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Spots Global Cancer Trial Database for Trial of Nilotinib and Adriamycin as Treatment in Liposarcomas and Leiomyosarcomas of Retroperitoneum

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Trial Identification

Brief Title: Trial of Nilotinib and Adriamycin as Treatment in Liposarcomas and Leiomyosarcomas of Retroperitoneum

Official Title: GEIS-27: Phase I/II Multicenter and Prospective Trial of Nilotinib and Adriamycin as Neoadjuvant Treatment in Liposarcomas and Leiomyosarcomas of Retroperitoneum

Study ID: NCT02587169

Study Description

Brief 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.

Detailed Description: 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Hospital Universitari Son Espases, Palma de Mallorca, Balearic Islands, Spain

Hospital Infanta Cristina, Badajoz, , Spain

Hospital Universitari Germans Trials i Pujol, Badalona, , Spain

Hospital de la Santa Creu i Sant Pau, Barcelona, , Spain

Hospital Universitari Vall d'Hebron, Barcelona, , Spain

Hospital Provincial de Castellón, Castellón, , Spain

Hospital Universitario de Canarias, La Laguna, , Spain

Complejo Asistencial Universitario de León, León, , Spain

Hospital Puerta de Hierro, Madrid, , Spain

Hospital Universitario La Paz, Madrid, , Spain

Hospital Universitario Ramón y Cajal, Madrid, , Spain

Hospital Universitario Virgen de la Arrixaca, Murcia, , Spain

Complejo Hospitalario de Navarra, Pamplona, , Spain

Hospital Marqués de Valdecilla, Santander, , Spain

Hospital Clínico Universitario de Santiago, Santiago de Compostela, , Spain

Hospital Virgen del Rocío, Sevilla, , Spain

Hospital Virgen de la Salud, Toledo, , Spain

Instituto Valenciano de Oncología, Valencia, , Spain

Hospital Xeral Cies, Vigo, , Spain

Hospital Universitario Miguel Servet, Zaragoza, , Spain

Contact Details

Name: Javier Martín, MD, PhD

Affiliation: Spanish Sarcoma Group (GEIS)

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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