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Continuing vs Intermittent Trabectedin in Patients With Advanced Soft Tissue Sarcoma

NCT01303094 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2026-03-16

No results posted yet for this study

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

Conditions

  • Soft Tissue Sarcoma
  • Uterine Sarcoma

Interventions

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.

Sponsors & Collaborators

  • French Sarcoma Group

    collaborator OTHER

  • Study Group of Bone Tumors

    collaborator OTHER

  • Centre Oscar Lambret

    lead OTHER

Principal Investigators

  • Nicolas PENEL, MD, PhD · Centre Oscar Lambret

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2018-05-16
Completion
2018-08-09

Countries

  • France

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 NCT01303094 on ClinicalTrials.gov