Study Comparing Hypofractionated and Standard Chemoradiation Treatments for Uterine Cervix Cancer

What this Trial Is About

Researchers are investigating treatment options for uterine cervix cancer, focusing on comparing a newer hypofractionated chemoradiotherapy approach with the conventional standard treatment. The study aims to find out if the shorter, higher-dose radiation schedule is not worse in terms of clinical response and side effects. This Phase 2 trial involves patients with cervical cancer stages IB to IIIC and is sponsored by Tehran University of Medical Sciences. Participants are randomly assigned to one of two groups. The experimental group receives external beam radiotherapy EBRT of 40 Gy delivered in 15 sessions over 3 weeks along with three weekly doses of chemotherapy drug cisplatin. The control group receives standard EBRT of 45 Gy in 25 sessions over 5 weeks with five weekly cisplatin doses. After EBRT, all patients undergo high dose rate brachytherapy consisting of 28 Gy over four weekly sessions. Throughout the study, patients are monitored for early and late side effects based on established criteria at multiple time points up to three years post-treatment. Clinical response is assessed using dynamic contrast-enhanced pelvic MRI at 3 months, 1 year, and 3 years after brachytherapy. The study also tracks progression-free survival, disease-specific survival, and overall survival over five years. Total participation includes treatment and long-term follow-up evaluations.

Clinical Response and Toxicity of Hypo-fractionated Chemoradiotherapy in Cervix Cancer