Study of Surgical Removal of Metastatic Lymph Nodes Before Chemoradiation in Women With Stage IIICr Cervical Cancer

What this Trial Is About

Researchers are evaluating the therapeutic effect of surgical debulking of bulky or multiple lymph nodes before concurrent chemoradiation therapy CCRT in women with cervical cancer stage IIICr. This prospective, multicenter, randomized clinical trial DEBULK trial aims to compare outcomes between surgical debulking plus CCRT and CCRT alone, addressing challenges posed by lymph node metastasis that can reduce radiotherapy effectiveness. The study includes two groups one receiving CCRT only, and the other undergoing surgical removal of bulky or multiple lymph nodes followed by CCRT. This phase III trial is conducted across multiple centers, assessing the impact of adding surgery prior to standard chemoradiation treatment on patient outcomes. Participants will be monitored through clinical evaluations including imaging to assess lymph node status, and follow-up for three years to measure progression-free survival as the primary outcome. Secondary outcomes include overall survival, treatment-related complications, and accuracy of lymph node imaging. The study involves informed consent, radiological assessments, and regular follow-ups to collect these data until the study ends in 2030.

Therapeutic Effect of Surgical Debulking of Metastatic Lymph Nodes in Cervical Cancer Stage IIICr