Clinical Trial: Study With Trabectedin Versus Adriamycin Plus Dacarbazine, in Patients With Advanced Solitary Fibrous Tumor
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: Solitary Fibrous Tumor: Phase II Study on Trabectedin Versus Adriamycin Plus Dacarbazine in Advanced Patients
Brief Summary: Phase II randomized study for the comparison of trabectedin versus doxorubicin plus dacarbazine in patients with advanced solitary fibrous tumor
Detailed Summary:
Patients with solitary fibrous tumor will be randomized to receive 6 cycles of trabectedin or doxorubicin plus dacarbazine.
In case of progression or unacceptable toxicity while under the experimental treatment prior to the completion of the 6 cycles, the patients will be offered to cross to the other arm (trabectedin arm to doxorubicin plus dacarbazine arm and vice versa).
Sponsor: Italian Sarcoma Group
Current Primary Outcome: Overall Tumor Response Rate [ Time Frame: From the date of randomization until the date of first documented progression or date of death from any cause, whichever came first assessed up to 54 weeks. ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Choi Response Rate [ Time Frame: week 6, week 12, week 18, then every 12 weeks up to 54 weeks ]Percentage of patient who experienced Complete or Partial Responses after treatment according to Choi Criteria.
- Overall Survival (OS) [ Time Frame: From enrollment up to 5 years ]Time from the date of enrollment to date of death
- Progression Free Survival (PFS) [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 52 weeks ]Survival free of progressive disease evaluated from enrollment up to progression according to RECIST, or death
- Clinical Benefit Rate (CBR) [ Time Frame: week 6, week 12, week 18, then every 12 weeks up to 54 weeks ]Percentage of patients who have achieved complete response, partial response or stable disease ≥ 6 months
- Response rate by RECIST after the cross over [ Time Frame: week 18, week 24, week 30, week 36 and then every 12 weeks up to 54 weeks ]Percentage of patient who experienced Complete or Partial Responses according RECIST 1.1 after cross over
- Progression Free Survival (PFS) after cross over up to progression according to RECIST, or death [ Time Frame: From date of cross over until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 52 weeks ]Survival free of progressive disease evaluated from
- Safety according to Common Terminology Criteria for Adverse Events (CTCAE) [ Time Frame: From enrollment every 3 weeks up to 54 weeks ]Safety profile of the treatment evaluated according to Common Terminology Criteria for Adverse Events version 4.03
Original Secondary Outcome: Same as current
Information By: Italian Sarcoma Group
Dates:
Date Received: December 19, 2016
Date Started: March 2017
Date Completion: March 2024
Last Updated: January 26, 2017
Last Verified: January 2017