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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

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
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.
Trial Details
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
(from sponsor)		 Uterine Cervical Neoplasms, Cervical Cancer
Related terms Uterine Cervical Neoplasms
Enrollment 340 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov