NCT04989647

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

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 514 (estimated)
• Sponsor: The Central and Eastern European Gynecologic Oncology Group · Academic / Other
• Sex: Female
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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%).

Detailed description

The role of adjuvant (chemo)radiotherapy in intermediate risk (IR) cervical cancer patients is controversial, supported by single randomised GOG 92 study performed more than 20 years ago. Intermediate-risk group is defined as lymph node negative but with a combination of negative prognostic factors (tumour size \>2 cm, lymphovascular space invasion, deep stromal invasion \>2/3). Recent retrospective studies showed excellent local control in intermediate risk group patients after radical surgery with no additional adjuvant treatment. CERVANTES trial is designed to bring level A evidence on the role of adjuvant treatment in IR patients in an international, prospective, randomised study. Patients will be registered into the trial before surgery and randomised after the final pathology report has been received into ARM A, with no additional treatment, and ARM B, receiving adjuvant (chemo)radiotherapy. Quality assurance program will be in place for both, radical surgery and adjuvant treatment.

Conditions

• Cervical Cancer

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2022-06-10
• Primary completion: 2029-12-01
• Completion: 2032-12-01
• First posted: 2021-08-04
• Last updated: 2023-09-07

Locations

1 site across 1 country: Czechia