About this trial
The goal of this clinical trial is to learn if laparoscopic radical hysterectomy incorporating modified tumor-free techniques (LRH-MTF) works to treat FIGO stage IB2 cervical cancer as good as abdominal radical hysterectomy (ARH). It will also learn about the safety of LRH-MTF. The main questions it aims to answer are:
Does LRH-MTF achieve a non-inferior disease-free survival rate at 4.5 years post - operation compared to ARH? What complications do patients have during and after the operation when receiving LRH-MTF? Researchers will compare LRH-MTF to ARH to see if LRH-MTF works no worse than ARH in treating FIGO stage IB2 cervical cancer.
Participants will:
1. Undergo either LRH-MTF or ARH as assigned by randomization. 2. Visit the hospital for follow-up according to the study schedule for various examinations including blood tests, imaging studies, and assessment of complications. 3. Complete quality-of-life questionnaires such as EORTC QLQ-C30, QLQ-CX24, FSFI, and FSDS-R at baseline (pre-operation) and specific time points during the follow - up period (post-operation 6 months, 1 year, 2 years, 3 years, 4.5 years).
Eligibility criteria
Qualifiers
None
Disqualifiers
None
Trial design
Treatments tested in this trial
- Laparoscopic radical hysterectomy incorporating modified tumor-free techniques
- Abdominal radical hysterectomy
Treatment groups
Sponsors and collaborators
Peking Union Medical College Hospital
Lead sponsor
Hebei Medical University Fourth Hospital
Collaborator
Second Hospital of Jilin University
Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Collaborator
Cangzhou Central Hospital
Collaborator
Zhejiang Cancer Hospital
Collaborator
Hunan Provincial Maternal and Child Health Care Hospital
Collaborator
LanZhou University
Collaborator
RenJi Hospital
Collaborator
The Fourth Military Medical University, Xijing Hospital
Collaborator
Shaanxi Hospital of Traditional Chinese Medicine
Collaborator
Affiliated Hospital of North Sichuan Medical College
Collaborator
Tianjin Central Hospital of Gynecology Obstetrics
Collaborator
Southwest Hospital, China
Collaborator
Obstetrics & Gynecology Hospital of Fudan University
Collaborator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Collaborator
Sichuan Cancer Hospital and Research Institute
Collaborator