Modified Tumor-free Techniques Operation to Cervical Cancer
Recruiting now · Not applicable
Conditions studied: Cervical Cancer Stage IB2
In brief
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).
Key facts
- Study ID
- NCT06836869
- Run by
- Peking Union Medical College Hospital
- People needed
- 524
- Starts
- 2025-02-20
- Expected to finish
- 2032-07-01
- Last updated by the study team
- 2026-03-27
Who can join
Age: 18 and older, up to 65. Sex: female. Healthy volunteers: not accepted.
Where it is running
- Tongji Medical College — Wuhan, China (enrolling)
- Sun Yat-sen Memorial Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (enrolling)
- Cangzhou Central Hospital — Cangzhou, Hebei, China (enrolling)
- The Fourth Hospital of Hebei Medical University — Shijiazhuang, Hebei, China (enrolling)
- Hunan Provincial Maternal and Child Health Care Hospital — Changsha, Hunan, China (enrolling)
- The Second Hospital of Jilin University — Changchun, Jilin, China (enrolling)
- Renji Hospital Affiliated to The Shanghai Jiao Tong University Medical School — Shanghai, Shanghai Municipality, China (enrolling)
- Affiliated Hospital of Shanxi University of Traditional Chinese Medicine — Xianyang, Shanxi, China (enrolling)
- The Fourth Military Medical University, Xijing Hospital — Xi’an, Shanxi, China (enrolling)
- Affiliated Hospital of North Sichuan Medical College — Nanchong, Sichuan, China (enrolling)
- Zhejiang cancer hospital — Hangzhou, Zhejiang, China (enrolling)
- Peking Union Medical College Hospital — Beijing, China (enrolling)
- Sichuan Cancer Hospital and Institute — Chengdu, China (enrolling)
- Southwest Hospital — Chongqing, China (enrolling)
- Obstetrics & Gynecology Hospital of Fudan University — Shanghai, China (enrolling)
- Tianjin Central Hospital of Gynecology Obstetrics — Tianjin, China (enrolling)
- The First Hospital of Lanzhou University — Lanzhou, Gansu, China
Full record on ClinicalTrials.gov
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