Actively Recruiting
Modified Tumor-free Techniques Operation to Cervical Cancer
Led by Peking Union Medical College Hospital · Updated on 2026-03-27
524
Participants Needed
17
Research Sites
384 weeks
Total Duration
On this page
Sponsors
P
Peking Union Medical College Hospital
Lead Sponsor
H
Hebei Medical University Fourth Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Modified Tumor-free Techniques Operation to Cervical Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 18 to 65 years old
- Confirmed primary cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma
- FIGO 2018 stage IB2 cervical cancer
- Cervical lesion size between greater than 2 cm and up to 4 cm measured by MRI or alternative imaging
- Scheduled for type C (Q-M classification) radical hysterectomy
- ECOG performance status of 0 or 1
- Willing and able to participate and complete follow-up and examinations
- Negative pregnancy test within 30 days before surgery for pre-menopausal women
- Laboratory tests show vital organs meet required standards
You will not qualify if you...
- Special pathological types such as gastric-type adenocarcinoma, neuroendocrine carcinoma, clear cell carcinoma, carcinosarcoma
- Imaging or histopathology showing pelvic or para-aortic lymph node metastasis
- History of pelvic or abdominal radiotherapy
- History of neoadjuvant chemotherapy
- Uterus larger than at 10 weeks of pregnancy
- Contraindications to surgery or anesthesia
- Unable to tolerate Trendelenburg position
- Unable to cooperate with treatment or follow-up
- Pregnant
- History of other malignancies unless cancer-free for over 3 years with no recurrence
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 17 locations
1
The First Hospital of Lanzhou University
Lanzhou, Gansu, China, 730000
Not Yet Recruiting
2
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510120
Actively Recruiting
3
Cangzhou Central Hospital
Cangzhou, Hebei, China, 061000
Actively Recruiting
4
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 050011
Actively Recruiting
5
Hunan Provincial Maternal and Child Health Care Hospital
Changsha, Hunan, China, 410000
Actively Recruiting
6
The Second Hospital of Jilin University
Changchun, Jilin, China, 130041
Actively Recruiting
7
Renji Hospital Affiliated to The Shanghai Jiao Tong University Medical School
Shanghai, Shanghai Municipality, China, 200001
Actively Recruiting
8
Affiliated Hospital of Shanxi University of Traditional Chinese Medicine
Xianyang, Shanxi, China, 712000
Actively Recruiting
9
The Fourth Military Medical University, Xijing Hospital
Xi’an, Shanxi, China, 710032
Actively Recruiting
10
Affiliated Hospital of North Sichuan Medical College
Nanchong, Sichuan, China, 637000
Actively Recruiting
11
Zhejiang cancer hospital
Hangzhou, Zhejiang, China, 310022
Actively Recruiting
12
Peking Union Medical College Hospital
Beijing, China, 100079
Actively Recruiting
13
Sichuan Cancer Hospital and Institute
Chengdu, China
Actively Recruiting
14
Southwest Hospital
Chongqing, China
Actively Recruiting
15
Obstetrics & Gynecology Hospital of Fudan University
Shanghai, China
Actively Recruiting
16
Tianjin Central Hospital of Gynecology Obstetrics
Tianjin, China
Actively Recruiting
17
Tongji Medical College
Wuhan, China
Actively Recruiting
Research Team
Y
Yuan Li, professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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