title: Phase III Randomized Study of Adjuvant Radiotherapy With Versus Without Concurrent Goserelin in Patients Who Have Undergone Surgery for Recurrent or Refractory Prostate Cancer

summary:
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as goserelin, may stop the adrenal glands from making androgens. Giving radiation therapy with or without goserelin after surgery may kill any tumor cells that remain after surgery. It is not yet known whether radiation therapy is more effective with or without goserelin in treating prostate cancer.

PURPOSE: This randomized phase III trial is studying radiation therapy and goserelin to see how well they work compared with radiation therapy alone in treating patients who have undergone surgery for recurrent or refractory prostate cancer.

ReferenceCitation: Carrie C, Magne N, Burban-Provost P, Sargos P, Latorzeff I, Lagrange JL, Supiot S, Belkacemi Y, Peiffert D, Allouache N, Dubray BM, Servagi-Vernat S, Suchaud JP, Crehange G, Guerif S, Brihoum M, Barbier N, Graff-Cailleaud P, Ruffion A, Dussart S, Ferlay C, Chabaud S. Short-term androgen deprivation therapy combined with radiotherapy as salvage treatment after radical prostatectomy for prostate cancer (GETUG-AFU 16): a 112-month follow-up of a phase 3, randomised trial. Lancet Oncol. 2019 Dec;20(12):1740-1749. doi: 10.1016/S1470-2045(19)30486-3. Epub 2019 Oct 16.

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

ReferenceCitation: Carrie C, Hasbini A, de Laroche G, Richaud P, Guerif S, Latorzeff I, Supiot S, Bosset M, Lagrange JL, Beckendorf V, Lesaunier F, Dubray B, Wagner JP, N'Guyen TD, Suchaud JP, Crehange G, Barbier N, Habibian M, Ferlay C, Fourneret P, Ruffion A, Dussart S. Salvage radiotherapy with or without short-term hormone therapy for rising prostate-specific antigen concentration after radical prostatectomy (GETUG-AFU 16): a randomised, multicentre, open-label phase 3 trial. Lancet Oncol. 2016 Jun;17(6):747-756. doi: 10.1016/S1470-2045(16)00111-X. Epub 2016 May 6. Erratum In: Lancet Oncol. 2016 Jun;17 (6):e223. Lancet Oncol. 2019 Jun;20(6):e293.

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.

lead_sponsor: UNICANCER

sponsor_collaborators: UNICANCER AstraZeneca

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 Hospitalier Regional de Besancon - Hopital Jean Minjoz

location_facility: Centre Hospitalier Intercommunal des Alpes du Sud


type: Other Identifier

title: An Eight-Week, Randomized, Double Blind, Two Parallel Groups, Study to Assess Clinical Response of Duloxetine 60 mg and 120 Per Day in Patients Hospitalized for Severe Depression

summary: An eight-week, randomized, double blind, two parallel groups, study to assess clinical response of duloxetine 60 milligrams (mg) and 120 mg per day in patients hospitalized for severe depression.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: result

ReferenceCitation: Brecht S, Desaiah D, Marechal ES, Santini AM, Podhorna J, Guelfi JD. Efficacy and safety of duloxetine 60 mg and 120 mg daily in patients hospitalized for severe depression: a double-blind randomized trial. J Clin Psychiatry. 2011 Aug;72(8):1086-94. doi: 10.4088/JCP.09m05723blu. Epub 2010 Sep 21.

ReferenceType: derived

ReferenceCitation: Demyttenaere K, Desaiah D, Raskin J, Cairns V, Brecht S. Suicidal thoughts and reasons for living in hospitalized patients with severe depression: post-hoc analyses of a double-blind randomized trial of duloxetine. Prim Care Companion CNS Disord. 2014;16(3):PCC.13m01591. doi: 10.4088/PCC.13m01591. Epub 2014 May 1.

oa_host_type: repository

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

host_type: repository

license_normalized: no license

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

version: publishedVersion

evidence: oa repository (via pmcid lookup)

repositories_concat: PubMed Central

unpaywall_oa_status: green

publisher_dissemination: Physicians Postgraduate Press, Inc

lead_sponsor: Eli Lilly and Company

sponsor_collaborators:
Eli Lilly and Company
Boehringer Ingelheim

location_country:
Italy
South Africa
Russian Federation
France

location_facility: For additional information regarding investigative sites for this trial contact 1-877-CTLILLY (1-877-285-4559 or 1-317-615-4559), Mon-Fri, 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST) or speak with your personal physician

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: A Multicenter Randomized Phase II Trial in NSCLC Stage IV et IIIB in Elderly Dependent Patients With Evaluation of the Sequence Gemcitabine First Line Followed by Erlotinib When Progression Versus Erlotinib First Line Followed by Gemcitabine When Progression.

summary: The purpose of this study is in non small-cell lung cancer stage IV et IIIB (T4 with pleural effusion) in elderly dependent patients with evaluation of the sequence Gemcitabine first line followed by Erlotinib when progression versus Erlotinib first line followed by Gemcitabine when progression

study_type: Observational

time_perspective: Prospective

lead_sponsor: Groupe Francais De Pneumo-Cancerologie

location_facility:
Site 42
Site 05
Site 26
Site 12
Site 27
Site 25
Site 19
Site 04
Site 06
Site 22
Site 07
Site 17
Site 20
Site 33
Site 00
Site 30
Site 32
Site 11
Site 43
Site 02
Site 14
Site 01
Site 41


title: A Phase II Randomised Trial of Second-line Treatment in Patients With Small Cell Lung Cancer (SCLC), Comparing Oral Combination Chemotherapy (CCNU, Cyclophosphamide, Etoposide) With Intravenous Association Chemotherapy.

summary: The purpose of this study is to determine treatment efficacy and tolerability of second-line treatment in patients with small cell lung cancer comparing oral combinaison chemotherapy with intravenous combination chemotherapy.

status: Unknown status

study_completion_date_type: Anticipated

enrollment_type: Anticipated

collaborators:
Baxter Healthcare Corporation
Amgen

sponsor_collaborators:
Groupe Francais De Pneumo-Cancerologie
Baxter Healthcare Corporation
Amgen

location_facility:
Site 05
Site 25
Site 27
Centre Hospitalier Les Oudairies
Site 04
Site 06
Site 22
Site 07
Site 17
Hospital Saint Antoine
Centre Hospitalier René Dubos
Site 33
Centre Hospitalier du Morvan
Hôpital Yves Le Foll
Centre François Baclesse
Site 32
Site 11
Site 43
Centre Hospitalier Régional
Hospital du Cluzeau
Site 14
Site 01
Centre Hospitalier Universitaire
Centre Hospitalier Lyon Sud

status_simplified: Unknown


title: A Multicenter Randomized Phase II Trial in NSCLC Stage IV and IIIB (T4 With Pleural Effusion) in Elderly Independent Patients the Schedule Docetaxel / Gemcitabine First Line Following by Erlotinib When Progression Versus Erlotinib First Line Following by/ Gemcitabine When Progression.

summary: The purpose of this study is to determine duration before progression of first-line treatment chemotherapy following erlotinib in second-line comparing erlotinib in first-line following chemotherapy in second-line in old patients with none small cell lung cancer.

collaborators:
Sanofi
Chugai Pharma USA

sponsor_collaborators:
Groupe Francais De Pneumo-Cancerologie
Sanofi
Chugai Pharma USA

location_facility:
Site 26
Site 12
Site 27
Site 25
Site 19
Site 04
Site 06
Site 22
Site 07
Site 17
Site 18
Site 20
Site 33
Site 00
Site 30
Site 32
Site 11
Site 48
Site 02
Site 14
Site 01
Site 41


title: Antiviral Effect of 4 Regimens of PEGASYS Plus Copegus in Patients With Genotype 1 Chronic Hepatitis C Non-responder to Previous Peginterferon Alfa-2a Plus Ribavirin Therapy

summary: This study will evaluate the efficacy and safety of 4 regimens of PEGASYS plus Copegus, in patients with chronic hepatitis C (CHC) genotype 1 who have failed to respond to previous treatment with standard doses of PEGASYS plus ribavirin. Patients will be randomized to one of 4 groups, to receive a)PEGASYS 360 micrograms/week plus Copegus 1000-1200mg/day, b)PEGASYS 180 micrograms twice weekly plus Copegus 1000-1200mg/day, c)PEGASYS 360micrograms/week plus Copegus 1200-1600mg/day, or d)PEGASYS 180 micrograms twice weekly plus Copegus 1200-1600mg/day. Following 48 weeks treatment, there will be a 24 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

ReferenceCitation: Chevaliez S, Hezode C, Soulier A, Costes B, Bouvier-Alias M, Rouanet S, Foucher J, Bronowicki JP, Tran A, Rosa I, Mathurin P, Alric L, Leroy V, Couzigou P, Mallat A, Charaf-Eddine M, Babany G, Pawlotsky JM. High-dose pegylated interferon-alpha and ribavirin in nonresponder hepatitis C patients and relationship with IL-28B genotype (SYREN trial). Gastroenterology. 2011 Jul;141(1):119-27. doi: 10.1053/j.gastro.2011.03.039. Epub 2011 Mar 24.

lead_sponsor: Hoffmann-La Roche


title: 9-10 Days Versus Prolonged Thromboprophylaxis in Patients Without Evidence of Ultrasound Proximal Thromboembolism After Total Knee Joint Replacement: a Randomized Controlled Trial

summary: The purpose of this study is to determine whether stopping Low Molecular Weight Heparin (LMWH) thromboprophylaxis is safe after total knee joint replacement. The investigators select patients without proximal thromboembolism assessed by bilateral venous ultrasound examination 7-10 days after surgery. the investigators hypothesis is that stopping thromboprophylaxis is equally effective than prolonging thromboprophylaxis in order to prevent post-surgery complications in this population.

primary_purpose: Prevention

ReferenceCitation: Barrellier MT, Lebel B, Parienti JJ, Mismetti P, Dutheil JJ, Vielpeau C; PROTHEGE study group; GETHCAM study group. Short versus extended thromboprophylaxis after total knee arthroplasty: a randomized comparison. Thromb Res. 2010 Oct;126(4):e298-304. doi: 10.1016/j.thromres.2010.07.018. Epub 2010 Aug 24.

lead_sponsor: University Hospital, Caen

location_facility:
Reims University Hospital
Clinique du Cèdre
Clinique St Jean Languedoc
Hospital University Lille
Hospital University Angers
Clinique St Marie
Polyclinique de Riaumont
Mignot Hospital
Hospital Nord Mayenne
Poitiers University Hospital
Clinique St André
Hospital Val D'ariège
Clinique St Jean
Caen University hospital
Hospital La Roche sur Yon
Hospital Alençon
Montluçon Hospital

intervention_type: Procedure

lead_sponsor_type: academique


title: Randomized Study of ACVBP Plus Rituximab Versus CHOP Plus Rituximab in Non Previously Treated Patients Aged From 60 to 65 Years With Diffuse Large B-Cell Lymphoma

summary: The primary objective of this study is to evaluate the efficacy of doxorubicin, cyclophosphamide, vindesine, bleomycin, and prednisone (ACVBP) plus rituximab in comparison to cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) plus rituximab in patients aged from 60 to 65 years with non-previously treated diffuse large B-cell lymphoma as measured by the event-free survival. The goal is to obtain a 10% increase of event-free survival at 3 years.

study_start_date_type: Actual

status: Terminated

ReferenceType: background

ReferenceCitation: Tilly H, Lepage E, Coiffier B, Blanc M, Herbrecht R, Bosly A, Attal M, Fillet G, Guettier C, Molina TJ, Gisselbrecht C, Reyes F; Groupe d'Etude des Lymphomes de l'Adulte. Intensive conventional chemotherapy (ACVBP regimen) compared with standard CHOP for poor-prognosis aggressive non-Hodgkin lymphoma. Blood. 2003 Dec 15;102(13):4284-9. doi: 10.1182/blood-2003-02-0542. Epub 2003 Aug 14.

ReferenceCitation: Coiffier B, Lepage E, Briere J, Herbrecht R, Tilly H, Bouabdallah R, Morel P, Van Den Neste E, Salles G, Gaulard P, Reyes F, Lederlin P, Gisselbrecht C. CHOP chemotherapy plus rituximab compared with CHOP alone in elderly patients with diffuse large-B-cell lymphoma. N Engl J Med. 2002 Jan 24;346(4):235-42. doi: 10.1056/NEJMoa011795.

ReferenceCitation: Ghesquieres H, Larrabee BR, Haioun C, Link BK, Verney A, Slager SL, Ketterer N, Ansell SM, Delarue R, Maurer MJ, Fitoussi O, Habermann TM, Peyrade F, Dogan A, Molina TJ, Novak AJ, Tilly H, Cerhan JR, Salles G. FCGR3A/2A polymorphisms and diffuse large B-cell lymphoma outcome treated with immunochemotherapy: a meta-analysis on 1134 patients from two prospective cohorts. Hematol Oncol. 2017 Dec;35(4):447-455. doi: 10.1002/hon.2305. Epub 2016 Jun 10.

version: acceptedVersion

publisher_dissemination: Wiley

ReferenceCitation: Copie-Bergman C, Cuilliere-Dartigues P, Baia M, Briere J, Delarue R, Canioni D, Salles G, Parrens M, Belhadj K, Fabiani B, Recher C, Petrella T, Ketterer N, Peyrade F, Haioun C, Nagel I, Siebert R, Jardin F, Leroy K, Jais JP, Tilly H, Molina TJ, Gaulard P. MYC-IG rearrangements are negative predictors of survival in DLBCL patients treated with immunochemotherapy: a GELA/LYSA study. Blood. 2015 Nov 26;126(22):2466-74. doi: 10.1182/blood-2015-05-647602. Epub 2015 Sep 15.

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

repositories_concat: closed

unpaywall_oa_status: bronze

publisher_dissemination: American Society of Hematology

lead_sponsor: Lymphoma Study Association

sponsor_collaborators:
Lymphoma Study Association
Fondation ARC

location_country: Switzerland Belgium France

location_facility: Groupe d'Etude des Lymphomes de l'adulte

location_facility: Service d'Hématologie - Centre Hospitalier Lyon-Sud

location_facility: Schweirische Arbeitsgruppe fur klinische Krebsforschung


title: A PHASE III RANDOMIZED STUDY ON POSTOPERATIVE RADIO- AND CHEMOTHERAPY IN PATIENTS WITH LOCALLY ADVANCED HEAD AND NECK CARCINOMAS

summary:
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if radiation therapy plus chemotherapy is more effective than radiation therapy alone in treating patients with head and neck cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of high-dose radiation therapy alone with high-dose radiation therapy plus cisplatin in treating patients with head and neck cancer who have undergone surgery to remove the cancer.

ReferenceCitation: Bernier J, Cooper JS, Pajak TF, van Glabbeke M, Bourhis J, Forastiere A, Ozsahin EM, Jacobs JR, Jassem J, Ang KK, Lefebvre JL. Defining risk levels in locally advanced head and neck cancers: a comparative analysis of concurrent postoperative radiation plus chemotherapy trials of the EORTC (#22931) and RTOG (# 9501). Head Neck. 2005 Oct;27(10):843-50. doi: 10.1002/hed.20279.

ReferenceCitation: Bernier J, Domenge C, Ozsahin M, Matuszewska K, Lefebvre JL, Greiner RH, Giralt J, Maingon P, Rolland F, Bolla M, Cognetti F, Bourhis J, Kirkpatrick A, van Glabbeke M; European Organization for Research and Treatment of Cancer Trial 22931. Postoperative irradiation with or without concomitant chemotherapy for locally advanced head and neck cancer. N Engl J Med. 2004 May 6;350(19):1945-52. doi: 10.1056/NEJMoa032641.

ReferenceCitation: Bernier J, Domenge C, Eschwege F, et al.: Chemo-radiotherapy, as compared to radiotherapy alone, significantly increases disease-free and overall survival in head and neck cancer patients after surgery: results of EORTC phase III trial 22931. [Abstract] Int J Radiat Oncol Biol Phys 51(3 suppl 1): A-1, 1, 2001.

ReferenceCitation: Valley JF, Bernier J, Tercier PA, Fogliata-Cozzi A, Rosset A, Garavaglia G, Mirimanoff RO. Quality assurance of the EORTC radiotherapy trial 22931 for head and neck carcinomas: the dummy run. Radiother Oncol. 1998 Apr;47(1):37-44. doi: 10.1016/s0167-8140(97)00218-1.

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

location_country:
Slovenia
Italy
Poland
United Kingdom
Netherlands
Switzerland
Belgium
Spain
Turkey
France

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Centre de Lute Contre le Cancer,Georges-Francois Leclerc

location_facility: Istituti Fisioterapici Ospitalieri - Roma

location_facility: Istituto Nazionale per lo Studio e la Cura dei Tumori

location_facility: Dokuz Eylul University School of Medicine


type: EudraCT Number

title: An Open-Label Multicenter Phase Ib Study of AN0025 in Combination With Pembrolizumab in Patients With Advanced Solid Tumors

summary: This is an open-label, multicenter, phase Ib study to evaluate the safety and preliminary efficacy of AN0025 in combination with pembrolizumab in patients with locally advanced/metastatic tumors. It will include a dose-limiting toxicity observation phase followed by an expansion phase. All enrolled patients will be treated with AN0025 and Pembrolizumab until the patient experiences disease progression, unacceptable toxicity or withdraws consent, or for a maximum of 35 cycles (approximately 2 years). The dose of pembrolizumab will remain constant at 200 mg every 3 weeks (Q3W) for each dose level of AN0025 and in each cohort.

status: Active, not recruiting

design_allocation: Non-Randomized

ipd_sharing: No

lead_sponsor: Adlai Nortye Biopharma Co., Ltd.

sponsor_collaborators:
Adlai Nortye Biopharma Co., Ltd.
Merck Sharp & Dohme LLC

location_country:
United States
France

location_facility: Washington University School of Medicine - Siteman Cancer Center

location_facility: University of Utah School of Medicine Huntsman Cancer Institute

status_simplified: Ongoing


title: An Open-Label, Intrapatient Dose Escalation Study to Evaluate the Safety, Tolerability, Immunogenicity, and Biological Activity of ATYR1940 in Patients With Limb Girdle and Facioscapulohumeral Muscular Dystrophies

acronym: FSHD

summary: The purpose of this study is to assess the safety and biological activity of ATYR1940 in participants with LGMD2B and FSHD.

lead_sponsor: aTyr Pharma, Inc.

location_country:
United States
Denmark
France

location_facility: Kennedy Krieger Institute; The Johns Hopkins University School of Medicine

location_facility: University of California, Irvine, ALS and Neuromuscular Center

location_facility: Centre d'nvestigation Clinique - Centre de Pharmacologie Clinique et d'Evaluations Thérapeutiques (CICCPCET)

location_facility: Institut de Myologie, Hôpital Pitié-Salpêtrière

location_facility: Rigshospitalet, University of Copenhagen

intervention_type: Biological


lead_sponsor: Bayer

summary: This study is to understand how the inhaled form of amikacin is spread throughout the human body and how it is eliminated from the body and to make sure that giving an inhaled form of Amikacin to patients is safe and well tolerated

ReferenceCitation: Luyt CE, Clavel M, Guntupalli K, Johannigman J, Kennedy JI, Wood C, Corkery K, Gribben D, Chastre J. Pharmacokinetics and lung delivery of PDDS-aerosolized amikacin (NKTR-061) in intubated and mechanically ventilated patients with nosocomial pneumonia. Crit Care. 2009;13(6):R200. doi: 10.1186/cc8206. Epub 2009 Dec 10.

sponsor_collaborators:
Bayer
Nektar Therapeutics

title: An Open-Label, Multicenter, Multinational Study to Assess the Safety,Tolerability and Pharmacokinetics of Aerosolized Amikacin Delivered Via the Pulmonary Drug Delivery System (NKTR-061) in Intubated and Mechanically- Ventilated Patients With Nosocomial Pneumonia

source: euctr


title: POS-VAP: Perpetual Observational Study - Ventilator Associated Pneumonia

acronym: POS-VAP

summary:
Ventilator associated pneumonia (VAP) is one of the most frequent healthcare associated infections in the Intensive Care Unit (ICU) and a significant burden among ICU patients under invasive mechanical ventilation (IMV).

Several preventive and therapeutic treatment options are being developed in the field of VAP that will require evaluation in future randomized controlled trials (RCTs).

RCTs are the gold standard for evaluating medical interventions but are difficult to perform in a population at risk of, or with, VAP.

status: Recruiting

ipd_sharing: Undecided

ipd_sharing_description: Data from this study will be used to inform future observational studies and RCTs about expected frequencies of exposures and clinical outcomes and expected recruitment rates for specific patient populations. Furthermore, the data will be used to support simulations to gain insight in the optimal design and required sample size of future RCTs as required for future embedded studies, which will be described in the appendices.

lead_sponsor: European Clinical Research Alliance for Infectious Diseases (ECRAID)

collaborators:
UMC Utrecht
University Hospital, Limoges

location_country: Romania Albania France

location_facility: Central Military Emergency University Hospital Dr. Carol Davila

intervention_type: Other


title: A Multicentre, Open Label, Randomised, Controlled, Basket, Pragmatic, Phase II, Clinical and Translational Study to Determine the Efficacy and Safety of Plitidepsin Versus Control in Immunocompromised Adult Patients With Symptomatic COVID-19 Requiring Hospital Care

acronym: NEREIDA

summary: The primary objective of this study is to evaluate efficacy of plitidepsin in pre-specified groups of immunocompromised patients with symptomatic COVID-19 requiring hospital care versus control in terms of mortality.

lead_sponsor: PharmaMar

location_country: Italy Poland Portugal Hungary Belgium Spain Greece Georgia France

location_facility: Hôpitaux Civils de Colmar - Centre Hospitalier Louis Pasteur

location_facility: Hospital Alvaro Cunqueiro - Clinico Universitario Vigo

location_facility: Centre Hospitalier Régional Universitaire de Tours

location_facility: Universitair Ziekenhuis Leuven - Campus Gasthuisberg

location_facility: Hospital da Senhora da Oliveira - Guimarães

location_facility: Wojewódzki Specjalistyczny Szpital im. Dr. Władysława Biegańskiego

location_facility: The First University Clinic of the Tbilisi State Medical University

location_facility: Les Hôpitaux Universitaires de Strasbourg

location_facility: Hospital Regional Universitario de Málaga - Hospital General

location_facility: Academician Vakhtang Bochorishvili Clinic

location_facility: Ltd Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: General Hospital for Thoracic Diseases Sotiria

location_facility: Centro Hospitalar de Vila Nova de Gaia/Espinho

location_facility: Hospital Universitario Fundación Jiménez Díaz

location_facility: Hospital Universitario Quirónsalud Madrid

location_facility: Complejo Asistencial Universitario de Salamanca - Hospital Clínico


title: Phase 1b Study of REGN5458 (Anti-BCMA x Anti-CD3 Bispecific Antibody) Plus Other Cancer Treatments for Patients With Relapsed/Refractory Multiple Myeloma

summary:
The study is researching an experimental drug called linvoseltamab in combination with other drugs for the treatment of a blood cancer called multiple myeloma. Linvoseltamab has previously been studied as a single agent (without other cancer treatments) in participants with multiple myeloma that returned after multiple prior therapies and needed to be treated again.

In the initial study, some participants treated with linvoseltamab had improvement of their myeloma, including complete responses (no evidence of myeloma in their bodies). This study is the first time linvoseltamab will be combined with other cancer therapies. The main goal is to understand if linvoseltamab can be given safely with other cancer treatments, and if so, what dose of linvoseltamab should be used for each combination.

The study is looking at several other research questions, including:

How many participants treated with linvoseltamab in combination with each of the other cancer treatments have improvement of their multiple myeloma
What side effects may happen from taking linvoseltamab together with another cancer treatment
How much study drug is in your blood at different times
Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)

ipd_sharing: Yes

ipd_sharing_description: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing

lead_sponsor: Regeneron Pharmaceuticals

location_country:
United States
Spain
Greece
France

location_facility: Hospital Universitario Marqués de Valdecilla (HUMV)

location_facility: Hospital Universitario Quiron Salud Madrid

location_facility: Hospital Clínico Universitario de Santiago

location_facility: Institut Clinic de Nefrologia i Urologia - ICNU, Hospital Clinic i Provincial de Barcelona

location_facility: Hospital Universitario Germans Trias i Pujol


title: Observational GORE® VIABAHN® Endoprosthesis With PROPATEN Bioactive Surface (VSX) Global Registry

summary: Collect real-world post-market clinical follow-up data on patients treated with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX)

lead_sponsor: W.L.Gore & Associates

location_country:
Germany
Italy
United Kingdom
Sweden
Netherlands
Belgium
Spain
Greece
France

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona

location_facility: Centre Hospitalier Unversitaire d'Angers

location_facility: S.C. Chirurgia Vascolare dell'A.O.U. di Modena

location_facility: Dipartimento di Scienze Chirurgiche e Morfologiche

location_facility: Centre Hospitalier Regional Universitaire de Brest

location_facility: Hospital Universitari Germans Trias i Pujol

intervention_type: Device


title: Phase II/III Study for Evaluation of the Diagnostic Performance of [18F]CTT1057 PET Imaging for the Detection of PSMA Positive Tumors Using Histopathology as a Standard of Truth

acronym: GuideView

summary:
The purpose of this study is to evaluate the diagnostic performance of [18F]CTT1057 as a PET imaging agent for detection and localization of PSMA positive tumors using histopathology as Standard of Truth (SoT). Tissue specimens from both the primary tumor and pelvic lymph nodes dissected during surgery from patients with newly-diagnosed high-risk prostate cancer (PCa) will be used for the histopathology assessments.

Approximately 195 participants will be enrolled to ensure that at least 156 participants are evaluable (i.e. have both an evaluable PET/CT scan and histopathology assessment and have not received any prohibited systemic antineoplastic therapy before the completion of PET/CT and surgery), which will be required for the calculation of the co-primary endpoints.

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

lead_sponsor: Novartis Pharmaceuticals

location_country:
Italy
Switzerland
United States
Spain
France

location_facility:
Explorer Molecular Imaging center
Novartis Investigative Site


title: Essai Randomise Comparant Deux Stategies De Chimiotherapie Dans Les Cancers Pancreatiques Avances: LV5FU2 Simplifie + Cisplatine Suivi de Gemcitabine, Versus Gemcitabine Suivi de LV5FU2 Simplifie + Cisplatine en Can de Progression

summary:
RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, cisplatin, 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) and giving them in different ways may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating metastatic pancreatic cancer.

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

ReferenceCitation: Dahan L, Bonnetain F, Ychou M, Mitry E, Gasmi M, Raoul JL, Cattan S, Phelip JM, Hammel P, Chauffert B, Michel P, Legoux JL, Rougier P, Bedenne L, Seitz JF; Federation Francophone de Cancerologie Digestive. Combination 5-fluorouracil, folinic acid and cisplatin (LV5FU2-CDDP) followed by gemcitabine or the reverse sequence in metastatic pancreatic cancer: final results of a randomised strategic phase III trial (FFCD 0301). Gut. 2010 Nov;59(11):1527-34. doi: 10.1136/gut.2010.216135.

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

location_facility: Centre Joliot Curie Des Docteurs Jean-Christophe Chardon Jacques Hernandez Et Laurent Gasnault

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

location_facility: Centre Hospital Universitaire Hop Huriez

location_facility: Centre Hospitalier Intercommunal St. Aubin les Elbeuf

location_facility: Centre Hospitalier de Chalons-en-Champagne

location_facility: Centre Hospitalier General de Mont de Marsan

location_facility: Centre Hospitalier Regional et Universitaire de Lille

location_facility: Centre Hospitalier Universitaire Ambroise Pare - Boulogne

location_facility: Centre Hospitalier Universitaire d'Amiens


title: Systematic Early Use of Neuromuscular Blocking Agents in ARDS Patients

summary: The use of neuromuscular blocking agents (NMBA) in ARDS patients has not been extensively investigated. The aim of the study is to show a reduction of the mortality rate of ARDS patients.

ReferenceCitation: Guerin C, Papazian L, Reignier J, Ayzac L, Loundou A, Forel JM; investigators of the Acurasys and Proseva trials. Effect of driving pressure on mortality in ARDS patients during lung protective mechanical ventilation in two randomized controlled trials. Crit Care. 2016 Nov 29;20(1):384. doi: 10.1186/s13054-016-1556-2.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Hospices Civils de Lyon

repository_normalized: HAL

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

ReferenceCitation: Papazian L, Forel JM, Gacouin A, Penot-Ragon C, Perrin G, Loundou A, Jaber S, Arnal JM, Perez D, Seghboyan JM, Constantin JM, Courant P, Lefrant JY, Guerin C, Prat G, Morange S, Roch A; ACURASYS Study Investigators. Neuromuscular blockers in early acute respiratory distress syndrome. N Engl J Med. 2010 Sep 16;363(12):1107-16. doi: 10.1056/NEJMoa1005372.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Hôpital de la croix rousse - Réanimation médicale

location_facility: Hôpital Saint-Louis - Réanimation médicale

location_facility: Hôpital de la Tronche - Réanimation médicale

location_facility: Hôpital Sainte-Marguerite - Réanimation médicale

location_facility: Réanimation Polyvalente - Hôpital Sainte-Marguerite

location_facility: Hôpital Pellegrin - Réanimation médicale

location_facility: Hôpital Pontchaillou - Réanimation médicale

location_facility: Hôpital Jean Minjoz - Réanimation médicale


title: Cardiovascular Risk Assessment In Patients With Hypertension And At Least Three Other Risk Factors, Treated With Caduet Compared To Usual Care: The Right Study

acronym: RIGHT

summary: Compare the reduction in Framingham's predicted 10-year risk of a coronary event (6) in patients with hypertension and at least three other cardiovascular risk factors (including diabetic patients) seen in private practice and randomized to either Caduet or usual care.

lead_sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.


title: Prospective Multicentric Study of Sentinel Lymph Node Assessment Following Previous Surgical Biopsy for Early Breast Cancer

acronym: GATA

summary: The purpose of this study is to assess the detection rate and false negative rate of sentinel lymph node biopsy following previous surgical biopsy for early breast cancer diagnosis.

ReferenceCitation: Renaudeau C, Lefebvre-Lacoeuille C, Campion L, Dravet F, Descamps P, Ferron G, Houvenaeghel G, Giard S, Tunon de Lara C, Dupre PF, Fritel X, Ngo C, Verhaeghe JL, Faure C, Mezzadri M, Damey C, Classe JM. Evaluation of sentinel lymph node biopsy after previous breast surgery for breast cancer: GATA study. Breast. 2016 Aug;28:54-9. doi: 10.1016/j.breast.2016.04.006. Epub 2016 May 20.

evidence: open (via page says license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

lead_sponsor: Institut Cancerologie de l'Ouest

location_facility:
Hopital Lariboisière
Institut Bergonié
Hospital
Hôpital Tenon
Institut Paoli Calmette
Centre Eugène Marquis
Centre Hospitalier
Hospîtal
Centre Claudius Regaud
centre Léon Berard
Centre René Gauducheau
Centre Oscar Lambret
Hopital Européen Georges Pompidou
Institut Jean Godinot
Centre Alexis Vautrin


title: Comparison Between Midazolam and Loxapine in the Treatment of Agitated Patients in the Emergency Department

summary:
Neuroleptics are used since a long time in the management of severely agitated patients. Loxapine is routinely used in our country, with, to our knowledge no severe adverse event reported, in this indication.

However, recently, benzodiazepines have appeared interesting in agitated patients, with the use of midazolam.

The aim of this study is to compare midazolam to loxapine in the treatment of severe agitated patients admitted in the emergency department.

lead_sponsor: University Hospital, Rouen

location_facility:
Emergecy department
Emergency Department


title: Multicentric Phase I/II Study Evaluating the Efficacy and Toxicity of Imatinib in Adult Patients With Aggressive Fibromatosis That Cannot be Treated by Surgery or Curative Radiotherapy

summary:
RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase I/II trial is studying the side effects of imatinib mesylate and to see how well it works in treating patients with recurrent or refractory aggressive fibromatosis.

ReferenceCitation: Penel N, Le Cesne A, Bui BN, Perol D, Brain EG, Ray-Coquard I, Guillemet C, Chevreau C, Cupissol D, Chabaud S, Jimenez M, Duffaud F, Piperno-Neumann S, Mignot L, Blay JY. Imatinib for progressive and recurrent aggressive fibromatosis (desmoid tumors): an FNCLCC/French Sarcoma Group phase II trial with a long-term follow-up. Ann Oncol. 2011 Feb;22(2):452-7. doi: 10.1093/annonc/mdq341. Epub 2010 Jul 9.

ReferenceCitation: Fayette J, Dufresne A, Penel N, et al.: Imatinib for the treatment of aggressive fibromatosis/desmoid tumors (AF/DT) failing local treatment: updated outcome and predictive factors for progression free survival: a FNCLCC French Sarcoma Group-GETO study. [Abstract] J Clin Oncol 25 (Suppl 18): A-10062, 560s, 2007.

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 Regional de Besancon - Hopital Jean Minjoz

location_facility: Centre Hospitalier Universitaire Bretonneau de Tours


title: Clinical Observations of Automatic Algorithms for Cardiac Pacing

summary: This study shall evaluate in daily medical practice the clinical results of the AV delay hysteresis search algorithm in patients with a INSIGNIA ULTRA or AVT pacemaker implanted for one of the three following indications: sinus node dysfunction, atrial disease (or bradycardia/tachycardia) and atrio-ventricular paroxysmal block. In addition use and outcome of automatic functions will be evaluated.

lead_sponsor: Boston Scientific Corporation

location_country: Guadeloupe France

location_facility:
CHR la Source
Clinique Notre Dame
CHU de Point à pitre
Clinique du Lac et d'Argonay
CH DAX
CHU Albert Michalon
CHRU- Hôpital Nord
CHG Saint Louis - SIH Eure Seine
Casamance
Clinique A. Brillard
Polyclinique du Bois
CHP de la Loire
CH de La Roche sur Yon
Clinique Belledone
CH d'Arles
CHU Nîmes
Clinique Ambroise Paré
CH Maréchal Joffre
Clinique St Hilaire
Clinique Cardiologique Aressy
Hôpital de Brabois
Polyclinique Bordeaux-Cauderan
CH Cherbourg
CH privé St. Martin
Polyclinique Sévigné
Clinique de L'Ormeau
CH Emile Muller
CHI de Castres
Hôpital Nord
Clinique Pasteur
Clinique Paulmy
CH Nevers
CHG de Pau
Nouvelles Cliniques Nantaises
Hôpital Fontenoy
Clinique des Cèdres
Polyclinique Louis Pasteur
CH Beauvais
CHG de Dinan
CH de Laval


title: A Randomized Cost-minimization Trial Comparing Pemetrexed (Alimta®) Versus Docetaxel (Taxotere®) as Second Line Treatment in Advanced Non Small Cell Lung Cancer (NSCLC): Study 05-06 of Groupe Français de Pneumo-Cancérologie (GFPC).

summary:
The indication of chemotherapy of 2nd line treatment in advanced non small cell lung cancer is now well established. The two treatments of reference are pemetrexed (alimta) and docetaxel (taxotere). Effectiveness and toxicity of the two drugs are largely documented in the literature.

Economic analyses are currently one of the criteria used in medical decision, beside effectiveness, quality of life and toxicities.

However, Economical comparison shows significant variations in the acquisition costs of the two drugs. Consequently, it appears interesting to carry out a randomized prospective study with on exclusive economical criteria of judgment.

As there is no difference in the effectiveness between the two treatments, a cost-minimization analysis will be carried out to appreciate the ratio benefit/risks from an economical point of view (payer).

lead_sponsor: University Hospital, Limoges

sponsor_collaborators:
University Hospital, Limoges
Groupe Francais De Pneumo-Cancerologie

location_facility: Service de pneumologie; Centre Hospitalier d'Annecy

location_facility: Service de Pneumologie - Hôpital St Antoine, Paris

location_facility: Service de Pneumologie-Neurologie ; Centre Hospitalier F. Quesnay

location_facility: Service de Pneumologie ; Hôpital saint Antoine, Paris

location_facility: Clinique Pneumologique; Hôpital Charles Nicolle

location_facility: Service de Pneumologie; Centre Hospitalier

location_facility: Service de Pneumologie-Allergologie; Centre Hospitalier Général

location_facility: Département des Maladies Respiratoires ; Hôpital Sainte Marguerite

location_facility: Service de Pneumologie et Réanimation ; Hôpital Hôtel Dieu - Paris

location_facility: Service de Pneumologie; Hôpital Bois Guillaume

location_facility: Service d'Oncologie Médicale; Clinique Sainte Marguerite

location_facility: Service de Pathologie Respiratoire; CHU de Limoges

location_facility: Service de Pneumologie; Hôpital de la Croix Rousse

location_facility: Service de Pneumologie ; Centre hospitalier

location_facility: Service de Pathologie Respiratoire; Hôpital d'Instruction des Armées Sainte-Anne


title: Phase I Dose-escalation of S 95005 (TAS-102) in Combination With Oxaliplatin in Metastatic Colorectal Cancer

summary: The main purpose of this study is to assess the safety and tolerability and to determine the recommended phase 2 dose of S 95005 given in combination with oxaliplatin in patients with metastatic colorectal cancer.

ReferenceCitation: Argiles G, Andre T, Hollebecque A, Calvo A, Dahan L, Cervantes A, Leger C, Amellal N, Fougeray R, Tabernero J. Phase I dose-escalation of trifluridine/tipiracil in combination with oxaliplatin in patients with metastatic colorectal cancer. Eur J Cancer. 2019 May;112:12-19. doi: 10.1016/j.ejca.2019.01.101. Epub 2019 Mar 16.

oa_host_type: closed

ipd_sharing_description:
Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.

Access can be requested for all interventional clinical studies:

used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope.

In addition, access can be requested for all interventional clinical studies in patients:

sponsored by Servier
with a first patient enrolled as of 1 January 2004 onwards
for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.

lead_sponsor: Institut de Recherches Internationales Servier

location_country:
Germany
Italy
Hungary
United Kingdom
Austria
Spain
France

location_facility: La Pitié Salpêtrière Centre Investigation clinique Paris Est

location_facility: St. Josef-Hospital, Klinikum der Ruhr-Universität Bochum Abteilung für Hämatologie und Onkologie

location_facility: Hospital Unviersitario Gregorio Marañon - Servicio de Oncología Médica

location_facility: Policlinico G.B. Rossi A.O.U.I. di Verona U.O.C. di Oncologia

location_facility: H. Valle de Hebrón - Servicio de Oncología - (VHIR)

location_facility: Hôpital Saint-Antoine Service d'Oncologie Médicale

location_facility: H. Clinico de Valencia INCLIVA - Departamento de Hematologia y Oncologia Medica 8ª planta

location_facility: H. Univ. Ramon y Cajal - Servicio de Oncología Medica

location_facility: H. Uni. Madrid Sanchinarro - CIOCC Servicio de Oncología

location_facility: Christie Hospital NHS Foundation Trust GI & Endocrine

location_facility: Semmelweis Egyetem I. sz. Belgyogyaszati Klinika - Klin. Farmakologiai Reszleg

location_facility: ICO Badalona. H. Germans Trials y Pujol - Servicio de Oncología médica

location_facility: Klinikum Wolfsburg Medizinische Klinik II

location_facility: Magyar Honvedseg Egeszsegugyi Kozpont Onkologiai Osztaly

location_facility: CHU de la Timone Hépato-Gastro-Entérologie - Oncology Digestive

location_facility: Ist.Scientifico Romagnolo per lo Studio e la Cura dei Tumori Department of Clinical Oncology

location_facility: Allgemeines Krankenhaus - Universitätskliniken Klinische Abteilung für Onkologie

location_facility: Orszagos Onkologiai Intezet "B" Belgyogyaszati-Onkologiai O. Es Klin. Farmakologiai O.

location_facility: ARNAS - Azienda Ospedaliera Garibaldi - Nesima Struttura Complessa di Oncologia Medica

location_facility: Universitätsklinikum Hamburg-Eppendorf II. Medizin. Klinik und Poliklinik (Onkologie, Hämatologie)

location_facility: Centre Eugène Marquis Service d'Oncologie Médicale

location_facility: Universitätsklinikum Ulm Zentrum für Innere Medizin, Klinik für Innere Medizin I

location_facility: Klinikum der Universität München Campus Großhadern, Medizinische Klinik und Poliklinik III


title: Multicenter, Randomized, Open-Label Study To Compare The Efficacy, Tolerance And Quality Of Life Of 5 Years Of Adjuvant Exemestane (Aromasin) Therapy With 2.5 To 3 Years Of Adjuvant Tamoxifen Therapy, Followed By 2 To 2.5 Years Of Exemestane For A Total Duration Of 5 Years To Treat HR+ Post-Menopausal Patients With Non-Metastatic Breast Cancer

acronym: TEAM

summary:
To compare recurrence free survival between two treatment groups (5 years with exemestane vs 2.5 to 3 years tamoxifen followed by 2 to 2.5 years of exemestane for a total duration of 5 years)

This Pfizer sponsored trial is part of an international collaboration of investigators conducting 7 similar yet independent studies in 9 countries. This study is designed to be part of the larger TEAM trial where the data from these 7 studies will be combined. A pre-specified analysis of the pooled data will be conducted. Link to TEAM Trial [971-ONC-0028-081/A5991026] Study Results: http://clinicaltrials.gov/ct2/show/results/NCT00036270?term=971-ONC-0028-081&rank=1

ReferenceCitation: Bayani J, Kornaga EN, Crozier C, Jang GH, Bathurst L, Kalatskaya I, Trinh QM, Yao CQ, Livingstone J, Boutros PC, Spears M, McPherson JD, Stein LD, Rea D, Bartlett JMS. Identification of Distinct Prognostic Groups: Implications for Patient Selection to Targeted Therapies Among Anti-Endocrine Therapy-Resistant Early Breast Cancers. JCO Precis Oncol. 2019 Dec;3:1-13. doi: 10.1200/PO.18.00373.

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Derks MGM, Bastiaannet E, van de Water W, de Glas NA, Seynaeve C, Putter H, Nortier JWR, Rea D, Hasenburg A, Markopoulos C, Dirix LY, Portielje JEA, van de Velde CJH, Liefers GJ. Impact of age on breast cancer mortality and competing causes of death at 10 years follow-up in the adjuvant TEAM trial. Eur J Cancer. 2018 Aug;99:1-8. doi: 10.1016/j.ejca.2018.04.009. Epub 2018 Jun 6.

repository_institution: University of Birmingham - University of Birmingham Research Portal

repository_normalized: Pure (Denmark)

version: submittedVersion

repositories_concat: Pure (Denmark)

ReferenceCitation: Derks MGM, Blok EJ, Seynaeve C, Nortier JWR, Kranenbarg EM, Liefers GJ, Putter H, Kroep JR, Rea D, Hasenburg A, Markopoulos C, Paridaens R, Smeets JBE, Dirix LY, van de Velde CJH. Adjuvant tamoxifen and exemestane in women with postmenopausal early breast cancer (TEAM): 10-year follow-up of a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2017 Sep;18(9):1211-1220. doi: 10.1016/S1470-2045(17)30419-9. Epub 2017 Jul 18.

ReferenceCitation: Kalatskaya I, Trinh QM, Spears M, McPherson JD, Bartlett JMS, Stein L. ISOWN: accurate somatic mutation identification in the absence of normal tissue controls. Genome Med. 2017 Jun 29;9(1):59. doi: 10.1186/s13073-017-0446-9.

repository_institution: University of Toronto - TSpace

repository_normalized: localhost

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

repository_institution: University of California - eScholarship University of California

repositories:
PubMed Central
escholarship.org
localhost

ReferenceCitation: Bartlett JM, Brookes CL, Piper T, van de Velde CJ, Stocken D, Lyttle N, Hasenburg A, Quintayo MA, Kieback DG, Putter H, Markopoulos C, Kranenbarg EM, Mallon EA, Dirix LY, Seynaeve C, Rea DW. Do type 1 receptor tyrosine kinases inform treatment choice? A prospectively planned analysis of the TEAM trial. Br J Cancer. 2013 Oct 29;109(9):2453-61. doi: 10.1038/bjc.2013.609. Epub 2013 Oct 3.

oa_colors: green hybrid

license: cc-by-nc-sa

license_normalized: cc-by-nc-sa

publisher_dissemination: Springer

ReferenceCitation: van de Velde CJ, Rea D, Seynaeve C, Putter H, Hasenburg A, Vannetzel JM, Paridaens R, Markopoulos C, Hozumi Y, Hille ET, Kieback DG, Asmar L, Smeets J, Nortier JW, Hadji P, Bartlett JM, Jones SE. Adjuvant tamoxifen and exemestane in early breast cancer (TEAM): a randomised phase 3 trial. Lancet. 2011 Jan 22;377(9762):321-31. doi: 10.1016/S0140-6736(10)62312-4.


acronym: Transplant BRaVE

lead_sponsor: Marjolein Spiering

summary: To combine Brentuximab Vedotin with Dexamethasone, AraC and Cisplatin (DHAP) chemotherapy in patients with Hodgkin lymphoma (HL) refractory to first line chemotherapy or in first relapse is expected to induce a significantly higher (metabolic) complete remission (CR) rate prior to consolidation with BEAM, as judged by FDG (18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose)-PET negativity. This will be compared with published data on DHAP salvage only. Increasing the metabolic CR rate prior to consolidation with high dose chemotherapy and autologous stem cell transplantation (ASCT) is expected to improve progression free survival (PFS) and overall survival (OS).

ReferenceCitation: Driessen J, Kersten MJ, Visser L, van den Berg A, Tonino SH, Zijlstra JM, Lugtenburg PJ, Morschhauser F, Hutchings M, Amorim S, Gastinne T, Nijland M, Zwezerijnen GJC, Boellaard R, de Vet HCW, Arens AIJ, Valkema R, Liu RDK, Drees EEE, de Jong D, Plattel WJ, Diepstra A; HOVON Lunenburg Lymphoma Phase I/II Consortium (LLPC). Prognostic value of TARC and quantitative PET parameters in relapsed or refractory Hodgkin lymphoma patients treated with brentuximab vedotin and DHAP. Leukemia. 2022 Dec;36(12):2853-2862. doi: 10.1038/s41375-022-01717-8. Epub 2022 Oct 14.

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

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

ReferenceCitation: Kersten MJ, Driessen J, Zijlstra JM, Plattel WJ, Morschhauser F, Lugtenburg PJ, Brice P, Hutchings M, Gastinne T, Liu R, Burggraaff CN, Nijland M, Tonino SH, Arens AIJ, Valkema R, van Tinteren H, Lopez-Yurda M, Diepstra A, De Jong D, Hagenbeek A. Combining brentuximab vedotin with dexamethasone, high-dose cytarabine and cisplatin as salvage treatment in relapsed or refractory Hodgkin lymphoma: the phase II HOVON/LLPC Transplant BRaVE study. Haematologica. 2021 Apr 1;106(4):1129-1137. doi: 10.3324/haematol.2019.243238.

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: Erasmus University Rotterdam - EUR Research Repository

repository_institution: Radboud University - Radboud Repository

publisher_dissemination: Ferrata Storti Foundation (Haematologica)

sponsor_collaborators:
Marjolein Spiering
Millennium: The Takeda Oncology Company

location_facility: Cambridge University Hospitals NHS Foundation Trust | Addenbrooke's Hospital

location_facility: King's College Hospital NHS Foundation Trust

title: Phase I/II Feasibility Study Combining Brentuximab Vedotin With Second Line Salvage Chemotherapy (DHAP) in Hodgkin Lymphoma Patients Refractory to First Line Chemotherapy or in First Relapse Who Are Eligible for High Dose Treatment Followed by Autologous Peripheral Blood Stem Cell Transplantation (ASCT)

location_country:
Denmark
Netherlands
United Kingdom
France


title: A Collaborative Retrospective Trial on the Efficacy and Safety of Intravitreal Dexamethasone Implant (Ozurdex) in Patients With Diabetic Macular Edema (DME). THE EUROPEAN DME REGISTRAR STUDY (ARTES)

acronym: ARTES

summary: To review the safety and efficacy of injections with Ozurdex (700 μg dexamethasone) in clinical practice management of patients with DME.

time_perspective: Retrospective

collaborators: European Vision Institute Clinical Research Network

location_country:
Finland
Italy
France
Portugal
United Kingdom
Sweden
Spain
Israel

location_facility: Department of Ophthalmology Tel Aviv Sourasky Medical Center

location_facility: Ophthalmic Research Unit, Department of Basic Medical Sciences, Neuroscience and Sense Organs

location_facility: Department of Ophthalmology Lariboisière Hospital

location_facility: Ophthalmology Clinical Trials Unit Frimley Park Hospital Foundation Trust

location_facility: Ophthalmology Department, Kaplan Medical Center

location_facility: Ophthalmology Department, Dos de Maig Hospital

location_facility: Servicio de Oftalmologia, Hospital Universitario Y Politecnico de la Fe

location_facility: Department of Ophthalmology, Centre Hospitalier Henri Duffaut,

location_facility: Center for Clinical Trials - Association for Innovation and Biomedical Research on Light and Image

location_facility: Instituto de Retina e Diabetes Ocular de Lisboa (IRL)

location_facility: Excellence Eye Research Centre University G. d'Annunzio of Chieti-Pescara

location_facility: NIHR Moorfields Clinical Research Facility, Moorfields Eye Hospital, NHS Foundation Trust

location_facility: Department of Ophthalmology, Kuopio University Hospital

location_facility: Ophthalmology Department, Hospital de LaPaz

location_facility: Department of Ophthalmology University of Udine

location_facility: Clinical Trial Unit, Department of Ophthalmology, CHU Nord, Aix Marseille University

location_facility: Hospital Vall d'Hebrón Department of Ophthalmology

location_facility: Centre for Clinical Trials, Department of Ophthalmology University of Padova

location_facility: Department of Ophthalmology University Vita Salute - Scientific Institute of San Raffael

location_facility: Department of Ophthalmology, Croix Rousse University Hospital


title: Nanostim Study for a Leadless Cardiac Pacemaker System

summary: The objective of the study is to confirm clinical performance and safety of the Nanostim leadless cardiac pacemaker system within its intended use and according to its instructions for use.

ReferenceCitation: Reddy VY, Miller MA, Knops RE, Neuzil P, Defaye P, Jung W, Doshi R, Castellani M, Strickberger A, Mead RH, Doppalapudi H, Lakkireddy D, Bennett M, Sperzel J. Retrieval of the Leadless Cardiac Pacemaker: A Multicenter Experience. Circ Arrhythm Electrophysiol. 2016 Dec;9(12):e004626. doi: 10.1161/CIRCEP.116.004626.

publisher_dissemination: Wolters Kluwer Health

lead_sponsor: Abbott Medical Devices

location_country:
Germany
Italy
United Kingdom
Netherlands
Spain
Czechia
France

location_facility: Herzzentrum Dresden GmbH Universitätsklinik

location_facility: Deutsches Herzzentrum München des Freistaates Bayern

location_facility: Manchester Heart Center, Manchester Royal Infirmary

location_facility: Universitätsmedizin Berlin - Campus Benjamin Franklin


title: WEB Clinical Assessment of IntraSaccular Aneurysm Therapy

acronym: WEBCAST

summary: The objective of this clinical study is to evaluate clinical utility of the WEB Aneurysm Embolization System used to embolize intracranial aneurysms

ReferenceCitation: Pierot L, Szikora I, Barreau X, Holtmannspoetter M, Spelle L, Klisch J, Herbreteau D, Costalat V, Fiehler J, Januel AC, Liebig T, Stockx L, Weber W, Berkefeld J, Moret J, Molyneux A, Byrne J. Aneurysm treatment with the Woven EndoBridge (WEB) device in the combined population of two prospective, multicenter series: 5-year follow-up. J Neurointerv Surg. 2023 Jun;15(6):552-557. doi: 10.1136/neurintsurg-2021-018414. Epub 2022 Jul 8.

publisher_dissemination: British Medical Journal

ReferenceCitation: Pierot L, Szikora I, Barreau X, Holtmannspoetter M, Spelle L, Herbreteau D, Fiehler J, Costalat V, Klisch J, Januel AC, Weber W, Liebig T, Stockx L, Berkefeld J, Moret J, Molyneux A, Byrne J. Aneurysm treatment with WEB in the cumulative population of two prospective, multicenter series: 3-year follow-up. J Neurointerv Surg. 2021 Apr;13(4):363-368. doi: 10.1136/neurintsurg-2020-016151. Epub 2020 Jun 12.

ReferenceCitation: Pierot L, Spelle L, Molyneux A, Byrne J; WEBCAST and French Observatory Investigators. Clinical and Anatomical Follow-up in Patients With Aneurysms Treated With the WEB Device: 1-Year Follow-up Report in the Cumulated Population of 2 Prospective, Multicenter Series (WEBCAST and French Observatory). Neurosurgery. 2016 Jan;78(1):133-41. doi: 10.1227/NEU.0000000000001106.

evidence: open (via crossref license)

lead_sponsor: Microvention-Terumo, Inc.

location_country: Germany Denmark Hungary France

location_facility: Klinikum der Johann Wolfgang Goethe Universität


title: A Phase IV Study, Prospective, Randomised, Open Label, Blinded Endpoint, Parallel Group, 9 Weeks of Comparison Between Oral Administration of Telmisartan Tablet (80mg Once Daily) and Amlodipine Tablet (10 mg Once Daily) on Biological PPAR Gamma Activities in Non Controlled Hypertensive Male Patients With Metabolic Syndrome

summary:
The objective of the study is to compare PPAR activities (increase of adiponectin level) between MICARDIS and amlodipine after 6 weeks of treatment in hypertensive patients with metabolic syndrome. Moreover, this study will compare serum level of inflammatory markers of the metabolic syndrome after 6 weeks of treatment.

An ancillary study performed in one center will assess adipocyte differentiation (PPAR gamma stimulation) in 30 subjects (15 per arm).

lead_sponsor: Boehringer Ingelheim

location_facility: 502.486.3303A Boehringer Ingelheim Investigational Site

location_facility: 502.486 3301A Boehringer Ingelheim Investigational Site

location_facility: 502.486.3316A Boehringer Ingelheim Investigational Site

location_facility: 502.486.3322A Boehringer Ingelheim Investigational Site

location_facility: 502.486.3309A Cabinet Médical Jean Charcot


title: Randomized Phase III Trial Comparing in a Preoperative Schedule the Result of Two Concurrent Chemoradiation Schemes (45 Gy + Capecitabine vs 50 Gy + Capecitabine - Oxaliplatin) on the Rate of Sterilization of the Operative Specimen in Resectable Rectal Carcinomas T3-4 No-2 Mo

summary:
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as capecitabine and oxaliplatin, 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. Giving radiation therapy together with combination chemotherapy before surgery may shrink the tumor so it can be removed. It is not yet known whether giving radiation therapy together with capecitabine is more effective with or without oxaliplatin before surgery in treating rectal cancer.

PURPOSE: This randomized phase III trial is studying radiation therapy, capecitabine, and oxaliplatin to see how well they work compared to radiation therapy and capecitabine in treating patients who are undergoing surgery for stage II or stage III rectal cancer.

ReferenceCitation: Gerard JP, Azria D, Gourgou-Bourgade S, Martel-Laffay I, Hennequin C, Etienne PL, Vendrely V, Francois E, de La Roche G, Bouche O, Mirabel X, Denis B, Mineur L, Berdah JF, Mahe MA, Becouarn Y, Dupuis O, Lledo G, Montoto-Grillot C, Conroy T. Comparison of two neoadjuvant chemoradiotherapy regimens for locally advanced rectal cancer: results of the phase III trial ACCORD 12/0405-Prodige 2. J Clin Oncol. 2010 Apr 1;28(10):1638-44. doi: 10.1200/JCO.2009.25.8376. Epub 2010 Mar 1.

ReferenceCitation: Azria D, Doyen J, Jarlier M, Martel-Lafay I, Hennequin C, Etienne P, Vendrely V, Francois E, de La Roche G, Bouche O, Mirabel X, Denis B, Mineur L, Berdah J, Mahe M, Becouarn Y, Dupuis O, Lledo G, Seitz J, Bedenne L, Gourgou-Bourgade S, Juzyna B, Conroy T, Gerard J. Late toxicities and clinical outcome at 5 years of the ACCORD 12/0405-PRODIGE 02 trial comparing two neoadjuvant chemoradiotherapy regimens for intermediate-risk rectal cancer. Ann Oncol. 2017 Oct 1;28(10):2436-2442. doi: 10.1093/annonc/mdx351.

license: publisher-specific-oa

license_normalized: publisher-specific

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 Hospitalier Intercommunal Le Raincy - Montfermeil

location_facility: Centre Hospitalier General Andre Boulloche

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

location_facility: Centre Hospital Regional Universitaire de Limoges


title: Open Label Phase II Study of MEN-10755 Administered Every 3 Weeks in Patients With Progressive Hormone Refractory Prostate Cancer

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of MEN-10755 in treating patients who have progressive prostate cancer that has not responded to hormone therapy.

ReferenceCitation: Fiedler W, Tchen N, Bloch J, Fargeot P, Sorio R, Vermorken JB, Collette L, Lacombe D, Twelves C; EORTC new drug development group. A study from the EORTC new drug development group: open label phase II study of sabarubicin (MEN-10755) in patients with progressive hormone refractory prostate cancer. Eur J Cancer. 2006 Jan;42(2):200-4. doi: 10.1016/j.ejca.2005.07.030. Epub 2005 Dec 7.

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

location_country: Germany France Switzerland Belgium Spain Israel

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


title: Open Label Phase II Study on RFS 2000 (9-Nitro-camptothecin, 9-NC) Administered as a "5 Days On-2 Days Off" Oral Treatment in Advanced Ovarian Cancer

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of nitrocamptothecin in treating patients who have advanced ovarian cancer.

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

location_country:
France
Italy
United Kingdom
Switzerland
Belgium
Spain
Israel


title: Diagnostic Strategy for Suspected Pulmonary Embolism in Emergency Departments Based on the 4-Level Pulmonary Embolism Clinical Probability Score: SPEED&PEPS Trial

acronym: SPEED&PEPS

summary:
The increased use of diagnostic imaging and especially computed tomography pulmonary angiography in patients suspected of pulmonary embolism (PE) is an important point of concerns.

The goal of this pragmatic cluster-randomized trial is to compare the diagnostic strategy based on the four-level pulmonary embolism probability score (4PEPS) and current practices.

The main questions it aims to answer is: "Does the diagnostic strategy based on 4PEPS significantly reduce the use of thoracic imaging without increasing the risk of serious adverse events as compared to current diagnostic practices?" Patients suspected of having PE in the participating emergency departments will be included and followed for 90 days. In ten centers, the emergency physicians will apply the 4PEPS strategy and in ten other centers, the emergency physicians will be free to do as they see fit. Researchers will compare the two groups of patients to see if the rate of diagnostic thoracic imaging tests and the rate of adverse events related to diagnostic strategies will differ.

ReferenceCitation: Roy PM, Friou E, Germeau B, Douillet D, Kline JA, Righini M, Le Gal G, Moumneh T, Penaloza A. Derivation and Validation of a 4-Level Clinical Pretest Probability Score for Suspected Pulmonary Embolism to Safely Decrease Imaging Testing. JAMA Cardiol. 2021 Jun 1;6(6):669-677. doi: 10.1001/jamacardio.2021.0064.

repository_institution: Indiana University - IUScholarWorks

repositories_concat: PubMed Central;scholarworks.iupui.edu

publisher_dissemination: American Medical Association

ReferenceCitation: Roy PM, Durieux P, Gillaizeau F, Legall C, Armand-Perroux A, Martino L, Hachelaf M, Dubart AE, Schmidt J, Cristiano M, Chretien JM, Perrier A, Meyer G. A computerized handheld decision-support system to improve pulmonary embolism diagnosis: a randomized trial. Ann Intern Med. 2009 Nov 17;151(10):677-86. doi: 10.7326/0003-4819-151-10-200911170-00003.

ReferenceCitation: Roy PM, Moumneh T, Penaloza A, Schmidt J, Charpentier S, Joly LM, Riou J, Douillet D. Diagnostic Strategy for Suspected Pulmonary Embolism in Emergency Departments Based on the 4-Level Pulmonary Embolism Clinical Probability Score: Study Protocol of SPEED&PEPS Trial. Diagnostics (Basel). 2022 Dec 9;12(12):3101. doi: 10.3390/diagnostics12123101.

publisher_dissemination: MDPI

ipd_sharing_description: Anonymized raw data on individual patients constituting the basis of the analysis, results and conclusions will be available to a third-party auditor and to researchers on reasonable and justified request to the main investigator (Prof. Pierre-Marie ROY - PMRoy@chu-angers.fr) after publication and approval by the study steering committee.

lead_sponsor: University Hospital, Angers

location_country: Belgium France

location_facility:
CHU Toulouse
CHU Nice
CH Rochefort
CHU Limoges
CHU Lyon
CHU Liège
CHU Tours
CH Troyes
CH La Rochelle
GH Paris
AP HP Clamart
CHU Rouen
CHU Angers
CHU Nantes
CH Argenteuil
CH Versailles
CH Agen
CHU Clermont Ferrand
CHR Metz Thionville
Cliniques Bruxelles
CHU Grenoble
CH Arpajon
CHU Poitiers

intervention_type: Diagnostic Test


title: European Multicentre Registry of Percutaneous Paravalvular Leak Closure - EuroPVL Study

acronym: EuroPVL

summary:
Paraprosthetic cardiac valve leaks are a progressive complication after after surgical or percutaneous heart valve replacement. These leaks can lead to heart failure and/or life-threatening hemolysis.

Percutaneous closure of para-prosthetic leaks has been developed as an alternative to surgery in high-risk patients. These procedures remain technically challenging with a significant risk of failure and complications, but this risk is improved since the development of dedicated prostheses and the increased experience of the operators. The data in the literature concerning percutaneous leak closure remain limited and disparate and mostly retrospective.The impact of the procedures on the quality of life of patients is not known. Beyond the technical aspects and the follow-up of major cardiovascular events, investigators also wonder what is the impact of these procedures on the quality of life of patients. Investigators hypothesize that even a partial reduction in paraprosthetic leakage may be associated with an improvement in quality of life through reduction of transfusion needs and/or reduction of dyspnea. A prospective study is warranted to assess the technical and clinical and clinical results of these procedures, together with the evaluation of the the possible benefit on the quality of life of the patients.

lead_sponsor: Centre Chirurgical Marie Lannelongue

sponsor_collaborators:
Centre Chirurgical Marie Lannelongue
Easy-CRF

location_country:
Italy
Lithuania
Poland
United Kingdom
Mexico
Belgium
Latvia
Spain
Greece
Turkey
Czechia
France

location_facility: National and kapodistrian university of athens

location_facility: hospital infantil de Mexico Frederico Gomez

location_facility: Pauls Stradins Clinical University Hospital


title: Water Vapor Thermotherapy vs. Combination Pharmacotherapy for Symptomatic Benign Prostatic Hyperplasia Refractory to Alpha Blocker Monotherapy in Sexually Active Men: A Multicenter Randomized Controlled Trial

acronym: VAPEUR RCT

summary: The study objective is to compare water vapor thermotherapy with the REZŪM™ System to dual drug therapy for the treatment of symptomatic benign prostatic hyperplasia refractory to alpha-blocker monotherapy in sexually active men.

location_country: Australia France

location_facility: Centre Hospitalier Universitaire de Lille


title: HOME-CoV: Hospitalization or Outpatient ManagEment of Patients With Confirmed or Probable SARS-CoV-2 Infection. A Before and After Implementation of a Consensus Help-decision Making Rule Study

acronym: HOME-CoV

summary:
COVID-19 pandemic has developed worldwide in less than 4 months. The clinical presentations are variable widely, ranging from simple rhinitis to major lung damage that can lead to death.

In many countries involved in the ongoing health disaster due to SARS-CoV-2 infection, hospital are overloaded. In this context, the decision to hospitalize or to manage COVID-19 patients at home is crucial and defining reliable and consensual criteria is a major issue.

HOME-CoV study is a multicentre quasi-experimental interventional study, before and after implementation of a help-decision making rule (HOME-CoV rule), developed via the Delphi method.

Our main hypothesis is that a strategy based on the consensual HOME-CoV rule compared to current practice is at least as safe as regards the 7-day-rate of adverse events (safety criterion) and more effective as regards the rate of patients eventually managed as outpatients (efficacy criterion).

ReferenceCitation: Douillet D, Penaloza A, Mahieu R, Morin F, Chauvin A, Gennai S, Schotte T, Montassier E, Thiebaud PC, Ghuysen Francois A, Dall'acqua D, Benhammouda K, Bissokele P, Violeau M, Joly LM, Andrianjafy H, Soulie C, Savary D, Riou J, Roy PM; Hospitalization or Outpatient Management of Patients With SARS-CoV-2 Infection Study Group. Outpatient Management of Patients With COVID-19: Multicenter Prospective Validation of the Hospitalization or Outpatient Management of Patients With SARS-CoV-2 Infection Rule to Discharge Patients Safely. Chest. 2021 Oct;160(4):1222-1231. doi: 10.1016/j.chest.2021.05.008. Epub 2021 May 15.

oa_colors: green other

evidence: open (via crossref license, author manuscript)

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

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

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

ReferenceCitation: Douillet D, Mahieu R, Boiveau V, Vandamme YM, Armand A, Morin F, Savary D, Dubee V, Annweiler C, Roy PM; HOME-CoV expert group. Outpatient management or hospitalization of patients with proven or suspected SARS-CoV-2 infection: the HOME-CoV rule. Intern Emerg Med. 2020 Nov;15(8):1525-1531. doi: 10.1007/s11739-020-02483-0. Epub 2020 Sep 4.

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

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

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

repository_institution: Research Square - Research Square

repository_normalized: Research Square

repositories:
HAL
PubMed Central
Research Square

repositories_concat: HAL;PubMed Central;Research Square

location_country: Monaco Belgium France

location_facility: Centre Hospitalier Universitaire de Nantes


acronym: ALBAN

summary:
This is an open-label, randomized, multicentric study in patients with high-risk non-muscle invasive bladder cancer who had never received BCG for this disease.

The objective is to evaluate the efficacy of atezolizumab as measured by recurrence-free survival.

sponsor_collaborators:
UNICANCER
Hoffmann-La Roche

location_facility: Hospital Universitario de Jerez de la Frontera

location_facility: Centre Hospitalier Universitaire Lyon Sud

location_facility: Centre Hospitalier Universitaire Bordeaux

location_facility: Hospital General Universitario Morales Meseguer

location_facility: Hôpital privé Toulon - Sainte Marguerite

location_facility: Centre Hospitalier Universitaire Marseille

title: An Open Label, Randomized, Phase III Trial, Evaluating Efficacy of Atezolizumab in Addition to One Year BCG (Bacillus CaLmette-Guerin) Bladder Instillation in BCG-naive Patients With High-risk Non-muscle Invasive Bladder cANcer

ipd_sharing_description: Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients

location_country: Spain Belgium France


title: A Randomized Phase III Trial of Platinum Chemotherapy Plus Paclitaxel With Bevacizumab and Atezolizumab Versus Platinum Chemotherapy Plus Paclitaxel and Bevacizumab in Metastatic (Stage IVB), Persistent, or Recurrent Carcinoma of the Cervix

acronym: BEATcc

summary:
The study will integrate the efficacy of combining the anti programmed death-ligand 1 (anti-PD-L1) agent atezolizumab with the current standard of care in Stage IVB , persistent or recurrent carcinoma of the cervix, namely cisplatin or carboplatin/paclitaxel/bevacizumab. It will be explored the combination of bevacizumab plus atezolizumab, with no patient selection based on PD-L1 expression, allowing an all-comer assessment of atezolizumab activity.

The study is a randomized open label phase III trial to investigate the impact of atezolizumab in combination with bevacizumab and cisplatin or carboplatin /paclitaxel chemotherapy on overall survival and will employ the intent to treat principle, and random assignment to one of the 2 arms will be balanced according to disease histology (squamous cell carcinoma vs adenocarcinoma), prior platinum therapy as a radiation sensitizer (no prior cis-Radiotherapy (RT) versus prior cis-RT) and chemotherapy backbone (cisplatin vs carboplatin).

This trial will be run in an open label design due to the following considerations: the control arm is the standard of care for women diagnosed with metastatic, persistant or recurrent cervical cancer because of its impact on overall survival and the primary endpoint of the study is overall survival (OS), so blinding is not needed to ensure a robust assessment.

ReferenceCitation: Grau JF, Farinas-Madrid L, Oaknin A. A randomized phase III trial of platinum chemotherapy plus paclitaxel with bevacizumab and atezolizumab versus platinum chemotherapy plus paclitaxel and bevacizumab in metastatic (stage IVB), persistent, or recurrent carcinoma of the cervix: the BEATcc study (ENGOT-Cx10/GEICO 68-C/JGOG1084/GOG-3030). Int J Gynecol Cancer. 2020 Jan;30(1):139-143. doi: 10.1136/ijgc-2019-000880. Epub 2019 Oct 23.

lead_sponsor: Grupo Español de Investigación en Cáncer de Ovario

collaborators: Multicenter Italian Trials in Ovarian cancer and gynecologic malignancies

location_country:
Germany
Italy
Norway
Japan
Sweden
United States
Spain
France

location_facility: Hospital Universitario Donostia- Donostia Unibertsitate Ospitalea

location_facility: Istituto Nazionale Tumori Di Napoli Irccs Pascale

location_facility: Groupe Hospitalier Diaconesses-Croix Saint-Simon

location_facility: Saitama medical university international medical center

location_facility: Hospital Clinico Universitario Virgen Arrixaca

location_facility: Niigata University Medical & Dental Hospital

location_facility: AOU Città della Salute e della Scienza di Torino, Presidio Sant'Anna

location_facility: Complejo Hospitalario Regional de Málaga

location_facility: AUSL Romagna - P.O. di Ravenna, Lugo, Faenza, Rimini e Cattolica

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Intitut Català d' Oncolgia L' Hospitalet

location_facility: Azienda Sanitaria Universitaria Integrata Di Udine

location_facility: Azienda Ospedaliero-Universitaria Di Ferrara

location_facility: Hosptial Clinico Universitario de Santiago de Compostela

location_facility: Azienda Ospedaliero Universitaria Pisana


acronym: UMBRELLA

lead_sponsor: Actelion

summary: The aim of the trial is to study the long-term safety of macitentan and to provide continued treatment with macitentan to patients with pulmonary arterial hypertension (PAH) and Chronic thromboembolic pulmonary hypertension (CTEPH) who were previously treated with macitentan in clinical studies.

location_facility: Federal North-West Medical Research Centre

location_facility: Federal State Budget Scientific Institution

location_facility: Minsk Regional Clinical Hospital Of The Red Banner Of Labor

location_facility: Federal State Budgetary Institution Of Ministry Of Health Of Russian Federation

location_facility: Cardiovascular Pathology Research Institute of Siberian Branch of RAMS

location_facility: Istanbul University Istanbul Medical Faculty

location_facility: Wojewodzki Szpital Specjalistyczny, Oddzial Kardiologiczny

location_facility: Wojewodzki Szpital Specjalistyczny im. Stefana Kardynala Wyszynskiego SPZOZ

location_facility: GH est - Hôpital Cardiovasculaire et Pneumologie Louis Pradel

location_facility: CHU de Montpellier - Arnaud de Villeneuve

location_facility: Hopital Bicêtre - Aphp Hôpitaux Universitaires Paris-Sud

location_facility: National Medical Research Center of Cardiology of MoH of Russian Federation

location_facility: CE 'Dnipropetrovsk Regional Clinical Center of Cardiology and Cardiosurgery'

location_facility: Centre Hospitalier Universitaire - de Nice - Hopital Pasteur

title: mUlticenter, Single-arM, Open-laBel, Long-teRm Safety Study With macitEntan in Patients With puLmonary Arterial Hypertension previousLy Treated With mAcitentan in Clinical Studies

location_country:
Belarus
Poland
Belgium
Turkey
Ukraine
Russian Federation
France


title: An Open Label Phase II Study to Evaluate the Efficacy and Safety of Induction and Consolidation Therapy With Dasatinib in Combination With Chemotherapy in Patients Aged 55 Years and Over With Philadelphia Chromosome Positive (Ph+ or BCR-ABL+) Acute Lymphoblastic Leukemia (ALL).

summary:
The use of imatinib in combination or in association with chemotherapy is now considered as the gold standard for the treatment of Ph+ ALL. The complete remission (CR) rate is 90% versus 20% to 40% with chemotherapy alone. The combination of imatinib, vincristine and dexamethasone is a well tolerated regimen in aged patients and is also associated with a high CR rate of 80% to 90% in patient aged 55 years and over.
However, despite high CR rates, the progression free survival rate at 12 months of patients treated with the combination of imatinib and chemotherapy is 30% to 50%. Relapses remain frequent and only patients intensified with allogenic haematopoietic stem cell transplantation are in long term remission. This strategy is not fully applicable to most patients aged 55 years and over.
Relapses after or during imatinib therapy in patients with Ph+ ALL are associated with BCR-ABL tyrosine kinase domain mutation in 80% of cases, predominantly of the p-loop. The exact incidence of the T315I mutation is controversial and can be estimated to be near 50%. Conversely, the detection of the T315I or F317 mutation in a patient is a very strong predictor of relapse.
Dasatinib is a potent SCR and BCR-ABL tyrosine kinase inhibitor with preserved in vitro activity in most of the BCR-ABL mutated cell lines, except for the T315I and F317 mutations. This is also the case in vivo, with patients harbouring BCR-ABL TK domain mutations remaining sensitive to dasatinib. The CHR rate in Ph+ ALL resistant to imatinib is 33% and the median progression-free survival is 3.7 months. Progression free survival (PFS) rate at 12 months is 22%.

The goal of this trial is to evaluate the efficacy and the tolerance of the combination of dasatinib with chemotherapy in the front-line setting as induction and consolidation therapy in Ph+ ALL patient aged 55 years and over. A European consensus has been reached to adopt a common chemotherapeutic schedule for patients aged 55 years and over. This schedule will be used in this trial with the addition of dasatinib as concomitant therapy during induction and alternating with chemotherapy during consolidation and maintenance. A CR rate of 90% and a progression free survival of 60% at 12 months are expected. The patients will be prospectively monitored for minimal residual disease and mutation.

lead_sponsor: Versailles Hospital

location_country: Germany Italy Belgium France

location_facility: Centre Hospitalier Départemental FELIX GUYON


acronym: BV-ICE

lead_sponsor: The Lymphoma Academic Research Organisation

summary:
This study is designed as a phase Ib/II trial. The first part (phase Ib) is a dose escalation design to explore the safety and assess the recommended phase 2 dose of Brentuximab Vedotin in Hodgkin lymphoma patients treated with ICE regimen.

The second part, depending on the selected dose after the completion of phase Ib part of the study, will further explore safety in addition to efficacy of the recommended dose of Brentuximab Vedotin in a selected population of patients treated with ICE with Hodgkin lymphoma.

ReferenceCitation: Stamatoullas A, Ghesquieres H, Feugier P, Andre M, Le Bras F, Gac AC, Borel C, Gastinne T, Quittet P, Morschhauser F, Ribrag V, Guidez S, Nicolas-Virelizier E, Berriolo-Riedinger A, Vander Borght T, Edeline V, Brice P. Final results of brentuximab vedotin combined with ifosfamide-carboplatin-etoposide in first refractory/relapsed Hodgkin lymphoma: a lymphoma study association phase I/II study. Leuk Lymphoma. 2022 Dec;63(13):3063-3071. doi: 10.1080/10428194.2022.2107204. Epub 2022 Aug 17.

publisher_dissemination: Informa

location_facility: Institut d'Hématologie de Basse Normandie - CHU Côte de Nacre

location_facility: CHU de Poitiers - Hôpital de La Milétrie

title: Phase I/II Feasibility Study of Brentuximab Vedotin in Refractory / Relapsed Hodgkin Lymphoma Patients Who Are Treated by Chemotherapy (ICE) in Second Line and Eligible for Autologous Transplantation


title: Intensive Treatment to Reach the Target With Golimumab in ulcErative coliTis- In-TARGET

acronym: In-TARGET

summary:
PHASE: IV

TYPE OF STUDY: With direct benefit

DESCRIPTIVE: multicenter, open-label, uncontrolled trial

INCLUSION CRITERIA: Adults with moderate to severe ulcerative colitis who failed corticosteroids and immunosupressive therapy, or are intolerant to immunosuppressors. All included patients will be naïve to anti-TNF therapy. Active disease at golimumab treatment initiation defined as a MAYO score ≥6 and with an endoscopic sub score ≥2.

OBJECTIVE: To determine the proportion of patients with Continuous Clinical Response (CCR) and endoscopic remission after one year of golumimab at week 54.

STUDY DESIGN:

Induction Phase :

Week 0: golimumab 200mg- Week 2: golimumab 100 mg- Week 6: golimumab 50 mg

Maintenance Phase I : Week 10-Week 54 Week 10-Week 54 • Patients with primary clinical response*: Standard regimen with golimumab 50 mg Q4W (or 100 mg Q4W if > 80 kg)

Patients without primary clinical response at week 10 or with flare between week 10-week 54*: Optimization to 100 mg Q4W (or combination therapy with azathioprine if > 80 kg or switch from azathioprine to methotrexate if already on azathioprine at golimumab initiation or patient with known intolerance to thiopurines)

Early escape at Week 18: Primary non-responders who are still not responding at week 18 to dose optimization at Weeks 10 and 14 will be considered treatment failures and will be followed up (call or visit) at week 54 for safety.

Clinical response is defined as a decrease from baseline in the Mayo score ≥30% and ≥3 points, accompanied by either a rectal bleeding sub score of 0 or 1 or a decrease from baseline in the rectal bleeding sub score ≥1

Intermittent Phase II : Week 54-Week 108

• Patients with CCR and MH at week 54 and on golimumab 50 mg every 4 weeks: Stop golimumab and continuation of thiopurines or methotrexate if on combination therapy

• Patients with CCR and MH at week 54 and on golimumab 100 mg every 4 weeks: De-escalation to 50 mg every 4 weeks and continuation of thiopurines or methotrexate if on combination therapy

• Restart/Escalate golimumab on flare (defined in section 4 of the protocol) to the phase I dose; 50 mg q4wk or 100mg q4wk (similar to the phase I regimen)

lead_sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

location_facility: CHU de Colmar- Hopital Trousseau Medecine A


title: Evaluation of Subcutaneous Implantable Cardiac Defibrillator in Brugada Patients

acronym: S-ICD Brugada

summary:
Brugada syndrome is an inherited arrhythmia syndrome with an increased risk of syncope and sudden death resulting from episodes of polymorphic ventricular tachychardia and fibrillation. Currently, there is no medical therapy for the Brugada syndrome and the only treatment available is the implantation of an ICD. There is no discussion on the interest of the ICD implantation in secondary prevention and in patients who experienced syncope but the best therapeutic is more difficult to draw in asymptomatic patients. Recently we demonstrated that in asymptomatic patients with a spontaneous type 1 aspect of Brugada syndrome, (i) there was a significant risk of ventricular arrhythmia, (ii) the problem of inappropriate shocks can be solve with a good ICD programming and (iii) the problem of lead failure remains the main problem in this young population very active and represent the main limitation to larger indication of ICD implantation in this population with a very long life expectancy as these patients had a normal life expectancy except the risk of ventricular arrhythmia.

In this context the S-ICD System (Boston Scientific Inc.) which is an implantable defibrillator technology that treats ventricular tachyarrhythmias using a subcutaneous pulse generator and electrode system rather than a transvenous lead system, represents a very attractive opportunity as it gives the possibility to protect the patients of the risk of ventricular arrhythmia with no risk of lead failure. However, as this is a new technology and as Brugada syndrome patients are a very specific population (very active patients, specific and changing over time ECG aspect that is at risk of T wave over sensing and high risk of SVT), it seems important to evaluate the effectiveness and the safety of S-ICD in this specific context.

lead_sponsor: Nantes University Hospital

location_country: Germany Italy Denmark Spain France

location_facility: Paris University Hospital - La pitié-Salpétrière


title: Modalities of Renal Replacement Therapy in Pediatric Acute Kidney Injury

acronym: EPURE

summary:
Limited prospective data is available to compare morbidity and mortality between renal replacement modalities in pediatric acute renal failure.

In the absence of clear standard of care, the choice of the extra renal replacement therapy modality is subject to clinical judgement, practical aspects, and costs.

This study will supply important data about usual modalities of pediatric acute extra renal replacement therapy and their impact on patient outcome and renal recovery. An obvious next step will be to conduct a randomized controlled trial comparing the different strategies.

lead_sponsor: Rennes University Hospital

location_country: Canada Réunion France

location_facility: Pediatric intensive care - Centre mère enfants

location_facility: Pediatric nephrology - Hôpital Couple-enfants

location_facility: Anesthesy-Pediatric reanimation - Nord University Hospital

location_facility: Nephrology - Pediatric emergency - Clocheville University Hospital

location_facility: Pediatry - Cote De Nacre University Hospital

location_facility: Pediatry - Hopital de la Mère et de l'Enfant

location_facility: Pediatric reanimation - Brabois Hospital

location_facility: Pediatric reanimation - Hôpital mère-enfant

location_facility: Pediatric Nephrology and dianetology - Arnaud de Villeneuve Hospital

location_facility: Réanimation et Surveillance - Robert Debre Hospital


title: Randomized Phase II/III Trial Comparing Folririnox Association [Oxaliplatin / Irinotecan / LV5FU2] Versus Gemcitabine in First Line of Chemotherapy in Metastatics Pancreas Cancers Patients

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

PURPOSE: This randomized phase II/III trial is studying how well combination chemotherapy works as first-line therapy in treating patients with metastatic pancreatic cancer.

ReferenceCitation: Conroy T, Desseigne F, Ychou M, Bouche O, Guimbaud R, Becouarn Y, Adenis A, Raoul JL, Gourgou-Bourgade S, de la Fouchardiere C, Bennouna J, Bachet JB, Khemissa-Akouz F, Pere-Verge D, Delbaldo C, Assenat E, Chauffert B, Michel P, Montoto-Grillot C, Ducreux M; Groupe Tumeurs Digestives of Unicancer; PRODIGE Intergroup. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med. 2011 May 12;364(19):1817-25. doi: 10.1056/NEJMoa1011923.

ReferenceCitation: Ychou M, Desseigne F, Guimbaud R, et al.: Randomized phase II trial comparing folfirinox (5FU/leucovorin [LV], irinotecan [I] and oxaliplatin [O]) vs gemcitabine (G) as first-line treatment for metastatic pancreatic adenocarcinoma (MPA): first results of the ACCORD 11 trial. [Abstract] J Clin Oncol 25 (Suppl 18): A-4516, 2007.

ReferenceCitation: Lambert A, Jarlier M, Gourgou Bourgade S, Conroy T. Response to FOLFIRINOX by gender in patients with metastatic pancreatic cancer: Results from the PRODIGE 4/ ACCORD 11 randomized trial. PLoS One. 2017 Sep 20;12(9):e0183288. doi: 10.1371/journal.pone.0183288. eCollection 2017.

repository_institution: University of Illinois at Chicago - INDIGO

evidence: oa repository (semantic scholar lookup)

publisher_dissemination: Public Library of Science

lead_sponsor: UNICANCER

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 Intercommunal St. Aubin les Elbeuf

location_facility: Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz

location_facility: Centre Hospitalier Universitaire d'Amiens

location_facility: Centre Hospitalier General de Mont de Marsan


title: Multicentre Randomized Trial Assessing the Efficacy of a Short Neoadjuvant and Concomitant Hormone Therapy to an Exclusive Curative Cornformational Radiotherapy of Locolized Prostate Cancer With Intermediate Prognosis

summary:
RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as triptorelin and flutamide, may stop the adrenal glands from making androgens. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving triptorelin and flutamide together with radiation therapy may be an effective treatment for prostate cancer. It is not yet known whether giving triptorelin and flutamide together with external-beam radiation therapy is more effective than external-beam radiation therapy alone in treating prostate cancer.

PURPOSE: This randomized phase III trial is studying triptorelin, flutamide, and external-beam radiation therapy to see how well they work compared to external-beam radiation therapy alone in treating patients with stage II or stage III prostate cancer.

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.

repository_institution: PubMed Central - Europe PMC

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

location_facility: Centre Hospitalier Universitaire Bretonneau de Tours

location_facility: Centre Hospitalier Intercommunal des Alpes du Sud

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

location_facility: Centre Hospital Regional Universitaire de Limoges


title: A Phase IIIb, Non-randomized, Open-label, Multi-Centre, Follow-on Safety Trial of Monthly Doses of Degarelix in Patients With Prostate Cancer

summary: Patients that completed any of the trials; CS27 (NCT00738673), CS28 (NCT00831233), CS30 (NCT00833248) or CS31 (NCT00884273) will be given the opportunity to receive monthly doses of degarelix until the drug is launched in their country. Safety parameters such as electrocardiogram (ECG), blood and urine samples and general health state will be studied. Note: patients completing the CS27 trial did not participate in the CS34 trial.

lead_sponsor: Ferring Pharmaceuticals

location_country: Italy Portugal Sweden Belgium Spain Turkey France

location_facility: Policlinico S.Orsola Malpighi - Universita' degli Studi di Bologna

location_facility: Azienda Ospedaliero Universitaria Ospedali riuniti

location_facility: Clinica Urologica - Azienda Ospedaliera di Perugia

location_facility: Hospital Clinico Universitario S. Carlos

location_facility: Hôpital Saint Louis - Radiotherapy Departement

location_facility: Istanbul University Faculty of Medicine - ÇAPA

location_facility: Azienda Ospedaliera S. Andrea - Universita' la Sapienza di Roma

location_facility: Ankara University Faculty of Medicine - Sıhhıye

location_facility: Marmara University Faculty of Medicine - Altunizade

location_facility: Cerrahpasa Faculty of Medicine - Kocamustafapasa

location_facility: Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone dell'Universita' degli Studi di Palermo

location_facility: S.C. Di Urologia - IRCCS Ospedale Casa Sollievo della Sofferenza

location_facility: Centre de Lutte Contre le Cancer Nantes-Atlantique Centre René Gauducheau

location_facility: Azienda Ospedaliero Universitaria S. Giovanni Battista - Molinette

location_facility: Centro Hospitalar Lisboa Norte, Hospital Santa Maria

location_facility: Hospital Universitario Principe de Asturias

location_facility: Fondazione IRCCS Ospedale Maggiore Policlinico Mangiagalli e Regina Elena

location_facility: Hospital Universitario Central de Asturias

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: Fondazione IRCCS Istituto Nazionale Tumori

location_facility: CRLC Val d' Aurelle - Oncology Radiotherapy


acronym: OCTAVIA

lead_sponsor: Hoffmann-La Roche

summary: This single arm study evaluated the efficacy and safety of first-line chemotherapy with carboplatin and dose-dense weekly paclitaxel plus bevacizumab (Avastin) in participants with epithelial ovarian, fallopian tube, or primary peritoneal cancer. Participants received 6-8 3-week cycles of treatment with bevacizumab 7.5 mg/kg intravenously (iv) on Day 1 of each cycle, paclitaxel 80 mg/m^2 iv on days 1, 8, and 15 of each cycle, and carboplatin iv to an area under the curve (AUC) of 6 on day 1 of each cycle. Following combination chemotherapy, bevacizumab could be continued to be given as a monotherapy.

ReferenceCitation: Gonzalez-Martin A, Gladieff L, Tholander B, Stroyakovsky D, Gore M, Scambia G, Kovalenko N, Oaknin A, Ronco JP, Freudensprung U, Pignata S; OCTAVIA Investigators. Efficacy and safety results from OCTAVIA, a single-arm phase II study evaluating front-line bevacizumab, carboplatin and weekly paclitaxel for ovarian cancer. Eur J Cancer. 2013 Dec;49(18):3831-8. doi: 10.1016/j.ejca.2013.08.002. Epub 2013 Sep 2.

location_facility: Institut Claudius Regaud; Departement Oncologie Medicale

location_facility: Instituto Valenciano Oncologia; Oncologia Medica

location_facility: Uni Hospital Linkoeping; Dept. of Oncology

location_facility: Centre Alexis Vautrin; Oncologie Medicale

location_facility: A.O. Universitaria Policlinico Di Modena; Oncologia

location_facility: Centre Georges Francois Leclerc; Oncologie 3

location_facility: Academisch Medisch Centrum; Inwendige Geneeskunde

location_facility: GH Paris Saint Joseph; Hopital De Jour Oncologie

location_facility: Academ Ziekenhuis Groningen; Medical Oncology

location_facility: Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia

location_facility: Chi Alpes Du Sud Site De Gap; Med Interne Et Polyvalente

location_facility: Centro Oncologico MD Anderson Internacional; Servicio de Oncologia

location_facility: Hôpital Saint Joseph; Oncologie Medicale

location_facility: Sint Elizabeth Ziekenhuis; Inwendige Geneeskunde

location_facility: St. Petersburg Oncology & Gynecology; City Clinical Oncology Dispensary

location_facility: Hopital Antoine Beclere; Service de Medecine Interne

location_facility: The Norvegian Radium Hospital Montebello; Dept of Oncology

location_facility: SBI of Healthcare of Stavropol region Stavropol Regional Clinical Oncology Dispensary

location_facility: Medical Radiological Scientific Center; Department of Radiotherapy of Gynaecological Disease

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Hospital Universitario Clínico San Carlos; Servicio de Oncologia

location_facility: Örebro University Hospital; Department of Gynecologic Oncology

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Hopital De La Miletrie; Hematologie Et Oncologie Medicale

location_facility: IRCCS Istituto Nazionale Tumori Fondazione Pascale; Oncologia Medica B

location_facility: Institut de Cancerologie de La Loire; Radiotherapie

location_facility: Russian Oncology Research Center n.a. N.N. Blokhin Dpt of Clinical Pharmacology and Chemotherapy

location_facility: Medisch Spectrum Twente Enschede; Internal Medicine

location_facility: Isala Klinieken, Locatie Sophia; Inwendige Geneeskunde

location_facility: Universita' Cattolica Del Sacro Cuore; Reparto Ginecologia Oncologica

location_facility: Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie

location_facility: Centre Antoine Lacassagne; Hopital De Jour A2

location_facility: Mc Haaglanden, Locatie Antoniushove; Interne Geneeskunde

location_facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia

location_facility: Hospital das Clinicas - FMUSP, Oncologia

location_facility: Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia

location_facility: Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia

location_facility: Ch De Brive La Gaillarde; Radiotherapie Oncologie

location_facility: Centre Hospitalier Henri Duffaut; Hematologie

title: A Single-arm Phase II Clinical Study Investigating the Addition of Bevacizumab to Carboplatin and Weekly Paclitaxel as First-line Treatment in Patients With Epithelial Ovarian Cancer

location_country:
Italy
Norway
United Kingdom
Brazil
Netherlands
Sweden
Spain
Russian Federation
France