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. ]

evaluate the activity of trabectedin and of adriamycin in combination with dacarbazine, according to Response Evaluation Criteria in Solid Tumor (RECIST), version 1.1


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