Soft Tissue Sarcoma Clinical Trial
Official title:
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
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
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
;
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