Modified Tumor-free Techniques Operation to Cervical Cancer (MOTTO)

March 23, 2026 updated by: xiang yang, Peking Union Medical College Hospital

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

A progress report will be conducted within 4 weeks after all participants have completed their 6-month postoperative visit (the 5th visit). The report will be performed by an independent third-party statistical team, which will provide a comprehensive analysis of the safety data, baseline characteristic, and perioperative indicators.

The study will perform one final analysis.

Study Type

Interventional

Enrollment (Estimated)

524

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China, 100079
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yang Xiang, MD
      • Chengdu, China
        • Recruiting
        • Sichuan Cancer Hospital and Institute
        • Contact:
      • Chongqing, China
      • Shanghai, China
        • Recruiting
        • Obstetrics & Gynecology Hospital of Fudan University
        • Contact:
      • Tianjin, China
        • Recruiting
        • Tianjin Central Hospital of Gynecology Obstetrics
        • Contact:
          • Hu
        • Contact:
      • Wuhan, China
    • Gansu
      • Lanzhou, Gansu, China, 730000
        • Not yet recruiting
        • The First Hospital of Lanzhou University
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Recruiting
        • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
        • Contact:
    • Hebei
      • Cangzhou, Hebei, China, 061000
        • Recruiting
        • Cangzhou Central Hospital
        • Contact:
      • Shijiazhuang, Hebei, China, 050011
        • Recruiting
        • The Fourth Hospital of Hebei Medical University
        • Contact:
    • Hunan
      • Changsha, Hunan, China, 410000
        • Recruiting
        • Hunan Provincial Maternal and Child Health Care Hospital
        • Contact:
    • Jilin
      • Changchun, Jilin, China, 130041
        • Recruiting
        • The Second Hospital of Jilin University
        • Contact:
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200001
        • Recruiting
        • Renji Hospital Affiliated to The Shanghai Jiao Tong University Medical School
        • Contact:
    • Shanxi
      • Xianyang, Shanxi, China, 712000
        • Recruiting
        • Affiliated Hospital of Shanxi University of Traditional Chinese Medicine
        • Contact:
      • Xi’an, Shanxi, China, 710032
        • Recruiting
        • The Fourth Military Medical University, Xijing Hospital
        • Contact:
    • Sichuan
      • Nanchong, Sichuan, China, 637000
        • Recruiting
        • Affiliated Hospital of North Sichuan Medical College
        • Contact:
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Recruiting
        • Zhejiang Cancer Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LRH-MTF
Laparoscopic radical hysterectomy incorporating modified tumor-free techniques
Procedure: Laparoscopic radical hysterectomy incorporating modified tumor-free techniques
Thoroughly examine the pelvic and abdominal cavities. Coagulation of the fallopian tubes are recommanded at the beginning of the surgery. The use of uterine manipulator is prohibited. An "8"-suture at the uterine fundus is recommended. Insert a trocar 3 cm above the pubic symphysis and suspend the uterus by pulling with a needle holder. Alternative methods are also acceptable. Perform pelvic lymphadenectomy. Conduct radical hysterectomy according to the Q-M classification type C. Before incising the vagina, the upper part of the vagina must be closed (using a cable tie or suture), or the vagina can be incised transvaginally after deflating the pneumoperitoneum. Sterilized distilled water or saline solution (≥1000 mL) is used to irrigate the pelvic cavity. The vaginal stump can be sutured either laparoscopically or transvaginally.
Active Comparator: ARH
Abdominal radical hysterectomy
Procedure: Abdominal radical hysterectomy
At the onset of surgery, comprehensively explore the pelvic and abdominal cavities. If intraperitoneal metastases are identified, radical hysterectomy should be aborted. Perform pelvic lymphadenectomy. After lymph node resection, remove the lymph nodes from the surgical field promptly. Sentinel lymph node mapping and biopsy are not performed in this study. Perform radical hysterectomy according to type C of the Q-M classification. It can be accompanied by or without bilateral salpingo - oophorectomy. For patients who retain their ovaries, bilateral ovarian transposition can be carried out. Before incising the vagina, close the upper segment of the vagina and/or the vaginal stump. This can be achieved using instruments such as a large right - angle clamp or an auricular clamp. Sterilized distilled water or saline solution (≥1000 mL) is used to irrigate the pelvic cavity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
4.5-year Disease-free Survival
Time Frame: From the surgery to the 4.5 years after the end of treatment
The time from the surgery until the first recurrence or death from any cause within 4.5 years after surgery. Recurrence needs to be confirmed by histopathology and/or imaging. If pathological evidence cannot be obtained, recurrence should be determined by two or more detection methods, and adjudicated by an independent Endpoint Event Evaluation Committee.
From the surgery to the 4.5 years after the end of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pattern of Reccurence
Time Frame: From surgery to the 4.5 years after the end of treatment
According to the location of the first recurrence, it is divided into intra-pelvic recurrence and distant recurrence. Analyze the differences in the location of tumor recurrence after different surgical methods to provide a reference for subsequent treatment and prognosis judgment.
From surgery to the 4.5 years after the end of treatment
Estimated surgical blood loss
Time Frame: From the start to the end of the surgery up to 24 hours
Calculate it as the difference in the weight of gauze/gauze pads before and after the surgery (g) divided by 1.05, plus the difference between the total volume of aspirated fluid and the volume of irrigation fluid at the end of the surgery (mL). Also, record whether blood transfusion is performed during the surgery and within 1 week after the surgery. In addition, record the changes in hemoglobin before and after the surgery to assess blood loss. Perform a complete blood count (hemoglobin) test within 1 week before the surgery and on the 1st day after the surgery.
From the start to the end of the surgery up to 24 hours
Operating time
Time Frame: From the start to the end of the surgery up to 24 hours
The time from making the first incision to completing the suturing.
From the start to the end of the surgery up to 24 hours
Gastrointestinal function recovery
Time Frame: From the end of surgery to the first postoperative flatus at 7 days.
Record the time (in hours) of the first postoperative flatus.
From the end of surgery to the first postoperative flatus at 7 days.
Length of hospital stay
Time Frame: From hospitalization to discharge up to 90 days.
The number of days from hospitalization to discharge.
From hospitalization to discharge up to 90 days.
Treatment cost
Time Frame: From enrollment to the 4.5 years after the end of treatment
The total cost of hospitalization and outpatient services related to this disease. Conduct cost - effectiveness analysis through incremental cost, improvement of functional outcomes, and quality - adjusted life - years.
From enrollment to the 4.5 years after the end of treatment
EORTC QLQ - C30 scale
Time Frame: From enrollment to the 4.5 years after the end of treatment

EORTC QLQ - C30 is short for European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30. Each of the 15 subscales of the EORTC QLQ - C30 is scored from 0 to 100.

For the functional scales (physical, role, emotional, cognitive, and social functioning), higher scores indicate better functioning and thus a better outcome. For the symptom scales (fatigue, nausea and vomiting, pain, etc.) and the global health status/QOL scale, a higher score on the symptom scales means more severe symptoms (a worse outcome), while a higher score on the global health status/QOL scale means a better quality of life. It is used to evaluate the quality of life at baseline (pre - operation) and at 6 months, 1 year, 2 years, 3 years and 4.5 years after surgery.
From enrollment to the 4.5 years after the end of treatment
EORTC QLQ - CX24 Scale
Time Frame: From enrollment to the 4.5 years after the end of treatment
EORTC QLQ - CX24 Scale is short for European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Cervical Cancer Module. Similar to the QLQ - C30, most of its subscales are scored from 0 to 100. Interpretation of Scores: The interpretation is generally in line with the QLQ - C30. Higher scores in functional aspects indicate better conditions, while higher scores in symptom-related aspects indicate more severe symptoms or worse outcomes. It is used to evaluate the quality of life at baseline (pre - operation) and at 6 months, 1 year, 2 years, 3 years and 4.5 years after surgery.
From enrollment to the 4.5 years after the end of treatment
FSFI Scale
Time Frame: From enrollment to the 4.5 years after the end of treatment

FSFI is short for Female Sexual Function Index. Minimum and Maximum Values: The total score of the FSFI ranges from 2 to 36. Interpretation of Scores: A higher score indicates better female sexual function and a better outcome in terms of sexual health. Scores below a certain threshold may indicate sexual dysfunction.

It is used to evaluate the sexual function at baseline (pre - operation) and at 6 months, 1 year, 2 years, 3 years and 4.5 years after surgery.
From enrollment to the 4.5 years after the end of treatment
FSDS - R Scale
Time Frame: From enrollment to the 4.5 years after the end of treatment

FSDS - R Scale is short for Female Sexual Distress Scale - Revised. Minimum and Maximum Values: The FSDS - R typically has a score range from 0 to 52.

Interpretation of Scores: In this scale, a higher score indicates a higher level of sexual distress, meaning a worse outcome. It reflects the degree of distress a woman experiences related to her sexual function or situation.

It is used to evaluate the sexual function at baseline (pre - operation) and at 6 months, 1 year, 2 years, 3 years and 4.5 years after surgery.
From enrollment to the 4.5 years after the end of treatment
Postoperative pain
Time Frame: From surgery to the third day after surgery
It is evaluated using the Visual Analogue Scale (VAS). Additionally, the types, quantities, and administration methods of postoperative analgesics are recorded.
From surgery to the third day after surgery
4.5-year Overall Survival
Time Frame: From the surgery to the 4.5 years after the end of treatment
The time interval from the surgery to death from any cause within 4.5 years after surgery.
From the surgery to the 4.5 years after the end of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Collaborators

Zhejiang Cancer Hospital
LanZhou University
RenJi Hospital
Southwest Hospital, China
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Hebei Medical University Fourth Hospital
Obstetrics & Gynecology Hospital of Fudan University
Cangzhou Central Hospital
Second Hospital of Jilin University
Sichuan Cancer Hospital and Research Institute
Tianjin Central Hospital of Gynecology Obstetrics
Hunan Provincial Maternal and Child Health Care Hospital
Affiliated Hospital of North Sichuan Medical College
Affiliated Hospital of Shanxi University of Traditional Chinese Medicine
The Fourth Military Medical University, Xijing Hospital
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2025

Primary Completion (Estimated)

July 1, 2032

Study Completion (Estimated)

July 1, 2032

Study Registration Dates

First Submitted

February 11, 2025

First Submitted That Met QC Criteria

February 15, 2025

First Posted (Actual)

February 20, 2025

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 23, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MOTTO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD used in the results publication will be shared.

IPD Sharing Time Frame

After the primary outcome results are published.

IPD Sharing Access Criteria

Qualified gynecologists can obtain an IPD by contacting the central contact person.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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