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Intermediate Risk Cervical Cancer: Radical Surgery +/- Adjuvant Radiotherapy
Sponsor: The Central and Eastern European Gynecologic Oncology Group
Summary
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%).
Official title: An International Randomised Trial of Radical Surgery Followed by Adjuvant (Chemo)Radiation Versus no Further Treatment in Patients With Early-stage, Intermediate-risk Cervical Cancer Patients
Key Details
Gender
FEMALE
Age Range
18 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
514
Start Date
2022-06-10
Completion Date
2032-12
Last Updated
2023-09-07
Healthy Volunteers
No
Conditions
Interventions
No adjuvant therapy
Patients will not receive any type of adjuvant therapy.
Adjuvant radiotherapy
Patients will receive adjuvant treatment composed of either pelvic radiotherapy external beam radiotherapy ± brachytherapy or concomitant chemoradiotherapy (pelvic radiotherapy + chemotherapy).
Locations (1)
General University Hospital in Prague
Prague, Czechia