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Clinical Trial Details
Treatment of Metastatic Soft Tissue Sarcoma (STS) Patients (FIBROSARC USA) (FIBROSARC USA)
Complete Title: A randomized study comparing the efficacy of the combination of doxorubicin and the
tumor-targeting human antibody-cytokine fusion protein L19TNF to doxorubicin alone as
first-line therapy in patients with advanced or metastatic soft tissue sarcoma.
Trial Phase: II
Investigator: Lee Cranmer
The present study is an open-label, randomized, controlled, two-arm multi-center study of the efficacy of L19TNF treatment in combination with doxorubicin versus doxorubicin alone in metastatic or unresectable soft-tissue sarcoma patients. In the study, 114 patients will be randomized in a 1:1 ratio to receive doxorubicin treatment (Arm 1) or L19TNF treatment in combination with doxorubicin (Arm 2). The primary objective of the trial is to evaluate if L19TNF in combination with doxorubicin (Arm 2) given for unresectable or metastatic soft tissue sarcoma improves efficacy measured as progression free survival, as compared to doxorubicin alone (Arm 1). Anti-cancer activity will be assessed every 6 weeks during therapy and every 12 weeks thereafter.
Keywords:
- Sarcoma
- Sarcoma, Metastatic
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Adult
Pediatric
II
Lee Cranmer
RG1718052
NCT03420014
A randomized study comparing the efficacy of the combination of doxorubicin and the
tumor-targeting human antibody-cytokine fusion protein L19TNF to doxorubicin alone as
first-line therapy in patients with advanced or metastatic soft tissue sarcoma.
Sarcoma
Sarcoma, Metastatic