Phase 3 Study of Moderated Hypofractionated Online Adaptive Radiotherapy Combined With Brachytherapy for Cervical Cancer

What this Trial Is About

Researchers are evaluating moderated hypofractionated online adaptive radiotherapy combined with high-dose-rate brachytherapy in patients with cervical cancer. This multicenter, phase 3, randomized controlled study aims to compare this experimental treatments safety and efficacy against the standard radiotherapy regimen. The study focuses on women aged 18 to 75 years with specific stages of cervical cancer and examines how this approach may reduce treatment duration and resource usage. Participants are randomly assigned to receive either the experimental treatment, which includes 43.35 Gy of external beam radiotherapy delivered in 17 fractions with online adaptive radiotherapy plus high-dose-rate brachytherapy and concurrent weekly chemotherapy or immunotherapy, or the standard treatment of 45 Gy external beam radiotherapy in 25 fractions with brachytherapy and concurrent chemotherapy or immunotherapy. Both groups receive weekly cisplatin or PD-1 inhibitors, and the study evaluates treatment over a defined period. Throughout the study, participants will be closely monitored for various outcomes including progression-free survival at 3 years, acute and late toxicities, overall survival, quality of life, tumor response, and treatment costs. Assessments include clinical evaluations and quality of life questionnaires over 3 years. The trial will also track locoregional progression, metastasis-free survival, and cervical cancer-specific survival. Safety and adherence will be carefully observed to understand the impact of the treatment regimens.

Moderated Hypofractionated Online Adaptive Radiotherapy in Cervical Cancer