Tests a keyhole surgery method for early-stage cervical cancer
Compares keyhole and open surgery to remove the uterus in women with early cervical cancer.
Plain-language title generated from the registry record
Registry title: Modified Tumor-free Techniques Operation to Cervical Cancer
Key facts
- Where
- Beijing, Cangzhou, Changchun, Changsha, Chengdu, Chongqing, Guangzhou, Hangzhou, Lanzhou, Nanchong, Shanghai, Shijiazhuang, Tianjin, Wuhan, Xi’an, and Xianyang, ChinaSee the 17 sites
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for women aged 18 to 65 with stage IB2 cervical cancer who are planned for a radical hysterectomy. It compares keyhole surgery with open abdominal surgery.
- Age
- 18 to 65 years
- Sex
- Women only
- Disease stage
- Primary cervical cancer (squamous cell, adenocarcinoma or adenosquamous), FIGO 2018 stage IB2. The tumour on MRI is larger than 2 cm (0.8 in) and no larger than 4 cm (1.6 in).
- Earlier treatment
- Cannot have had radiotherapy to the pelvis or abdomen, or chemotherapy before surgery. Must be scheduled for type C radical hysterectomy.
Main reasons for not taking part
- Rare cancer types such as gastric-type adenocarcinoma, neuroendocrine, clear cell or carcinosarcoma
- Cancer spread to pelvic or para-aortic lymph nodes
- Uterus larger than at 10 weeks of pregnancy
- Pregnancy
- Another cancer, unless cancer-free for more than 3 years
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT06836869, who can take part
Where in China
- Peking Union Medical College HospitalBeijing, ChinaTaking people
- Cangzhou Central HospitalCangzhou, ChinaTaking people
- The Second Hospital of Jilin UniversityChangchun, ChinaTaking people
- Hunan Provincial Maternal and Child Health Care HospitalChangsha, ChinaTaking people
- Sichuan Cancer Hospital and InstituteChengdu, ChinaTaking people
- Southwest HospitalChongqing, ChinaTaking people
- Sun Yat-sen Memorial Hospital, Sun Yat-sen UniversityGuangzhou, ChinaTaking people
- Zhejiang Cancer HospitalHangzhou, ChinaTaking people
- The First Hospital of Lanzhou UniversityLanzhou, ChinaNot yet recruiting
- Affiliated Hospital of North Sichuan Medical CollegeNanchong, ChinaTaking people
- Obstetrics&Gynecology Hospital of Fudan UniversityShanghai, ChinaTaking people
- Renji Hospital Affiliated to The Shanghai Jiao Tong University Medical SchoolShanghai, ChinaTaking people
- The Fourth Hospital of Hebei Medical UniversityShijiazhuang, ChinaTaking people
- Tianjin Central Hospital of Gynecology ObstetricsTianjin, ChinaTaking people
- Tongji Medical CollegeWuhan, ChinaTaking people
- The Fourth Military Medical University, Xijing HospitalXi’an, ChinaTaking people
- Affiliated Hospital of Shanxi University of Traditional Chinese MedicineXianyang, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Peking Union Medical College Hospital
- Trial code
- NCT06836869
- Record updated
- 27 March 2026
- Original description
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:Read full original descriptionShow less
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
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).
Inclusion Criteria:; 1.1 Females aged 18 to 65 years old. 1.2 Histologically confirmed primary cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma; 1.3 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; 1.5 Scheduled to receive type C (Q - M classification) radical hysterectomy. 1.6 Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; 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; 1.10 Laboratory test indicators of vital organs meet the standards; Exclusion Criteria:; 2.1 Special pathological types (gastric - type adenocarcinoma, neuroendocrine carcinoma, clear cell carcinoma, carcinosarcoma, etc.); 2.2 Imaging examinations suggest pelvic or para - aortic lymph node metastasis (MRI or CT shows a short - axis diameter of ≥1.5 cm, or SUV ≥2.5), or histopathology indicates lymph node metastasis; 2.3 History of pelvic and abdominal radiotherapy. 2.4 History of neoadjuvant chemotherapy. 2.5 Uterus larger than that at 10 weeks of pregnancy. 2.6 Contraindications for surgery and anesthesia (such as severe medical comorbidities); 2.7 Patients who cannot tolerate the Trendelenburg position. 2.8 Patients who cannot cooperate with treatment and follow - up. 2.9 Pregnant patients. 2.10 History of other malignancies, except for those who have been cancer - free for more than 3 years with no current evidence of tumor recurrence.