Phase 3 Study Comparing Standard and Hypofractionated IMRT Radiation with Chemotherapy for High-Risk Cervical Cancer After Radical Hysterectomy

What this Trial Is About

Researchers are investigating the safety and effectiveness of two types of radiation therapy combined with chemotherapy for patients with high-risk cervical cancer who have undergone radical hysterectomy. This phase 3 randomized trial compares conventional fractionated intensity modulated radiation therapy IMRT and hypofractionated IMRT, aiming to evaluate side effects and treatment outcomes. Previous studies suggested hypofractionated IMRT with chemotherapy may offer high survival rates and low toxicity, prompting this larger trial to confirm those findings. Participants are randomly assigned to one of two groups. The conventional fractionation group receives 1.8-2.0 Gy per session for 25-28 sessions total dose 40-50.4 Gy along with weekly chemotherapy for 5-6 sessions. The hypofractionation group receives 2.5 Gy per session for 16 sessions total dose 40 Gy with chemotherapy weekly for 3 sessions. Both groups may also receive brachytherapy. Randomization considers lymph node metastasis status and cancer type. During the study, participants will be monitored for local control of cancer up to 3 years, overall survival and disease-free survival up to 5 years, and acute and late side effects. Quality of life will be assessed at baseline, end of treatment, and periodically for up to 5 years. The study involves regular clinical evaluations, toxicity assessments, and long-term follow-up to understand treatment impact and safety.

Comparison of Conventional and Hypofractionated IMRT in High-Risk Cervical Cancer Post-Radical Hysterectomy