NCT01303094

Continuing vs Intermittent Trabectedin in Patients With Advanced Soft Tissue Sarcoma

Phase II Randomized Trial to Evaluate Two Strategies: Continuing Versus Intermittent (Drug-holiday) Trabectedin-regimen in Patients With Advanced Soft Tissue Sarcoma Experiencing Response or Stable Disease After the Sixth Cycle

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Centre Oscar Lambret · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This randomization discontinuation trial will allow for concomitant evaluation of the following: * Side effects and benefits of immediate continuation of Trabectedin after the sixth cycle * Side effects and benefits of a drug holiday

Detailed description

Selection part (220 patients): Trabectedin (depending on dose reductions : between 1.5 and 1 mg/m²/3 weeks; over 24 hour administration) until progression, intolerance or 6 cycles (according to the SPC of Trabectedin) Randomized part (50 patients): After the 6 first cycles, if there is not progression or unacceptable toxicity, the patients will be randomly assigned to continuous or "intermittent/holiday" therapy with CT-scan evaluation every 6 weeks in both arms * Arm A Continuation of Trabectedin (between 1.5 and 1 mg/m²/3 weeks; over 24 hour administration) until progression or intolerance * Arm B "Intermittent/holiday" therapy. Rechallenge of Trabectedin will be implemented in the event of progression; in this case administration of Trabectedin will occur until the second progression or intolerance

Conditions

• Soft Tissue Sarcoma
• Uterine Sarcoma

Interventions

Type	Name	Description
DRUG	Trabectedin	Trabectedin will be administered without drug holiday in Arm A until unacceptable toxicity, progressive disease or patient decision. The treatment beyond disease progression and in case of intolerance will be decided according to investigator discretion. In case of progression after drug discontinuation by patient decision, a re-challenge of Trabectedin is possible.
OTHER	Drug: holiday	A drug-holiday will start after the 6th cycle until disease progression, and then Trabectedin will be re-challenged. Trabectedin will be administered until unacceptable toxicity, second evidence of progressive disease or patient decision.

Timeline

• Start date: 2011-02-01
• Primary completion: 2018-05-16
• Completion: 2018-08-09
• First posted: 2011-02-24
• Last updated: 2026-03-16

Locations

16 sites across 1 country: France