Modified Tumor-free Techniques Operation to Cervical Cancer

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorPeking Union Medical College Hospital

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

524 Participants
are divided into 2 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