NCT06836869Recruiting
Modified Tumor-free Techniques Operation to Cervical Cancer
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
Source: ClinicalTrials.gov · Last updated 27 Mar 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 524 (estimated)
- First submitted
- 11 Feb 2025
- Start date
- 20 Feb 2025
- Primary completion date
- Jul 2032
- Lead sponsor
- Peking Union Medical College Hospital
- Diseases
- Cervical cancer
- NCT number
- NCT06836869
What you commit to
- Study type: Interventional
- Planned participants: 524
- From 20 Feb 2025 to the primary completion date, Jul 2032
- 17 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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.
Age in the registry: 18 years to 65 years · Sex: Female · Does not accept healthy volunteers
Sites (17)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking Union Medical College Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Cangzhou Central Hospital Coordinator of this site? Confirm its status | Cangzhou | China | Recruiting |
| The Second Hospital of Jilin University Coordinator of this site? Confirm its status | Changchun | China | Recruiting |
| Hunan Provincial Maternal and Child Health Care Hospital Coordinator of this site? Confirm its status | Changsha | China | Recruiting |
| Sichuan Cancer Hospital and Institute Coordinator of this site? Confirm its status | Chengdu | China | Recruiting |
| Southwest Hospital Coordinator of this site? Confirm its status | Chongqing | China | Recruiting |
| Sun Yat-sen Memorial Hospital, Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Zhejiang Cancer Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
| The First Hospital of Lanzhou University Coordinator of this site? Confirm its status | Lanzhou | China | Not yet recruiting |
| Affiliated Hospital of North Sichuan Medical College Coordinator of this site? Confirm its status | Nanchong | China | Recruiting |
| Renji Hospital Affiliated to The Shanghai Jiao Tong University Medical School Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Obstetrics&Gynecology Hospital of Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| The Fourth Hospital of Hebei Medical University Coordinator of this site? Confirm its status | Shijiazhuang | China | Recruiting |
| Tianjin Central Hospital of Gynecology Obstetrics Coordinator of this site? Confirm its status | Tianjin | China | Recruiting |
| Tongji Medical College Coordinator of this site? Confirm its status | Wuhan | China | Recruiting |
| The Fourth Military Medical University, Xijing Hospital Coordinator of this site? Confirm its status | Xi’an | China | Recruiting |
| Affiliated Hospital of Shanxi University of Traditional Chinese Medicine Coordinator of this site? Confirm its status | Xianyang | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.