NCT03023124

Study With Trabectedin Versus Adriamycin Plus Dacarbazine, in Patients With Advanced Solitary Fibrous Tumor

Solitary Fibrous Tumor: Phase II Study on Trabectedin Versus Adriamycin Plus Dacarbazine in Advanced Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Italian Sarcoma Group · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Phase II randomized study for the comparison of trabectedin versus doxorubicin plus dacarbazine in patients with advanced solitary fibrous tumor

Detailed description

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).

Conditions

• Solitary Fibrous Tumors

Interventions

Type	Name	Description
DRUG	Trabectedin	Treatment with trabectedin repeated every 21 days for 6 cycles
DRUG	Adriamycin	Treatment with Adriamycin at day 1 every 21 days for 6 cycles
DRUG	Dacarbazine	Treatment with Dacarbazine at days 1 and 2 every 21 days for 6 cycles

Timeline

• Start date: 2018-03-04
• Primary completion: 2024-12-06
• Completion: 2024-12-06
• First posted: 2017-01-18
• Last updated: 2024-12-09

Locations

6 sites across 1 country: Italy