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Evaluation of Concomitant Chemo-radiotherapy With Cisplatine vs Gemcitabin in Locally Advanced Cervicouterine Cancer

NCT06156514 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2025-05-28

No results posted yet for this study

Summary

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.

Conditions

  • Locally Advanced Cervical Cancer
  • Gemcitabine
  • Chemo-radiotherapy

Interventions

DRUG

Gemcitabine

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

DRUG

Cisplatin

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

Sponsors & Collaborators

  • National Institute of Cancerología

    lead OTHER_GOV

Principal Investigators

  • Eder A Arango, MD · National Cancer Institute of Mexico

  • Lucely C Cetina, MSc, PhD · National Cancer Institute of Mexico

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-06
Primary Completion
2026-11-30
Completion
2029-12-31

Countries

  • Mexico

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06156514 on ClinicalTrials.gov