Chondrosarcoma Clinical Trial
Official title:
GEIS-27: Phase I/II Multicenter and Prospective Trial of Nilotinib and Adriamycin as Neoadjuvant Treatment in Liposarcomas and Leiomyosarcomas of Retroperitoneum
Phase I/II multicenter and prospective trial of nilotinib and adriamycin as neoadjuvant
treatment in liposarcomas and leiomyosarcomas of retroperitoneum.
The main objective of this study is to improve relapse-free survival (RFS)and overall
survival (OS) decreasing from 50% to 30% the relapse percentage at 5 years in patients with
resected sarcoma of retroperitoneum.
Secondary objectives include the analysis of antitumoral activity through response rate
(RECIST and tissular changes), the assessment of positive correlation between biomarkers and
clinical results, the study of long term overall survival, and the analysis of the safety
profile of the nilotinib-adriamycin combination.
The trial hypothesis is that the nilotinib-adriamycin combination is synergistic and
therefore better response results are expected (from 20% as P0 to 40% as P1). The study
seeks to find a positive correlation between biomarkers and clinical results in
retroperitoneal liposarcoma and leiomyosarcoma treated with the mentioned combination.
The study involves the participation of 20 hospitals of the Spanish Sarcoma Group (GEIS).
The treatment consists of 4 neoadjuvant cycles of nilotinib-adriamycin on patients with
resectable retroperitoneal sarcoma. The research comprises a robust translational study as
well as histological and radiological reviews.
The nilotinib-adriamycin combination will be given in 4 cycles of 21 days. In each cycle,
nilotinib will be administered at fixed dose of 400 mg/12h orally during 6 consecutive days
(1-6) and endovenous adriamycin (20 minutes) on day 5 at three levels (in phase I, dosage of
60 mg/m2, 65 mg/m2, and 75 mg/m2 will be tested to determine the recommended dose for phase
II).
Phase I includes patients with retroperitoneal liposarcoma, retroperitoneal leiomyosarcoma
and chondrosarcoma. Phase II is focused on retroperitoneal liposarcoma and leiomyosarcoma
only.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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