A Phase II study, randomized, non-comparative treatment with induction chemotherapy with cisplatin and gemcitabine followed by chemoradiation or definitive chemoradiation in invasive carcinomas of the locally advanced uterine cervical cancer

• Grant number: 14/01696-1
• Support Opportunities: Regular Research Grants
• Start date: August 01, 2014
• End date: July 31, 2017
• Field of knowledge: Health Sciences - Medicine - Medical Clinics
• Principal Investigator: Roberto Jun Arai
• Grantee: Roberto Jun Arai
• Host Institution: Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira (ICESP). Coordenadoria de Serviços de Saúde (CSS). Secretaria da Saúde (São Paulo - Estado). São Paulo , SP, Brazil
• Associated researchers: Heloisa de Andrade Carvalho ; Maria Del Pilar Estevez Diz ; Paulo Marcelo Gehm Hoff ; Samantha Cabral Severino da Silva

Abstract

Cervical cancer is the second leading cause of cancer death in women worldwide. Despite preventive strategies, about 25% of cases are locally advanced at diagnosis, even in developed countries. A decade ago, the standard treatment of locally advanced cervical cancer (CCLA) consists in chemoradiation with platin-based agents and since then, there has been little progress in reducing morbidity and mortality. Objectives: This is a randomized phase II, prospective, non-comparative study, which aims to determine the progression-free survival in two groups of patients with CCLA: (1) treated with induction chemotherapy with cisplatin and gemcitabine followed by chemoradiation and (2) treated with chemoradiation alone. Methods: Patients with histologically confirmed cervical carcinoma EC FIGO IIB to IVA, candidates for treatment with definitive chemoradiation will be randomized to one of two treatment groups: (1) standard treatment with definitive chemoradiation (CDDP 40 mg/m2 administered in EV D1, D8, D15, D29 and D36, with concomitant radiotherapy - total dose of 45 Gy applied in 25 fractions of 1.8 Gy in brachytherapy and four inserts 7 to 7.5 Gy, calculated at the point A, (2) induction chemotherapy gemcitabine with cisplatin 25 mg/m2 1000 mg/m2, both in D1 and D8, via EV, every 21 days for 3 cycles followed by definitive chemoradiation, as described in group 1. Will be assessed as a primary outcome, progression free survival at 3 years and the secondary endpoints are response rate, the rate of locoregional control, the incidence of acute and chronic toxicities in both treatment groups and overall survival at 3 years. Time-dependent outcomes will be estimated through the Kaplan-Meyer. The assessments of tumor response will be made according to the criteria of RECIST 1.1. (AU)