Phase II randomized study for the comparison of trabectedin versus doxorubicin plus dacarbazine in patients with advanced solitary fibrous tumor
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
23
Treatment with trabectedin repeated every 21 days for 6 cycles
Treatment with Adriamycin at day 1 every 21 days for 6 cycles
Treatment with Dacarbazine at days 1 and 2 every 21 days for 6 cycles
Nuovo Ospedale di Prato
Prato, Firenze, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, MI, Italy
Policlinico Universitario Campus Biomedico
Roma, RM, Italy
IRCCS Istituto ortopedico Rizzoli
Bologna, Italy
Overall Tumor Response Rate
evaluate the activity of trabectedin and of adriamycin in combination with dacarbazine, according to Response Evaluation Criteria in Solid Tumor (RECIST), version 1.1
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.
Choi Response Rate
Percentage of patient who experienced Complete or Partial Responses after treatment according to Choi Criteria.
Time frame: week 6, week 12, week 18, then every 12 weeks up to 54 weeks
Overall Survival (OS)
Time from the date of enrollment to date of death
Time frame: From enrollment up to 5 years
Progression Free Survival (PFS)
Survival free of progressive disease evaluated from enrollment up to progression according to RECIST, or death
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
Clinical Benefit Rate (CBR)
Percentage of patients who have achieved complete response, partial response or stable disease ≥ 6 months
Time frame: week 6, week 12, week 18, then every 12 weeks up to 54 weeks
Response rate by RECIST after the cross over
Percentage of patient who experienced Complete or Partial Responses according RECIST 1.1 after cross over
Time frame: week 18, week 24, week 30, week 36 and then every 12 weeks up to 54 weeks
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Fondazione Del Piemonte Per L'Oncologia Ircc Di Candiolo -
Candiolo, Italy
Ospedale Giaccone
Palermo, Italy
Progression Free Survival (PFS) after cross over up to progression according to RECIST, or death
Survival free of progressive disease evaluated from
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
Safety according to Common Terminology Criteria for Adverse Events (CTCAE)
Safety profile of the treatment evaluated according to Common Terminology Criteria for Adverse Events version 4.03
Time frame: From enrollment every 3 weeks up to 54 weeks