Overview

Trial Comparing Trabectedin to the Best Supportive Care in Patients With Sarcoma

Status:
Completed
Trial end date:
2018-07-14
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 3
Details
Lead Sponsor:
Gustave Roussy, Cancer Campus, Grand Paris
Treatments:
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Trabectedin