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

NCT04989647 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 514

Last updated 2023-09-07

No results posted yet for this study

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%).

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).

Sponsors & Collaborators

  • The Central and Eastern European Gynecologic Oncology Group

    lead OTHER

Principal Investigators

  • David Cibula, prof. · General University Hospital in Prague, Czech Republic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-10
Primary Completion
2029-12-31
Completion
2032-12-31

Countries

  • Czechia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04989647 on ClinicalTrials.gov