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

Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2022
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%).
Epistemonikos ID: 83b534e4479a4c449bb6b185574d51263845fc4b
First added on: May 09, 2024