectal cancer.

ReferenceCitation: Manfredi S, Bouché O, Rougier P, Dahan L, Loriot MA, Aparicio T, Etienne PL, Lafargue JP, Lécaille C, Legoux JL, Le Malicot K, Maillard E, Lecomte T, Khemissa F, Breysacher G, Michel P, Mitry E, Bedenne L. High-Dose FOLFIRI plus Bevacizumab in the Treatment of Metastatic Colorectal Cancer Patients with Two Different UGT1A1 Genotypes: FFCD 0504 Study. Mol Cancer Ther. 2015 Dec;14(12):2782-8. doi: 10.1158/1535-7163.MCT-15-0293. Epub 2015 Oct 22.

family: Manfredi

full_name: Sylvain Manfredi

given: Sylvain

family: Bouché

full_name: Olivier Bouché

family: Rougier

full_name: Philippe Rougier

given: Philippe

family: Dahan

full_name: Laetitia Dahan

given: Laetitia

family: Loriot

full_name: Marie Anne Loriot

given: Marie Anne

family: Aparicio

full_name: Thomas Aparicio

given: Thomas

family: Etienne

full_name: Pierre Luc Etienne

given: Pierre Luc

family: Lafargue

full_name: Jean Pierre Lafargue

given: Jean Pierre

family: Lécaille

full_name: Cedric Lécaille

given: Cedric

family: Legoux

full_name: Jean Louis Legoux

given: Jean Louis

family: Le Malicot

full_name: Karine Le Malicot

given: Karine

family: Maillard

full_name: Emilie Maillard

given: Emilie

family: Lecomte

full_name: Thierry Lecomte

family: Khemissa

full_name: Faiza Khemissa

given: Faiza

family: Breysacher

full_name: Gilles Breysacher

given: Gilles

family: Michel

full_name: Pierre Michel

given: Pierre

family: Mitry

full_name: Emmanuel Mitry

given: Emmanuel

family: Bedenne

full_name: Laurent Bedenne

given: Laurent

journal_name: Molecular Cancer Therapeutics

publisher: American Association for Cancer Research (AACR)

lead_sponsor: Federation Francophone de Cancerologie Digestive

location_facility: Centre Hospitalier General Lucien Hussel

location_facility: Centre Hospitalier de Chalons-en-Champagne

location_facility: Centre Hospitalier Universitaire d'Amiens


title: Open Label, Randomized, Multicenter Phase II Study of a Combination of Torisel® (Temsirolimus) and Avastin® (Bevacizumab) Versus Sutent® (Sunitinib) and Versus a Combination of Avastin® (Bevacizumab) and Roféron® (Interferon Alpha-2a) in First-line Treatment of Patients With Metastatic Renal Cell Carcinoma.

acronym: TORAVA

summary:
The TORAVA trial is designed to evaluate the progression-free rate at 48 weeks of a combination of Torisel® and Avastin® given at first-line treatment in patients with metastatic renal cancer.

Eligible patients will be randomly assigned, in a 2:1:1 ratio, to either Avastin® + Torisel®, or Sutent® or IFN+Avastin®.

ReferenceCitation: Escudier B, Eisen T, Stadler WM, Szczylik C, Oudard S, Siebels M, Negrier S, Chevreau C, Solska E, Desai AA, Rolland F, Demkow T, Hutson TE, Gore M, Freeman S, Schwartz B, Shan M, Simantov R, Bukowski RM; TARGET Study Group. Sorafenib in advanced clear-cell renal-cell carcinoma. N Engl J Med. 2007 Jan 11;356(2):125-34. Erratum in: N Engl J Med. 2007 Jul 12;357(2):203.

ReferenceCitation: Motzer RJ, Hutson TE, Tomczak P, Michaelson MD, Bukowski RM, Rixe O, Oudard S, Negrier S, Szczylik C, Kim ST, Chen I, Bycott PW, Baum CM, Figlin RA. Sunitinib versus interferon alfa in metastatic renal-cell carcinoma. N Engl J Med. 2007 Jan 11;356(2):115-24.

ReferenceCitation: Hudes G, Carducci M, Tomczak P, Dutcher J, Figlin R, Kapoor A, Staroslawska E, Sosman J, McDermott D, Bodrogi I, Kovacevic Z, Lesovoy V, Schmidt-Wolf IG, Barbarash O, Gokmen E, O'Toole T, Lustgarten S, Moore L, Motzer RJ; Global ARCC Trial. Temsirolimus, interferon alfa, or both for advanced renal-cell carcinoma. N Engl J Med. 2007 May 31;356(22):2271-81.

ReferenceCitation: Négrier S, Gravis G, Pérol D, Chevreau C, Delva R, Bay JO, Blanc E, Ferlay C, Geoffrois L, Rolland F, Legouffe E, Sevin E, Laguerre B, Escudier B. Temsirolimus and bevacizumab, or sunitinib, or interferon alfa and bevacizumab for patients with advanced renal cell carcinoma (TORAVA): a randomised phase 2 trial. Lancet Oncol. 2011 Jul;12(7):673-80. doi: 10.1016/S1470-2045(11)70124-3. Epub 2011 Jun 12.

family: Négrier

full_name: Sylvie Négrier

given: Sylvie

family: Gravis

full_name: Gwenaëlle Gravis

given: Gwenaëlle

family: Pérol

full_name: David Pérol

given: David

family: Chevreau

full_name: Christine Chevreau

given: Christine

family: Delva

full_name: Rémy Delva

given: Rémy

family: Bay

full_name: Jacques-Olivier Bay

given: Jacques-Olivier

family: Blanc

full_name: Ellen Blanc

given: Ellen

family: Ferlay

full_name: Céline Ferlay

given: Céline

family: Geoffrois

full_name: Lionnel Geoffrois

given: Lionnel

family: Rolland

full_name: Frédéric Rolland

given: Frédéric

family: Legouffe

full_name: Eric Legouffe

given: Eric

family: Sevin

full_name: Emmanuel Sevin

family: Laguerre

full_name: Brigitte Laguerre

given: Brigitte

family: Escudier

full_name: Bernard Escudier

given: Bernard

ReferenceCitation: Polena H, Creuzet J, Dufies M, Sidibé A, Khalil-Mgharbel A, Salomon A, Deroux A, Quesada JL, Roelants C, Filhol O, Cochet C, Blanc E, Ferlay-Segura C, Borchiellini D, Ferrero JM, Escudier B, Négrier S, Pages G, Vilgrain I. The tyrosine-kinase inhibitor sunitinib targets vascular endothelial (VE)-cadherin: a marker of response to antitumoural treatment in metastatic renal cell carcinoma. Br J Cancer. 2018 May;118(9):1179-1188. doi: 10.1038/s41416-018-0054-5. Epub 2018 Mar 22.

family: Polena

full_name: Helena Polena

given: Helena

family: Creuzet

full_name: Julie Creuzet

given: Julie

family: Dufies

full_name: Maeva Dufies

given: Maeva

family: Sidibé

full_name: Adama Sidibé

given: Adama

family: Khalil-Mgharbel

full_name: Abir Khalil-Mgharbel

given: Abir

family: Salomon

full_name: Aude Salomon

given: Aude

location_facility: Centre Hospitalier Universiariare Lyon, Hôpital Lyon Sud

location_facility: Clinique Valdegour-Centre médical Oncogard

location_facility: Centre Hospitalier Universitaire DUPUTRYEN

location_facility: Centre Hospitalier Universitaire de Bordeaux - Hôpital St André

location_facility: Centre Hospilier Universitaire de Poitiers

location_facility: Centre Hospitalier Universitaire de Lille - Hôpital Claude Huriez

location_facility: Centre Hospitalier Universitaire de Besançon


title: Pharmaco-epidemiological Description of the Patient Population Treated With Aptivus Under Market Conditions, Safety & Efficacy

summary: To obtain information on clinical practices for patients treated by Aptivus in real life

lead_sponsor: Boehringer Ingelheim

location_facility: 1182.127.3301 Boehringer Ingelheim Investigational Site


title: A Randomised, Multicentre, Single-Blind, Phase IV Study, of the Efficacy, Safety, and Acceptability of Moviprep® Versus Colopeg® in Colonoscopy Preparation.

acronym: NORMO

summary:
Primary:

- To demonstrate the superiority of Moviprep® versus Colopeg® in gut cleansing prior to colonoscopy.

Secondary:

To assess the safety of Moviprep® versus Colopeg®.
To assess acceptability of Moviprep® versus Colopeg®.

ReferenceCitation: Bitoun A, Ponchon T, Barthet M, Coffin B, Dugué C, Halphen M; Norcol Group. Results of a prospective randomised multicentre controlled trial comparing a new 2-L ascorbic acid plus polyethylene glycol and electrolyte solution vs. sodium phosphate solution in patients undergoing elective colonoscopy. Aliment Pharmacol Ther. 2006 Dec;24(11-12):1631-42. Epub 2006 Nov 10.

lead_sponsor: Norgine

location_facility: Service d'Hépato-Gastroentérologie, CHRU NANCY, HOPITAL DE BRABOIS

location_facility: Service de Gastroentérologie du Pr. MARTEAU, HÔPITAL LARIBOISIERE

location_facility: Centre Des Maladies Du Foie Et de L'Appareil Digestif

location_facility: Service de Gastro-Entérologie, HOPITAL TROUSSEAU CHRU de Tours

location_facility: Service de Gastroentérologie, HOPITAL DE L'ARCHET

location_facility: Service de Gastro-Entérologie, HÔPITAL GEORGES POMPIDOU

location_facility: Service de Gastroentérologie du Dr. Chousterman, HOPITAL INTERCOMMUNAL

location_facility: Service de Gastroentérologie,CENTRE HOSPITALIER d'AVIGNON

location_facility: Service des Maladies de l'Appareil Digestif, Centre Hospitalier Régional et Universitaire

location_facility: Service de Gastroentérologie du Pr. LEREBOURS, HOPITAL CHARLES NICOLLE


lead_sponsor: Ipsen

acronym: DECAPUB

location_facility:
Hôpital Archet 2
Hôpital St-Vincent de Paul
Hôpital Necker - Enfants Malades
Hôpital Hotel-Dieu (CHU)
Hôpital des Enfants
American Memorial Hospital
Hôpital de la Timone Enfants
Hôpital Trousseau
Hôpital Charles Nicolle
Hôpital Hautepierre
Hôpital de la Gespe
Hôpital Flaubert
Hôpital Robert Debré
Hôpital Saint-Jacques
Hôpital du Bocage
Hôpital Jeanne de Flandre
Medical Centre
Hôpital Debrousse

title: Phase III, Multicentre, Non-comparative, Open and Single Stage Study to Assess the Efficacy and Safety of Pamoate of Triptorelin 11.25 MG in Children With Precocious Puberty

summary: The purpose of the study is to assess the efficacy of triptorelin 11.25 mg pamoate in the delay of premature onset of puberty in girls less than 9 years and boys less than 10 years. This is measured by assessing the proportion of children who have a suppressed Luteinizing Hormone (LH) response to Gonadotropin Releasing Hormone (GnRH) test performed 3 months after injection with triptorelin 11.25 mg.


title: An Open Label Study to Evaluate the Safety of NeoRecormon in the Treatment of Anemia in Patients With Chronic Hepatitis C Who Are Treated With Pegylated Interferon + Ribavirin Combination Therapy

summary: This single arm study will assess the safety of NeoRecormon in the correction of anemia in patients with chronic hepatitis C who are being treated with Pegylated interferon + ribavirin combination therapy. Patients will receive NeoRecormon at a starting dose of 30,000 IU s.c. which will be adjusted as required to maintain a target Hb of 11-13g/dL. The anticipated time on study treatment is 1 year, and the target sample size is 100-500 individuals.


title: A Double-blind, Double-dummy, Randomized, Parallel Groups Study to Assess the Efficacy, Safety and Tolerability of Switching Patients With Early Parkinson's Disease (PD) From Pramipexole IR to Pramipexole ER or Pramipexole IR

summary:
The objectives of this trial conducted in early Parkinson's disease (PD) patients are:

To assess if patients with early Parkinson's disease (PD) can be successfully switched (overnight switching) from Pramipexole (PPX) Immediate Release (IR) to Pramipexole Extended Release (ER). A successful switch at a specific visit is defined as no worsening of the Unified Parkinsons Disease Rating Scale (UPDRS) parts II+III score by more than 15% from baseline and no drug-related adverse events leading to withdrawal;
To establish if this successful switch can be obtained with or without dose-adaptation;
To provide information about the conversion ratio (mg:mg) from Pramipexole IR to Pramipexole ER.

location_country: Germany France Netherlands

location_facility: 248.636.3313A Boehringer Ingelheim Investigational Site

location_facility: 248.636.3303B Boehringer Ingelheim Investigational Site

location_facility: 248.636.3308E Boehringer Ingelheim Investigational Site

location_facility: 248.636.31004 Boehringer Ingelheim Investigational Site

location_facility: 248.636.3305A Boehringer Ingelheim Investigational Site

location_facility: 248.636.49003 Boehringer Ingelheim Investigational Site

location_facility: 248.636.49001 Boehringer Ingelheim Investigational Site

location_facility: 248.636.3305B Boehringer Ingelheim Investigational Site

location_facility: 248.636.3304A Boehringer Ingelheim Investigational Site

location_facility: 248.636.3307C Boehringer Ingelheim Investigational Site

location_facility: 248.636.49007 Boehringer Ingelheim Investigational Site

location_facility: 248.636.3306B Boehringer Ingelheim Investigational Site

location_facility: 248.636.31002 Boehringer Ingelheim Investigational Site

location_facility: 248.636.3301A Boehringer Ingelheim Investigational Site

location_facility: 248.636.49002 Boehringer Ingelheim Investigational Site

location_facility: 248.636.3303C Boehringer Ingelheim Investigational Site

location_facility: 248.636.3312A Boehringer Ingelheim Investigational Site

location_facility: 248.636.49006 Boehringer Ingelheim Investigational Site

location_facility: 248.636.49005 Boehringer Ingelheim Investigational Site

location_facility: 248.636.3301D Boehringer Ingelheim Investigational Site

location_facility: 248.636.3302B Boehringer Ingelheim Investigational Site

location_facility: 248.636.31006 Boehringer Ingelheim Investigational Site

location_facility: 248.636.3308C Boehringer Ingelheim Investigational Site

location_facility: 248.636.3309B Boehringer Ingelheim Investigational Site

location_facility: 248.636.49004 Boehringer Ingelheim Investigational Site

location_facility: 248.636.31005 Boehringer Ingelheim Investigational Site

location_facility: 248.636.3303A Boehringer Ingelheim Investigational Site

location_facility: 248.636.3302A Boehringer Ingelheim Investigational Site

location_facility: 248.636.3308B Boehringer Ingelheim Investigational Site

location_facility: 248.636.3312B Boehringer Ingelheim Investigational Site

location_facility: 248.636.31003 Boehringer Ingelheim Investigational Site

location_facility: 248.636.31001 Boehringer Ingelheim Investigational Site

location_facility: 248.636.3301B Boehringer Ingelheim Investigational Site

location_facility: 248.636.49008 Boehringer Ingelheim Investigational Site

location_facility: 248.636.3311A Boehringer Ingelheim Investigational Site

location_facility: 248.636.3308D Boehringer Ingelheim Investigational Site


acronym: PROPICE

location_facility:
CHAMBON Françoise
LANGERON Olivier
SCHOEFFLER Pierre
BELLOUCIF Sadek
RABUEL Christophe
CAPDEVILLA Xavier
BONNEMAISON Julie
DUVERGER Daniel
COUVRET Claude
BARRE Jeanne
THERY Philippe
CHEVALEREAUD Erick
FUZIER Régis
RIPART Jacques
SZTARCK François
TISSIER Dominique
PEGOIX Michel
AUSSET Sylvain
CHARRET Françoise
MARTIN
LEMANISSIER Denis
MAZUIRE Elisabeth
LIGNOT Sophie
BEGOU Gérard
GAERTNER Elisabeth
LETOURNEAU Bernard
BAYLOT Denis
PERON Alain
GARANGER Thierry

title: Prospective, Multicentre, Open-label Study Evaluating 1.5 mg/Day of Fondaparinux,in Venous Thromboembolic Events Prevention in Patients With Renal Impairment and Undergoing a Major Orthopaedic Surgery. PROPICE Study

summary:
Fondaparinux is an antithrombotic agent having already received a regulatory approval by the European Authorities in venous thromboembolic event prevention after major orthopaedic surgery, as total hip replacement (THR), total knee replacement (TKR), hip fracture (HF). The bleeding risk associated with this prescription is highly related to renal function evaluated by creatinin clearance (CrCl). In order to reduce the bleeding risk, it has been proposed to prescribe fondaparinux 1.5 mg/day in patients with a CrCl between 20 and 50ml/mn instead of 2.5mg/day (European MMA). In the meantime, this approval is essentially based on simulated pharmakinetic data without any support of clinical data.

prospective, multicentre, open-label study evaluating the safety profile of fondaparinux 1.5 mg/day, subcutaneously administered, in patients with a renal impairment defined by a CrCl between 20 and 30 ml/min and undergoing a major orthopaedic surgery.


title: Effect of Early Prescription of Immunosuppressants on First Three-year Course of Crohn's Disease

acronym: RAPID

summary: Pluricentric randomized study comparing two therapeutic strategies at beginning of Crohn's disease: early immunosuppressants (prescription within the six first months following diagnosis) vs. conventional strategy (immunosuppressants given only in case of steroid failure, in a selected group of patients being at high risk of disabling course. The hypothesis is that immunosuppressants given early may improve the disease course during the 3 following years in this subset of patients.

ReferenceCitation: Beaugerie L, Seksik P, Nion-Larmurier I, Gendre JP, Cosnes J. Predictors of Crohn's disease. Gastroenterology. 2006 Mar;130(3):650-6.

ReferenceCitation: Cosnes J, Nion-Larmurier I, Beaugerie L, Afchain P, Tiret E, Gendre JP. Impact of the increasing use of immunosuppressants in Crohn's disease on the need for intestinal surgery. Gut. 2005 Feb;54(2):237-41. Erratum in: Gut. 2005 May;54(5):734.

ReferenceCitation: Cosnes J, Bourrier A, Laharie D, Nahon S, Bouhnik Y, Carbonnel F, Allez M, Dupas JL, Reimund JM, Savoye G, Jouet P, Moreau J, Mary JY, Colombel JF; Groupe d'Etude Thérapeutique des Affections Inflammatoires du Tube Digestif (GETAID). Early administration of azathioprine vs conventional management of Crohn's Disease: a randomized controlled trial. Gastroenterology. 2013 Oct;145(4):758-65.e2; quiz e14-5. doi: 10.1053/j.gastro.2013.04.048. Epub 2013 Apr 30.

family: Cosnes

full_name: Jacques Cosnes

given: Jacques

family: Bourrier

full_name: Anne Bourrier

given: Anne

family: Laharie

full_name: David Laharie

given: David

family: Nahon

full_name: Stéphane Nahon

given: Stéphane

family: Bouhnik

full_name: Yoram Bouhnik

given: Yoram

family: Carbonnel

full_name: Franck Carbonnel

given: Franck

family: Allez

full_name: Matthieu Allez

given: Matthieu

family: Dupas

full_name: Jean–Louis Dupas

given: Jean–Louis

family: Reimund

full_name: Jean–Marie Reimund

given: Jean–Marie

family: Savoye

full_name: Guillaume Savoye

given: Guillaume

family: Jouet

full_name: Pauline Jouet

given: Pauline

family: Moreau

full_name: Jacques Moreau

family: Mary

full_name: Jean–Yves Mary

given: Jean–Yves

family: Colombel

full_name: Jean–Frédéric Colombel

given: Jean–Frédéric

journal_name: Gastroenterology

title: Early Administration of Azathioprine vs Conventional Management of Crohn's Disease: A Randomized Controlled Trial

lead_sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

location_facility:
Hopital Haut Leveque
Chu Strasbourg
Hopital Beaujon
Ch Le Raincy Montfermeil
Chru Lille
Chu Clermont-Ferrand
Hopital Saint Louis
Hopital St Antoine
Chu Nantes
CHU NICE
CHU LYON
Hopital Bichat
Chu Besancon
Hopital Louis Mourrier
Chu Reims
Hopital Lariboisiere
Chu Rouen
Chu Tours
Institut Mutualiste Montsouris (Imm)
Chu Marseille - Hopital Nord
Hopital Georges Pompidou
CHU CAEN
Hopital Cochin
Chu Amiens
Chu Toulouse
Hopital Bicetre


title: A Randomized, Open-label Study to Investigate the Impact of Bone Marker Feedback on Persistence to Once Monthly Oral Bonviva (Ibandronate) Treatment for Post-menopausal Osteoporosis.

summary: This 2 arm study will assess the impact of bone marker feedback, using blood sampling and communication of results at week 5, on persistence to monthly Bonviva (150mg po) in women with post-menopausal osteoporosis. The study will also assess safety, quality of life and patient satisfaction. All patients will receive Bonviva 150mg po monthly, and will be randomized into the bio-feedback or no bio-feedback study arms. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.

ReferenceCitation: Roux C, Giraudeau B, Rouanet S, Dubourg G, Perrodeau E, Ravaud P. Monitoring of bone turnover markers does not improve persistence with ibandronate treatment. Joint Bone Spine. 2012 Jul;79(4):389-92. doi: 10.1016/j.jbspin.2011.05.001. Epub 2011 Jun 23.

family: Roux

full_name: Christian Roux

given: Christian

family: Giraudeau

full_name: Bruno Giraudeau

given: Bruno

family: Rouanet

full_name: Stéphanie Rouanet

given: Stéphanie

family: Dubourg

full_name: Geneviève Dubourg

given: Geneviève

family: Perrodeau

full_name: Elodie Perrodeau

given: Elodie

family: Ravaud

full_name: Philippe Ravaud

given: Philippe

journal_name: Joint Bone Spine


title: Phase II of Sunitinib (SUTENT®) in First Line for Patients With Locally Advanced or Metastatic Papillary Renal Cell Carcinoma - SUPAP

summary:
RATIONALE: Sunitinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying how well sunitinib works as first-line therapy in treating patients with locally advanced or metastatic papillary renal cell (kidney) cancer.

study_start_date_type: Actual

ReferenceCitation: Cabarrou B, Boher JM, Bogart E, Tresch-Bruneel E, Penel N, Ravaud A, Escudier B, Mahier Ait-Oukhatar C, Delord JP, Roché H, Filleron T. How to report toxicity associated with targeted therapies? Ann Oncol. 2016 Aug;27(8):1633-8. doi: 10.1093/annonc/mdw218. Epub 2016 May 23.

family: Cabarrou

full_name: B. Cabarrou

given: B.

family: Boher

full_name: J.M. Boher

family: Bogart

full_name: E. Bogart

given: E.

family: Tresch-Bruneel

full_name: E. Tresch-Bruneel

family: Penel

full_name: N. Penel

given: N.

full_name: A. Ravaud

given: A.

family: Escudier

full_name: B. Escudier

family: Mahier Ait-Oukhatar

full_name: C. Mahier Ait-Oukhatar

given: C.

family: Delord

full_name: J.P. Delord

family: Roché

full_name: H. Roché

given: H.

family: Filleron

full_name: T. Filleron

given: T.

journal_name: Annals of Oncology

evidence: open (via crossref license)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

ReferenceCitation: Ravaud A, Oudard S, De Fromont M, Chevreau C, Gravis G, Zanetta S, Theodore C, Jimenez M, Sevin E, Laguerre B, Rolland F, Ouali M, Culine S, Escudier B. First-line treatment with sunitinib for type 1 and type 2 locally advanced or metastatic papillary renal cell carcinoma: a phase II study (SUPAP) by the French Genitourinary Group (GETUG)†. Ann Oncol. 2015 Jun;26(6):1123-1128. doi: 10.1093/annonc/mdv149. Epub 2015 Mar 23.

family: Oudard

full_name: S. Oudard

given: S.

family: De Fromont

full_name: M. De Fromont

given: M.

family: Chevreau

full_name: C. Chevreau

family: Gravis

full_name: G. Gravis

given: G.

family: Zanetta

full_name: S. Zanetta

family: Theodore

full_name: C. Theodore

family: Jimenez

full_name: M. Jimenez

family: Sevin

full_name: E. Sevin

location_facility: Centre Hospitalier Universitaire Bretonneau de Tours

location_facility: Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

location_facility: Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz

location_facility: Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes


status: Terminated

location_facility: Hôpital Nord - Oncologie Multidisciplinaire & Innovations Thérapeutiques

location_facility: APHP - CHU Avicenne - Oncologie Medicale

location_facility: Chambray Les Tours - Clinique Léonard de Vinci

location_facility: Hôpitaux du Léman - Pneumologie et Maladies Infectieuruses

title: Comparison of 2 Chemotherapy Regimens in Non-small-cell Lung Cancer (NSCLC) Patients Relapsing After Surgery and Peri-operative Chemotherapy. A Randomized Phase III Study.

summary: Relapses after perioperative chemotherapy and surgery

status_simplified: Unknown


title: Study of Positron Emission Tomography With 3'-Deoxy-3'-[18F] Fluoro-thymidine ([18F]-FLT) for the Evaluation of Response to Neoadjuvant Chemotherapy for Cancers of the Breast

summary:
RATIONALE: Diagnostic procedures, such as positron emission tomography (PET) using 3'-deoxy-3'-(18F) fluorothymidine, may be effective in assessing the response to chemotherapy before surgery in treating locally advanced breast cancer.

PURPOSE: This clinical trial is studying how well positron emission tomography using 3'-deoxy-3'-(18F) fluorothymidine works in treating women with locally advanced cancer in one breast who are receiving chemotherapy.

lead_sponsor: UNICANCER

location_facility: Centre Hospitalier Regional et Universitaire d'Angers

location_facility: Centre de Lutte Contre le Cancer Georges-Francois Leclerc


title: A Randomized, Open Label Study to Evaluate the Effect of Doxycycline on Tarceva-induced Skin Rash in Patients With Non-small Cell Lung Cancer After Failure of First Line Chemotherapy

summary: This 2 arm study will evaluate the management of Tarceva-induced skin rash in patients with non-small cell lung cancer who have failed first-line chemotherapy for advanced disease. Eligible patients will be randomized to receive a)doxycycline 100mg po daily or b)no preventative treatment; all patients will receive Tarceva 150mg/kg po daily. The anticipated time on study treatment is until disease progression or intolerable toxicity, and the target sample size is 100-500 individuals.


title: A Randomized, Double-blind Study of the Efficacy of Intravenous Bonviva in the Relief of Pain After Recent Vertebral Osteoporotic Fracture in Osteoporotic Patients.

summary: This 2 arm study will assess the efficacy and safety of intravenous Bonviva in patients with osteoporosis experiencing pain after recent vertebral osteoporotic fracture. Patients will be randomized to receive either Bonviva (3mg i.v. bolus injection) or placebo. The anticipated time on study treatment is <3 months, and the target sample size is 100-500 individuals.


type: Other Grant/Funding Number

title: Specific Care and Assistance Plan for Alzheimer's Disease: Impact Study on Disease Progression and Management Modalities

acronym: PLASA

summary:
The main objective of this work is to assess the feasibility and efficacy of a specific Care and Assistance Plan for Alzheimer's disease (PLASA). The main outcome measure selected is incapacity in carrying out the basic activities of daily living, evaluated by the ADCS-ADL scale .

The PLASA was developed by a working group appointed by the Direction Générale de la Santé as part of the government programme of action on Alzheimer's disease (October 2001, Ministère de l'Emploi et de la Solidarité).

primary_purpose: Supportive Care

ReferenceCitation: Callahan CM, Boustani MA, Unverzagt FW, Austrom MG, Damush TM, Perkins AJ, Fultz BA, Hui SL, Counsell SR, Hendrie HC. Effectiveness of collaborative care for older adults with Alzheimer disease in primary care: a randomized controlled trial. JAMA. 2006 May 10;295(18):2148-57.

ReferenceCitation: Teri L, Gibbons LE, McCurry SM, Logsdon RG, Buchner DM, Barlow WE, Kukull WA, LaCroix AZ, McCormick W, Larson EB. Exercise plus behavioral management in patients with Alzheimer disease: a randomized controlled trial. JAMA. 2003 Oct 15;290(15):2015-22.

ReferenceCitation: Teri L, Logsdon RG, McCurry SM. Nonpharmacologic treatment of behavioral disturbance in dementia. Med Clin North Am. 2002 May;86(3):641-56, viii. Review.

ReferenceCitation: Vickrey BG, Mittman BS, Connor KI, Pearson ML, Della Penna RD, Ganiats TG, Demonte RW Jr, Chodosh J, Cui X, Vassar S, Duan N, Lee M. The effect of a disease management intervention on quality and outcomes of dementia care: a randomized, controlled trial. Ann Intern Med. 2006 Nov 21;145(10):713-26.

ReferenceCitation: Nourhashemi F, Andrieu S, Gillette-Guyonnet S, Giraudeau B, Cantet C, Coley N, Vellas B; PLASA Group. Effectiveness of a specific care plan in patients with Alzheimer's disease: cluster randomised trial (PLASA study). BMJ. 2010 Jun 3;340:c2466. doi: 10.1136/bmj.c2466.

family: Nourhashemi

full_name: F. Nourhashemi

given: F.

family: Andrieu

full_name: S. Andrieu

family: Gillette-Guyonnet

full_name: S. Gillette-Guyonnet

family: Giraudeau

full_name: B. Giraudeau

family: Cantet

full_name: C. Cantet

family: Coley

full_name: N. Coley

family: Vellas

full_name: B. Vellas

journal_name: BMJ

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

ReferenceCitation: Nourhashemi F, Gillette-Guyonnet S, Andrieu S, Rolland Y, Ousset PJ, Vellas B; PLASA group. A randomized trial of the impact of a specific care plan in 1120 Alzheimer's patients (PLASA Study) over a two-year period: design and baseline data. J Nutr Health Aging. 2008 Apr;12(4):263-71.

lead_sponsor: University Hospital, Toulouse

location_facility: University Hospital, Hôpital Xavier Arnozan

location_facility: Hospital Center Notre Dame du Bon Secours

location_facility: University Hospital BROCA - La Rochefoucauld

intervention_type: Procedure


ReferenceCitation: Guidet B, Martinet O, Boulain T, Philippart F, Poussel JF, Maizel J, Forceville X, Feissel M, Hasselmann M, Heininger A, Van Aken H. Assessment of hemodynamic efficacy and safety of 6% hydroxyethylstarch 130/0.4 vs. 0.9% NaCl fluid replacement in patients with severe sepsis: the CRYSTMAS study. Crit Care. 2012 May 24;16(3):R94. doi: 10.1186/cc11358.

family: Guidet

full_name: Bertrand Guidet

given: Bertrand

family: Martinet

full_name: Olivier Martinet

given: Olivier

family: Boulain

full_name: Thierry Boulain

given: Thierry

family: Philippart

full_name: Francois Philippart

given: Francois

family: Poussel

full_name: Jean Poussel

given: Jean

family: Maizel

full_name: Julien Maizel

given: Julien

family: Forceville

full_name: Xavier Forceville

given: Xavier

family: Feissel

full_name: Marc Feissel

given: Marc

family: Hasselmann

full_name: Michel Hasselmann

given: Michel

family: Heininger

full_name: Alexandra Heininger

given: Alexandra

family: Van Aken

full_name: Hugo Van Aken

given: Hugo

currency_apc_doaj: GBP

journal_name: Critical Care

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Artxiker

repository_normalized: HAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Paris Observatory

repositories:
HAL
PubMed Central

publisher_dissemination: Springer

publisher_group: Springer

title: Assessment of hemodynamic efficacy and safety of 6% hydroxyethylstarch 130/0.4 vs. 0.9% NaCl fluid replacement in patients with severe sepsis: The CRYSTMAS study

lead_sponsor: Fresenius Kabi

location_country: Germany France

acronym: CRYSTMAS

location_facility: Hôpital Avicenne, Service de Réanimation

location_facility: Centre Hospitalier d'Avignon, Service de Réanimation Polyvalente

location_facility: Hôpital Civil de Strasbourg, Service de Réanimation Médicale

location_facility: Hôpital St Louis, Département Anesthésie et Réanimation Chirurgicale

location_facility: CHU de Bicêtre, Dpt d'Anesthésie Réanimation Chir.

location_facility: CHU de Dijon - Hôpital du Bocage Service de Réanimation Médicale

location_facility: Centre Hospitalier de Belfort-Montbéliard, Service de Réanimation et Maladies Infectieuses, Site de Belfort

location_facility: CHI Poissy - St Germain en Laye, Site de St Germain en Laye

location_facility: CHU Nîmes, Service de Réanimation, Division Anesthésie-Réa Douleur Urgence, Groupe Hospitalo-Universitaire Caremeau,

location_facility: Centre Hospitalier Fleyriat, Service de Réanimation Polyvalente

location_facility: CH Sud Francilien, Site Gilles de Corbeil, Réanimation Polyvalente

location_facility: Universitätsklinikum Tübingen, Klinik für Anästhesiologie und Intensivmedizin

location_facility: Hôpital Saint-Joseph, Service de Réanimation Polyvalente

location_facility: Hôpital Lapeyronie / CHU Montpellier, Département d'Anesthésie Réanimation

location_facility: Hôpital Central, Service Anesthésie-Réanimation, Chirurgicale CHU

location_facility: Hôpital Sud, Unité de Réanimation Médicale

location_facility: Hôpital de la Source, Réanimation Polyvalente

location_facility: Klinik und Poliklinik für Anästhesiologie und operative Intensivmedizin der Westf. Wilhelms-Universität

location_facility: Klinik und Poliklinik für Anästhesiologie und Intensivtherapie - Universitätsklinikum Leipzig AöR

location_facility: Centre Hospitalier de Metz, Réa Polyvalente

location_facility: CH Manchester, Service de Réanimation Polyvalente

location_facility: Hôpital St Antoine, Réanimation Médicale

title: Effects of Voluven on Hemodynamics and Tolerability of Enteral Nutrition in Patients With Severe Sepsis

summary: The rapidity and the quality of fluid resuscitation in patients with severe sepsis are important factors for the prevention of secondary multi-organ failure. Vascular filling may also have an impact on tolerability of enteral nutrition. The earliness and quantity of calories provided by enteral nutrition may have an impact on morbidity and mortality. This study will asses the effects of volume expansion on hemodynamics and tolerability of enteral nutrition in patients with severe sepsis. A Data Monitoring Committee will review regularly safety data of the study.


title: Thalidomide for the Treatment of Cytopenias of Patients With Low Risk Myelodysplastic Syndromes

summary:
The GFM previously conducted a dose-escalating phase II trial of thalidomide in MDS with a minimum dose of 200mg/d and a maximum dose 800mg/d. Responses were evaluated according to IWG criteria at week 16 and thalidomide continued up to week 56 in responders. 82% patients received at least 8 weeks of treatment and were evaluable. 59% had hematological improvement, mainly on the erythroid lineage (Increase of Hemoglobin). Most responses were observed at low doses and between 4 and 8 weeks.

The objectives of this trial (Thal-SMD-20) are to evaluate the efficacy and tolerance of lower doses thalidomide in low risk MDS patients with transfusion-dependant anemia.

ReferenceCitation: Bouscary D, Legros L, Tulliez M, Dubois S, Mahe B, Beyne-Rauzy O, Quarre MC, Vassilief D, Varet B, Aouba A, Gardembas M, Giraudier S, Guerci A, Rousselot P, Gaillard F, Moreau A, Rousselet MC, Ifrah N, Fenaux P, Dreyfus F; Groupe Français des Myélodysplasies (GFM). A non-randomised dose-escalating phase II study of thalidomide for the treatment of patients with low-risk myelodysplastic syndromes: the Thal-SMD-2000 trial of the Groupe Français des Myélodysplasies. Br J Haematol. 2005 Dec;131(5):609-18.

lead_sponsor: Groupe Francophone des Myelodysplasies

location_facility:
CHU de Brest - Hopital Morvan
Hopital Necker
CH Joffre
Hopital Avicenne
CH de la Cote Basque
CHU de Nice - Hopital de l'Archet 1
CHU de Nantes
Hopital Saint Antoine
CHU d'Angers
CHU Albert Michallon
CHU de Limoges
Hopital Cochin
Centre Henry Becquerel
Hotel Dieu
Institut Paoli Calmette
CHU Dijon
CHU Purpan
CHRU de Lille - Hopital C. Huriez
CHU Nancy-Brabois
CH d'Avignon


title: Evaluation of the CHOndromodulating Effect of DIAcerein in Osteoarthritis of the Hip. ECHODIAH.

acronym: ECHODIAH

summary:
We carried out a 3 years, randomized, double-blind, placebo-controlled, multicenter clinical trial in patients with hip osteoarthritis in order to:

evaluate the ability of diacerein, an interleukin-1β inhibitor, to slow the progressive decrease in joint space width observed in patients with hip osteoarthritis
to investigate the potential structure-modifying effect of diacerein in patients with hip osteoarthritis

This study compare also after ten years the percentage of patients in each treatment group who require a hip replacement surgery

ReferenceCitation: Dougados M, Nguyen M, Berdah L, Maziéres B, Vignon E, Lequesne M; ECHODIAH Investigators Study Group. Evaluation of the structure-modifying effects of diacerein in hip osteoarthritis: ECHODIAH, a three-year, placebo-controlled trial. Evaluation of the Chondromodulating Effect of Diacerein in OA of the Hip. Arthritis Rheum. 2001 Nov;44(11):2539-47.

lead_sponsor: Laboratoires NEGMA

location_facility: Hôpital Cochin, clinique de rhumatologie


title: An Open Label Study to Evaluate the Effect of Avastin in Association With Chemotherapy on Progression-free Survival in Patients With Progressive Advanced/Metastatic Well-differentiated Digestive Endocrine Tumors of the Gastrointestinal Tract

summary: This 2 arm study will assess the efficacy and safety of two systemic treatments including Avastin in patients with previously-untreated progressive locally advanced/metastatic well-differentiated digestive endocrine tumors. Patients with duodeno-pancreatic tumors (arm 1) will be treated with 5FU/streptozotocin iv (5FU 400mg/m2/d D1 to D5;streptozotocin 500mg/m2/d/iv D1 to D5;D1=D42) every 6 weeks, plus Avastin 7.5mg/kg iv every 3 weeks. Patients with gastrointestinal tract tumors (arm 2) will be treated with Xeloda 1000mg/m2 po bid D1 to D14 plus Avastin 7.5mg/kg iv D1=D21 every 3 weeks. The patients will be treated with chemotherapy for a minimum of 6 months, unless there is tumor progression and/or unacceptable toxicity. The anticipated time on study treatment is until disease progression or unacceptable toxicity, and the target sample size is <100 individuals.

lead_sponsor: Hoffmann-La Roche


ReferenceCitation: Gajdos V, Soubeyrand B, Vidor E, Richard P, Boyer J, Sadorge C, Fiquet A. Immunogenicity and safety of combined adsorbed low-dose diphtheria, tetanus and inactivated poliovirus vaccine (REVAXIS (®)) versus combined diphtheria, tetanus and inactivated poliovirus vaccine (DT Polio (®)) given as a booster dose at 6 years of age. Hum Vaccin. 2011 May;7(5):549-56. Epub 2011 May 1.

intervention_type: Biological

lead_sponsor: Sanofi Pasteur, a Sanofi Company

acronym: REVAXIS® versus DT Polio® as a second booster in 6 year-old children

title: Comparison of the Immunogenicity and Safety of a Combined Adsorbed Low Dose Diphtheria, Tetanus and Inactivated Poliomyelitis Vaccine (REVAXIS®) With a Combined Diphtheria, Tetanus and Inactivated Poliomyelitis Vaccine (DT Polio®) When Given as a Booster Dose at 6 Years of Age

summary:
Primary objective:

To demonstrate the non inferiority between REVAXIS® and DT Polio® when given as a second booster to healthy 6 year-old children .

Secondary objectives:

Additional immunogenicity assessments.
To describe the safety profile of a single dose of REVAXIS® or DT-Polio®


title: A Phase II Study of Maintenance With Azacitidine in MDS Patients Achieving Complete or Partial Remission (CR or PR) After Intensive Chemotherapy

summary:
A phase II multicentre trial of maintenance with Azacitidine in MDS patients achieving complete or partial remission (CR or PR) after intensive chemoterapy.

The primary objective is response duration (MDS or AML)

location_facility:
Hopital Archet
CHRU de Limoges
Hopital Haut Leveque
Hopital Paoli Calmette
CHU d'Amiens
Hopital Henri Mondor
CH Versailles
CHU Albert Michallon
Hopital Saint Louis
Hopital Hautepierre
Hopital d'Instruction des Armées Percy
CHU Brabois
CH d'Avignon
CHU de Caen
CHU de Dijon
Hopital Hotel Dieu
Hopital Purpan
CHU Pontchaillou
Hopital Edouard Herriot
Hopital Jean-Bernard
CHRU Hurriez
CHU Angers
Hopital Saint Antoine
Hopital Cochin
CHRU de Reims


title: Phase III, Multicenter, Open-label, Randomized Trial of Tarceva® vs Chemotherapy in Patients With Advanced NSCLC With Mutations in the TK Domain of the EGFR

summary: A Phase III, multicenter, open-label, randomized trial of Erlotinib (Tarceva®) versus chemotherapy in patients with advanced NSCLC with mutations in the Tyrosine Kinase (TK) domain of the EGFR.

ReferenceCitation: Karachaliou N, Mayo-de las Casas C, Queralt C, de Aguirre I, Melloni B, Cardenal F, Garcia-Gomez R, Massuti B, Sánchez JM, Porta R, Ponce-Aix S, Moran T, Carcereny E, Felip E, Bover I, Insa A, Reguart N, Isla D, Vergnenegre A, de Marinis F, Gervais R, Corre R, Paz-Ares L, Morales-Espinosa D, Viteri S, Drozdowskyj A, Jordana-Ariza N, Ramirez-Serrano JL, Molina-Vila MA, Rosell R; Spanish Lung Cancer Group. Association of EGFR L858R Mutation in Circulating Free DNA With Survival in the EURTAC Trial. JAMA Oncol. 2015 May;1(2):149-57. doi: 10.1001/jamaoncol.2014.257.

family: Karachaliou

full_name: Niki Karachaliou

given: Niki

name: Laboratory of Molecular Biology, Pangaea Biotech, Barcelona, Spain

family: Mayo-de las Casas

full_name: Clara Mayo-de las Casas

given: Clara

family: Queralt

full_name: Cristina Queralt

given: Cristina

family: de Aguirre

full_name: Itziar de Aguirre

given: Itziar

name: Service de Pathologie Respiratoire et d’Allergologie, Hôpital du Cluzeau, Limoges, France

family: Melloni

full_name: Boris Melloni

given: Boris

name: Medical Oncology Service, Catalan Institute of Oncology, Hospital Duran i Reynals, L’Hospitalet, Spain

family: Cardenal

full_name: Felipe Cardenal

given: Felipe

name: Medical Oncology Service, Hospital General Universitario Gregorio Marañón, Madrid, Spain

family: Garcia-Gomez

full_name: Ramon Garcia-Gomez

given: Ramon

name: Medical Oncology Service, Hospital General de Alicante, Alicante, Spain

family: Massuti

full_name: Bartomeu Massuti

given: Bartomeu

name: Medical Oncology Service, Hospital 12 de Octubre, Madrid, Spain

family: Sánchez

full_name: José Miguel Sánchez

given: José Miguel

name: Medical Oncology Service, Catalan Institute of Oncology, Hospital Dr Josep Trueta, Girona, Spain

family: Porta

full_name: Ruth Porta

given: Ruth

name: Medical Oncology Service, Hospital La Paz, Madrid, Spain

family: Ponce-Aix

full_name: Santiago Ponce-Aix

given: Santiago

family: Moran

full_name: Teresa Moran

given: Teresa

family: Carcereny

full_name: Enric Carcereny

given: Enric

name: Medical Oncology Service, Hospital Vall d’Hebron, Barcelona, Spain

family: Felip

full_name: Enriqueta Felip

given: Enriqueta

name: Medical Oncology Service, Hospital Son Llatzer, Palma de Mallorca, Spain

family: Bover

full_name: Isabel Bover

given: Isabel

name: Medical Oncology Service, Hospital Clínic de Valencia, Valencia, Spain

family: Insa

full_name: Amelia Insa

given: Amelia

name: Medical Oncology Service, Hospital Clínic, Barcelona, Spain

family: Reguart

full_name: Noemí Reguart

given: Noemí

name: Medical Oncology Service, Hospital Lozano Blesa, Zaragoza, Spain

family: Isla

full_name: Dolores Isla

given: Dolores

family: Vergnenegre

full_name: Alain Vergnenegre

given: Alain

name: Azienda Ospedaliera San Camillo-Forlanini, Rome, Italy17European Institute of Oncology, Milan, Italy

family: de Marinis

full_name: Filippo de Marinis

given: Filippo

name: Medical Oncology Service, Centre François Baclesse, Caen, France

family: Gervais

full_name: Radj Gervais

given: Radj

name: CHU Rennes Hopital Ponchaillou, Rennes, France

family: Corre

full_name: Romain Corre

given: Romain

name: Medical Oncology Service, Hospital Universitario Virgen del Rocío, Sevilla, Spain

family: Paz-Ares

full_name: Luis Paz-Ares

given: Luis

family: Morales-Espinosa

name: Instituto Oncológico Dr Rosell, Quiron-Dexeus University Hospital, Barcelona, Spain3Catalan Institute of Oncology, Hospital Germans Trias i Pujol, Badalona, Spain22MORe Foundation, Barcelona, Spain23Cancer Therapeutic Innovation Group, New York, New York

title: Association ofEGFRL858R Mutation in Circulating Free DNA With Survival in the EURTAC Trial

ReferenceCitation: Karachaliou N, Gimenez-Capitan A, Drozdowskyj A, Viteri S, Moran T, Carcereny E, Massuti B, Vergnenegre A, de Marinis F, Molina MA, Teixido C, Rosell R. ROR1 as a novel therapeutic target for EGFR-mutant non-small-cell lung cancer patients with the EGFR T790M mutation. Transl Lung Cancer Res. 2014 Jun;3(3):122-30. doi: 10.3978/j.issn.2218-6751.2014.03.02.

ReferenceCitation: Costa C, Molina MA, Drozdowskyj A, Giménez-Capitán A, Bertran-Alamillo J, Karachaliou N, Gervais R, Massuti B, Wei J, Moran T, Majem M, Felip E, Carcereny E, Garcia-Campelo R, Viteri S, Taron M, Ono M, Giannikopoulos P, Bivona T, Rosell R. The impact of EGFR T790M mutations and BIM mRNA expression on outcome in patients with EGFR-mutant NSCLC treated with erlotinib or chemotherapy in the randomized phase III EURTAC trial. Clin Cancer Res. 2014 Apr 1;20(7):2001-10. doi: 10.1158/1078-0432.CCR-13-2233. Epub 2014 Feb 3.

publisher_dissemination: American Association for Cancer Research

title: The Impact of EGFR T790M Mutations and BIM mRNA Expression on Outcome in Patients with EGFR-Mutant NSCLC Treated with Erlotinib or Chemotherapy in the Randomized Phase III EURTAC Trial

ReferenceCitation: Rosell R, Carcereny E, Gervais R, Vergnenegre A, Massuti B, Felip E, Palmero R, Garcia-Gomez R, Pallares C, Sanchez JM, Porta R, Cobo M, Garrido P, Longo F, Moran T, Insa A, De Marinis F, Corre R, Bover I, Illiano A, Dansin E, de Castro J, Milella M, Reguart N, Altavilla G, Jimenez U, Provencio M, Moreno MA, Terrasa J, Muñoz-Langa J, Valdivia J, Isla D, Domine M, Molinier O, Mazieres J, Baize N, Garcia-Campelo R, Robinet G, Rodriguez-Abreu D, Lopez-Vivanco G, Gebbia V, Ferrera-Delgado L, Bombaron P, Bernabe R, Bearz A, Artal A, Cortesi E, Rolfo C, Sanchez-Ronco M, Drozdowskyj A, Queralt C, de Aguirre I, Ramirez JL, Sanchez JJ, Molina MA, Taron M, Paz-Ares L; Spanish Lung Cancer Group in collaboration with Groupe Français de Pneumo-Cancérologie and Associazione Italiana Oncologia Toracica. Erlotinib versus standard chemotherapy as first-line treatment for European patients with advanced EGFR mutation-positive non-small-cell lung cancer (EURTAC): a multicentre, open-label, randomised phase 3 trial. Lancet Oncol. 2012 Mar;13(3):239-46. doi: 10.1016/S1470-2045(11)70393-X. Epub 2012 Jan 26.

location_facility: Università di Roma "La Sapienza" Az.Policlinico Umb.I°

location_facility: Centre Hospitalier de La Région D'Annecy

location_facility: Centre Hospitalier Universitaire D'Angers


title: Study Multicentric, Randomised, in Duplicate Blind Person of the Impact of a Per Operatory Strategy of Optimization of the Cardiac Output on the Forecast of the Old Subjects Operated for Fracture of the Upper End of the Femur " FRACTALE "

acronym: FRACTALE

summary: The aim of this study is to assess whether intra-operative fluid supplementation (to improve tissue perfusion) can reduce the incidence of postoperative complications in elderly patients with hip fracture.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Centre Hospitalier Universitaire de Poitiers

location_facility: Centre Hospitalier Universitaire de La Cote de Nacre