Study Comparing Para-aortic Lymphadenectomy Plus Chemoradiation Versus Standard Chemoradiation in Women With Locally Advanced Cervical Cancer Stage IIIC1

What this Trial Is About

Researchers are evaluating treatments for patients with stage IIIC1 cervical cancer to determine if adding para-aortic lymphadenectomy before tailored chemoradiation improves disease-free survival compared to standard imaging with FDG-PETCT followed by chemoradiation. This international, multicenter, randomized open-label phase III study includes 510 patients, including 200 in France. The study also explores biological and radiomic factors as well as sentinel lymph node accuracy and cost-utility outcomes. Participants are randomly assigned to one of two treatment groups the control arm receives standard chemo-radiotherapy and brachytherapy based on EMBRACE II and ESGOESTRO guidelines, while the experimental arm undergoes pretherapeutic para-aortic lymphadenectomy by minimally invasive surgery followed by tailored chemo-radiotherapy and brachytherapy. Both traditional and robotically assisted laparoscopic approaches are allowed. Treatments may also follow protocols from INTERLACE and KEYNOTE-A18 studies if applicable. Throughout the study, participants will be monitored for five years to assess disease-free survival as the primary outcome. Additional outcomes include overall survival, cancer-specific survival, metastasis-free survival, para-aortic free survival, treatment-related adverse events, quality of life measures, cost-utility analysis, and imaging accuracy. Evaluations include clinical exams, imaging reviews, questionnaires, and toxicity assessments to understand treatment effects and safety over the long term.

PARa-aOrtic LymphAdenectomy in Locally Advanced Cervical Cancer