Trial Comparing Trabectedin to the Best Supportive Care in Patients With Sarcoma (TSAR)
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|ClinicalTrials.gov Identifier: NCT02672527|
Recruitment Status : Completed
First Posted : February 3, 2016
Last Update Posted : August 16, 2018
As the transparency committee of the Haute Autorité de Santé pointed out due to lack of data regarding comparative trial of Yondelis versus best supportive care, activity of Yondelis in soft tissue sarcoma remain to be assessed.
For an antineoplastic drug toxicity is moderate. As previous studies shown, overall survival data for patients with advanced or metastatic STS are of poor prognosis despite improvement of results this last years. For example, median overall survival increased from 12,3 months (1987-1991) to 11,4 months (1992-1996) and then 18 months (2002-2006).
Considering the latest results with and without Trabectedin, the investigators may consider that comparing Trabectedin with best supportive care is ethically acceptable as long as patients consent to enter the trial.
|Condition or disease||Intervention/treatment||Phase|
|Soft Tissue Sarcoma||Drug: Trabectedin Drug: Dexamethasone||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||103 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Phase III Trial Comparing Trabectedin (Yondelis®) to the Best Supportive Care in Patients With Advanced Soft Tissue Sarcoma|
|Actual Study Start Date :||January 22, 2015|
|Actual Primary Completion Date :||July 14, 2018|
|Actual Study Completion Date :||July 14, 2018|
At Day 1 (D1), premedication with dexamethasone (20 mg) and a 5-HT3 receptor antagonist anti-emetic agent will be intravenously administered 30 minutes prior to trabectedin administration. Trabectedin will be administered through a central venous catheter at a starting dose of 1.5 mg/m² over 24 hours, diluted in at least 500 mL of normal saline solution or of glucose 5% injectable solution.
Each treatment cycle will last 21 days. Treatment duration: the treatment might be pursued until disease progression according to RECIST 1.1, or patient refusal, or toxicities.
In case of disease progression, the further treatments will be based on investigator's judgement.
Other Name: Yondelis
No Intervention: BSC
Patients will receive the best supportive care (BSC) in order to alleviate their symptoms and improve their Quality of Life (QoL).
Antineoplastic agents (including surgery, radiotherapy, thermotherapy, chemotherapy, immunotherapy, hormonal treatment or antibodies-based treatments) are prohibited.
Treatment duration: the treatment might be pursued until disease progression according to RECIST 1.1, or patient refusal.
In case of disease progression, a treatment with trabectedin will be proposed (cross-over). In case of patient refusal, the further treatments will be based on investigator's judgement.
- Progression Free Survival [ Time Frame: Assessed every three weeks after randomization then every six weeks until progression or death of any cause whichever came first up to 30 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02672527
|Gustave Roussy Cancer Campus Grand Paris|
|Villejuif, Val De Marne, France, 94805|