The purpose of this phase II study is to determine the survival free disease of patients diagnosed with invasive locally advanced carcinomas of uterine cervix treated with induction chemotherapy with cisplatin and gemcitabine followed by chemoradiation and definitive chemoradiation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
50 mg/m2 - Day 1
Gemcitabine 1000mg/m2 on day 1 and day 8.
Cisplatin 40 mg/m2 on day 1, day8, day15, day22, day 36 of radiotherapy period.
45 Gy
80 Gy
ICESP
São Paulo, São Paulo, Brazil
RECRUITINGDisease free survival
Time frame: From the randomization until the end of the treatment - up to 36 month.
Response rate
Time frame: 36 month after the end of the treatment.
Locoregional disease control rate
Time frame: 36 month after the end of treatment.
Acute and chronic toxicity in both arms
Time frame: From the randomization until the end of the treatment.
Overall survival
Time frame: 36 month after the end of the treatment.
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