A Phase 3 interventional study of Gemcitabine and Cisplatin in Locally Advanced Cervical Cancer, Gemcitabine and Chemo-radiotherapy, sponsored by National Institute of Cancerología. Recruiting at 1 site in Mexico. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-28.
Sponsored by National Institute of Cancerología · Phase 3, Interventional, and Treatment
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.
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.
1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.
This study's planned enrollment of 140 is above the median of 100 across 1,377 interventional studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms studies →National Institute of Cancerología is the lead sponsor of 38 studies on the registry; 10 are open to participants now.
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Women with Age ≥ 18 years.
Patients with adequate hematological and hepatic functioning, defined by the following parameters:
Patients with a prior diagnosis of the following comorbidities:
Exclusion Criteria:
Criteria Interruption of Treatment (Withdrawal of patients)
A patient will be discontinued from the study under the following circumstances:
To receive concomitant chemotherapy based on gemcitabine at 300 mg / m2 weekly
Drug: Gemcitabine
To receive concomitant chemotherapy based on cisplatin 40 mg / m2 weekly
Drug: Cisplatin
Weekly 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
Weekly 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.
Time frame: 3 year
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
Time frame: 8 weeks at the end of treatment
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.
Time frame: 1 year
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).
Time frame: 1 year
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
Time frame: Through the study completion, an average of 6 years.
To evaluate the quality of life of patients with locally advanced cervical cancer with stages IB2-IVA, with comorbidities and preserved renal function with the EORTC QLQ-30.
The quality of life to be evaluated with a given score from 0 to 100, based on the answers of the EORTC QLQ-30 y QLQ Cx-24 questionnaires (patient answer in a 0-4 scale) to the patients at the beginning of treatment, at the fourth week of treatment, during brachytherapy and every three months during the first year of follow up. For symptom scales a high score is indicative of greater problems and for functional scales a low score is indicative of greater problems.
Time frame: 1.5 years.
To evaluate the quality of life of patients with locally advanced cervical cancer with stages IB2-IVA, with comorbidities and preserved renal function with the EORTC QLQ CX-24 questionnaires.
The quality of life to be evaluated with a given score from 0 to 100, based on the answers of the EORTC QLQ-30 y QLQ Cx-24 questionnaires (patient answer in a 0-4 scale) to the patients at the beginning of treatment, at the fourth week of treatment, during brachytherapy and every three months during the first year of follow up. For symptom scales a high score is indicative of greater problems and for functional scales a low score is indicative of greater problems.
Time frame: 1.5 years.
Plan to share: No
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