Evaluation of Concomitant Chemo-radiotherapy With Cisplatine vs Gemcitabin in Locally Advanced Cervicouterine Cancer
140 patients around the world
Available in Mexico
This is a phase III clinical trial, open, randomized 1: 1, controlled, noninferiority, in
a single hospital center. This study will include 564 patients with the diagnosis of
malignant tumors of epithelial origin of the cervix.
Patients will be randomized 1: 1, arm "A" (experimental) to receive concomitant
chemotherapy based on gemcitabine at 300 mg / m2 weekly and Arm "B" (control) to receive
cisplatin 40 mg / m2 weekly, both arms with RT 50.4 Gy in 5 weeks plus 30Gy brachytherapy
at the end of the concomitance. These patients will be treated in the gynecology-oncology
service, candidates for chemo-radiotherapy, it is intended that the recruitment of
patients be done in the first 48 months, with a follow-up of 3 years. It is intended to
include 3 patients per month, until the total sample is completed in four years. The
study is divided into three phases, the first of QT / RT concomitant with gemcitabine or
cisplatin depending on the randomized arm; with an approximate duration of 1.5 months
with a weekly visit, the second phase is brachytherapy in both arms which lasts from 2 to
7 days, and finally the follow-up phase which lasts for 3 years with a visit every 3
months. In each of the visits we will evaluate the safety of the medication; evaluating
adverse events, including laboratory abnormalities as well as acute and chronic toxicity,
with the classification according to the common toxicity criteria (CTCAE v4.03) and the
efficacy will obtain proportions of clinical and imaging response (TC and / or PET-CT)
with the criteria of RECIST v1.1 and / or PERCIST 1.0.
Patient numbers to include. This study will include 140 patients. Test drug, dosage, mode
of administration: Gemcitabine at 300 mg / m2 weekly intravenous administration.
Duration of the study 9 years.