Trial of Nilotinib and Adriamycin as Treatment in Liposarcomas and Leiomyosarcomas of Retroperitoneum
Status:
Unknown status
Trial end date:
2015-12-01
Target enrollment:
Participant gender:
Summary
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.