Spots Global Cancer Trial Database for Olaparib Treatment in BRCA Mutated Ovarian Cancer Patients After Complete or Partial Response to Platinum Chemotherapy
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Trial Identification
Brief Title: Olaparib Treatment in BRCA Mutated Ovarian Cancer Patients After Complete or Partial Response to Platinum Chemotherapy
Official Title: Phase III Randomised, Double Blind, Placebo Controlled Study of Olaparib Maintenance Monotherapy in Platinum Sensitive Relapsed BRCA Mutated Ovarian Cancer Patients With a Complete or Partial Response Following Platinum Based Chemotherapy
Study ID: NCT01874353
Study Description
Brief Summary: A Phase III, randomised, double-blind, placebo-controlled, multi-centre study to assess the efficacy of olaparib maintenance monotherapy in relapsed high grade serous ovarian cancer (HGSOC) patients (including patients with primary peritoneal and / or fallopian tube cancer) or high grade endometrioid cancer with BRCA mutations (documented mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function)) who have responded following platinum based chemotherapy.
Detailed Description: Comparison of olaparib against a placebo in patients with ovarian cancer whose cancer has already improved by taking platinum based chemotherapy. The patients must also have a fault in their DNA which codes for the BRCA protein. The BRCA protein helps mend broken DNA in the cells of the body; if this protein doesn't work properly it can increase the chance of getting cancer. The aim of this study is to see whether patients taking olaparib tablets last longer until their cancer gets worse, compared to those taking the placebo tablet. The study is also looking to see if there is an overall improvement to how long the patients survive whilst taking olaparib tablets compared to the placebo tablets; and the quality of their life whilst living with ovarian cancer.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
University of Alabama at Birmingham, Birmingham, Alabama, United States
Palo Alto Foundation Medical Group, San Francisco, California, United States
University of Colorado, Aurora, Colorado, United States
The Hospital of Central Connecticut, New Britain, Connecticut, United States
Gynecologic Cancer Center, Orlando, Florida, United States
North Shore University, Evanston, Illinois, United States
Greater Baltimore Medical Center, Baltimore, Maryland, United States
Johns Hopkins, Baltimore, Maryland, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
MD Anderson at Cooper Cancer Center, Voorhees, New Jersey, United States
Womens Cancer Care Associates, Albany, New York, United States
Winthrop Gynecologic Oncology Associates, Mineola, New York, United States
OSU JamesCare at Mill Run, Hilliard, Ohio, United States
Henry Joyce Cancer Clinic, Nashville, Tennessee, United States
Aurora St Lukes Medical Center, Milwaukee, Wisconsin, United States
Mercy Hospital for Women, Heidelberg, , Australia
The Royal Womens Hospital, Parkville, , Australia
Prince of Wales Hospital, Randwick, , Australia
U.Z. Gent, Gent, , Belgium
UZ Leuven Gasthuisberg, Leuven, , Belgium
Centro Diagnóstico Barretos, Barretos, , Brazil
Centro Regional Integrado de Oncologia, Fortaleza, , Brazil
Hospital Araujo Jorge, Goiânia, , Brazil
Hospital de Caridade de Ijuí, Ijuí, , Brazil
Centro de Novos Tratamentos Itajai, Itajai, , Brazil
Hospital de Clinicas de Porto Alegre, Porto Alegre, , Brazil
Irmandade da Santa Casa de Misericordia de Porto Alagre, Porto Alegre, , Brazil
Hospital de Base São José do Rio Preto, São José do Rio Preto, , Brazil
Centro de Referencia da Saude da Mulher, São Paulo, , Brazil
Instituto do Câncer de São Paulo, São Paulo, , Brazil
Juravinski Cancer Centre, Hamilton, Ontario, Canada
London Health Sciences Centre, London, Ontario, Canada
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
Sunnybrook Health Sciences Center, Toronto, Ontario, Canada
CHUM - Hopital Norte-Dame, Montreal, Quebec, Canada
CHUS Site Fleurimont, Sherbrooke, Quebec, Canada
Hotel-Dieu de Quebec, Quebec, , Canada
Beijing Cancer Hospital, Beijing, , China
The Tumor Hospital affiliated to China Medical Science Insti, Beijing, , China
1st Hospital of Jilin university, Changchun, , China
Jilin Provincial Cancer Hospital, Changchun, , China
Hunan Cancer Hospital, Changsha, , China
West China Hospital Affiliated to Sichuan University, Chengdu, , China
ChongQing Cancer Hospital, Chongqing, , China
Research Site, Guangzhou, , China
Women's Hospital, Zhejaing University School of Medicine, Hangzhou, , China
The Tumour Hospital of Harbin Medical University, Harbin, , China
Zhejiang Cancer Hospital, Huangzhou, Huangzhou, , China
JINAN, Qi Lu Hosp. of SD Univ., Ji Nan, , China
Research Site, Shanghai, , China
Shanghai Cancer Hospital of Fudan University, Shanghai, , China
The First Affiliated Hospital of Soochow University, Suzhou, , China
First affiliated hospital college of XianJiaotong University, Xian, , China
Institut Bergonie, Bordeaux, , France
CAC François Baclesse, Caen Cedex, , France
69LYON, C Bérard, Onco, Lyon Cedex 08, , France
Centre Catherine de Sienne, Nantes,, , France
Institut Curie Paris Et Saint Cloud, Paris Cedex 5, , France
75PARIS, H Tenon, Onco, Paris, , France
Hopital Européen Georges Pompidou, Paris, , France
69PIERREBE, CH Lyon Sud,, Pierre Benite Cedex, , France
92STCLOUD, C Huguenin, Onco, Saint Cloud, , France
Institut Claudius Regaud, Toulouse, , France
Centre Alexis Vautrin, Vandoeuvre Les Nancy, , France
Institut Gustave Roussy, Villejuif Cedex, , France
Helios-Kliniken Berlin - Buch, Berlin, , Germany
Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, , Germany
Klinikum Essen-Mitte,Evang. Huyssens-Stiftung/Knapps gGmbH, Essen, , Germany
Johann-Wolfgang Goethe-Universität, Frankfurt, , Germany
Medizinische Hochschule Hannover, Hannover, , Germany
Universitätsklinikum Schleswig-Holstein, Lübeck, , Germany
Klinikum rechts der Isar der Technischen Universität, München, , Germany
Onkologie Ravensburg, Ravensburg, , Germany
Universitätsklinikum Rostock, Rostock, , Germany
Rambam Health Care Campus, Haifa, , Israel
Sapir Medical Centre, Kfar Saba, , Israel
Tel Hashomer, Ramat Gan, , Israel
Istituto Europeo di Oncologia, Milano, , Italy
Azienda Ospedaliera Policlinico Di Modena, Modena, , Italy
Istituto Nazionale Tumori Fondazione Pascale, Napoli, , Italy
Istituto Oncologico Veneto Irccs, Padova, , Italy
Istituto Regina Elena-Polo Oncologico Ifo, Roma, , Italy
Policlinico Universitario A. Gemelli, Roma, , Italy
Hyogo Cancer Center, Akashi-shi, , Japan
National Cancer Center Hospital, Chuo-ku, , Japan
National Hospital Organization Kyushu Cancer Center, Fukuoka, , Japan
Saitama Medical University International Medical Center, Hidaka-shi, , Japan
National Hospital Organization Shikoku Cancer Center, Matsuyama-shi, , Japan
Niigata University Medical and Dental Hospital, Niigata-shi, , Japan
Kindai University Hospital, Osakasayama-shi, , Japan
Hokkaido University Hospital, Sapporo-shi, , Japan
Shizuoka Cancer Center, Sunto-gun, , Japan
Asan Medical Center, Seoul, , Korea, Republic of
Gangnam Severance Hospital, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Netherlands Cancer Institute Antoni van Leeuwenhoek Hospital, Amsterdam, , Netherlands
Maastricht Universitair Medisch Centrum, Maastricht, , Netherlands
Universitair Medisch Centrum St. Radboud, Nijmegen, , Netherlands
Erasmus Medisch Centrum, Rotterdam, , Netherlands
Niepubliczny Zaklad Opieki Zdrowotnej Innowacyjna Medycyna, Grzepnica, , Poland
SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii, Olsztyn, , Poland
Wojewódzki Szpital Specjalistyczny w Olsztynie, Olsztyn, , Poland
Centrum Onkologii Instytut im Marii Sklodowskiej-Curie, Warszawa, , Poland
Szpital Specjalistyczny im. Swietej Rodziny SPZOZ, Warszawa, , Poland
Chemotherapy Department, Russian Cancer Research Centre, Moscow, , Russian Federation
St.Petersburg City Oncology Dispensary, Dept. Gynecology, Saint Petersburg, , Russian Federation
Leningrad Regional Oncology Dispensary, St.Petersburg, , Russian Federation
Barcelona,H.Clinic i Provincial,Oncología, Barcelona, , Spain
Barcelona,H.de la Sta.Creu i S.Pau,Oncología, Barcelona, , Spain
Córdoba,H.Reina Sofía,Oncología, Córdoba, , Spain
Gerona,H.Josep Trueta,Oncología, Gerona, , Spain
Madrid, H.C.S.Carlos,Oncología, Madrid, , Spain
Madrid,H.12 de Octubre,Oncología, Madrid, , Spain
Hospital Provincial de Navarra, Pamplona, , Spain
Valencia, IVO, Oncología, Valencia, , Spain
Valencia,H.C.U.Valencia,Oncología, Valencia, , Spain
City Hospital Birmingham Cancer Trials Team, Birmingham, , United Kingdom
Addenbrooke's Hospital, Cambridge, , United Kingdom
Arden Cancer Centre, Coventry, , United Kingdom
Edinburgh Cancer Research UK Centre, Edinburgh, , United Kingdom
Cancer Research UK and UCL Cancer Trials Centre, London, , United Kingdom
Royal Marsden Hospital, London, , United Kingdom
The Christie NHS Foundation Trust, Manchester, , United Kingdom
Royal Marsden Hospital and Institute of Cancer Research, Sutton, , United Kingdom
Contact Details
Name: Professor E Pujade-Lauraine, MD, PhD
Affiliation: Universite de Paris Descartes, France
Role: PRINCIPAL_INVESTIGATOR
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