Modified Tumor-free Techniques Operation to Cervical Cancer

NCT06836869 | Recruiting DMC

• 1 other identifier: MOTTO
• Study Type: interventional
• Target: 524
• Locations: 1 country
• Sites: 17

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. 1.Undergo either LRH-MTF or ARH as assigned by randomization.
2. 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. 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).

Conditions

Cervical Cancer Stage IB2

Keywords

radical hysterectomy; Modified Tumor-Free Techniques; cervical cancer; FIGO stage 1B2; laparotomy; laparoscopic surgery

Outcome Measures

Primary Outcomes (1)

• 4.5-year Disease-free Survival

  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 Outcomes (12)

• 4.5-year Overall Survival

  From the surgery to the 4.5 years after the end of treatment

• Pattern of Reccurence

  From surgery to the 4.5 years after the end of treatment

• Estimated surgical blood loss

  From the start to the end of the surgery up to 24 hours

• Operating time

  From the start to the end of the surgery up to 24 hours

• Postoperative pain

  From surgery to the third day after surgery

Study Arms (2)

LRH-MTF

EXPERIMENTAL

Laparoscopic radical hysterectomy incorporating modified tumor-free techniques

Procedure: Laparoscopic radical hysterectomy incorporating modified tumor-free techniques

ARH

ACTIVE COMPARATOR

Abdominal radical hysterectomy

Procedure: Abdominal radical hysterectomy

Interventions

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.

LRH-MTF

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.

ARH

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females aged 18 to 65 years old. 1.2 Histologically confirmed primary cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma.
• 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.
• Scheduled to receive type C (Q - M classification) radical hysterectomy. 1.6 Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
• 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.
• Laboratory test indicators of vital organs meet the standards

You may not qualify if:

• Special pathological types (gastric - type adenocarcinoma, neuroendocrine carcinoma, clear cell carcinoma, carcinosarcoma, etc.).
• 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.
• 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).
• 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.

Sponsors & Collaborators

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

Study Sites (17)

The First Hospital of Lanzhou University

Lanzhou, Gansu, 730000, China

NOT YET RECRUITING

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

Guangzhou, Guangdong, 510120, China

RECRUITING

Cangzhou Central Hospital

Cangzhou, Hebei, 061000, China

RECRUITING

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050011, China

RECRUITING

Hunan Provincial Maternal and Child Health Care Hospital

Changsha, Hunan, 410000, China

RECRUITING

The Second Hospital of Jilin University

Changchun, Jilin, 130041, China

RECRUITING

Renji Hospital Affiliated to The Shanghai Jiao Tong University Medical School

Shanghai, Shanghai Municipality, 200001, China

RECRUITING

Affiliated Hospital of Shanxi University of Traditional Chinese Medicine

Xianyang, Shanxi, 712000, China

RECRUITING

The Fourth Military Medical University, Xijing Hospital

Xi’an, Shanxi, 710032, China

RECRUITING

Affiliated Hospital of North Sichuan Medical College

Nanchong, Sichuan, 637000, China

RECRUITING

Zhejiang cancer hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

Peking Union Medical College Hospital

Beijing, 100079, China

RECRUITING

Sichuan Cancer Hospital and Institute

Chengdu, China

RECRUITING

Southwest Hospital

Chongqing, China

RECRUITING

Obstetrics & Gynecology Hospital of Fudan University

Shanghai, China

RECRUITING

Tianjin Central Hospital of Gynecology Obstetrics

Tianjin, China

RECRUITING

Tongji Medical College

Wuhan, China

RECRUITING

Related Publications (4)

• Kanao H, Aoki Y, Fusegi A, Omi M, Nomura H, Tanigawa T, Okamoto S, Kurita T, Netsu S, Omatsu K, Yunokawa M. Feasibility and Outcomes of "No-Look No-Touch" Laparoscopic Radical Trachelectomy for Early-Stage Cervical Cancer. J Clin Med. 2021 Sep 15;10(18):4154. doi: 10.3390/jcm10184154.

  PMID: 34575265 BACKGROUND

• Chiva L, Zanagnolo V, Querleu D, Martin-Calvo N, Arevalo-Serrano J, Capilna ME, Fagotti A, Kucukmetin A, Mom C, Chakalova G, Aliyev S, Malzoni M, Narducci F, Arencibia O, Raspagliesi F, Toptas T, Cibula D, Kaidarova D, Meydanli MM, Tavares M, Golub D, Perrone AM, Poka R, Tsolakidis D, Vujic G, Jedryka MA, Zusterzeel PLM, Beltman JJ, Goffin F, Haidopoulos D, Haller H, Jach R, Yezhova I, Berlev I, Bernardino M, Bharathan R, Lanner M, Maenpaa MM, Sukhin V, Feron JG, Fruscio R, Kukk K, Ponce J, Minguez JA, Vazquez-Vicente D, Castellanos T, Chacon E, Alcazar JL; SUCCOR study Group. SUCCOR study: an international European cohort observational study comparing minimally invasive surgery versus open abdominal radical hysterectomy in patients with stage IB1 cervical cancer. Int J Gynecol Cancer. 2020 Sep;30(9):1269-1277. doi: 10.1136/ijgc-2020-001506. Epub 2020 Aug 11.

  PMID: 32788262 BACKGROUND

• 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.

  PMID: 30380365 BACKGROUND

• 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.

  PMID: 39700500 BACKGROUND

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Yuan Li, professor

CONTACT

+8617810376318; liyuan10833@pumch.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: February 11, 2025
• First Posted: February 20, 2025
• Study Start: February 20, 2025
• Primary Completion (Estimated): July 1, 2032
• Study Completion (Estimated): July 1, 2032
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: After the primary outcome results are published.
• Access Criteria: Qualified gynecologists can obtain an IPD by contacting the central contact person.

Locations

CN (17)