The purpose of this phase III clinical trial, is to evaluate the efficacy and safety of concomitant chemo-radiotherapy with Cisplatin vs Gemcitabine as the first line of treatment in patients with locally advanced cervical cancer, with comorbidities and preserved renal function.
Singed informed consent.
Women with Age ≥ 18 years.
-In women of childbearing age it should be documented: a) negative pregnancy test in serum at the beginning of the study (14 days before the start of QT-RT); b) Accept the use of some method of contraception approved by your attending physician during the study and 12 weeks after the treatment has ended.
-In postmenopausal women (surgical or natural menopause) at least one of the following parameters must be met for inclusion.
Patients with a second neoplasm.
Pregnant or lactating patients.
Patients with small cell and / or neuroendocrine CaCu.
Patients with impaired renal function with a GFR <or equal to 60ml / min calculated by the CKD-EPI formula
Parallel
Gemcitabine
DrugWeekly application of gemcitanibe at 300 mg/m2 intravenously in a 30-minute infusion, concomitantly with radiotherapy for a total of 5-6 weeks followed by bachytherapy, in patients diagnosed with locally advanced cervical cancer
Cisplatin
DrugWeekly application of Cisplatin at 40 mg/m2 intravenously in a 60-minute infusion, concomitantly with radiotherapy for a total of 5-6 weeks followed by bachytherapy, in patients diagnosed with locally advanced cervical cancer
To assess the efficacy of concomitant chemoradiotherapy with gemcitabine versus cisplatin in patients with locally advanced cervical cancer (stages IB2-IVA), who have comorbidities and preserved renal function, with progression-free survival rate.
Efficacy will be estimated with progression-free survival: this is defined as the period from the randomization to the first progression documented by imaging studies by RECIST criteria.
To determine the objective response rate after the treatment of concomitant QT-RT with Gemcitabine vs cisplatin in patients with locally advanced cervical cancer with stages IB2-IVA, with comorbidities and preserved renal function.
Objective response rate: Percentage of people in a study or treatment group who have a partial or complete response to treatment in a given period of time. The measurement is evaluated with RECIST v1.1 or PERCIST criteria
Incidence of Treatment-Emergent Adverse Events of concomitant QT-RT with gemcitabine vs cisplatin in patients with locally advanced cervical cancer with stages IB2-IVA with comorbidities and preserved renal function.
This incidence of Treatment-Emergent Adverse Events will be evaluated through the toxicity profile of the treatment, the evaluation will be classified with the CTCAE v 4.3 criteria.
Determine the Overall Response Rate (ORR) defined as the percentage of people in the study with partial or complete response to treatment in a given period of time, assessed by RECIST v1.1 and PERCIST criteria.
Percentage of people in a study or treatment group who have a partial or complete response to treatment in a given period of time. The measurement is evaluated with RECIST v1.1 or PERCIST criteria * Complete response as the absence of medible disease. * Partial response as the reduction of al least 30% of the size of the tumor (medible disease).
Document the prevalence of comorbidities in this group of patients
Point prevalence: refers to the number of cases of a health event at a given time. This is the case to evaluate the presence of comorbidities in patients with cervical cancer at the time of diagnosis of the oncological disease
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