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Brief Title: Study With Trabectedin Versus Adriamycin Plus Dacarbazine, in Patients With Advanced Solitary Fibrous Tumor
Official Title: Solitary Fibrous Tumor: Phase II Study on Trabectedin Versus Adriamycin Plus Dacarbazine in Advanced Patients
Study ID: NCT03023124
Brief 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).
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Nuovo Ospedale di Prato, Prato, Firenze, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, MI, Italy
Policlinico Universitario Campus Biomedico, Roma, RM, Italy
IRCCS Istituto ortopedico Rizzoli, Bologna, , Italy
Fondazione Del Piemonte Per L'Oncologia Ircc Di Candiolo -, Candiolo, , Italy
Ospedale Giaccone, Palermo, , Italy
Name: Silvia Stacchiotti, MD
Affiliation: Italian Sarcoma Group
Role: PRINCIPAL_INVESTIGATOR