Leiomyosarcoma Clinical Trial
Official title:
Time to Secondary Resistance to Trabectedin After Interruption Versus Continuation in Responding Patients With Liposarcoma, Leiomyosarcoma and Synovial Sarcoma
Two arm, randomized, open-label study, to determine the best time to secondary resistance between responding patients who discontinue treatment and resumed Trabectedin at the time of progression versus patients who continued treatment until progression. T
This is an Italian, multicenter, randomized, open-label , two arm, study, to determine the
best time to secondary resistance between responding patients who discontinue treatment and
resumed Trabectedin at the time of progression versus patients who continued treatment until
progression. The aim is to evaluate the best clinical practice for responding patients as
Trabectedin has an acceptable safety profile with no evidence of cumulative toxicity.
After signing informed consent and being assessed for eligibility criteria , eligible
patients will start the trabectedin treatment.
All the patients who will complete 6 cycles of treatment without disease progression will be
be randomized to continue Trabectedin versus "treatment interruption" followed by
re-challenge at progression. Patients randomized to discontinue treatment will be candidate
to other 6 cycles of treatment and if they do not progress, to another interruption. The
treatment will be resumed again at progression for other 6 cycles and this scheme of
treatment will be proposed until progression under Trabectedin.
The study will be conducted in Italy in approximately 12 centers, in order to recruit 330
evaluable patients over a 4 year period. The follow-up will last approximately 3 years.
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