Less invasive surgery for cervical cancer put to the test
NCT ID NCT06836869
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study compares a newer, less invasive laparoscopic hysterectomy (with special tumor-free techniques) to the standard open abdominal surgery for stage IB2 cervical cancer. About 524 women will be randomly assigned to one of the two surgeries. The main goal is to see if the laparoscopic approach is as effective at preventing cancer recurrence over 4.5 years, while also being safer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Laparoscopic radical hysterectomy with modified tumor-free techniques
- What this could lead to
- If successful, this could offer a less invasive surgical option for stage IB2 cervical cancer with similar effectiveness and fewer complications.
- What could go wrong
- This is a non-inferiority trial, so the laparoscopic approach may prove no better than the standard. Results may not apply to other cancer stages or types.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 524 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2025
- Expected to finish
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Jul 2032
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
1. 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 2. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
17 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Affiliated Hospital of North Sichuan Medical College
RECRUITINGNanchong, Sichuan, 637000, China
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Affiliated Hospital of Shanxi University of Traditional Chinese Medicine
RECRUITINGXianyang, Shanxi, 712000, China
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Cangzhou Central Hospital
RECRUITINGCangzhou, Hebei, 061000, China
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Hunan Provincial Maternal and Child Health Care Hospital
RECRUITINGChangsha, Hunan, 410000, China
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Obstetrics & Gynecology Hospital of Fudan University
RECRUITINGShanghai, China
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Peking Union Medical College Hospital
RECRUITINGBeijing, 100079, China
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Renji Hospital Affiliated to The Shanghai Jiao Tong University Medical School
RECRUITINGShanghai, Shanghai Municipality, 200001, China
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Sichuan Cancer Hospital and Institute
RECRUITINGChengdu, China
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Southwest Hospital
RECRUITINGChongqing, China
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Sun Yat-sen Memorial Hospital, Sun Yat-sen University
RECRUITINGGuangzhou, Guangdong, 510120, China
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The First Hospital of Lanzhou University
NOT_YET_RECRUITINGLanzhou, Gansu, 730000, China
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The Fourth Hospital of Hebei Medical University
RECRUITINGShijiazhuang, Hebei, 050011, China
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The Fourth Military Medical University, Xijing Hospital
RECRUITINGXi’an, Shanxi, 710032, China
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The Second Hospital of Jilin University
RECRUITINGChangchun, Jilin, 130041, China
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Tianjin Central Hospital of Gynecology Obstetrics
RECRUITINGTianjin, China
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Tongji Medical College
RECRUITINGWuhan, China
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Zhejiang cancer hospital
RECRUITINGHangzhou, Zhejiang, 310022, China
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