NCT02672527

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

A Randomized Phase III Trial Comparing Trabectedin (Yondelis®) to the Best Supportive Care in Patients With Advanced Soft Tissue Sarcoma

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 103 (actual)
• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Soft Tissue Sarcoma

Interventions

Type	Name	Description
DRUG	Trabectedin
DRUG	Dexamethasone

Timeline

• Start date: 2015-01-22
• Primary completion: 2018-07-14
• Completion: 2018-07-14
• First posted: 2016-02-03
• Last updated: 2018-08-16

Locations

1 site across 1 country: France