Modified Tumor-free Techniques Operation to Cervical Cancer

Last updated: March 15, 2025
Sponsor: Peking Union Medical College Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cervical Cancer

Uterine Disorders

Treatment

Laparoscopic radical hysterectomy incorporating modified tumor-free techniques

Abdominal radical hysterectomy

Clinical Study ID

NCT06836869
MOTTO-1B2
  • Ages 18-65
  • Female

Study Summary

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).

Eligibility Criteria

Inclusion

  1. Inclusion Criteria:

1.1 Females aged 18 to 65 years old. 1.2 Histologically confirmed primary cervicalsquamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma.

1.3 FIGO 2018 stage IB2. 1.4 The maximum diameter of the cervical lesion measured byMRI is >2 cm and ≤4 cm. For those with MRI contraindications, PET/CT, CT, orultrasound can be used as alternatives.

1.5 Scheduled to receive type C (Q - M classification) radical hysterectomy. 1.6Eastern 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. 1.8Able 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

  1. 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 Design

Total Participants: 524
Treatment Group(s): 2
Primary Treatment: Laparoscopic radical hysterectomy incorporating modified tumor-free techniques
Phase:
Study Start date:
February 20, 2025
Estimated Completion Date:
July 31, 2032

Study Description

This trial is planned to conduct one early analysis and one final analysis. The trial has an open-label design, and the early analysis is a non-blinded analysis. An independent third-party statistical team will analyze the safety data, baseline characteristics of the subjects, and perioperative-related indicators, aiming to evaluate the safety of the treatment and the perioperative outcome indicators. The time point for the early analysis is within approximately 4 weeks after 100% of the subjects have completed the 6th month (the 5th visit) after the surgery.

Connect with a study center

  • The First Hospital of Lanzhou University

    Lanzhou, Gansu 730000
    China

    Site Not Available

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    Guangzhou, Guangdong 510120
    China

    Site Not Available

  • Cangzhou Central Hospital

    Cangzhou, Hebei 061000
    China

    Site Not Available

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei 050011
    China

    Site Not Available

  • Hunan Provincial Maternal and Child Health Care Hospital

    Changsha, Hunan 410000
    China

    Site Not Available

  • The Second Hospital of Jilin University

    Changchun, Jilin 130041
    China

    Site Not Available

  • Renji Hospital Affiliated to The Shanghai Jiao Tong University Medical School

    Shanghai, Shanghai 200001
    China

    Site Not Available

  • The Fourth Military Medical University, Xijing Hospital

    Xi'an, Shanxi 710032
    China

    Site Not Available

  • Affiliated Hospital of Shanxi University of Traditional Chinese Medicine

    Xianyang, Shanxi 712000
    China

    Site Not Available

  • Affiliated Hospital of North Sichuan Medical College

    Nanchong, Sichuan 637000
    China

    Site Not Available

  • Zhejiang cancer hospital

    Hangzhou, Zhejiang 310022
    China

    Site Not Available

  • Peking Union Medical College Hospital

    Beijing, 100079
    China

    Active - Recruiting

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