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Study on Leiomyosarcoma, Liposarcomas and Synovial Sarcoma With Trabectedin

NCT03773510 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2019-05-13

No results posted yet for this study

Summary

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

Conditions

  • Leiomyosarcoma
  • Liposarcoma
  • Synovial Sarcoma

Interventions

DRUG

Trabectedin discontinuation

Patients who did not progressed after 6 cycles of trabectedin will stop the treatment and resume drug in case of progression for other 6 cycles. The treatment will be resumed again at progression for other 6 cycles and this scheme of treatment will be proposed until progression under trabectedin.

DRUG

Trabectedin continuation

Patients who did not progressed after 6 cycles of trabectedin will continue the treatment until Progressive Disease or unacceptable toxicity

Sponsors & Collaborators

  • PharmaMar

    collaborator INDUSTRY

  • Italian Sarcoma Group

    lead NETWORK

Principal Investigators

  • Roberta Sanfilippo, MD · Fondazione IRCCS INT di Milano

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-28
Primary Completion
2025-10-01
Completion
2025-10-01

Countries

  • Italy

Study Locations

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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 NCT03773510 on ClinicalTrials.gov