Randomized Study of Concurrent Chemoradiotherapy With or Without Adjuvant Chemotherapy for Advanced Cervical Cancer Using Intensity-Modulated Radiation and 3D Afterloading Based on 2018 FIGO Staging

What this Trial Is About

Researchers are evaluating the clinical effectiveness of combining concurrent chemoradiotherapy with adjuvant chemotherapy versus concurrent chemoradiotherapy alone in treating locally advanced cervical cancer. This prospective, randomized controlled trial focuses on patients staged according to the 2018 FIGO system. The study aims to clarify the role of additional chemotherapy after standard intensity-modulated radiation therapy and three-dimensional afterloading treatment, addressing the ongoing debate about its benefits for disease-free and overall survival. Participants receive either concurrent intensity-modulated radiotherapy combined with chemotherapy followed by adjuvant chemotherapy using paclitaxel combined with platinum, or concurrent chemoradiotherapy alone. Treatment is delivered using advanced radiation techniques that improve biological effects compared to traditional methods. Patients who achieve complete response after initial treatment are randomized to either receive the additional chemotherapy or be observed without it. During the study, participants will be closely monitored for disease progression and survival outcomes, with progression-free survival as the primary measure and overall survival as a secondary measure. Assessments include regular clinical evaluations, laboratory tests, and imaging as per clinical standards. The study follows patients over an extended period, up to 1000 months, to gather long-term data on treatment impact and safety. The trial is sponsored by the Fourth Affiliated Hospital of Guangxi Medical University and is expected to complete by mid-2027.

Concurrent Chemoradiotherapy Combined With Adjuvant Chemotherapy Treated Advanced Cervical Cancer