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Clinical Trial 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


Clinical Trial 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 ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01303094
Study type Interventional
Source Centre Oscar Lambret
Contact
Status Completed
Phase Phase 2
Start date February 2011
Completion date August 9, 2018

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