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COMPLETEDPHASE2

Continuing vs Intermittent Trabectedin in Patients With Advanced Soft Tissue Sarcoma

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

NCT01303094•Centre Oscar Lambret

View on ClinicalTrials.gov

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

Detailed 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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Inoperable or metastatic soft tissue sarcoma and/or uterine sarcoma
•Measurable lesions (RECIST 1.1)
•Performance status ≤ 2
•Age ≥ 18
•Normal hematological parameters (polynuclear neutrophils ≥ 1500, hemoglobin level ≥ 9 g/dl, platelets counts ≥ 100,000)
•Adequate biological parameters :
•Adequate hepatic function (bilirubin ≤ ULN , SGPT/ALT and SGOT/AST ≤ 2.5 x ULN)
•Alkaline phosphatases ≤ 2.5 x ULN, If Alkaline phosphatases ≥ 2.5 ULN, hepatic isoenzymes 5-nucleotidases or GGT tests must be performed; hepatic isoenzymes 5- nucleotidases and/or GGT must be within the normal range
•Albumin ≥ 25 g/L
•Adequate renal function : Serum creatinine ≤ 1.5 x ULN
+20 more criteria

Exclusion Criteria

•Patients that have received more than one regimen of chemotherapy for metastatic or inoperable soft tissue or uterine sarcoma, after the failure/intolerance of doxorubicin and ifosfamide. Maintenance treatment does not count as treatment line
•The following histological subtypes : GIST, rhabdomyosarcoma, aggressive fibromatosis, desmoïd tumour, PNET, carcinosarcoma, and all bone sarcomas
•Single tumour in an irradiated region
•Other malignant tumour over the past five years (except basal cell carcinoma or cervical carcinoma in situ adequately treated)
•Currently active bacterial or fungus infection (\> grade 2 CTC \[CTCAE\] Version 4.02). Known HIV1, HIV2, hepatitis B or hepatitis C infections
•Presence of known leptomeningeal or brain metastasis
•Patients unable to receive corticotherapy
•Any circumstance that could jeopardise compliance or proper follow-up during the trial
•Pregnant or nursing women
•Tumour progression (according to RECIST 1.1) during the first six Yondelis cycles
+8 more criteria

Locations (16)

Saint-Jacques Hospital

Besançon, France

Institut Bergonié

Bordeaux, France

Centre François Baclesse

Caen, France

Centre Jean Perrin

Clermont-Ferrand, France

Centre Georges François Leclerc

Dijon, France

Centre Oscar Lambret

Lille, France

Léon Bérard Center

Lyon, France

Centre Léon Bérard

Lyon, France

Paoli Calmette Institute

Marseille, France

CHU Timone Adultes

Marseille, France

Key Dates

Start Date

February 1, 2011

Primary Completion Date

May 16, 2018

Completion Date

August 9, 2018

Last Updated

March 16, 2026

Enrollment

ACTUAL participants

Conditions

Soft Tissue SarcomaUterine Sarcoma

Interventions

Trabectedin

DRUG

Drug: holiday

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 16, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Continuing vs Intermittent Trabectedin in Patients With Advanced Soft Tissue Sarcoma

Inclusion Criteria

Exclusion Criteria

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68Ga-DOTATATE PET/CT for the Diagnosis of Soft Tissue Sarcomas

First-in-Human Study of ADCE-D01 in Soft Tissue Sarcoma