Clinical trial NCT06836869: Modified Tumor-free Techniques Operation to Cervical Cancer
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cervical Cancer Stage IB2
Keywords: radical hysterectomy
Modified Tumor-Free Techniques
cervical cancer
FIGO stage 1B2
laparotomy
laparoscopic surgery
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: Hebei Medical University Fourth Hospital
name: Second Hospital of Jilin University
name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Cangzhou Central Hospital
name: Zhejiang Cancer Hospital
name: Hunan Provincial Maternal and Child Health Care Hospital
name: LanZhou University
name: Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
name: The Fourth Military Medical University, Xijing Hospital
name: Affiliated Hospital of Shanxi University of Traditional Chinese Medicine
name: Afﬁliated Hospital of North Sichuan Medical College
name: Tianjin Central Hospital of Gynecology Obstetrics
First posted: 2025-02-20
Enrollment: 524
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a prospective, multi-center, open-label, blind endpoint evaluation (PROBE), non-inferiority, randomized controlled trial with a parallel-group design. The main hypothesis of this study is that laparoscopic radical hysterectomy incorporating modified tumor-free techniques (LRH-MTF) is non-inferior to abdominal radical hysterectomy (ARH) in terms of disease-free survival at 4.5 years post-operation. A non-inferiority margin of 7% is set based on previous studies. This means that as long as the difference in the 4.5-year disease-free survival rate between LRH-MTF and ARH is within this non-inferiority margin, LRH-MTF will be considered non-inferior to ARH. If LRH-MTF meets this criterion, it can potentially offer the advantages of minimally invasive surgery, such as reduced surgical trauma, shorter hospital stay, and faster recovery, while maintaining comparable oncological outcomes.
Primary purpose: TREATMENT

Brief 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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 4.5-year Disease-free Survival
timeFrame: From enrollment to the 4.5 years after the end of treatment
Secondary outcomes:
measure: 4.5-year Overall Survival
timeFrame: From enrollment to the 4.5 years after the end of treatment
measure: Pattern of Reccurence
timeFrame: From surgery to the 4.5 years after the end of treatment
measure: Estimated surgical blood loss
timeFrame: From the start to the end of the surgery up to 24 hours
measure: Operating time
timeFrame: From the start to the end of the surgery up to 24 hours
measure: Postoperative pain
timeFrame: From surgery to the third day after surgery
measure: Gastrointestinal function recovery
timeFrame: From the end of surgery to the first postoperative flatus at 7 days.
measure: Length of hospital stay
timeFrame: From hospitalization to discharge up to 90 days.
measure: Treatment cost
timeFrame: From enrollment to the 4.5 years after the end of treatment
measure: EORTC QLQ - C30 scale
timeFrame: From enrollment to the 4.5 years after the end of treatment
measure: EORTC QLQ - CX24 Scale
timeFrame: From enrollment to the 4.5 years after the end of treatment
measure: FSFI Scale
timeFrame: From enrollment to the 4.5 years after the end of treatment
measure: FSDS - R Scale
timeFrame: From enrollment to the 4.5 years after the end of treatment
Other outcomes:
Locations:
city: Lanzhou
country: China
facility: The First Hospital of Lanzhou University
state: Gansu
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University
state: Guangdong
city: Cangzhou
country: China
facility: Cangzhou Central Hospital
state: Hebei
city: Shijiazhuang
country: China
facility: The Fourth Hospital of Hebei Medical University
state: Hebei
city: Changsha
country: China
facility: Hunan Provincial Maternal and Child Health Care Hospital
state: Hunan
city: Changchun
country: China
facility: The Second Hospital of Jilin University
state: Jilin
city: Shanghai
country: China
facility: Renji Hospital Affiliated to The Shanghai Jiao Tong University Medical School
state: Shanghai
city: Xi'an
country: China
facility: The Fourth Military Medical University, Xijing Hospital
state: Shanxi
city: Xianyang
country: China
facility: Affiliated Hospital of Shanxi University of Traditional Chinese Medicine
state: Shanxi
city: Nanchong
country: China
facility: Affiliated Hospital of North Sichuan Medical College
state: Sichuan
city: Hangzhou
country: China
facility: Zhejiang cancer hospital
state: Zhejiang
city: Beijing
country: China
facility: Peking Union Medical College Hospital
city: Tianjin
country: China
facility: Tianjin Central Hospital of Gynecology Obstetrics
Study officials:
References:
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citation: Ramirez PT, Frumovitz M, Pareja R, Lopez A, Vieira M, Ribeiro R, Buda A, Yan X, Shuzhong Y, Chetty N, Isla D, Tamura M, Zhu T, Robledo KP, Gebski V, Asher R, Behan V, Nicklin JL, Coleman RL, Obermair A. Minimally Invasive versus Abdominal Radical Hysterectomy for Cervical Cancer. N Engl J Med. 2018 Nov 15;379(20):1895-1904. doi: 10.1056/NEJMoa1806395. Epub 2018 Oct 31.
citation: Li Y, Zhao J, Ding X, Liang C, Wang W, Ren T, Jiang F, Yang J, Xiang Y. Oncologic Outcomes of Laparoscopic Radical Hysterectomy Incorporating Modified Tumor-Free Techniques. Obstet Gynecol. 2025 Feb 1;145(2):134-143. doi: 10.1097/AOG.0000000000005805. Epub 2024 Dec 19.