Continuing vs Intermittent Trabectedin in Patients With Advanced Soft Tissue Sarcoma
- Registration Number
- NCT01303094
- Lead Sponsor
- Centre Oscar Lambret
- 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
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 53
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Continuation of Trabectedin Trabectedin patient receives 6 cycles of trabectedin, then one dose 15 days after the 6th cycle, every 3 weeks until progression/ toxicity
- Primary Outcome Measures
Name Time Method PFS rate 24 weeks after randomization 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.
- Secondary Outcome Measures
Name Time Method Survival rates 12 and 24 months after randomization Median progression-free and median overall survivals Up to 5 years after randomization Post-randomization cost of care For one year after randomization Cost of care will be evaluated by macro-costing approach
Progression free survival rates 12 and 54 weeks after randomization According to RECIST 1.1
Clinical and biological predictive factors for non progression at the 6th cycle At baseline Collected data at baseline : age, gender, comorbidity, disease history, previous treatment, tumor description, biological parameters
Self estimation of general health status For 1 year after randomization 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
Response rate 6, 12 and 18 weeks after randomization stabilisation, complete and partial responses according to RECIST 1.1
Tolerability - safety Up to 30 days after the last study drg administration According to NCI-CTC V4.0 scale
Trial Locations
- Locations (16)
Saint-Jacques Hospital
🇫🇷Besancon, France
Centre François Baclesse
🇫🇷Caen, France
Centre Jean Perrin
🇫🇷Clermont Ferrand, France
CHU Timone Adultes
🇫🇷Marseille, France
Centre René Huguenin
🇫🇷St Cloud, France
Institut Claudius Regaud
🇫🇷Toulouse, France
Institut Gustave Roussy
🇫🇷Villejuif, France
Centre Oscar Lambret
🇫🇷Lille, France
Centre Antoine Lacassagne
🇫🇷Nice, France
Léon Bérard Center
🇫🇷Lyon, France
Institut Bergonié
🇫🇷Bordeaux, France
Paoli Calmette Institute
🇫🇷Marseille, France
Centre Georges François Leclerc
🇫🇷Dijon, France
Centre Léon Bérard
🇫🇷Lyon, France
Centre Henri Becquerel
🇫🇷Rouen, France
Institut Curie
🇫🇷Paris, France