Soft Tissue Sarcoma Clinical Trial
Official title:
A Randomized Phase III Trial Comparing Trabectedin (Yondelis®) to the Best Supportive Care in Patients With Advanced Soft Tissue Sarcoma
As the transparency committee of the Haute Autorité de Santé pointed out due to lack of data
regarding comparative trial of Yondelis versus best supportive care, activity of Yondelis in
soft tissue sarcoma remain to be assessed.
For an antineoplastic drug toxicity is moderate. As previous studies shown, overall survival
data for patients with advanced or metastatic STS are of poor prognosis despite improvement
of results this last years. For example, median overall survival increased from 12,3 months
(1987-1991) to 11,4 months (1992-1996) and then 18 months (2002-2006).
Considering the latest results with and without Trabectedin, the investigators may consider
that comparing Trabectedin with best supportive care is ethically acceptable as long as
patients consent to enter the trial.
n/a
Status | Clinical Trial | Phase | |
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Recruiting |
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Completed |
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