A Multicenter, Non-inferiority Trial to Compare the Effectiveness and Safety of Laparoscopic Radical Hysterectomy Incorporating Modified Tumor-free Techniques Versus Abdominal Radical Hysterectomy in Patients With Stage IB2 Cervical Cancer

Status: Recruiting
Location: See all (13) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 1 Females aged 18 to 65 years old. 1.2 Histologically confirmed primary cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma.

• 3 FIGO 2018 stage IB2. 1.4 The maximum diameter of the cervical lesion measured by MRI is \>2 cm and ≤4 cm. For those with MRI contraindications, PET/CT, CT, or ultrasound can be used as alternatives.

• 5 Scheduled to receive type C (Q - M classification) radical hysterectomy. 1.6 Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.

• 7 Willing to participate in this trial and sign the informed consent form. 1.8 Able to cooperate and complete follow - up and relevant examinations. 1.9 For pre - menopausal women, a negative pregnancy test within 30 days before surgery.

• 10 Laboratory test indicators of vital organs meet the standards

Locations
Other Locations
China
Peking Union Medical College Hospital
RECRUITING
Beijing
Cangzhou Central Hospital
NOT_YET_RECRUITING
Cangzhou
The Second Hospital of Jilin University
RECRUITING
Changchun
Hunan Provincial Maternal and Child Health Care Hospital
NOT_YET_RECRUITING
Changsha
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
NOT_YET_RECRUITING
Guangzhou
Zhejiang cancer hospital
NOT_YET_RECRUITING
Hangzhou
The First Hospital of Lanzhou University
NOT_YET_RECRUITING
Lanzhou
Affiliated Hospital of North Sichuan Medical College
NOT_YET_RECRUITING
Nanchong
Renji Hospital Affiliated to The Shanghai Jiao Tong University Medical School
NOT_YET_RECRUITING
Shanghai
The Fourth Hospital of Hebei Medical University
NOT_YET_RECRUITING
Shijiazhuang
Tianjin Central Hospital of Gynecology Obstetrics
NOT_YET_RECRUITING
Tianjin
The Fourth Military Medical University, Xijing Hospital
NOT_YET_RECRUITING
Xi’an
Affiliated Hospital of Shanxi University of Traditional Chinese Medicine
NOT_YET_RECRUITING
Xianyang
Contact Information
Primary
Yuan Li, professor
liyuan10833@pumch.cn
+8617810376318
Time Frame
Start Date: 2025-02-20
Estimated Completion Date: 2032-07
Participants
Target number of participants: 524
Treatments
Experimental: LRH-MTF
Laparoscopic radical hysterectomy incorporating modified tumor-free techniques
Active_comparator: ARH
Abdominal radical hysterectomy
Sponsors
Collaborators: Hebei Medical University Fourth Hospital, Second Hospital of Jilin University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Tianjin Central Hospital of Gynecology Obstetrics, Affiliated Hospital of Shanxi University of Traditional Chinese Medicine, RenJi Hospital, Hunan Provincial Maternal and Child Health Care Hospital, Zhejiang Cancer Hospital, LanZhou University, Cangzhou Central Hospital, Affiliated Hospital of North Sichuan Medical College, The Fourth Military Medical University, Xijing Hospital
Leads: Peking Union Medical College Hospital

This content was sourced from clinicaltrials.gov