A Phase 2 interventional study of Trabectedin and Drug: holiday in Soft Tissue Sarcoma and Uterine Sarcoma, sponsored by Centre Oscar Lambret. Completed at 16 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-16.
Sponsored by Centre Oscar Lambret · Phase 2, Interventional, and Treatment
This randomization discontinuation trial will allow for concomitant evaluation of the following:
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
1,667 studies on the registry are indexed under Sarcoma; 393 are open to participants now.
This study's enrollment of 53 is above the median of 40 across 1,283 interventional studies indexed under Sarcoma.
Browse Sarcoma studies →Centre Oscar Lambret is the lead sponsor of 127 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria (for the selection part):
Exclusion Criteria (for the selection part):
Inclusion Criteria (for the randomized part):
Exclusion Criteria (for the randomized part):
patient receives 6 cycles of trabectedin, then one dose 15 days after the 6th cycle, every 3 weeks until progression/ toxicity
Drug: Trabectedin
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
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
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
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.
Time frame: 24 weeks after randomization
Response rate
stabilisation, complete and partial responses according to RECIST 1.1
Time frame: 6, 12 and 18 weeks after randomization
Progression free survival rates
According to RECIST 1.1
Time frame: 12 and 54 weeks after randomization
Survival rates
Time frame: 12 and 24 months after randomization
Median progression-free and median overall survivals
Time frame: Up to 5 years after randomization
Tolerability - safety
According to NCI-CTC V4.0 scale
Time frame: Up to 30 days after the last study drg administration
Clinical and biological predictive factors for non progression at the 6th cycle
Collected data at baseline : age, gender, comorbidity, disease history, previous treatment, tumor description, biological parameters
Time frame: At baseline
Post-randomization cost of care
Cost of care will be evaluated by macro-costing approach
Time frame: For one year after randomization
Self estimation of general health status
Evaluation every 6 weeks by 100-mm-long horizontal visual analog scale (VAS) that ranged from worst imaginable health (as bad as death, 0) to perfect health
Time frame: For 1 year after randomization
Plan to share: No
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Centre Oscar Lambret