Clinical Efficacy of Adjuvant Chemotherapy in Patients With Locally Advanced Cervical Cancer Who Did Not Meet the NCCN Guidelines for Adjuvant Treatment After NACT Combined With Surgery

• Status: Recruiting
• Trial end date: 2028-02-01

Summary

This is a prospective, phase 3 randomized controlled clinical trial. Cervical cancer patients with FIGO stage IB3, Ⅱ A2 or IIB with tumor size> 4 cm will be enrolled. Patients will undergo 2-3 cycles of neoadjuvant chemotherapyradical (NACT) followed by laparotomic or laparoscopic hysterectomy + pelvic lymphadenectomy with cervical cancer foci sealed before dissection of the vagina and without uterine manipulator. Patients meet criteria of adjuvant therapy according to NCCN guideline after surgery will be weeded out, and who do not meet criteria of adjuvant therapy will be randomly selected to undergo adjuvant chemotherapy or just follow-up visit. The primary endpoint was disease-free survival (DFS) rate at 5 year. The secondary endpoints were 5-year overall survival (OS), safety and quality of life.

• Phase: Phase 3

Details

• Lead Sponsor: Huazhong University of Science and Technology
• Collaborators: First Affiliated Hospital of Chongqing Medical University; Hunan Cancer Hospital; Obstetrics & Gynecology Hospital of Fudan University; Qilu Hospital of Shandong University; The Third Xiangya Hospital of Central South University; Women's Hospital School Of Medicine Zhejiang University