Laparoscopic or Abdominal Radical Hysterectomy for Cervical Cancer(Stage IA1 With LVSI, IA2)

Overview

The purpose of this study is to confirm whether there is a difference between laparoscopic radical hysterectomy (LRH) and abdominal radical hysterectomy (ARH) in patient survival for Cervical Cancer (Stage IA1 with LVSI, IA2)

Full Title of Study: “A Multicenter Noninferior Randomized Controlled Study Comparing the Efficacy of Laparoscopic Versus Abdominal Radical Hysterectomy for Cervical Cancer (Stage IA1 With LVSI, IA2)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2024

Detailed Description

The purpose of this study is to compare LRH (or robotic-assisted) and ARH in patients with cervical cancer (Stage IA1 with LVSI, IA2), by a multicenter stratified randomized controlled study, mainly including the following aspects: 1. To compare the differences in PFS and OS between patients receiving LRH and ARH. 2. To investigate whether PFS and OS in LRH can be improved by more rigorous specification of surgical details (including tumor-free principles and standard surgical scopes). 3. To assess postoperative complications and quality of survival.

Interventions

  • Other: Total Laparoscopic or Robotic Radical Hysterectomy
    • Stage IA1 with lymphovascular interstitial infiltration and IA2 surgical approach was type B (modified radical hysterectomy plus bilateral pelvic lymph node dissection, i.e., resection of 1~2 cm of the parametrium and 1~2 cm of the vagina) with abdominal para-aortic lymph node dissection if necessary (surgical staging according to FIGO 2018 and surgical staging according to Querleu-Morrow staging).
  • Other: Total Abdominal Radical Hysterectomy
    • Stage IA1 with lymphovascular interstitial infiltration and IA2 surgical approach was type B (modified radical hysterectomy plus bilateral pelvic lymph node dissection, i.e., resection of 1~2 cm of the parametrium and 1~2 cm of the vagina) with abdominal para-aortic lymph node dissection if necessary (surgical staging according to FIGO 2018 and surgical staging according to Querleu-Morrow staging).

Arms, Groups and Cohorts

  • Experimental: 1
    • the group of LRH
  • Active Comparator: 2
    • the group of ARH

Clinical Trial Outcome Measures

Primary Measures

  • the rate of PFS at 5 years
    • Time Frame: 5 years from surgery
    • The curves of PFS at 5 years will be estimated using the Kaplan-Meier method. The logrank test will be used to test the above hypothesis, the 5-year PFS rate difference and its 95% confidence interval (CI) for the comparison between the two groups will be estimated.

Secondary Measures

  • the rate of OS at 5 years
    • Time Frame: 5 years from surgery
    • Compare between groups(Cox proportional hazards model will be used to estimate the hazard ratio and 95% CI for the effect of treatment on the 5-year OS rate.)

Participating in This Clinical Trial

Inclusion Criteria

1. Clinical diagnosis of squamous carcinoma of the cervix, adenocarcinoma, squamous adenocarcinoma (IA1 with lymphovascular interstitial invasion, stage IA2). 2. Age ≥ 21 years and ≤ 70 years. 3. Surgery type B and C (refer to Q-M surgical staging) 4. Normal range of liver and kidney function and blood count (specific details below) Hemoglobin > 60g/L Platelets > 70*109/L Leukocytes > 3*109/L Creatinine < 50mg/dL Transaminase abnormal indicators ≤ 3 Maximum value of transaminases not exceeding 3 times the corresponding normal value. 5. No history of other malignancies. 6. Non-pregnancy. 7. Physical strength classification: Karnofsky score ≥ 60; 8. Subjects voluntarily joined the study, signed the informed consent form, were compliant and cooperated with the follow-up. 9. No psychiatric disorders and other serious immune system disorders (e.g. lupus erythematosus, myasthenia gravis, HIV infection, etc.) (Note: Maximum diameter measurement of cervical lesions is based on PET-CT, or CT, or MRI) Exclusion Criteria:

1. Those who are contraindicated for various surgeries and cannot undergo surgery. 2. Patients who have received pelvic/abdominal radiotherapy irradiation or neoadjuvant chemotherapy for cervical cancer. 3. Patients with recurrent cervical cancer 4. Patients with CT, MRI or PET-CT suggesting suspicious metastasis of pelvic lymph nodes with maximum diameter >2cm after further improvement of preoperative examination.

Gender Eligibility: Female

Minimum Age: 21 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hua Jiang
  • Collaborator
    • Children’s Hospital of Fudan University
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Hua Jiang, Chief Physician – Obstetrics & Gynecology Hospital of Fudan University
  • Overall Official(s)
    • Hua Jiang, PHD, Principal Investigator, The Obstetrics and Gynecology Hospital of Fudan University
  • Overall Contact(s)
    • Hua Jiang, PHD, (021)33189900-6529, jianghua@fudan.edu.cn

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