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).

Sex

Female

Minimum age

18 Years

Maximum age

65 Years

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.

• BACKGROUNDKanao 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
• BACKGROUNDChiva 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
• BACKGROUNDRamirez 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
• BACKGROUNDLi 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