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

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.

NCT Number	NCT04733820
Lead Sponsor	Huazhong University of Science and Technology Collaborators: Women's Hospital School Of Medicine Zhejiang University, Qilu Hospital of Shandong University, Obstetrics & Gynecology Hospital of Fudan University, First Affiliated Hospital of Chongqing Medical University, Hunan Cancer Hospital, The Third Xiangya Hospital of Central South University
Conditions	Uterine Cervical Neoplasms, Cervical Cancer
Enrollment	340 participants
Start Date	2021-02-01
Primary Completion	2028-02-01 (estimated)
Study Completion	2028-02-01 (estimated)
Updated on ClinicalTrials.gov	2021-02-02