Doxorubicin Hydrochloride or Trabectedin in Treating Patients With Previously Untreated Advanced or Metastatic Soft Tissue Sarcoma
Stopped early · Phase 2/Phase 3
Conditions studied: Sarcoma
In brief
RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride and trabectedin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether trabectedin is more effective than doxorubicin hydrochloride in treating patients with advanced or metastatic soft tissue sarcoma. PURPOSE: This randomized phase II/III trial is studying the safety of trabectedin compared with doxorubicin hydrochloride and to see how well they work in treating patients with advanced or metastatic soft tissue sarcoma.
Key facts
- Study ID
- NCT01189253
- Run by
- European Organisation for Research and Treatment of Cancer - EORTC
- People needed
- 133
- Starts
- 2011-05-01
- Expected to finish
- 2015-06-01
- Last updated by the study team
- 2014-08-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Sarcoma Oncology Center — Santa Monica, California, United States
- Stanford Hospital and Clinics — Stanford, California, United States
- Holden Comprehensive Cancer Center at University of Iowa — Iowa City, Iowa, United States
- Dana Farber Institute — Boston, Massachusetts, United States
- Massachussets General Hospital — Boston, Massachusetts, United States
- Methodist Estabrook Cancer Center — Omaha, Nebraska, United States
- Carolinas Hematology-Oncology Associates — Charlotte, North Carolina, United States
- Pennsylvania Oncology Hematology Associates, Incorporated - Philadelphia — Philadelphia, Pennsylvania, United States
- Medical University Vienna — Vienna, Austria
- HôPITAUX UNIVERSITAIRES BORDET-ERASME - INSTITUT JULES BORDET — Brussels, Belgium
- Cliniques Universitaires St. Luc — Brussels, Belgium
- U.Z. Gasthuisberg — Leuven, Belgium
- Aarhus University Hospital — Aarhus, Denmark
- Herlev Hospital - University Copenhagen — Herlev, Denmark
- Institut Bergonie — Bordeaux, France
- Centre Georges-Francois-Leclerc — Dijon, France
- Centre Oscar Lambret — Lille, France
- Centre Leon Berard — Lyon, France
- ASSISTANCE PUBLIQUE - HôPITAUX DE MARSEILLE - HôPITAL DE LA TIMONE — Marseille, France
- Institut de Cancerologie de L'Ouest (Ico) - Centre Rene Gauducheau — Nantes - Saint Herblain, France
- Institut Curie — Paris, France
- Institut Gustave Roussy — Villejuif, France
- Helios Klinikum Bad Saarow — Bad Saarow, Germany
- Universitaetsklinikum Koeln — Cologne, Germany
- Universitaetsklinikum Carl Gustav Carus — Dresden, Germany
Full record on ClinicalTrials.gov
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