Quelle stadification pour les cancers du col de l’utérus localement avancés ? - PAROLA/ENGOT-Cx18, essai clinique randomisé de phase III évaluant l’impact de la stadification chirurgicale sur la survie sans récidive dans les cancers du col de l’utérus localement avancés

Résumé fourni par la source

Background. Positron emission tomography/computed tomography (PET/CT) fails to detect approximately 25 % of para-aortic lymph node metastases in patients with PET/CT-defined stage IIIC1 cervical cancer. Surgical staging could modify treatment and improve para-aortic and distant disease control rate. Primary objective. To determine whether tailored chemoradiotherapy based on surgical staging and pathological assessment of para-aortic lymph nodes improves three-year disease-free survival compared to PET/CT-based staging alone. Hypothesis. Surgical staging followed by tailored chemoradiotherapy will enhance disease-free survival while avoiding unnecessary prophylactic extended-field chemoradiotherapy in patients with stage IIIC1 cervical cancer. Trial design. This international multicenter randomised phase III trial enrolls eligible patients in a 1:1 randomisation between PET/CT staging followed by chemoradiotherapy (control arm) and surgical staging followed by tailored chemoradiotherapy (experimental arm). Randomisation is stratified by tumour stage, treatment centre, and adjuvant therapy use. Endpoints. The primary endpoint is disease-free survival, defined as the time from randomisation to relapse or death. Secondary endpoints include overall survival, para-aortic metastasis-free survival, and treatment-related morbidity.

Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.