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RECRUITING
NCT04989647
PHASE3

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

Sponsor: The Central and Eastern European Gynecologic Oncology Group

View on ClinicalTrials.gov

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

RADIATION

No adjuvant therapy

Patients will not receive any type of adjuvant therapy.

RADIATION

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