PARa-aOrtic LymphAdenectomy in Locally Advanced Cervical Cancer

What this Trial Is About

Researchers are studying patients with stage IIIC1 cervical cancer to see if adding a surgical procedure called para-aortic lymphadenectomy before chemoradiation improves disease-free survival compared to the usual method of using FDG-PET/CT imaging followed by chemoradiation. This international, multicenter, randomized open-label phase III trial aims to compare these two approaches to better understand treatment outcomes and includes additional biological and imaging studies to explore immune changes and predictive factors. Participants are randomly assigned to one of two treatment groups. The control group receives standard chemo-radiotherapy and brachytherapy based on established guidelines. The experimental group undergoes minimally invasive para-aortic lymphadenectomy followed by tailored chemo-radiotherapy and brachytherapy. Both laparoscopic and robotic-assisted surgical methods are allowed. Treatments may also be adapted according to other ongoing studies if deemed appropriate by the physician. Each participant will be followed for five years, during which researchers will monitor disease-free survival as the primary outcome. Secondary outcomes include overall survival, cancer-specific survival, metastasis-free survival, treatment side effects, quality of life assessments, and cost-utility analysis. Additional evaluations involve imaging accuracy and biological markers. Participants will attend scheduled visits and assessments throughout the study and follow-up period.

PARa-aOrtic LymphAdenectomy in Locally Advanced Cervical Cancer