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Brief Title: An Efficacy and Safety Study of Trabectedin Versus Doxorubicin-Based Chemotherapy in Participants With Translocation-Related Sarcomas (TRS)
Official Title: A Randomized, Multicenter, Phase III Trial of Trabectedin (Yondelis) Versus Doxorubicin-based Chemotherapy as First-Line Therapy in Patients With Translocation-Related Sarcomas (TRS)
Study ID: NCT00796120
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of trabectedin compared to standard doxorubicin in participants with advanced translocation-related sarcomas (cancer of connective tissue cells) (TRS).
Detailed Description: This is a randomized (study drug assigned by chance), multicenter (when more than one hospital or medical school team work on a medical research study), Phase 3 trial to evaluate the efficacy and safety of trabectedin as compared to standard doxorubicin in participants with advanced TRS. Participants will be randomized in a 1:1 ratio to either of the 2 treatment groups, that is, trabectedin or doxorubicin plus ifosfamide group. Participants in trabectedin group will receive trabectedin 1.5 milligram per square meter (mg/m\^2) given as a 24-hour continuous intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) every 3 weeks and in doxorubicin plus ifosfamide group participants will receive doxorubicin 60 or 75 mg/m\^2 intravenously every 3 weeks followed by ifosfamide 6 to 9 gram (g)/m\^2 every 3 weeks. Participants in either treatment arm will continue receiving therapy in the absence of progressive disease (PD) or intolerable side effects, until the participants' consent is withdrawn or the eligibility criteria for continuing treatment are no longer fulfilled, or when a concurrent condition precludes continuation of treatment. Efficacy will be assessed primarily by evaluating progression-free survival (PFS). Participants' safety will be monitored throughout the trial.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
, Santa Monica, California, United States
, Boston, Massachusetts, United States
, Albuquerque, New Mexico, United States
, Philadelphia, Pennsylvania, United States
, Houston, Texas, United States
, Salt Lake City, Utah, United States
, Boreaux, , France
, Lille, , France
, Lyon, , France
, Paris, , France
, Villejuif, , France
, Bad Saarow, , Germany
, Köln, , Germany
, Mannheim, , Germany
, Barcelona, , Spain
, Palma De Mallorca N/A, , Spain
, Valencia N/A, , Spain
, Edinburgh, , United Kingdom
, Glasgow, , United Kingdom
, London, , United Kingdom
, Manchester, , United Kingdom
Name: Johnson & Johnson Pharmaceutical Research & Development, LLC Clinical Trial
Affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Role: STUDY_DIRECTOR