CLINICAL TRIAL SUMMARY

MDACC Study No:2008-0547 (clinicaltrials.gov NCT No: NCT00796120)
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)
Principal Investigator:Shreyaskumar R. Patel
Treatment Agent:Doxorubicin; Ifosfamide; Mesna; Trabectedin
Study Status:Terminated
Study Description:The goal of this clinical research study is to compare 2 chemotherapy
treatments. Trabectedin will be compared with doxorubicin-based therapy
(either doxorubicin alone or doxorubicin plus ifosfamide). Researchers want to
learn if and how long these treatments may help to control TRS. The safety of
these treatments will also be studied.

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Disease Group:Sarcoma
Phase of Study:Phase III
Treatment Agents:Doxorubicin
Ifosfamide
Mesna
Trabectedin
Treatment Location:Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions
Estimated Length of Stay in Houston:Not applicable
Supported By:PharmaMar S.A.
Return Visit:Screening visit, treatment every three weeks in both arms. Labwork on day 1,8
and 15 of each cycle. End of treatment visit.

Home Care:Patients can receive supportive care during the trial.


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Physician Name:Shreyaskumar R. Patel
Dept:Sarcoma Medical Oncology
For Clinical Trial Enrollment:713-792-3626
For General Questions about Clinical Trials:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)


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