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

NCT02672527 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2018-08-16

No results posted yet for this study

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

DRUG

Trabectedin

DRUG

Dexamethasone

Sponsors & Collaborators

  • Gustave Roussy, Cancer Campus, Grand Paris

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-22
Primary Completion
2018-07-14
Completion
2018-07-14

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02672527 on ClinicalTrials.gov