PARa-aOrtic LymphAdenectomy in locally advanced cervical cancer (PAROLA trial): a GINECO, ENGOT, and GCIG study
Abstract
Background: Positron emission tomography/computed tomography (PET/CT) fails to detect approximately 25% of aortic lymph node metastasis in patients with PET/CT stage IIIC1 cervical cancer. Surgical staging could lead to treatment modification and to improved para- aortic and distant control.Primary Objective(s): To demonstrate if chemoradiation with tailored external beam radiation field based on surgical staging and pathologic examination of the para-aortic lymph node is associated with improved 3- year disease- free survival compared with patients staged with PET/CT staging only.Study Hypothesis: Surgical staging followed by tailored chemoradiation will improve disease- free survival while avoiding unnecessary prophylactic extended- field chemoradiation in patients with International Federation of Gynecology and Obstetrics (FIGO) stage IIIC1 cervical cancer.Trial Design: This is an international multicenter, randomized, phase III study.
Eligible patients will be randomized 1:1 between PET/CT staging followed by chemoradiation (control arm), or surgical staging followed by tailored chemo-radiation (experimental arm). Randomization will be stratified by tumor stage according to TNM classification, center, and adjuvant treatment.Major Inclusion/Exclusion: Criteria Main inclusion criteria are histologically proven PET/CT FIGO stage IIIC1 cervical cancer.
Main exclusion criteria include unequivocal positive common iliac or para- aortic lymph node at pre-therapeutic imaging PET/CT.Primary Endpoint(s): The primary endpoint is disease-free survival defined as the time from randomization until first relapse (local, regional, or distant), or death from any cause. Sample Size: 510 eligible patients Estimated Dates for Completing Accrual and Presenting Results: The estimated date for completing accrual will be Q2 2027.
The estimated date for presenting results will be Q4 2030.