Intermediate Risk Cervical Cancer: Radical Surgery +/- Adjuvant Radiotherapy

The objective of the trial is to evaluate if adjuvant (chemo)radiation is associated with a disease-free survival benefit after radical surgery in patients with intermediate risk cervical cancer. The primary endpoint of the study is the disease-free survival from the day of randomisation. A total of 514 patients are required to achieve 80% power on 5% significance level with non-inferiority margin of 5% to test the difference between the ARMs using Cox proportional hazards model. The maximal tolerated margin for non-inferiority in 2-year DFS is 5% (including expected drop-out rate of 10%).

NCT Number	NCT04989647
Lead Sponsor	The Central and Eastern European Gynecologic Oncology Group
Conditions	Cervical Cancer
Enrollment	514 participants
Start Date	2022-06-10
Primary Completion	2029-12 (estimated)
Study Completion	2032-12 (estimated)
Updated on ClinicalTrials.gov	2023-09-07