acronym: GuidePath

lead_sponsor: Novartis Pharmaceuticals

summary:
The current study aims at evaluating the diagnostic performance of [18F]CTT1057 as a PET imaging agent for detection and localization of PSMA positivity in patients diagnosed of biochemical recurrence of prostate cancer (PCa), using a composite truth standard.

Approximately 190 participants will be enrolled to ensure at least 152 participants are evaluable (i.e. have both an evaluable [18F]CTT1057 PET/CT scan imaging, and at least one evaluable CTS assessment and have not received any prohibited systemic antineoplastic therapy before the completion of PET/CTs and CTS procedures), which will be required for the calculation of the co-primary endpoints.

location_facility:
Explorer Molecular Imaging center
Novartis Investigative Site

title: Phase III Study for Evaluation of the Diagnostic Performance of [18F]CTT1057 PET Imaging in Patients With Prostate Cancer With Rising PSA Levels [Biochemical Recurrence (BCR)]

primary_purpose: Diagnostic

ipd_sharing_description:
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

location_country:
United States
Spain
Switzerland
France


type: Other Identifier

title: Prospective Multicenter Trial Assessing the Efficacy of a Novel 3D Cartography-based Targeted Focal Microwave Therapy in Men With Localized Intermediate-risk Prostate Cancer

acronym: VIOLETTE

summary: Multicenter, prospective, European, single-arm, open-label, 12-month follow-up clinical trial. The purpose of this study is to evaluate the efficacy of a 3D cartography-based targeted microwave ablation for the treatment of the index lesion in patients with intermediate risk prostate cancer.

study_start_date_type: Actual

status: Unknown status

study_completion_date_type: Anticipated

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Koelis

location_country: Belgium France

location_facility: Hôpital Cochin (Assistance Publique - Hôpitaux de Paris)

location_facility: Centre Hospitalier Universitaire de Bordeaux

location_facility: Urologie Nantes Clinique & Institut d'Urologie - Site Atlantis

location_facility: Hôpital de la Pitié-Salpêtrière (Assistance Publique - Hôpitaux de Paris)

intervention_type: Device

lead_sponsor_type: industriel

status_simplified: Unknown


title: A Postmarketing Observational Cohort Study to Evaluate Effectiveness and Safety of Ponatinib (Iclusig®) in Patients With BCR-ABL Positive ALL in Standard Clinical Practice in Europe - "POSEIDON"

summary: The purpose of this study is to evaluate the effectiveness and safety of ponatinib (Iclusig®) in patients with BCR-ABL positive acute lymphoblastic leukemia (ALL) in standard clinical practice in Europe.

study_start_date_type: Anticipated

status: Withdrawn

study_type: Observational

time_perspective: Other

enrollment_type: Actual

lead_sponsor: Incyte Biosciences International Sàrl

location_country: Czechia Germany France

location_facility:
University Hospital Amiens
University Hospital Grenoble
University Hospital Angers
University Hospital Bordeaux
University Hospital Rostock
Ihbt/Úhkt
University Cancer Institute Oncopole
University Hospital Halle/Saale
University Hospital Munich
University Hospital Lyon


title: A Randomized Controlled Study of PneumRx Endobronchial Coil System Versus Standard-of-Care Medical Management in the Treatment of Subjects With Severe Emphysema

acronym: ELEVATE

summary: This study will look at outcomes between Endobronchial Coil Treatment and Control groups in patients with severe heterogeneous and or homogeneous emphysema.

status: Completed

study_completion_date_type: Actual

design_allocation: Randomized

ReferenceType: derived

ReferenceCitation: Agrawal A. Interventional Pulmonology: Diagnostic and Therapeutic Advances in Bronchoscopy. Am J Ther. 2021 Feb 9;28(2):e204-e216. doi: 10.1097/MJT.0000000000001344.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Wolters Kluwer Health

lead_sponsor: Boston Scientific Corporation

sponsor_collaborators:
Boston Scientific Corporation
PneumRx, Inc.

location_country:
Germany
Italy
United Kingdom
Netherlands
Austria
France

location_facility: Krankenhaus vom Roten Kreuz Bad Cannstatt GmbH

location_facility: Centre Hospitalier Universitaire de Nice

location_facility: Ludwig Boltzmann Institut Fur COPD und pneumologische Epidemologie

location_facility: Charite Berlin - Medizinische Klinik mit Schwerpunkt Infektiologie und Pneumologie

status_simplified: Completed


title: Phase III Randomized Trial of Local Excision Versus Total Mesorectal Excision in Downstaged T2T3 Low Rectal Cancer After Radiochemotherapy

acronym: GRECCAR 2

summary: Patients with T2T3 low rectal cancer (size =< 4 cm) received neoadjuvant treatment (50Gy in 5 weeks with concomitant chemotherapy. Good responders (residual tumour =< 2 cm) are randomised in local vs rectal excision, 6-8 weeks after treatment. The composite end point evaluates the rate of patients with death, recurrence, major morbidity or severe after effects at two years.

primary_purpose: Supportive Care

ReferenceCitation: Teste B, Rouanet P, Tuech JJ, Valverde A, Lelong B, Rivoire M, Faucheron JL, Jafari M, Portier G, Meunier B, Sielezneff I, Prudhomme M, Marchal F, Dubois A, Capdepont M, Denost Q, Rullier E. Early and late morbidity of local excision after chemoradiotherapy for rectal cancer. BJS Open. 2021 May 7;5(3):zrab043. doi: 10.1093/bjsopen/zrab043.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Oxford University Press

ReferenceCitation: Rullier E, Vendrely V, Asselineau J, Rouanet P, Tuech JJ, Valverde A, de Chaisemartin C, Rivoire M, Trilling B, Jafari M, Portier G, Meunier B, Sieleznieff I, Bertrand M, Marchal F, Dubois A, Pocard M, Rullier A, Smith D, Frulio N, Frison E, Denost Q. Organ preservation with chemoradiotherapy plus local excision for rectal cancer: 5-year results of the GRECCAR 2 randomised trial. Lancet Gastroenterol Hepatol. 2020 May;5(5):465-474. doi: 10.1016/S2468-1253(19)30410-8. Epub 2020 Feb 7.

oa_host_type: publisher

evidence: open (via crossref license, author manuscript)

license: publisher-specific-oa

license_normalized: publisher-specific

version: acceptedVersion

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

ReferenceCitation: Rullier E, Rouanet P, Tuech JJ, Valverde A, Lelong B, Rivoire M, Faucheron JL, Jafari M, Portier G, Meunier B, Sileznieff I, Prudhomme M, Marchal F, Pocard M, Pezet D, Rullier A, Vendrely V, Denost Q, Asselineau J, Doussau A. Organ preservation for rectal cancer (GRECCAR 2): a prospective, randomised, open-label, multicentre, phase 3 trial. Lancet. 2017 Jul 29;390(10093):469-479. doi: 10.1016/S0140-6736(17)31056-5. Epub 2017 Jun 7.

lead_sponsor: University Hospital, Bordeaux

collaborators:
Sanofi
Roche Pharma AG

sponsor_collaborators:
University Hospital, Bordeaux
Sanofi
Roche Pharma AG

location_facility: Département de Radiothérapie - Centre Jean Perrin - 58 rue Montalembert

location_facility: Département de Chirurgie Oncologique - Centre Léon Bérard - 28 rue Laennec

location_facility: Département de Radiothérapie - Centre Paul Strauss - 3 rue de la Porte de l'Hôpital

location_facility: Département Médico-Chirurgical de Pathologie Digestive - Hôpital Lariboisière - 2 rue Ambroise Paré

location_facility: Service de Chirurgie Digestive et Générale - CHU Brabois - avenue de Bourgogne

location_facility: Département de Chirurgie Oncologique - Centre Alexis Vautrin - Avenue de Bourgogne

location_facility: Centre Radiothérapie Oncologie Moyenne Garonne - 13 Quai du Docteur Calabet

location_facility: Service de Chirurgie Oncologique - Centre René Gauducheau - Boulevard Jacques Monod

location_facility: Service de Chirurgie Digestive et viscérale - CHU Timone - 264 rue Saint Pierre

location_facility: Service de Chirurgie Digestive - Hôpital Hautepierre

location_facility: Service de chirurgie digestive - hôpital Saint André - 1 rue Jean Burguet

location_facility: Service de Chirurgie Générale et Digestive - Hôpital Beaujon - 100 boulevard du Général Leclerc

location_facility: Service de Chirurgie Viscérale - CHU pontchaillou - 2 rue Henri Le Guilloux

location_facility: Service de Chirurgie Digestive - Hôpital ambroise Paré - 9 avenue Charles de Gaulle

location_facility: Service de Chirurgie Digestive - Hôpital des Diaconnesses - la Croix Saint-Simon - 125 rue d'Avron

location_facility: Service de Chirurgie Générale et Digestive - Hôtel Dieu - CHU Clermont-Ferrand - Boulevard Léon Malfreyt

location_facility: Service de Radiothérapie - Clinique Tivoli - 220 rue Mandron

location_facility: Service de Chirurgie Digestive - CHU Charles Nicolle - 1 rue Germont

location_facility: Service de Chirurgie Viscérale - Clinique Charcot - 51-52 rue Commandant Charcot

location_facility: Service de Chirurgie Viscérale, Digestive et Cancérologique - CHRU J.Minoz - Boulevard Fleming

location_facility: Service de Chirurgie Oncologique - Institut Bergonié - 229, cours de l'Argonne

location_facility: Service de Radiothérapie-Oncologie - centre Henri Becquerel - rue d'Amiens

location_facility: Département d'Oncologie Médicale - Institut Claudius Régaud - 20-24 rue du Pont Saint Pierre

location_facility: Service de Chirurgie Digestive - Hôpital Purpan - Place du Docteur Baylac

location_facility: Département des Radiations - Centre Eugène Marquis - rue de la Bataille Flandres-Dunkerque

location_facility: Service d'Oncologie - Radiothérapie - Hôpital Tenon - 4 rue de la Chine

location_facility: Service de Chirurgie Générale et Digestive - Hôpital Saint-Antoine - 184 rue du Faubourg Saint-Antoine

location_facility: Centre d'Oncologie et Radiothérapie - rue du Dr Schweitzer

location_facility: Département de Chirurgie Oncologique - Centre Oscar Lambret - 3 rue Combemale

location_facility: Service d'Oncologie-Radiothérapie - Centre antoine Lacassagne - 33 avenue de Valombrose

location_facility: Service de Chirurgie Générale - Hôpitaux Civils de Lyon

location_facility: Service de Chirurgie Digestive - Hôpital A. Michallon - CHU de Grenoble - Boulevard de la Chantourne

location_facility: Département de Chirurgie Oncologique - CRLC Val d'Aurelle

location_facility: Service de Radiothérapie - Oncologie - Centre Hospitalier Lyon Sud - Hôpitaux Civils de Lyon - 165 chemin du Grand Revoyet

location_facility: Service de Chirurgie Générale - Hôpital Archet II

location_facility: Service de Cancérologie - Radiothérapie - Hôpital Saint-Louis - 1 avenue Claude Vellefeaux

intervention_type: Procedure

lead_sponsor_type: academique


title: Multicenter Pilot Clinical Study of Adjuvant Chemotherapy for Subjects Over 70 Years: Impact on the Independence and Quality of Life of the Administration of Anthracycline-Based Chemotherapy in Adjuvant Setting for Patients Presenting With Immediately Operable Breast Cancer, Hormone Receptor Negative (RH-), and Lymph Node Positive (pN+) or pN0 But of Scarff-Bloom-Richardson* Grade III and ≥ 2cm [GERICO]

summary:
RATIONALE: Drugs used in chemotherapy, such as doxorubicin and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving combination chemotherapy after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial is studying how well giving doxorubicin together with cyclophosphamide works in treating older women with stage I , stage II, or stage III breast cancer that has been removed by surgery.

design_allocation: Non-Randomized

lead_sponsor: UNICANCER

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

intervention_type: Drug


acronym: HIPELD

lead_sponsor: Air Liquide Santé International

summary: The objective of this study is to evaluate the incidence of Post-Operative Delirium (POD), diagnosed with the Confusion Assessment Method (CAM), in elderly patients undergoing hip fracture surgery under general anaesthesia with xenon or sevoflurane, for a period of four days post-surgery.

ReferenceCitation: Coburn M, Sanders RD, Maze M, Nguyen-Pascal ML, Rex S, Garrigues B, Carbonell JA, Garcia-Perez ML, Stevanovic A, Kienbaum P, Neukirchen M, Schaefer MS, Borghi B, van Oven H, Tognu A, Al Tmimi L, Eyrolle L, Langeron O, Capdevila X, Arnold GM, Schaller M, Rossaint R; HIPELD Study Investigators. The hip fracture surgery in elderly patients (HIPELD) study to evaluate xenon anaesthesia for the prevention of postoperative delirium: a multicentre, randomized clinical trial. Br J Anaesth. 2018 Jan;120(1):127-137. doi: 10.1016/j.bja.2017.11.015. Epub 2017 Nov 21.

oa_colors: green hybrid

evidence: open (via crossref license)

evidence: oa repository (via OAI-PMH title and first author match)

repository_institution: California Digital Library - eScholarship

version: submittedVersion

ReferenceCitation: Coburn M, Sanders RD, Maze M, Rossaint R; HIPELD Investigators. The Hip Fracture Surgery in Elderly Patients (HIPELD) study: protocol for a randomized, multicenter controlled trial evaluating the effect of xenon on postoperative delirium in older patients undergoing hip fracture surgery. Trials. 2012 Sep 27;13:180. doi: 10.1186/1745-6215-13-180.

sponsor_collaborators:
Air Liquide Santé International
OptumInsight

location_facility: Centre Hospitalier Universitaire de Grenoble

location_facility: Centre Hospitalier Régional Universitaire de Montpellier

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Centre Hospitalier Universitaire de Toulouse

location_facility: . Klinik für Anästhesiologie - Universitätsklinikum Düsseldorf

location_facility: CHU Pontchaillou - Université de Rennes 1

title: An International, Multi-center, Randomized, Controlled Trial Evaluating The Effect of Xenon on Post-operative Delirium in Elderly Patients Undergoing Hip Fracture Surgery

source: euctr

location_country:
Germany
Italy
United Kingdom
Belgium
Spain
France


title: An Open-Label, Multi-Center Controlled Clinical Trial Of Eculizumab in Adolescent Patients With Plasma Therapy-Sensitive Atypical Hemolytic Uremic Syndrome (AHUS)

acronym: aHUS

summary: The purpose of this study is to determine whether eculizumab is safe and effective in the treatment of adolescent patients with plasma therapy-sensitive Atypical Hemolytic-Uremic Syndrome (aHUS).

ReferenceCitation: Pugh D, O'Sullivan ED, Duthie FA, Masson P, Kavanagh D. Interventions for atypical haemolytic uraemic syndrome. Cochrane Database Syst Rev. 2021 Mar 23;3(3):CD012862. doi: 10.1002/14651858.CD012862.pub2.

oa_host_type: repository

unpaywall_oa_status: green

publisher_dissemination: Wiley

ReferenceCitation: Legendre CM, Licht C, Muus P, Greenbaum LA, Babu S, Bedrosian C, Bingham C, Cohen DJ, Delmas Y, Douglas K, Eitner F, Feldkamp T, Fouque D, Furman RR, Gaber O, Herthelius M, Hourmant M, Karpman D, Lebranchu Y, Mariat C, Menne J, Moulin B, Nurnberger J, Ogawa M, Remuzzi G, Richard T, Sberro-Soussan R, Severino B, Sheerin NS, Trivelli A, Zimmerhackl LB, Goodship T, Loirat C. Terminal complement inhibitor eculizumab in atypical hemolytic-uremic syndrome. N Engl J Med. 2013 Jun 6;368(23):2169-81. doi: 10.1056/NEJMoa1208981.

oa_colors: green other

evidence: open (via free article)

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

repository_institution: Lund University - Lund University Publications

unpaywall_oa_status: bronze

publisher_dissemination: Massachusetts Medical Society

lead_sponsor: Alexion Pharmaceuticals, Inc.

location_country:
Germany
Italy
United Kingdom
Sweden
Netherlands
Canada
France


summary: The purpose of this study is to determine whether eculizumab is safe and effective in the treatment of adult patients with plasma therapy-sensitive Atypical Hemolytic-Uremic Syndrome (aHUS).

repositories_institution: Lund University - Lund University Publications

title: An Open-label, Multi-center Controlled Clinical Trial of Eculizumab in Adult Patients With Plasma Therapy-sensitive Atypical Hemolytic Uremic Syndrome (AHUS)


title: A Phase IV, Open-Label, Randomized, Multicenter Trial Assessing the Efficacy of a Treatment Maintenance Phase With Unboosted vs. Boosted Reyataz After an Induction Phase With Reyataz and Ritonavir in Treatment Naive HIV Patients (the INDUMA Study)

acronym: INDUMA

summary: The purpose of this study is to compare the proportion of subjects with HIV-1 RNA viral load < 50 c/mL through Week 48 of the Maintenance Phase among HIV-infected subjects with an initial undetectable viral load following an Induction Phase with an ATV/RTV containing HAART regimen, when switched to ATV versus remaining on ATV/RTV, whilst continuing their previous NRTI backbone.

lead_sponsor: Bristol-Myers Squibb

location_country:
Germany
Ireland
Italy
Portugal
United Kingdom
Latvia
Spain
Estonia
Russian Federation
France


title: DEPISTORL - THANCS (Trial of Head And Neck Cancer Screening) Randomized Multicenter Trial to Assess the Impact of a Screening Program for Heavy Alcohol Drinkers and Smokers Treated in Alcohol Addiction Clinics on Upper Aerodigestive Tract Cancer Mortality.

summary: Randomized multicenter trial to assess the impact of a screening program for heavy alcohol drinkers and smokers treated in alcohol addiction clinics on upper aerodigestive tract cancer mortality.

primary_purpose: Prevention

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

location_facility:
Hôpital ARCHET II
Centre Paul Cézanne
Institut_Gustave-Roussy
Clinique Philae
Centre Hospitalier de LENS
Centre Hospitalier du Mans
CHR de la Réunion
Hopital de Saint Cloud
CHU de Nancy
CHIAB Annemasse Bonneville
Centre Hospitalier MONTPERRIN
Centre Hospitalier d'ARRAS
CHS de L'Yonne
CHU le Bocage
CHU de Lille
Centre Hospitalier de DIEPPE
Hôpital de la Source
Centre Hospitalier des Chanaux
Centre de soins de suite Marienbronn
Centre Hospitalier Louis Sevestre
CHU de Nantes
C.A.S.A.
Centre hospitalier Lyon sud
Centre ANPAA d'Orléans
Hopital Paul Brousse
Chg Beziers
CHU de Strasbourg - Hôpital Hautepierre
Centre ANPAA 51 de Reims
Chba Vannes
Ch Saint-Egreve
CHU Hôpital Gabriel Montpied
CHBS Lorient
Hôpitaux du Leman
CHU Hôpital Pontchaillou
Centre Hospitalier du Centre Bretagne


title: Evaluation of the Efficacy of the Thermal Cure in the Prevention of the Post-Thrombotic Syndrome After a Deep Venous Thrombosis of Lower Limbs.

summary: The main objective of this study is to demonstrate that hydrotherapy in a specific place can reduce the risk of post-thrombotic syndrome.

status: Terminated

ReferenceType: background

ReferenceCitation: Prandoni P, Lensing AW, Cogo A, Cuppini S, Villalta S, Carta M, Cattelan AM, Polistena P, Bernardi E, Prins MH. The long-term clinical course of acute deep venous thrombosis. Ann Intern Med. 1996 Jul 1;125(1):1-7. doi: 10.7326/0003-4819-125-1-199607010-00001.

ReferenceCitation: Kahn SR, Kearon C, Julian JA, Mackinnon B, Kovacs MJ, Wells P, Crowther MA, Anderson DR, Van Nguyen P, Demers C, Solymoss S, Kassis J, Geerts W, Rodger M, Hambleton J, Ginsberg JS; Extended Low-intensity Anticoagulation for Thrombo-embolism (ELATE) Investigators. Predictors of the post-thrombotic syndrome during long-term treatment of proximal deep vein thrombosis. J Thromb Haemost. 2005 Apr;3(4):718-23. doi: 10.1111/j.1538-7836.2005.01216.x. Epub 2005 Feb 23.

ReferenceCitation: Labropoulos N, Leon LR Jr. Duplex evaluation of venous insufficiency. Semin Vasc Surg. 2005 Mar;18(1):5-9. doi: 10.1053/j.semvascsurg.2004.12.002.

ReferenceCitation: Asbeutah AM, Riha AZ, Cameron JD, McGrath BP. Reproducibility of duplex ultrasonography and air plethysmography used for the evaluation of chronic venous insufficiency. J Ultrasound Med. 2005 Apr;24(4):475-82. doi: 10.7863/jum.2005.24.4.475.

ReferenceCitation: Launois R, Reboul-Marty J, Henry B. Construction and validation of a quality of life questionnaire in chronic lower limb venous insufficiency (CIVIQ). Qual Life Res. 1996 Dec;5(6):539-54. doi: 10.1007/BF00439228.

lead_sponsor: Association Francaise pour la Recherche Thermale

location_facility:
Les thermes
Etablissmeent thermal
Etablissement thermal
Dax thermal
Chênes
L'avenue
Le Grand Hôtel
Saint-Pierre
Les arènes
Le Splendid
Le Regina
Les écureuils
Le miradour
Foch
Christus
Bérot
Caliceo
Sarrailh
Domaine d'heurteboise
Borda


title: An Open Label, Parallel-Arm, Multicenter Trial Assessing the Acceptability of 4 Dosages of a New Fixed Dose Combination of Fenofibrate and Metformin in Patients With Type 2 Diabetes and Dyslipidemia

summary: The primary objective was to assess the acceptability of a 4-week treatment of 4 new fixed-dose combinations of fenofibrate and metformin, in patients with type 2 diabetes and dyslipidemia.

lead_sponsor: Solvay Pharmaceuticals

location_facility:
Site 26
Site 7
Site 1
Site 12
Site 27
Site 25
Site 23
Site 4
Site 13
Site 17
Site 20
Site 24
Site 8
Site 33
Site 2
Site 28
Site 29
Site 30
Site 32
Site 11
Site 10
Site 5
Site 21
Site 9
Site 34


title: A Prospective, Open-Label Multi Center Trial Evaluating The Safety And Efficacy Of 0.3 Mg/Eye Pegaptanib Sodium (Macugen) Intravitreous Injection Given Every 6 Weeks For 54 Weeks In Patients With Small Neovascular Age-Related Macular Degeneration (AMD) Lesions

summary: To evaluate the efficacy, based on the best-corrected visual acuity (using the ETDRS chart), of a 0.3 mg/eye pegaptanib sodium intravitreous injection given every 6 weeks for 54 weeks in patients with exudative age-related macular degeneration and evidence of recent onset, subfoveal and/or juxtafoveal choroidal neovascularization.

lead_sponsor: Pfizer

sponsor_collaborators:
Pfizer
ITEC GROUP 3


title: A Prospective Randomised Single-Blinded Multicentric and Pivotal Phase III Study Comparing the Efficacy, Safety and Acceptability of a New 2 Litres Gut Lavage Solution NRL994 Versus a Sodium Phosphate Solution for Colonoscopy Preparation

summary: The aim of the study is to compare a new 2 litre bowel cleansing product versus a sodium phosphate solution already on the market. Efficacy of each bowel preparation, safety and acceptability will be assessed.

ReferenceCitation: Fordtran JS, Santa Ana CA, Cleveland MvB. A low-sodium solution for gastrointestinal lavage. Gastroenterology. 1990 Jan;98(1):11-6. doi: 10.1016/0016-5085(90)91284-d.

lead_sponsor: Norgine

location_facility: Unité Endoscopies Digestives, Hôpital Lariboisière, 2 rue Ambroise Paré

location_facility: Centre Hospitalier De Montpellier Hôpital St Eloi


type: EudraCT Number

title: The AVANTAGE Study - A Randomized, Multicenter, Phase IV, Open-label Prospective Study Comparing Injection Site Reaction and Injection Site Pain in Patients With Relapsing Remitting Multiple Sclerosis (RRMS) or After a First Demyelinating Event Suggestive of MS Newly Started on Interferon Beta-1b (Betaferon®) or Interferon Beta-1a (Rebif®).

summary: The purpose of this study is to compare the injection site reaction and injection site pain after subcutaneous administration of either Betaferon 250µg or Rebif 44µg using different autoinjectors.

lead_sponsor: Bayer


title: Randomized Phase II-III Study of Chemoradiation With Fluorouracil and Cisplatin Versus Chemotherapy (Gemcitabine/Oxaliplatin) in Non Resectable But Non Metastatic Cancer of the Biliary Tract

summary:
RATIONALE: Drugs used in chemotherapy, such as fluorouracil, cisplatin, oxaliplatin, and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether giving fluorouracil and cisplatin together with radiation therapy is more effective than giving gemcitabine together with oxaliplatin in treating nonmetastatic biliary tract cancer.

PURPOSE: This randomized phase II/III trial is studying fluorouracil, cisplatin, and radiation therapy to see how well they work compared to gemcitabine and oxaliplatin in treating patients with nonmetastatic biliary tract cancer that cannot be removed by surgery.

ReferenceType: result

ReferenceCitation: Phelip JM, Vendrely V, Rostain F, Subtil F, Jouve JL, Gasmi M, Michel P, Le Malicot K, Smith D, Seitz JF, Fauchart JP, Martin P, Bennouna J, Morin T, Bonnet I, Maingon P, Lepage C, Chauffert B. Gemcitabine plus cisplatin versus chemoradiotherapy in locally advanced biliary tract cancer: Federation Francophone de Cancerologie Digestive 9902 phase II randomised study. Eur J Cancer. 2014 Nov;50(17):2975-82. doi: 10.1016/j.ejca.2014.08.013. Epub 2014 Sep 17.

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

location_facility: Centre Hospitalier General de Mont de Marsan


title: Randomized Study of Classic vs Simplified Leucovorin Calcium and Fluorouracil With or Without Irinotecan in Patients Aged At Least 75 Years With Advanced Colorectal Cancer

summary:
RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) in different doses or combinations may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating colorectal cancer.

PURPOSE: This randomized clinical trial is studying how well fluorouracil works together with leucovorin with or without irinotecan in treating older patients with metastatic colorectal cancer .

ReferenceCitation: Aparicio T, Jouve J, Teillet L, et al.: Geriatric factors to predict toxicity and dose-intensity reduction in FFCD 2001-02 phase III study comparing a first-line chemotherapy of LV5FU2 or FOLFIRI in treatment of metastatic colorectal cancer (mCRC) in elderly patients. [Abstract] J Clin Oncol 29 (Suppl 15): A-9111, 2011.

ReferenceCitation: Mitry E, Phelip JM, Bonnetain F, et al.: Phase III trial of chemotherapy with or without irinotecan in the front-line treatment of metastatic colorectal cancer in elderly patients (FFCD 2001-02 trial): results of a planned interim analysis. [Abstract] American Society of Clinical Oncology 2008 Gastrointestinal Cancers Symposium, 25-27 January 2008, Orlando, FL. A-281, 2008.

ReferenceCitation: Aparicio T, Lavau-Denes S, Phelip JM, Maillard E, Jouve JL, Gargot D, Gasmi M, Locher C, Adhoute X, Michel P, Khemissa F, Lecomte T, Provencal J, Breysacher G, Legoux JL, Lepere C, Charneau J, Cretin J, Chone L, Azzedine A, Bouche O, Sobhani I, Bedenne L, Mitry E; FFCD investigators. Randomized phase III trial in elderly patients comparing LV5FU2 with or without irinotecan for first-line treatment of metastatic colorectal cancer (FFCD 2001-02). Ann Oncol. 2016 Jan;27(1):121-7. doi: 10.1093/annonc/mdv491. Epub 2015 Oct 20.

ReferenceCitation: Aparicio T, Jouve JL, Teillet L, Gargot D, Subtil F, Le Brun-Ly V, Cretin J, Locher C, Bouche O, Breysacher G, Charneau J, Seitz JF, Gasmi M, Stefani L, Ramdani M, Lecomte T, Mitry E. Geriatric factors predict chemotherapy feasibility: ancillary results of FFCD 2001-02 phase III study in first-line chemotherapy for metastatic colorectal cancer in elderly patients. J Clin Oncol. 2013 Apr 10;31(11):1464-70. doi: 10.1200/JCO.2012.42.9894. Epub 2013 Mar 4.

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

repository_normalized: HAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

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

repositories_concat: HAL

publisher_dissemination: American Society of Clinical Oncology (ASCO)

lead_sponsor: Federation Francophone de Cancerologie Digestive

location_facility: Centre Hospitalier Intercommunal de la Haute-Saone

location_facility: Centre Hospitalier Intercommunal St. Aubin les Elbeuf

location_facility: Centre Hospitalier Universitaire de Bicetre

location_facility: Hopital d'Instruction des Armees du Val de Grace

location_facility: Centre Hospitalier Universitaire d'Amiens

location_facility: Centre Hospitalier Universitaire de Rouen

location_facility: Centre hospitalier de Charleville Mezieres

location_facility: Centre Hospitalier Universitaire Henri Mondor

location_facility: Centre Hospital Universitaire Hop Huriez

location_facility: Centre Hospitalier de Chalons-en-Champagne

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

location_facility: Pole Sante Sarthe et Loir Hopital Pierre Daguet

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

location_facility: Centre Hospital Regional Universitaire de Limoges


acronym: SonoFIRST

lead_sponsor: Assistance Publique - Hôpitaux de Paris

summary:
Glioblastoma (GBM) is an aggressive cancer with a progression-free survival (PFS) of 7 months and an overall survival (OS) of 15 months. Many therapeutic approaches have failed to improve the prognosis of patients to date. One of the main reasons is the presence of blood brain barrier (BBB) which limits therapeutic agents uptake in the brain. GBM is also considered to have a "cold" (unresponsive) immunological microenvironment due to factors released by the tumor and the presence of BBB limiting the transit of immune cells from the systemic circulation. Therefore, by-passing the BBB appears as a promising strategy.

The objective of the Phase II clinical trial, SonoFIRST, is to evaluate if the use of therapeutic ultrasound device, sonoCloud-9 (SC9) could improve the progression free survival of newly diagnosed GBM patients, treated by concurrent temoradiation and adjuvant temozolomide. The transient opening of the BBB by ultrasound with the SonoCloud-9 (SC9) device, predicts the increase in the penetration of temozolomide (TMZ) into the brain and the stimulation of cerebral immunity with the prospect of improving the survival of 160,000 new brain tumor patients each year in Europe and the United States.

ReferenceCitation: Carpentier A, Canney M, Vignot A, Reina V, Beccaria K, Horodyckid C, Karachi C, Leclercq D, Lafon C, Chapelon JY, Capelle L, Cornu P, Sanson M, Hoang-Xuan K, Delattre JY, Idbaih A. Clinical trial of blood-brain barrier disruption by pulsed ultrasound. Sci Transl Med. 2016 Jun 15;8(343):343re2. doi: 10.1126/scitranslmed.aaf6086.

ReferenceCitation: Idbaih A, Canney M, Belin L, Desseaux C, Vignot A, Bouchoux G, Asquier N, Law-Ye B, Leclercq D, Bissery A, De Rycke Y, Trosch C, Capelle L, Sanson M, Hoang-Xuan K, Dehais C, Houillier C, Laigle-Donadey F, Mathon B, Andre A, Lafon C, Chapelon JY, Delattre JY, Carpentier A. Safety and Feasibility of Repeated and Transient Blood-Brain Barrier Disruption by Pulsed Ultrasound in Patients with Recurrent Glioblastoma. Clin Cancer Res. 2019 Jul 1;25(13):3793-3801. doi: 10.1158/1078-0432.CCR-18-3643. Epub 2019 Mar 19.

location_facility: Hospices Civils de Lyon, Hôpital Pierre Wertheimer

location_facility: Centre hospitalier Universitaire d'Angers

location_facility: Centre hospitalier universitaire vaudois CHUV

location_facility: APHP-Sorbonne, Pitié Salpêtrière Hospital

status: Recruiting

title: Multisite Open-label Randomized Phase II Clinical Trial in Newly Diagnosed Glioblastoma Treated by Concurrent Temoradiation and Adjuvant Temozolomide +/- Ultrasound-induced Blood Brain Barrier Opening.

location_country: Switzerland Belgium France

status_simplified: Ongoing


title: Randomized Study of Second-Line Therapy Comprising Irinotecan With or Without Capecitabine in Patients Aged At Least 75 Years With Colorectal Cancer

summary:
RATIONALE: Drugs used in chemotherapy, such as irinotecan and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether irinotecan and capecitabine are more effective than irinotecan alone in treating colorectal cancer.

PURPOSE: This randomized phase II trial is studying irinotecan and capecitabine to see how well they work as second-line therapy compared to irinotecan alone in treating older patients with progressive, metastatic colorectal cancer that cannot be removed by surgery.

sponsor_collaborators: Federation Francophone de Cancerologie Digestive

location_facility: Centre Hospitalier General - St. Nicolas

location_facility: Centre Hospitalier Universitaire Ambroise Pare - Boulogne


title: CAOCT Study is a Prospective, Multi-centre, Single Cohort, Diagnostic Accuracy Study, Planned to Include 131 Patients in About 3 European Countries After Successful Return of Spontaneous Circulation After Out of Hospital Cardiac Arrest

summary: Out-of-hospital cardiac arrest (OHCA) is a leading cause of sudden death in Europe and the United States. Mortality is currently close to 40% among those patients who had been successfully resuscitated after OHCA associated with ventricular fibrillation or pulseless ventricular tachycardia . Coronary artery disease is observed in up to 70% of patients with OHCA and immediate coronary angiography . Current European and American guidelines recommend immediate coronary angiography with primary angioplasty in OHCA patients with ST-segment elevation on ECG after successful resuscitation . Furthermore, the identification of the culprit lesion by coronary angiography among patients with an acute coronary syndrome (ACS) and no OHCA is challenging. In a recent cardiac magnetic resonance study, Heitner et al. found that in almost half of the patients with non-ST segment elevation ACS, the culprit lesion was not properly detected or identified by coronary angiography. In the Coronary Angiography after cardiac arrest (COACT) trial, a randomized controlled trial comparing immediate versus delayed coronary angiography after OHCA in patients without ST segment elevation on ECG, some degree of coronary artery disease was found in 64.5% of the patients in the immediate angiography group and an unstable coronary lesion was identified in only 13.6% of the patients. However, in survivors of OHCA without ST segment elevation on ECG, the use of intra coronary optical computerized tomography (OCT) led to identification of plaque rupture (27%), plaque erosion (36%) and coronary thrombosis (59%) undetected on angiography. There is hence a clear need to improve causality diagnosis among patients resuscitated after OHCA and without ST segment elevation on ECG, and, in the case of coronary artery disease detection, to better identify the culprit vessel/lesion ultimately leading to a targeted treatment. These are the reasons why we have designed a prospective, multi-centre, single cohort, diagnostic accuracy study: to better explore the incidence of a true ACS among OHCA survivors and to evaluate the accuracy of angiography to detect the culprit lesion when compared to OCT.

time_perspective: Prospective

ReferenceCitation: McDonnell SJ, Gates S, Perkins GD. Utstein recommendations for reporting out of hospital cardiac arrest (OHCA) registry studies-A review of the literature. Resuscitation. 2017;118:e103.

ReferenceCitation: Miller LM, Gal A. Cardiovascular system and lymphatic vessels. Pathologic basis of veterinary disease. 2017:561.

ReferenceCitation: Hepler MD, Schafer MF. Chapter 18 - Surgical Treatment of Lumbar Spinal Disorders. In: Benzon HT, Rathmell JP, Wu CL, Turk DC, Argoff CE, editors. Raj's Practical Management of Pain (Fourth Edition). Philadelphia: Mosby; 2008. p. 389-400.

ReferenceCitation: Marso SP. 23 - Revascularization Approaches. In: de Lemos JA, Omland T, editors. Chronic Coronary Artery Disease: Elsevier; 2018. p. 337-54.

ReferenceCitation: Ibrahim K, editor Increased rate of stentthrombosis due to clopidogrel resistance in patients in therapeutic hypothermia after sudden cardiac death. European Heart Journal; 2011: OXFORD UNIV PRESS GREAT CLARENDON ST, OXFORD OX2 6DP, ENGLAND.

ReferenceCitation: Degrell P, Picard F, Combaret N, Mogi S, Motreff P, Cariou A, Varenne O. Coronary atherothrombosis in cardiac arrest survivors without ST-segment elevation on ECG. Resuscitation. 2019 Jun;139:189-191. doi: 10.1016/j.resuscitation.2019.01.046. Epub 2019 Mar 27. No abstract available.

evidence: open (via free pdf)

ReferenceCitation: Garcia-Garcia HM, McFadden EP, Farb A, Mehran R, Stone GW, Spertus J, Onuma Y, Morel MA, van Es GA, Zuckerman B, Fearon WF, Taggart D, Kappetein AP, Krucoff MW, Vranckx P, Windecker S, Cutlip D, Serruys PW; Academic Research Consortium. Standardized End Point Definitions for Coronary Intervention Trials: The Academic Research Consortium-2 Consensus Document. Circulation. 2018 Jun 12;137(24):2635-2650. doi: 10.1161/CIRCULATIONAHA.117.029289.

repository_institution: University of Bern - Bern Open Repository and Information System

ReferenceCitation: Heitner JF, Senthilkumar A, Harrison JK, Klem I, Sketch MH Jr, Ivanov A, Hamo C, Van Assche L, White J, Washam J, Patel MR, Bekkers SCAM, Smulders MW, Sacchi TJ, Kim RJ. Identifying the Infarct-Related Artery in Patients With Non-ST-Segment-Elevation Myocardial Infarction. Circ Cardiovasc Interv. 2019 May;12(5):e007305. doi: 10.1161/CIRCINTERVENTIONS.118.007305.

ReferenceCitation: Lemkes JS, Janssens GN, van der Hoeven NW, Jewbali LSD, Dubois EA, Meuwissen M, Rijpstra TA, Bosker HA, Blans MJ, Bleeker GB, Baak R, Vlachojannis GJ, Eikemans BJW, van der Harst P, van der Horst ICC, Voskuil M, van der Heijden JJ, Beishuizen A, Stoel M, Camaro C, van der Hoeven H, Henriques JP, Vlaar APJ, Vink MA, van den Bogaard B, Heestermans TACM, de Ruijter W, Delnoij TSR, Crijns HJGM, Jessurun GAJ, Oemrawsingh PV, Gosselink MTM, Plomp K, Magro M, Elbers PWG, van de Ven PM, Oudemans-van Straaten HM, van Royen N. Coronary Angiography after Cardiac Arrest without ST-Segment Elevation. N Engl J Med. 2019 Apr 11;380(15):1397-1407. doi: 10.1056/NEJMoa1816897. Epub 2019 Mar 18.

repository_institution: University of Groningen / Centre for Information Technology - University of Groningen research database

ReferenceCitation: Noc M, Fajadet J, Lassen JF, Kala P, MacCarthy P, Olivecrona GK, Windecker S, Spaulding C; European Association for Percutaneous Cardiovascular Interventions (EAPCI); Stent for Life (SFL) Group. Invasive coronary treatment strategies for out-of-hospital cardiac arrest: a consensus statement from the European association for percutaneous cardiovascular interventions (EAPCI)/stent for life (SFL) groups. EuroIntervention. 2014 May;10(1):31-7. doi: 10.4244/EIJV10I1A7.

publisher_dissemination: Europa Digital & Publishing

ReferenceCitation: O'Gara PT, Kushner FG, Ascheim DD, Casey DE Jr, Chung MK, de Lemos JA, Ettinger SM, Fang JC, Fesmire FM, Franklin BA, Granger CB, Krumholz HM, Linderbaum JA, Morrow DA, Newby LK, Ornato JP, Ou N, Radford MJ, Tamis-Holland JE, Tommaso CL, Tracy CM, Woo YJ, Zhao DX; American College of Cardiology Foundation; American Heart Association Task Force on Practice Guidelines; American College of Emergency Physicians; Society for Cardiovascular Angiography and Interventions. 2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction: executive summary: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines: developed in collaboration with the American College of Emergency Physicians and Society for Cardiovascular Angiography and Interventions. Catheter Cardiovasc Interv. 2013 Jul 1;82(1):E1-27. doi: 10.1002/ccd.24776. Epub 2013 Jan 8. No abstract available.

ReferenceCitation: Patel N, Patel NJ, Macon CJ, Thakkar B, Desai M, Rengifo-Moreno P, Alfonso CE, Myerburg RJ, Bhatt DL, Cohen MG. Trends and Outcomes of Coronary Angiography and Percutaneous Coronary Intervention After Out-of-Hospital Cardiac Arrest Associated With Ventricular Fibrillation or Pulseless Ventricular Tachycardia. JAMA Cardiol. 2016 Nov 1;1(8):890-899. doi: 10.1001/jamacardio.2016.2860.

publisher_dissemination: American Medical Association

ReferenceCitation: Roger VL, Weston SA, Killian JM, Pfeifer EA, Belau PG, Kottke TE, Frye RL, Bailey KR, Jacobsen SJ. Time trends in the prevalence of atherosclerosis: a population-based autopsy study. Am J Med. 2001 Mar;110(4):267-73. doi: 10.1016/s0002-9343(00)00709-9.

ReferenceCitation: Zahger D. Immediate coronary angiography in survivors of out-of-hospital cardiac arrest. N Engl J Med. 1997 Oct 30;337(18):1321-2. doi: 10.1056/NEJM199710303371816. No abstract available.

ReferenceCitation: Spaulding CM, Joly LM, Rosenberg A, Monchi M, Weber SN, Dhainaut JF, Carli P. Immediate coronary angiography in survivors of out-of-hospital cardiac arrest. N Engl J Med. 1997 Jun 5;336(23):1629-33. doi: 10.1056/NEJM199706053362302.

ReferenceCitation: Jiangping S, Zhe Z, Wei W, Yunhu S, Jie H, Hongyue W, Hong Z, Shengshou H. Assessment of coronary artery stenosis by coronary angiography: a head-to-head comparison with pathological coronary artery anatomy. Circ Cardiovasc Interv. 2013 Jun;6(3):262-8. doi: 10.1161/CIRCINTERVENTIONS.112.000205. Epub 2013 May 21.

ReferenceCitation: Penela D, Magaldi M, Fontanals J, Martin V, Regueiro A, Ortiz JT, Bosch X, Sabate M, Heras M. Hypothermia in acute coronary syndrome: brain salvage versus stent thrombosis? J Am Coll Cardiol. 2013 Feb 12;61(6):686-7. doi: 10.1016/j.jacc.2012.10.029. Epub 2012 Dec 19. No abstract available.

ReferenceCitation: Joffre J, Varenne O, Bougouin W, Rosencher J, Mira JP, Cariou A. Stent thrombosis: an increased adverse event after angioplasty following resuscitated cardiac arrest. Resuscitation. 2014 Jun;85(6):769-73. doi: 10.1016/j.resuscitation.2014.02.013. Epub 2014 Feb 23.

ReferenceCitation: Bjelland TW, Hjertner O, Klepstad P, Kaisen K, Dale O, Haugen BO. Antiplatelet effect of clopidogrel is reduced in patients treated with therapeutic hypothermia after cardiac arrest. Resuscitation. 2010 Dec;81(12):1627-31. doi: 10.1016/j.resuscitation.2010.07.002. Epub 2010 Aug 19.

ReferenceCitation: Rosencher J, Gouffran G, Bougouin W, Varenne O. Optimal antiplatelet therapy in out-hospital cardiac arrest patients treated by primary percutaneous coronary intervention. Resuscitation. 2015 May;90:e7-8. doi: 10.1016/j.resuscitation.2015.02.030. Epub 2015 Mar 7. No abstract available.

ReferenceCitation: Adrie C, Adib-Conquy M, Laurent I, Monchi M, Vinsonneau C, Fitting C, Fraisse F, Dinh-Xuan AT, Carli P, Spaulding C, Dhainaut JF, Cavaillon JM. Successful cardiopulmonary resuscitation after cardiac arrest as a "sepsis-like" syndrome. Circulation. 2002 Jul 30;106(5):562-8. doi: 10.1161/01.cir.0000023891.80661.ad.

location_facility: Clinical Center of Serbia. School of medicine


title: Inhaled Sedation in COVID-19-related Acute Respiratory Distress Syndrome (ISCA): an International Research Data Study in the Recent Context of Widespread Disease Resulting From the 2019 (SARS-CoV2) Coronavirus Pandemics (COVID-19)

acronym: ISCA

summary:
The authors hypothesized that inhaled sedation, either with isoflurane or sevoflurane, might be associated with improved clinical outcomes in patients with COVID-19-related ARDS, compared to intravenous sedation.

The authors therefore designed the "Inhaled Sedation for COVID-19-related ARDS" (ISCA) non-interventional, observational, multicenter study of data collected from the patients' medical records in order to:

assess the efficacy of inhaled sedation in improving a composite outcome of mortality and time off the ventilator at 28 days in patients with COVID-19-related ARDS, in comparison to a control group receiving intravenous sedation (primary objective),
investigate the effects of inhaled sedation, compared to intravenous sedation, on lung function as assessed by gas exchange and physiologic measures in patients with COVID-19-related ARDS (secondary objective),
report sedation practice patterns in critically ill patients during the COVID-19 pandemics (secondary objective).

time_perspective: Retrospective

ReferenceCitation: Blondonnet R, Quinson A, Lambert C, Audard J, Godet T, Zhai R, Pereira B, Futier E, Bazin JE, Constantin JM, Jabaudon M. Use of volatile agents for sedation in the intensive care unit: A national survey in France. PLoS One. 2021 Apr 15;16(4):e0249889. doi: 10.1371/journal.pone.0249889. eCollection 2021.

license: cc-by

license_normalized: cc-by

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

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

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

publisher_dissemination: Public Library of Science

ipd_sharing: Undecided

lead_sponsor: University Hospital, Clermont-Ferrand

collaborators: Hospital Clínico Universitario de Valencia

location_country:
Germany
Switzerland
United States
Spain
France

location_facility: University Medical Center Schleswig-Holstein

location_facility: Beth Israel Deaconess Medical Center, Inc.


title: Oxytocin Treatment in Neonates and Infants Aged From 0 to 3 Months With Prader-Willi Syndrome : a Study of Safety and Efficacy on Oral and Social Skills and Feeding Behavior of Intranasal Administration of Oxytocin vs Placebo

summary: Prospective, randomized, placebo-controlled, double-blind part of the phase III trial to assess the safety and efficacy of 4 weeks oxytocin (OT) administration on oral and social skills in neonates/infants with Prader-Willi Syndrome (PWS) aged less than 3 months at inclusion. Phase III clinical trial.

ReferenceCitation: Borie AM, Dromard Y, Guillon G, Olma A, Manning M, Muscatelli F, Desarmenien MG, Jeanneteau F. Correction of vasopressin deficit in the lateral septum ameliorates social deficits of mouse autism model. J Clin Invest. 2021 Jan 19;131(2):e144450. doi: 10.1172/JCI144450.

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

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - memSIC

publisher_dissemination: American Society for Clinical Investigation

lead_sponsor: University Hospital, Toulouse

collaborators: International Clinical Trials Association

collaborators: Epidemiological and Clinical Research Information Network

location_country: Germany Belgium France

location_facility: Groupe Hospitalier Necker - Enfants Malades

location_facility: Centre de réfrence Prader-Willi, Hospital of infants

appel_a_projets: PHRCN

region: Occitanie

nom_etablissement: CHU TOULOUSE

type_etablissement: CH

titre: Traitement par ocytocine en période post-natale dans le syndrome de Prader-Willi: Effets à court et à long terme d'administrations quotidiennes pendant 7 jours chez des bébés de 0 à 5 mois sur la succion/déglutition, le développement et les compétences socio-cognitives (Essai clinique de phase III).

discipline_principale: endocrinologie / diabétologie / métabolisme et nutrition

nom_porteur: TAUBER

prenom_porteur: Maithe


title: PHIL Evaluation in the Endovascular Treatment of Intracranial Cerebral ArterioVenous Malformation a European Multi-center, Observational, Prospective, Single Arm and Open Label Study

summary: The primary objective of this study is to assess the efficacy and safety of PHIL® liquid embolic agent in endovascular embolization of cerebral arteriovenous malformations.

lead_sponsor: Microvention-Terumo, Inc.

sponsor_collaborators:
Microvention-Terumo, Inc.
ClinSearch

location_country:
France
United Kingdom
Denmark
Spain
Sweden

location_facility: Hospital Universitario General de Catalunya

location_facility: Hospital Regional Universitario Carlos Haya

location_facility: Hospital Universitario Virgen de la Arrixaca


title: PHIL Evaluation in the Endovascular Treatment of Intracranial Dural AVF, a European Multi-center, Observational, Prospective, Single Arm and Open Label Study.

summary: The primary objective of this study is to demonstrate the safety and efficacy of the PHIL® liquid in endovascular treatment of dural arteriovenous fistula.


title: Phase II Study of an Association of L-asparaginase-Methotrexate-Dexamethasone for Relapsing and/or Refractory Nasal and Nasal-type NK-T-cell Lymphoma

summary:
Nasal/nasal type NK-T-cell lymphoma is a rare and severe type of non-Hodgkin's lymphoma (NHL) more frequent in Asia than in western countries. When localised, radiotherapy seems to be the best treatment. When radiotherapy cannot be used because of dissemination or relapse, chemotherapy protocols used for other types of NHL give poor results and survival is poor. Recently papers from China and Japan reported the efficacy of a drug: l-asparaginase, usually used to treat acute lymphoblastic leukemia. In vitro a selective apoptosis of NK-cell tumours by l-asparaginase was shown on tumour cell lines and samples.

The investigators propose a phase II protocol for patients with refractory or relapsing nasal/nasal type NK-T-cell lymphoma using a regimen combining l-asparaginase, methotrexate and dexamethasone. Biological studies will be conducted trying to find factors which could predict responses to this chemotherapy.

Since january 2009, the study concerns all patients with nasal/nasal type NK-T-cell lymphoma who have not received asparaginase before.

ReferenceCitation: Jaccard A, Gachard N, Marin B, Rogez S, Audrain M, Suarez F, Tilly H, Morschhauser F, Thieblemont C, Ysebaert L, Devidas A, Petit B, de Leval L, Gaulard P, Feuillard J, Bordessoule D, Hermine O; GELA and GOELAMS Intergroup. Efficacy of L-asparaginase with methotrexate and dexamethasone (AspaMetDex regimen) in patients with refractory or relapsing extranodal NK/T-cell lymphoma, a phase 2 study. Blood. 2011 Feb 10;117(6):1834-9. doi: 10.1182/blood-2010-09-307454. Epub 2010 Dec 1.

lead_sponsor: University Hospital, Limoges

location_facility: Service d'Hématologie Clinique, CHU de Reims

location_facility: Service de Radiothérapie, Polyclinique Bordeaux Nord

location_facility: Service d'Immunologie Clinique 2, Hôpital Saint Louis

location_facility: Service d'Hématologie et de Thérapie Cellulaire - CHU Limoges

location_facility: Département d'Immuno-Hématologie, Hôpital Saint-Louis

location_facility: Service d'Hématologie Clinique, Groupe Hospitalier Pitié-Salpétrière

location_facility: Département d'Oncologie - Institut Paoli Calmettes

location_facility: Service d'Hématologie Clinique, Groupe Hospitalier Necker

location_facility: Service d'Hématologie Clinique, CHU Dijon

location_facility: Service d'Hématologie Clinique - Hôpital Henri Mondor


title: Age-adjusted D-dimer Cut-off to Rule Out Pulmonary Embolism in the Emergency Department : A Real Life Impact Study

acronym: RELAX-PE

summary:
A multicentre multinational prospective management outcome study has recently proven the safety of a diagnostic strategy combining clinical probability assessment with an age-adjusted D-dimer cut-off, defined as a value of (age x 10) in patients > 50 years, for ruling out PE in outpatients, with a very low likelihood of subsequent symptomatic VTE. Moreover, this study showed that such a strategy increased the diagnostic yield of D-dimers, as it allowed ruling out PE without further investigation in a significantly higher proportion of patients than when using standard cut-off, particularly so in patients 75 years or older.

The objective of the present study is to confirm in a prospective cohort of "real life" patients the usefulness of the age-adjusted D-dimer cut-off to rule out PE in patients presenting to the emergency department with suspected PE.

ReferenceCitation: Righini M, Van Es J, Den Exter PL, Roy PM, Verschuren F, Ghuysen A, Rutschmann OT, Sanchez O, Jaffrelot M, Trinh-Duc A, Le Gall C, Moustafa F, Principe A, Van Houten AA, Ten Wolde M, Douma RA, Hazelaar G, Erkens PM, Van Kralingen KW, Grootenboers MJ, Durian MF, Cheung YW, Meyer G, Bounameaux H, Huisman MV, Kamphuisen PW, Le Gal G. Age-adjusted D-dimer cutoff levels to rule out pulmonary embolism: the ADJUST-PE study. JAMA. 2014 Mar 19;311(11):1117-24. doi: 10.1001/jama.2014.2135. Erratum In: JAMA. 2014 Apr 23-30;311(16):1694.

repository_institution: University of Liège - Open Repository and Bibliography

ReferenceCitation: Robert-Ebadi H, Robin P, Hugli O, Verschuren F, Trinh-Duc A, Roy PM, Schmidt J, Fumeaux T, Meyer G, Hayoz D, Carron PN, Salaun PY, Sarasin F, Rutschmann O, Le Gal G, Righini M. Impact of the Age-Adjusted D-Dimer Cutoff to Exclude Pulmonary Embolism: A Multinational Prospective Real-Life Study (the RELAX-PE Study). Circulation. 2021 May 4;143(18):1828-1830. doi: 10.1161/CIRCULATIONAHA.120.052780. Epub 2021 May 3. No abstract available.

lead_sponsor: University Hospital, Geneva

collaborators: Centre Hospitalier Universitaire Vaudois

location_facility: Groupement Hospitalier de l'Ouest Lémanique

intervention_type: Other


title: A Prospective, Multi-center, Open-label, Single-arm, Phase 2 Study to Assess the Efficacy and Safety of Clazosentan in Reversing Angiographically-confirmed Cerebral Vasospasm in Adult Subjects With Aneurysmal Subarachnoid Hemorrhage (aSAH) Treated by Surgical Clipping or Endovascular Coiling

acronym: REVERSE

summary: The purpose of this study is to evaluate the safety and potential therapeutic benefit of use of clazosentan in reversing cerebral vasospasm (a narrowing of blood vessels in the brain due to the presence of blood in the space around the brain) in patients who have suffered a condition known as aneurysmal subarachnoid hemorrhage caused by bleeding onto the surface of the brain from a ruptured brain aneurysm

lead_sponsor: Idorsia Pharmaceuticals Ltd.

location_country: Finland Switzerland France

location_facility:
Site 3004
Site 1006
Site 1005
Site 1001
Site 3001
Site 3005
Site 1002
Site 3003
Site 3002
Site 1004
Site 2002


summary:
Objectives:

Primary Objective:

To identify and preselect patients with chronic HBV mono infection, who are undetectable for anti-Ad5 nAb, currently being treated with nucleo(t)sides, for participation in the TG1050.02 Phase1/1b First in Man (FIM) study.

Secondary Objectives:

To assess the prevalence of undetectable anti-Ad5 nAb in chronic HBV mono-infected patients.

Methodology:

Patients with chronic HBV mono-infection, who are currently being treated with nucleo(t)sides for their HBV infection, will be enrolled in this study to measure Ad5 nAb levels. A single peripheral blood collection (4 mL) will be obtained and Ad5 nAb titers will be measured by a central laboratory using a newly validated assay.

primary_purpose: Screening

lead_sponsor: Transgene

location_country: Germany Canada France


title: Efficacy of EGb 761® 120mg Twice a Day Versus Placebo on Cognitive Impairment in Patients With Multiple Sclerosis. A Randomised, Double-blind, Multicentre, Parallel Groups Placebo Controlled Phase III Study.

summary: The purpose of this study is to determine whether the use of EGb 761 by patients with Relapsing-Remitting Multiple Sclerosis is effective in improving cognition, when compared to placebo.

lead_sponsor: Ipsen

location_facility:
CHU Hôpital de Pontchaillou
Hôpital J. Minjoz
Hôpital Saint Joseph
Hôpital Laënnec
14 bis Rue du Chapeau Rouge
Hôpital Gui de Chauliac
Centre Hospitalier du Pays d'Aix
Groupe Hospitalier Pellegrin
Centre Hospitalier
Hôpital Léopold Bellan
Hôpital Universitaire Dupuytren
CHG Dijon
Hôpital Charles Nicolle
CHU de Reims - Hôpital Maison Blanche
Hôpital Civil de Colmar
Hôpital de la cavale Blanche
Centre Hospitalier René Dubos
Hôpital Central
Hôpital Neurologique
CHU de Bordeaux
Hôpital Delafontaine
Hopital Nord
Hôpital Henri Mondor
Hôpital Nord - CHU d'Amiens
CHU Hôpital Gabriel Montpied
Hôpital Pasteur
Centre Hospitalier François
Hôpital Guillaume et Réne
Cabinet Médical


title: Phase II-III Study of an Optimized LV-5FU-Oxaliplatin Strategy in Metastatic Colorectal Cancer. Optimox2 Study. C02-2

summary:
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating colorectal cancer.

PURPOSE: This randomized phase II/III trial is studying two combination chemotherapy regimens to compare how well they work in treating patients with metastatic colorectal cancer that cannot be removed by surgery.

ReferenceCitation: Chibaudel B, Maindrault-Goebel F, Lledo G, Mineur L, Andre T, Bennamoun M, Mabro M, Artru P, Carola E, Flesch M, Dupuis O, Colin P, Larsen AK, Afchain P, Tournigand C, Louvet C, de Gramont A. Can chemotherapy be discontinued in unresectable metastatic colorectal cancer? The GERCOR OPTIMOX2 Study. J Clin Oncol. 2009 Dec 1;27(34):5727-33. doi: 10.1200/JCO.2009.23.4344. Epub 2009 Sep 28.

lead_sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

location_facility:
Polyclinique De Courlancy
Hopital Duffaut
Centre Hospitalier de Dreux
Hopital Robert Boulin
Clinique Saint Jean
Clinique des Jockeys
Hopital Drevon
Hopital Louis Pasteur - Le Coudray
Intercommunal Hospital
Infirmerie Protestante
Hopital Europeen Georges Pompidou
Centre Medico-Chirurgical Foch
Hopital Tenon
Hopital Saint Antoine
C.H. Senlis
Clinique Victor Hugo
Institut Sainte Catherine


title: Essai De Phase III De Chimiotherapie Par FOLFOX 4 Ou Par Une Succession FOLFOX 7 - FOLFIRI Chez Des Patients Ayant Des Metastases Resecables D'Origine Colorectale - MIROX

acronym: MIROX

summary: PURPOSE: This randomized phase III trial is studying two different combination chemotherapy regimens to compare how well they work in treating patients with colorectal cancer and resectable metastases.

ReferenceCitation: Hamidou Z, Chibaudel B, Hebbar M, Hug de Larauze M, Andre T, Louvet C, Brusquant D, Garcia-Larnicol ML, de Gramont A, Bonnetain F. Time to Definitive Health-Related Quality of Life Score Deterioration in Patients with Resectable Metastatic Colorectal Cancer Treated with FOLFOX4 versus Sequential Dose-Dense FOLFOX7 followed by FOLFIRI: The MIROX Randomized Phase III Trial. PLoS One. 2016 Jun 16;11(6):e0157067. doi: 10.1371/journal.pone.0157067. eCollection 2016.

repository_institution: PubMed Central - Europe PMC

evidence: oa repository (semantic scholar lookup)

repositories_concat: PubMed Central;pdfs.semanticscholar.org

ReferenceCitation: Hebbar M, Chibaudel B, Andre T, Mineur L, Smith D, Louvet C, Dutel JL, Ychou M, Legoux JL, Mabro M, Faroux R, Auby D, Brusquant D, Khalil A, Truant S, Hadengue A, Dalban C, Gayet B, Paye F, Pruvot FR, Bonnetain F, Landi B, Flesch M, Carola E, Martin P, Vaillant E, de Gramont A; Group Cooperateur Multidisciplinaire en Oncologie (GERCOR) Group. FOLFOX4 versus sequential dose-dense FOLFOX7 followed by FOLFIRI in patients with resectable metastatic colorectal cancer (MIROX): a pragmatic approach to chemotherapy timing with perioperative or postoperative chemotherapy from an open-label, randomized phase III trial. Ann Oncol. 2015 Feb;26(2):340-7. doi: 10.1093/annonc/mdu539. Epub 2014 Nov 17. Erratum In: Ann Oncol. 2015 May;26(5):1040. Taieb, J [removed]; Brucker, P [removed].

sponsor_collaborators: GERCOR - Multidisciplinary Oncology Cooperative Group

location_facility: Centre Hospital Universitaire Hop Huriez

location_facility: Centre Hospitalier Intercommunal Le Raincy - Montfermeil

location_facility: Clinique Specialise du Littoral-Cote d'Opale


title: A Randomized, Double-Blind, Comparative Parallel Group Study of Analgesic Effectiveness and Safety of Three Different Doses of Lamaline® New Formulation vs Dafalgan® Codeine, After 10 Days Administration in Subjects With Painful Gonarthrosis.

summary: This study aims to assess the analgesic effectiveness and safety of three different doses of a new formulation of Lamaline® versus Dafalgan® Codeine after 10 days administration in subjects with painful gonarthrosis

location_facility:
Site 127
Site 26
Site 55
Site 36
Site 453
Site 204
Site 68
Site 451
Site 321
Site 35
Site 46
Site 44
Site 31
Site 39
Site 66
Site 62
Site 120
Site 72
Site 75
Site 20
Site 24
Site 47
Site 71
Site 73
Site 8
Site 70
Site 316
Site 6
Site 494
Site 37
Site 11
Site 457
Site 109
Site 124
Site 21
Site 320
Site 52
Site 115
Site 462
Site 138
Site 133
Site 74
Site 34
Site 76
Site 3
Site 122
Site 209
Site 16
Site 410
Site 503
Site 22
Site 121
Site 208
Site 13
Site 126
Site 45
Site 49
Site 128
Site 449
Site 78
Site 61
Site 228
Site 225
Site 57
Site 489
Site 314
Site 461
Site 69
Site 29
Site 301
Site 506
Site 30
Site 502
Site 79
Site 313
Site 112
Site 102
Site 458
Site 134
Site 137
Site 77
Site 9
Site 507
Site 107
Site 498
Site 7
Site 136
Site 488
Site 101
Site 219
Site 60
Site 58
Site 110
Site 401
Site 67
Site 306
Site 130
Site 23
Site 53
Site 65
Site 117
Site 116
Site 132
Site 123
Site 4
Site 54
Site 423
Site 18
Site 215
Site 432
Site 129
Site 202
Site 131
Site 213
Site 28
Site 413
Site 32
Site 103
Site 64
Site 41
Site 43
Site 105
Site 14
Site 63
Site 433
Site 405
Site 42
Site 51
Site 40
Site 12
Site 25
Site 315
Site 459
Site 207
Site 27
Site 140
Site 19
Site 302
Site 15
Site 104
Site 318
Site 17
Site 402
Site 118
Site 33
Site 50
Site 139
Site 201
Site 496
Site 2
Site 511
Site 414
Site 125
Site 59
Site 454
Site 114
Site 224
Site 56
Site 221
Site 135
Site 48
Site 106
Site 10
Site 495
Site 119
Site 5
Site 113
Site 38
Site 319
Site 108
Site 460


title: Multicenter Study, Randomized and Pragmatic, Comparing Two Therapeutic Strategies : Use or Non-use of Epoetin Beta in Patients Infected by Chronic Hepatitis C and Treated by Combination Therapy Peginterferon Alfa-2a Plus Ribavirin

summary: The purpose is to demonstrate a correction of anemia in hepatitis C virus treatment with peginterferon plus ribavirin.

lead_sponsor: University Hospital, Angers

location_facility:
UH Clermont Ferrand
H Montauban
H Orléans
H Grasse
H Le Mans
H Tenon
UH Grenoble
UH Rouen
UH Tours
UH Caen
H Tourcoing
H Châteauroux
UH Limoges
H saint-Antoine
H La Roche sur Yon
UH Lyon
H Corbeil-Essonnes
H Saint-Joseph
H Pau
H Creil
UH Montpellier
UH Toulouse
H Avignon
H Saint-Dizier
UH Dijon
H Freyming-Merlebach
H Dreux
H Aix en Provence
H Créteil
UH Poitiers
UH Nantes
Arnault Tzanck Institute
H Bourgoin-Jallieu
UH Brest
H montélimar
UH Rennes
UH Angers


title: Open-Label, Multi-Center, Phase 2 Study of Anti-CCR4 Monoclonal Antibody KW-0761 (Mogamulizumab) in Subjects With Previously Treated Peripheral T-cell Lymphoma (PTCL)

summary: The primary objective of this study is to determine the overall response rate of KW-0761 for the treatment of patients with relapsed or refractory PTCL. KW-0761 targets CCR4. CCR4 is the receptor for macrophage derived chemokines MDC/CCL22 and TARC/CCL17. Chemokines are considered to play a role both in the recruitment of immune and inflammatory cells for anti-tumor response and in the selective homing of neoplastic B and T cells.

ReferenceCitation: Zinzani PL, Karlin L, Radford J, Caballero D, Fields P, Chamuleau ME, d'Amore F, Haioun C, Thieblemont C, Gonzalez-Barca E, Garcia CG, Johnson PW, van Imhoff GW, Ng T, Dwyer K, Morschhauser F. European phase II study of mogamulizumab, an anti-CCR4 monoclonal antibody, in relapsed/refractory peripheral T-cell lymphoma. Haematologica. 2016 Oct;101(10):e407-e410. doi: 10.3324/haematol.2016.146977. Epub 2016 Jul 14. No abstract available.

endpoint_id: fhisxppmrqpajgzqkvft

repository_institution: Alma Mater Studiorum Università di Bologna - Archivio istituzionale della ricerca - Alma Mater Studiorum Università di Bologna

repository_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

repositories_institution: University of Groningen / Centre for Information Technology - University of Groningen research database

publisher_dissemination: Ferrata Storti Foundation (Haematologica)

lead_sponsor: Kyowa Hakko Kirin Pharma, Inc.

location_country:
Italy
United Kingdom
Denmark
Netherlands
Spain
France

location_facility: Institut Catalá D'Oncologia, Hospital Duran y Reynals

location_facility: Universitair Medisch Centrum Groningen (UMCG)

location_facility: Vrije Universiteit Medisch Centrum (VUMC)

location_facility: Cancer Research UK Centre/Southhampton General Hospital

location_facility: Hospital Clínico Universitario de Salamanca

intervention_type: Biological


title: DOVIGIST: Phase II Trial to Evaluate the Efficacy and Safety of Dovitinib (TKI258) in Patients With Gastrointestinal Stromal Tumors Refractory and/or Intolerant to Imatinib

summary: The purpose of this study is to evaluate the efficacy and safety of Dovitinib in patients with gastrointestinal stromal tumors refractory and/or intolerant to Imatinib

lead_sponsor: Novartis Pharmaceuticals

location_country: Finland Italy Germany Spain France


acronym: REASON

summary: This study investigates the safety and efficacy of Acetyl-L-Carnitine and compares it to the safety and efficacy of a placebo (inactive) tablet in the prevention of Sagopilone-induced peripheral neuropathy. Patients will receive intravenous infusion of sagopilone for 3 hours on day 1 of a 3-weeks cycle. Treatment with Sagopilone will be given as long as the patient is benefitting. In addition patients will receive ALC or placebo, starting 1 week before first sagopilone infusion and ending 30-33 days after the last infusion with sagopilone. Safety will be determined by laboratory and other evaluations. Efficacy of ALC will be determined by the incidence of all grades of peripheral neuropathy with the results of a patient questionnaire. Efficacy of the combination of ALC and Sagopilone will be determined by the tumor response.

ReferenceCitation: Campone M, Berton-Rigaud D, Joly-Lobbedez F, Baurain JF, Rolland F, Stenzl A, Fabbro M, van Dijk M, Pinkert J, Schmelter T, de Bont N, Pautier P. A double-blind, randomized phase II study to evaluate the safety and efficacy of acetyl-L-carnitine in the prevention of sagopilone-induced peripheral neuropathy. Oncologist. 2013;18(11):1190-1. doi: 10.1634/theoncologist.2013-0061. Epub 2013 Oct 8.

title: (REASON) Double-blind, Randomized Phase II Study to Evaluate the Safety and Efficacy of Acetyl-l-carnitine in the Prevention of Sagopilone-induced Peripheral Neuropathy.

location_country:
Germany
Italy
United Kingdom
Netherlands
Belgium
France


title: Prospective, Open-Label, Non-Comparative, Multicenter Study for the Secondary Prophylaxis of Invasive Fungal Infections (IFI) With Voriconazole in Patients With Allogeneic Stem Cell Transplants (SCT).

acronym: VOSIFI

summary: To prevent recurrence of invasive fungal infection in patients with allogeneic stem cell transplants

lead_sponsor: Pfizer

collaborators: European Society for Blood and Marrow Transplantation

location_country:
Germany
Portugal
United Kingdom
Sweden
Switzerland
Belgium
Spain
France


title: Randomized Phase II of TARCEVA™ (Erlotinib) Versus Temozolomide Or BCNU in Patients With Recurrent Glioblastoma Multiforme

summary:
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as temozolomide and carmustine, work in different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether erlotinib is more effective than temozolomide or carmustine in treating recurrent glioblastoma multiforme.

PURPOSE: This randomized phase II trial is studying erlotinib to see how well it works compared to temozolomide or carmustine in treating patients with recurrent glioblastoma multiforme.

ReferenceCitation: van den Bent MJ, Brandes AA, Rampling R, Kouwenhoven MC, Kros JM, Carpentier AF, Clement PM, Frenay M, Campone M, Baurain JF, Armand JP, Taphoorn MJ, Tosoni A, Kletzl H, Klughammer B, Lacombe D, Gorlia T. Randomized phase II trial of erlotinib versus temozolomide or carmustine in recurrent glioblastoma: EORTC brain tumor group study 26034. J Clin Oncol. 2009 Mar 10;27(8):1268-74. doi: 10.1200/JCO.2008.17.5984. Epub 2009 Feb 9.

ReferenceCitation: van den Bent MJ, Brandes A, Rampling R, et al.: Randomized phase II trial of erlotinib (E) versus temozolomide (TMZ) or BCNU in recurrent glioblastoma multiforme (GBM): EORTC 26034. [Abstract] J Clin Oncol 25 (Suppl 18): A-2005, 2007.

lead_sponsor: European Organisation for Research and Treatment of Cancer - EORTC

location_country:
Italy
United Kingdom
Netherlands
Belgium
France

location_facility: University Medical Center Rotterdam at Erasmus Medical Center

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


title: Randomized Phase II Study Evaluating the Efficacy of Gemcitabine Versus the Gemcitabine/Docetaxel Combination as Second Line Treatment in Metastatic or Relapsed and Inoperable Uterine or Soft Tissue Leiomyosarcomas

summary:
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether giving gemcitabine together with docetaxel is more effective than giving gemcitabine alone as second-line therapy in treating uterine or soft tissue leiomyosarcoma.

PURPOSE: This randomized phase II trial is studying gemcitabine and docetaxel to see how well they work compared to gemcitabine alone as second-line therapy in treating patients with metastatic or relapsed, unresectable uterine or soft tissue leiomyosarcoma.

ReferenceCitation: Duffaud F, Bui BN, Penel N, et al.: A FNCLCC French Sarcoma Group--GETO multicenter randomized phase II study of gemcitabine (G) versus gemcitabine and docetaxel (G+D) in patients with metastatic or relapsed leiomyosarcoma (LMS). [Abstract] J Clin Oncol 26 (Suppl 15): A-10511, 2008.

ipd_sharing_description: Individual participant data will not be shared at an individual level.

lead_sponsor: UNICANCER

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

location_facility: Centre Hospitalier Universitaire Bretonneau de Tours

location_facility: Centre Hospitalier Universitaire d'Amiens


title: Evaluation of a New Therapeutic Strategy in Early and Active Relapsing-Remitting Multiple Sclerosis: Induction Treatment With Mitoxantrone Followed by Long-Term Treatment With Interferon-beta1b

summary: The aim of the study is to determine whether a therapeutic strategy combining mitoxantrone and interferon beta1b can delay disease progression of at least one point on EDSS scale in patients with clinically very active relapsing-remitting multiple sclerosis.

lead_sponsor: Rennes University Hospital

collaborators: Wyeth is now a wholly owned subsidiary of Pfizer

location_country: Italy France

location_facility: Dipartimento di Scienze Neurologiche e Psichiatriche

location_facility: Psichiatriche dell'Università di Bari, Policlinico

location_facility: Clinica Neurologica Università di Torino


title: Multicentric Phase II Study Evaluating the Efficacy and Toxicity of Weekly Paclitaxel in Locally Advanced or Metastatic Soft Tissue Angiosarcomas That Cannot be Treated by Surgery

summary:
RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well paclitaxel works in treating patients with locally advanced or metastatic soft tissue angiosarcoma or lymphangiosarcoma that cannot be removed by surgery.

ReferenceCitation: Penel N, Bui BN, Bay JO, Cupissol D, Ray-Coquard I, Piperno-Neumann S, Kerbrat P, Fournier C, Taieb S, Jimenez M, Isambert N, Peyrade F, Chevreau C, Bompas E, Brain EG, Blay JY. Phase II trial of weekly paclitaxel for unresectable angiosarcoma: the ANGIOTAX Study. J Clin Oncol. 2008 Nov 10;26(32):5269-74. doi: 10.1200/JCO.2008.17.3146. Epub 2008 Sep 22.

location_facility: Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz


type: Other Grant/Funding Number

title: Radiation Dose Intensity Study in Breast Cancer in Young Women: a Randomized Phase III Trial of Additional Dose to the Tumor Bed

summary: hypothesis: 10 Gy additional boost to the tumor bed will yield an increase in local control at 10 years from 88% to 93%, with still acceptable cosmesis.

status: Active, not recruiting

lead_sponsor: The Netherlands Cancer Institute

sponsor_collaborators:
The Netherlands Cancer Institute
UNICANCER

location_country: Netherlands France

location_facility:
Institut Bergonié
Centre Hospitalier Lyon Sud
Centre Val d'Aurelle
Centre Antoine Lacassagne
Hôpital Saint Louis
Centre René Huguenin
CHU de Tours
The Netherlands Cancer Institute
Hôpital J-Minjoz
CHU Henri Mondor
Centre René Gauducheau
Institut Gustave Roussy
Centre Oscar Lambret
Centre Paul Strauss
Centre Eugène Marquis
Institut Paoli Calmettes
Centre Henri Becquerel
Institut Curie


title: A Post Marketing Surveillance Study of Dysport Formulated With a Batch of Bulk Active Substance From a New Primary Manufacturing Facility at the Centre for Applied Microbiology & Research (CAMR)

summary: The purpose of this study is to provide further information regarding the risks and benefits of Dysport in marketed indications.

location_country:
Germany
Russian Federation
France

location_facility: Institute of Medical Aestetic "Vallex-M"

location_facility: Scientific Research Institute of Neurology

location_facility: Federal Centre "Pediatric Rehabilitology"

location_facility: Centre for Aesthetic Dermatology and Surgery of Russian Academy of Sciences

location_facility: Klinikum der Stadt Villingen-Schwenningen

location_facility: Centre of plastic surgery "Reconstruction and Recreation"

location_facility: Alma-Ata State Institute of Postgraduate Education


title: Development of an Evaluation Method of Elderly Condition in Patient Receiving Chemotherapy Treatment . Geriatric Oncology Protocol in Aquitaine Country.

summary: Incidence of cancer in 75+ years old is 16,500 new cases per year, more than fifty percent of people with cancerThey are very few therapeutic trials dedicated. Oncologists hesitate to treat them because they are either afraid of inducing toxicity or of breaking down quality of life. Consequently, we decided to launch a protocol with both oncologists and geriatricians which principal aim is to find out if geriatric assessment data can help to better predict for chemotherapy toxicity, loss of autonomy and survival. We plan to accrue 360 patients diagnosed for cancer, including digestive, pulmonary, prostate, lymphoma, bladder, ovary cancer for whom first-line chemotherapy is planned. Patients are initially classified according to usual methods of medical oncology practice into three groups: patients who can receive standard treatment, reduced standard treatment or treatment adapted to the frail condition. Around Aquitaine, , we organised seven teams composed of one geriatrician and one nurse. Two kind of teams were activated: one which cover ten treatment sites in Bordeaux area and six sedentary teams which worked half a day a week in designated hospitals . Geriatric evaluation included test of cognitive functions (MMS), nutritional status (MNA), co-morbidity (CIRS-G), mobility (Get up and Go), activities (ADL;IADL), quality of life (QLQ-C30), depression (GDS-15) and Lachs-Balducci screening. Patients have four geriatric evaluations : before treatment, day 1 cycle 2, day 1 cycle 4, day 1 cycle 7 and/or end of chemotherapy. Since September 2002, 177 patients have been included, 112 have finished: 47.3% have received four evaluations, 16.1% died before the end of protocol, 14.3% stopped because they were in progression and changed their treatment, 11.6% met administrative problem that didn't allow all evaluations, 7.1% declined after inclusion and 3.6% finished their treatment before. The following results have been obtained: before treatment, 73% of these patients were at risk of undernutrition (MNA< 23.5), about 1/3 had one or more inability or a risk of falls (38% IADL<6, 29% get up and go>20seconds, 27% ADL>1, 34% PS<1), 28% of them had altered cognitive functions (MMS<24), 29% were depressive (GDS-15>6), 25% thought they had poor quality of life (QLQ-C30<4). Protocol will be closed in September 2005.

ReferenceCitation: Soubeyran P, Fonck M, Blanc-Bisson C, Blanc JF, Ceccaldi J, Mertens C, Imbert Y, Cany L, Vogt L, Dauba J, Andriamampionona F, Houede N, Floquet A, Chomy F, Brouste V, Ravaud A, Bellera C, Rainfray M. Predictors of early death risk in older patients treated with first-line chemotherapy for cancer. J Clin Oncol. 2012 May 20;30(15):1829-34. doi: 10.1200/JCO.2011.35.7442. Epub 2012 Apr 16.

ReferenceCitation: Hoppe S, Rainfray M, Fonck M, Hoppenreys L, Blanc JF, Ceccaldi J, Mertens C, Blanc-Bisson C, Imbert Y, Cany L, Vogt L, Dauba J, Houede N, Bellera CA, Floquet A, Fabry MN, Ravaud A, Chakiba C, Mathoulin-Pelissier S, Soubeyran P. Functional decline in older patients with cancer receiving first-line chemotherapy. J Clin Oncol. 2013 Nov 1;31(31):3877-82. doi: 10.1200/JCO.2012.47.7430. Epub 2013 Sep 23.

lead_sponsor: Institut Bergonié

sponsor_collaborators:
Institut Bergonié
Sanofi-Synthelabo
Aventis Pharmaceuticals
Amgen
Chugai Pharmaceutical
Bristol-Myers Squibb

location_facility: Centre Hospitalier Universitaire de Perigueux

location_facility: Centre Hospitalier Universitaire de Mont de Marsan

location_facility: Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest

location_facility: Centre Hospitalier Universitaire de Bayonne

location_facility: Centre Hospitalier Universitaire de Villeneuve sur Lot

location_facility: Centre Hospitalier Universitaire de Bordeaux


title: Trial UFT/RT Randomized Multicenter Phase III Randomized Trial Testing Ftorafur (UFT) Associated With Neoadjuvant Radiotherapy Versus Radiotherapy Alone in Rectal Adenocarcinoma

acronym: UFT RT Phase 3

summary:
RATIONALE: Drugs used in chemotherapy, such as 5-fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing and also as a radiosensibilisant. Radiation therapy uses high-energy x-rays to kill tumor cells. 5-fluorouracil may make tumor cells more sensitive to radiation therapy. Oral 5-fluorouracil is more convenient for ambulatory patients. Giving UFT (Tegafur and Uracil) with radiation therapy before surgery may shrink the tumor so it can be removed.

PURPOSE: This phase III trial is studying how well giving UFT with radiation therapy works in treating patients who are undergoing surgery for operable rectal cancer.

lead_sponsor: Institut Cancerologie de l'Ouest

sponsor_collaborators:
Institut Cancerologie de l'Ouest
Merck Sharp & Dohme LLC

location_facility: Institut de Cancérologie et d'Hématologie

location_facility: Centre d'Oncologie-radiothérapie d'Eure et Loir


title: A Randomized Phase II Trial of Early Change of a Chemotherapeutic Doublet Versus Four Cycles of Chemotherapy in Advanced Non Small Cell Lung Cancer.

summary: The optimal strategy in advanced non small cell lung cancer with stable disease is not well known. There is no published study assessing an early change of chemotherapeutic drugs in these patients.Accordingly, we conduct this trial with the objective to improve the rate of objective responses by the switch to another doublet after 2 cycles of CDDP-gemcitabine association for patients with stable diseases (SD).

collaborators: Groupe Français de Pneumologie Cancérologie (GFPC)

location_facility: Service de Pneumologie, Hôpital Pontchailloux

location_facility: Service de Pneumologie - Hôpital St Antoine

location_facility: Service de Pneumologie, Hôpital Bois Guillaume

location_facility: Service de Pneumologie, Hôpital de la Croix Rousse

location_facility: Hôpital Charles Nicolle, Service de Pneumologie


title: Double-Blind Long-term Study Comparing the Efficacy and Safety of Olanzapine Versus Haloperidol in Patients With Schizophrenia Previously Stabilized With Conventional Antipsychotic Treatment

summary: The objective of this study is to demonstrate that there is a benefit in switching chronic schizophrenic patients from conventional antipsychotic to olanzapine in terms of efficacy, neurological safety and patient's outcome.

lead_sponsor: Eli Lilly and Company

location_facility: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) , or speak with your personal physician


title: OPERA: French Observational Study on Patients Implanted With a Guidant PRIZM or Vitality Defibrillator

summary: This study evaluates the date of the first appropriate and/or inappropriate therapy in patients implanted with a Guidant PRIZM or VITALITY defibrillator and is evaluating eventual predictive risk factors for appropriate/inappropriate therapies as well as the influence of the programmed parameters on these therapies.

lead_sponsor: Boston Scientific Corporation

location_facility:
GH La Timone
CHRU Robert Debré
CH Avignon
CH St. Joseph
CHU Nice
CHU Michalon
CHU Hopital la Cavale Blanche
CHG Aix en Provence
CHU Tours
CHU Rangueil
Hopital Neuro-cardiologique
CH Amiens
CHG Pau
CMC Arnaud Tzanck
CHU D'Orleans
CHU Rouen
CHU Angers
CH La Roche sur Yon
CHU Toulon
CHU Dupuytren
Hopital Angouleme
CHU Nantes
CHU Montpellier
CHG Albi
CHU Pontchaillou
Hôpital Princesse de Grâce
CHU Clermont Ferrand
Hopital Nord
CHG Martigues
CH Besancon
CHG Chateauroux
Hopital Antoine Beclere
Hopital Cote de Nacre


title: Short and Long Term Evaluation of Electrical Measurements and Defibrillation Energies, Results of ATP and Diagnostic Functions of Devices Connected to Endotak RELIANCE® Defibrillation Leads

summary: The objective of this study is to demonstrate the efficacy of the ENDOTAK® RELIANCE™ defibrillation leads connected to a defibrillator or a cardiac resynchronization defibrillator from implant until 12 months.

location_facility:
Clinique St. Gatien
CH Avignon
CHU Nice
CHU Michalon
CHU Rangueil
CH Amiens
CHG Pau
CHU Brabois
CMC Arnaud Tzanck
CHU D'Orleans
CHU La Timone
Clinique Cardiologique Aressy
CHU Henri Mondor
CHU Rouen
CHU du Morvan
CHU Angers
Nouvelle Clinique Nantaise
CHU Nantes
CHU Montpellier
Hôpital Côte de Nacre
CH Hôpital Nord
Centre cardiologique du Nord
Clinique Bizet
CHU Pontchaillou
Hôpital Angoulème


title: Evolution of IGF-1 in Children Born Small for Gestational Age and With Growth Retardation, Treated by Genotonorm Especially Evolution After Dose Adaptation.

summary: To estimate the percentage of children with serum IGF-1 > 2 standard deviation (compared to a child of the same gender and age and without growth hormone (GH) deficiency) 9 months and 12 months after initiation of GH treatment.


title: Efficacy and Safety of Diclofenac Sodium Gel in Hand Osteoarthritis

summary: This study will test the efficacy and safety of topical diclofenac sodium gel in the treatment of hand osteoarthritis.

ReferenceCitation: Barthel HR, Peniston JH, Clark MB, Gold MS, Altman RD. Correlation of pain relief with physical function in hand osteoarthritis: randomized controlled trial post hoc analysis. Arthritis Res Ther. 2010;12(1):R7. doi: 10.1186/ar2906. Epub 2010 Jan 11.

lead_sponsor: Novartis

location_country: Germany France


title: Evolution Of Growth Rate In Children Suffering From A Disease Associated With Growth Retardation and Treated By Genotonorm. A Pilot Study.

summary: To show an increase in annual growth rate 3 years after Visit 2. Annual growth rate in standard deviation (SD) after 3 years will be compared to growth rate before the start of GH treatment.


title: Evolution Of Growth Rate In Children With Growth Retardation Related To Long-term Corticotherapy And Treated By Genotonorm

summary: To estimate the evolution of height and growth rate over 5 years of growth hormone (GH) treatment To estimate the prognostic factors of growth rate with GH treatment To confirm the good clinical and biological safety of GH treatment in such children

ReferenceCitation: Basmaison O, Ranchin B, Zouater H, Robertson A, Gomez R, Koppiker N. Efficacy and safety of recombinant growth hormone treatment in children with growth retardation related to long-term glucocorticosteroid therapy. Ann Endocrinol (Paris). 2019 Sep;80(4):202-210. doi: 10.1016/j.ando.2019.02.001. Epub 2019 Mar 4.

location_facility: Service de Pédiatrie- Centre Hospitalier Intercommunal

location_facility: Groupe Hospitalier Necker - Enfants Malades

location_facility: Groupe hospitalier Est- Hôpital Femme, Mère, Enfant

location_facility: CHU Tours - Centre Pediatrique Gatien de Cocheville

location_facility: Centre Hospitalier Intercommunal d'Annemasse-Bonneville, Service de Pédiatrie et Néonatologie

location_facility: Groupe hospitalier Est-Hôpital Femme, Mère, Enfant


title: Voriconazole For Primary Therapy Of Proven, Chronic Bronchopulmonary Aspergillosis, In Minimally Immunocompromised Or, Non-Immunocompromised Hosts

summary: To evaluate the efficacy of voriconazole (VFend(R)) as first line treatment for proven chronic bronchopulmonary aspergillosis, in minimally immunocompromised or non-immunocompromised patients after 6 months of treatment i.e. chronic necrotizing pulmonary


title: Phase 3 Multi-Center, Double-Blind, Randomized, Parallel Group, Forced Titration Study Of The Efficacy, Safety, And Tolerability Of Torcetrapib/Atorvastatin Compared To Fenofibrate In Subjects With Fredrickson Type IIB Dyslipidemia (Mixed Hyperlipidemia

summary:
The Torcetrapib project was terminated on December 2, 2006 due to safety findings.

To assess the HDL-C increase and non-HDL lowering effect of torcetrapib/atorvastatin vs. fenofibrate.


title: Prospective Study, Randomized Controlled Trial Between Medical Treatment by Methotrexate Versus Conservative Surgical Treatment (Group 1) and Conservative Versus Radical Surgical Treatment (Group 2) to Evaluate Subsequent Fertility

summary: Three protocols are used to treat ectopic pregnancies: medical treatment by methotrexate, conservative surgery or radical surgery. There are no data about subsequent fertility except in a cohort study. The investigators propose to evaluate the true subsequent fertility with a follow-up of 2 years, in a randomized controlled trial.

ReferenceCitation: Fernandez H, Gervaise A. Ectopic pregnancies after infertility treatment: modern diagnosis and therapeutic strategy. Hum Reprod Update. 2004 Nov-Dec;10(6):503-13. doi: 10.1093/humupd/dmh043. Epub 2004 Sep 23.

ReferenceCitation: Bourel G, Pelletier-Fleury N, Bouyer J, Delbarre A, Fernandez H, Capmas P. Cost-effectiveness analysis of medical management versus conservative surgery for early tubal pregnancy. Hum Reprod. 2019 Feb 1;34(2):261-267. doi: 10.1093/humrep/dey352.

ReferenceCitation: Fernandez H, Capmas P, Lucot JP, Resch B, Panel P, Bouyer J; GROG. Fertility after ectopic pregnancy: the DEMETER randomized trial. Hum Reprod. 2013 May;28(5):1247-53. doi: 10.1093/humrep/det037. Epub 2013 Mar 12.

lead_sponsor: Hopital Antoine Beclere

location_facility: Assistance Publique Hôpitaux de Marseille ; Hôpital Nord

location_facility: Versailles Hospital ; Hôpital André Mignot

location_facility: Assistance Publique Hôpitaux de Marseille ; Maternité de la Conception


title: Phase 2/3 Study Evaluating Efficacy and Safety of Erythrocytes Encapsulating L-asparaginase (GRASPA)Versus Reference L-asparaginase Treatment in Combination With Standard Polychemotherapy in Patient With First Recurrence of Philadelphia Negative Acute Lymphoblastic Leukemia

acronym: GRASPIVOTALL

summary:
Asparaginase is a cornerstone in the treatment of ALL, but its utility is limited by toxicities including hypersensitivity. Clinical allergy is associated with inactivation of asparaginase by antibodies (A-Abs), which can also neutralize asparaginase without any clinical signs of hypersensitivity (silent inactivation). GRASPA improves pharmacokinetics, tolerability and maintain circulating asparaginase activity due to the protective barrier of the erythrocyte membrane.

This study is run to confirm the benefit/risk profile of GRASPA at 150 IU/kg in combination with the COOPRALL regimen in adults and children patients with relapsed ALL, with or without known hypersensitivity to L-asparaginase.

lead_sponsor: ERYtech Pharma

location_country: Belgium France

location_facility: Institut Hematologie Oncologie Pediatrique


title: A European Randomised Phase 3 Study to Assess the Efficacy and Safety of TOOKAD® Soluble for Localised Prostate Cancer Compared to Active Surveillance

summary:
The aims of this study are:

to assess the impact of TOOKAD® Soluble-Vascular Targeted Photodynamic Therapy (VTP) on the rate of absence of definite cancer using patients on active surveillance as a comparison (co-primary objective A) and
to determine the difference in rate of treatment failure associated with observed progression of disease from low risk prostate cancer to moderate or higher risk prostate cancer in men who undergo TOOKAD® Soluble-VTP compared to men on active surveillance (co-primary objective B).

ReferenceCitation: Azzouzi AR, Vincendeau S, Barret E, Cicco A, Kleinclauss F, van der Poel HG, Stief CG, Rassweiler J, Salomon G, Solsona E, Alcaraz A, Tammela TT, Rosario DJ, Gomez-Veiga F, Ahlgren G, Benzaghou F, Gaillac B, Amzal B, Debruyne FM, Fromont G, Gratzke C, Emberton M; PCM301 Study Group. Padeliporfin vascular-targeted photodynamic therapy versus active surveillance in men with low-risk prostate cancer (CLIN1001 PCM301): an open-label, phase 3, randomised controlled trial. Lancet Oncol. 2017 Feb;18(2):181-191. doi: 10.1016/S1470-2045(16)30661-1. Epub 2016 Dec 20.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - UFC - Université de Franche-Comté

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repositories:
HAL
UCL Discovery

repositories_concat: HAL;UCL Discovery

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inria

ReferenceCitation: Azzouzi AR, Barret E, Bennet J, Moore C, Taneja S, Muir G, Villers A, Coleman J, Allen C, Scherz A, Emberton M. TOOKAD(R) Soluble focal therapy: pooled analysis of three phase II studies assessing the minimally invasive ablation of localized prostate cancer. World J Urol. 2015 Jul;33(7):945-53. doi: 10.1007/s00345-015-1505-8. Epub 2015 Feb 25.

evidence: open (via page says license)

repositories:
PubMed Central
UCL Discovery

repositories_concat: PubMed Central;UCL Discovery

publisher_dissemination: Springer-Nature

ReferenceCitation: Lebdai S, Villers A, Barret E, Nedelcu C, Bigot P, Azzouzi AR. Feasibility, safety, and efficacy of salvage radical prostatectomy after Tookad(R) Soluble focal treatment for localized prostate cancer. World J Urol. 2015 Jul;33(7):965-71. doi: 10.1007/s00345-015-1493-8. Epub 2015 Jan 23.

ipd_sharing: Yes

ipd_sharing_description: The data are available in case report form for each patient

lead_sponsor: Steba Biotech S.A.

location_country:
Finland
Italy
Germany
United Kingdom
Sweden
Netherlands
Switzerland
Belgium
Spain
France

location_facility: Unità Operativa Urologia Lucca - c/o Azienda USL 2 - Ospedale Campo di Marte

location_facility: Department of Urology-Tampere University Hospital-

location_facility: Clinique d'Urologie et de Transplantation Rénale CHU Grenoble

location_facility: Department of Urology-Hospital Clinic, University of Barcelona

location_facility: Dept. of Urology-University Hospitals Leuven

location_facility: Centre Hospitalier Universitaire Lyon Sud

location_facility: Hospital 12 de Octubre - Departmento de Urologia

location_facility: Unità Operativa Urologica di Savona, Ospedale San Paolo di Savona

location_facility: Service d'Urologie - Centre Hospitalier Universitaire d'Angers

location_facility: Vinzenz Krankenhaus - Department of Urology

location_facility: Martini-Klinik am UKE Hamburg-Eppendorf Prostate Cancer Center

location_facility: Universitätsklinikum "Carl Gustav Carus" der Technischen Universität

location_facility: Hospital Universitari de Bellbitge-Servico de Urologia

location_facility: Complejo Hospitalario Regional Virgen Del Rocio-Department Urology

location_facility: ATURO-Gemeinschaftspraxis für Urologie und Andrologie

location_facility: Unità di Chirurgia Urologica Mininvasiva

location_facility: Osp. S. Giov. Battista Molinette-Dipartimento di Discipline Medico-Chirurgiche Urologia

location_facility: Centre Hospitalier Universitaire de Rangueil


acronym: RiBECCA

lead_sponsor: Hoffmann-La Roche

summary: This randomized, open-label, parallel group study will assess the effect on response rate and the safety of MabThera added to either bendamustine or chlorambucil in patients with chronic lymphocytic leukemia. Patients will be randomized to receive six 4-week cycles of either A) MabThera (375mg/m2 iv day 1 of cycle 1, 500mg/m2 iv cycles 2-6) plus bendamustine (90mg/m2 as first-line or 70mg/m2 as second-line therapy, iv on days 1 and 2, cycles 1-6), or B)MabThera plus chlorambucil (10mg/m2 po daily, days 1-7, cycles 1-6). Patients in group B can receive up to 6 further cycles of chlorambucil as monotherapy. Anticipated time on study treatment is 6-12 months, and target sample size is 600-700 individuals.

title: A Randomized Study to Assess the Effect on Response Rate of MabThera (Rituximab) Added to a Standard Chemotherapy, Bendamustine or Chlorambucil, in Patients With Chronic Lymphocytic Leukemia

location_country:
Finland
France
Portugal
United Kingdom
Tunisia
Spain
Turkey
Sweden


title: Randomized Phase III Trial Comparing an Association of Hormonal Treatment and Docetaxel Versus the Hormonal Treatment Alone in Metastatic Prostate Cancers

summary:
RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as goserelin, may stop the adrenal glands from making androgens. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving hormone therapy together with docetaxel may be an effective treatment for prostate cancer. It is not yet known whether giving hormone therapy together with docetaxel is more effective than hormone therapy alone in treating prostate cancer.

PURPOSE: This randomized phase III trial is studying hormone therapy and docetaxel to see how well they work compared to hormone therapy alone in treating patients with metastatic prostate cancer.

ReferenceCitation: Gravis G, Fizazi K, Joly F, et al.: Safety results from a phase III trial comparing androgen-deprivation therapy (ADT) plus docetaxel versus ADT alone in hormone-naïve metastatic prostate cancer (GETUG-AFU 15/0403). [Abstract] 2010 Genitourinary Cancers Symposium, March 5-7, 2010, San Francisco, California. A-43, 2010.

ReferenceCitation: Gravis G, Fizazi K, Joly F, et al.: Randomized phase III study comparing docetaxel and androgen deprivation therapy (ADT) versus ADT alone in androgen dependent metastatic prostate cancer (GETUG-15/0403): a French national muticentric study sponsored by the French Federation des Centres. [Abstract] American Society of Clinical Oncology 2007 Prostate Cancer Symposium, 22-24 February 2007, Orlando, FL. A-161, 2007.

ReferenceCitation: Campillo-Gimenez B, Buscail C, Zekri O, Laguerre B, Le Prise E, De Crevoisier R, Cuggia M. Improving the pre-screening of eligible patients in order to increase enrollment in cancer clinical trials. Trials. 2015 Jan 16;16:15. doi: 10.1186/s13063-014-0535-7.

ReferenceCitation: Trump DL. Commentary on "Androgen-deprivation therapy alone or with docetaxel in non-castrate metastatic prostate cancer (GETUG-AFU 15): a randomised, open-label, phase 3 trial." Gravis G, Fizazi K, Joly F, Oudard S, Priou F, Esterni B, Latorzeff I, Delva R, Krakowski I, Laguerre B, Rolland F, Theodore C, Deplanque G, Ferrero JM, Pouessel D, Mourey L, Beuzeboc P, Zanetta S, Habibian M, Berdah JF, Dauba J, Baciuchka M, Platini C, Linassier C, Labourey JL, Machiels JP, El Kouri C, Ravaud A, Suc E, Eymard JC, Hasbini A, Bousquet G, Soulie M, Medical Oncology and Biostatistics, Institut Paoli-Calmettes, Marseille, France. Lancet Oncol 2013;14(2):149-58 [Epub 2013 Jan 8]. Urol Oncol. 2013 Nov;31(8):1845. doi: 10.1016/j.urolonc.2013.08.011.

ReferenceCitation: Gravis G, Fizazi K, Joly F, Oudard S, Priou F, Esterni B, Latorzeff I, Delva R, Krakowski I, Laguerre B, Rolland F, Theodore C, Deplanque G, Ferrero JM, Pouessel D, Mourey L, Beuzeboc P, Zanetta S, Habibian M, Berdah JF, Dauba J, Baciuchka M, Platini C, Linassier C, Labourey JL, Machiels JP, El Kouri C, Ravaud A, Suc E, Eymard JC, Hasbini A, Bousquet G, Soulie M. Androgen-deprivation therapy alone or with docetaxel in non-castrate metastatic prostate cancer (GETUG-AFU 15): a randomised, open-label, phase 3 trial. Lancet Oncol. 2013 Feb;14(2):149-58. doi: 10.1016/S1470-2045(12)70560-0. Epub 2013 Jan 8.

ReferenceCitation: Huang X, Chau CH, Figg WD. Challenges to improved therapeutics for metastatic castrate resistant prostate cancer: from recent successes and failures. J Hematol Oncol. 2012 Jul 2;5:35. doi: 10.1186/1756-8722-5-35.

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

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

location_facility: Centre Hospitalier Universitaire Henri Mondor

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

location_facility: Centre Hospitalier Universitaire Bretonneau de Tours

location_facility: Centre Hospitalier General de Mont de Marsan

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

location_facility: Centre Hospital Regional Universitaire de Limoges