Continuing vs Intermittent Trabectedin in Patients With Advanced Soft Tissue Sarcoma

NCT01303094 | Completed Phase 2 DMC

• 2 other identifiers: T-DIS-10012010-022613-26
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 16

Brief 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

Outcome Measures

Primary Outcomes (1)

• PFS rate 24 weeks after randomization

  In each arms among non progressive patients after the 6 first cycles of Trabectedin : occurrence of progression or death 24 weeks after the date of randomization. Intention to treat analysis. Centralised radiological review.

  24 weeks after randomization

Secondary Outcomes (8)

• Response rate

  6, 12 and 18 weeks after randomization

• Progression free survival rates

  12 and 54 weeks after randomization

• Survival rates

  12 and 24 months after randomization

• Median progression-free and median overall survivals

  Up to 5 years after randomization

• Tolerability - safety

  Up to 30 days after the last study drg administration

Study Arms (2)

Continuation of Trabectedin

OTHER

patient receives 6 cycles of trabectedin, then one dose 15 days after the 6th cycle, every 3 weeks until progression/ toxicity

Drug: Trabectedin

"Drug holiday" therapy

OTHER

patient receives 6 cycles of trabectedin, then one dose 15 days after the 6th cycle and he stops the drug until progression and re-challenge

Other: Drug: holiday

Interventions

Trabectedin DRUG

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.

Also known as: Yondelis

Continuation of Trabectedin

Drug: holiday OTHER

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.

Also known as: No drug

"Drug holiday" therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Creatine phosphokinase ≤ 2.5 x ULN
• Adequate central venous access
• Pregnant or lactating women or men of reproductive potential must use effective contraceptive methods
• Patient covered by government health insurance
• Information sheet given to the patient (Patient information sheet 1)

You may not qualify if:

• 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
• Patient registered in the selection part
• Stable tumour or objective response (CR + PR) after 6 Trabectedin (Yondelis®) cycles, according to local assessment
• Available copies of thoraco-abdominal and pelvic scan performed prior to the first cycle and after the sixth cycle
• Performance status ≤ 2
• Patients receiving at least 1 mg/m²/3 weeks of Trabectedin at the time of the sixth cycle
• Normal hematological parameters (polynuclear neutrophils ≥ 1500, hemoglobin level ≥ 9 g/dl, platelets counts ≥ 100,000)

Sponsors & Collaborators

• Study Group of Bone Tumors: collaborator
• Centre Oscar Lambret: lead
• French Sarcoma Group: collaborator

Study Sites (16)

Saint-Jacques Hospital

Besançon, 25 000, France

Location

Institut Bergonié

Bordeaux, 33076, France

Location

Centre François Baclesse

Caen, 14076, France

Location

Centre Jean Perrin

Clermont-Ferrand, 63011, France

Location

Centre Georges François Leclerc

Dijon, 21079, France

Location

Centre Oscar Lambret

Lille, 59020, France

Location

Léon Bérard Center

Lyon, 69 008, France

Location

Centre Léon Bérard

Lyon, 69008, France

Location

Paoli Calmette Institute

Marseille, 13 273, France

Location

CHU Timone Adultes

Marseille, 13385, France

Location

Centre Antoine Lacassagne

Nice, 06189, France

Location

Institut Curie

Paris, 75005, France

Location

Centre Henri Becquerel

Rouen, 76038, France

Location

Centre René Huguenin

Saint-Cloud, 92210, France

Location

Institut Claudius Regaud

Toulouse, 31052, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

Related Publications (1)

• Le Cesne A, Blay JY, Domont J, Tresch-Bruneel E, Chevreau C, Bertucci F, Delcambre C, Saada-Bouzid E, Piperno-Neumann S, Bay JO, Mir O, Ray-Coquard I, Ryckewaert T, Valentin T, Isambert N, Italiano A, Clisant S, Penel N. Interruption versus continuation of trabectedin in patients with soft-tissue sarcoma (T-DIS): a randomised phase 2 trial. Lancet Oncol. 2015 Mar;16(3):312-9. doi: 10.1016/S1470-2045(15)70031-8. Epub 2015 Feb 11.

  PMID: 25680558 DERIVED

MeSH Terms

Conditions

Sarcoma

Interventions

Trabectedin; Treatment Interruption

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Dioxoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Treatment Adherence and Compliance; Attitude to Health; Delivery of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Nicolas PENEL, MD, PhD

  Centre Oscar Lambret

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2011
• First Posted: February 24, 2011
• Study Start: February 1, 2011
• Primary Completion: May 16, 2018
• Study Completion: August 9, 2018
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (16)