Phase III Study Comparing Weekly Cisplatin Versus Gemcitabine with Radiation for Women 18 and Older with Locally Advanced Cervical Cancer and Kidney Function Preserved

What this Trial Is About

Researchers are evaluating the safety and effectiveness of two chemotherapy drugs, Cisplatin and Gemcitabine, given alongside radiotherapy as the first treatment for women with locally advanced cervical cancer who have other health conditions but good kidney function. This phase III clinical trial aims to compare these treatments to see which is better for patients with this type of cancer. The study is randomized and controlled, designed to test if Gemcitabine is not worse than Cisplatin in this setting. Participants will be randomly assigned to one of two groups one group will receive weekly doses of Gemcitabine at 300 mgm2 intravenously, and the other group will get weekly Cisplatin at 40 mgm2 intravenously. Both groups will also receive external radiotherapy totaling 50.4 Gy over 5 weeks, followed by a 30 Gy brachytherapy treatment lasting 2 to 7 days. The treatment phase lasts about 1.5 months, with weekly visits during chemotherapy and radiotherapy. After treatment, participants will enter a 3-year follow-up phase with visits every 3 months. During the study, participants will have regular assessments to monitor safety, side effects, and treatment response using clinical exams and imaging like CT or PET-CT scans. Researchers will measure progression-free survival over 3 years and evaluate quality of life with questionnaires. They will also track adverse events and the presence of other health conditions. The full study is expected to last around 9 years, including patient recruitment and follow-up.

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