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NCT Number: NCT06836869

Modified Tumor-free Techniques Operation to 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).

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Key information

Conditions

Cervical Cancer Stage IB2 Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The First Hospital of Lanzhou University, Lanzhou, Gansu, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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.

Treatment and study plan

Laparoscopic radical hysterectomy incorporating modified tumor-free techniques

Procedure

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.

Abdominal radical hysterectomy

Procedure

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. Length of hospital stay

    Time frame: From hospitalization to discharge up to 90 days.

    The number of days from hospitalization to discharge.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yuan Li, professor

CONTACT

[email protected]

+8617810376318

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Collaborators

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

Registry information

Official study title

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

Acronym: MOTTO

Important dates

Study start
2025
Primary completion
2032
Study completion
2032
First posted
Feb 20, 2025
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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