Non-randomized Concurrent Controlled Trial of Surgery Staging or Image Staging of Locally Advanced Cervical Cancer

What this Trial Is About

Researchers are evaluating whether surgery staging is better than image staging for women with locally advanced cervical cancer. This prospective, non-randomized controlled trial aims to compare the effects of these two staging methods on progression-free survival and overall survival. The study focuses on patients with specific cervical cancer stages and types, seeking to improve treatment outcomes by assessing different approaches to staging before chemoradiation therapy. Participants are assigned to one of two groups without randomization. One group receives standard image staging followed by concurrent chemoradiation, which includes pelvic or extended-field external beam radiation therapy (EBRT), platinum-based chemotherapy, and brachytherapy. The other group undergoes surgery staging via open or minimally invasive para-aortic lymph node dissection up to at least the inferior mesenteric artery, followed by chemoradiation within 28 days. Chemoradiation protocols are consistent across groups, but extended-field EBRT is tailored based on pathological findings in the surgery group. During the study, participants will be closely monitored for disease progression and survival over three and five years. Researchers will assess progression-free survival at three years as the primary outcome and overall survival and complications at one and five years as secondary outcomes. The study involves regular imaging, biopsies, and clinical assessments to track responses and side effects. Participation lasts throughout treatment and includes follow-up visits to ensure safety and evaluate long-term results.

Comparing the Efficacy of Surgery Staging and Image Staging of Locally Advanced Cervical Cancer