RecruitingPhase 3NCT06156514

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

Evaluation 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, is a Phase III Clinical Trial.

Sponsor

National Institute of Cancerología

Enrollment

140 participants

Start Date

Nov 6, 2019

Study Type

INTERVENTIONAL

Conditions

Locally Advanced Cervical Cancer Gemcitabine Chemo-radiotherapy

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two chemotherapy drugs — cisplatin versus gemcitabine — given together with radiation therapy (chemoradiation) in women with locally advanced cervical cancer. The goal is to find out which combination is more effective and better tolerated. **You may be eligible if...** - You are a woman aged 18 or older - You have been diagnosed with locally advanced cervical cancer - You are a suitable candidate for chemoradiation treatment - If you could become pregnant, you agree to use contraception and have a negative pregnancy test **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have conditions that prevent safe chemotherapy or radiation - You do not meet the required health and lab criteria Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGemcitabine

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

DRUGCisplatin

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

Locations(1)

National Cancer Institute of Mexico

Mexico City, Mexico City, Mexico

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NCT06156514

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