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%).
Pathologically confirmed invasive cervical cancer
FIGO IB1-IIA
Squamous cell cancer or HPV-related adenocarcinoma
tumour ≥4 cm OR
Adenosquamous cancer or adenocarcinoma unusual type (non-HPV related - such as: mucinous, clear cell, mesonephric) or other rare tumour types (those not listed in the inclusion criteria)
Inconclusive primary site of disease
Unequivocally positive lymph node by imaging (by radiological subjective assessment)
FIGO <IB1 / >IIA
The Central and Eastern European Gynecologic Oncology Group
Lead sponsor
General University Hospital, Prague
Sponsor institution