Laparoscopic or Abdominal Radical Hysterectomy for Cervical Cancer(Stage IB3,IIA2)

Not Applicable

Recruiting

• Conditions: Cervical Cancer
• Interventions: Other: Total Laparoscopic or Robotic Radical Hysterectomy; Other: Total Abdominal Radical Hysterectomy

• Registration Number: NCT04939831
• Lead Sponsor: Obstetrics & Gynecology Hospital of Fudan University

Brief Summary

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 IB3, IIA2).

Detailed Description

The purpose of this study is to compare LRH (or robotic-assisted) and ARH in patients with cervical cancer (Stage IB3, IIA2), 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.

Study Timeline

• Study Start: 2021-05-12
• Study First Submitted: 2021-06-09
• Study First Submitted QC: 2021-06-17
• Study First Posted: 2021-06-25
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-02
• Last Update Posted: 2021-11-10
• Primary Completion: 2024-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 1104

Inclusion Criteria

1. Clinical diagnosis of squamous carcinoma of the cervix, adenocarcinoma, squamous adenocarcinoma (Stage IB3,IIA2).
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)

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Total Laparoscopic or Robotic Radical Hysterectomy	the group of LRH
2	Total Abdominal Radical Hysterectomy	the group of ARH

Primary Outcome Measures

Name	Time	Method
the rate of OS at 5 years	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.)

Secondary Outcome Measures

Name	Time	Method
the rate of PFS at 5 years	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.

Trial Locations

Locations (1)

The Obstetrics and Gynecology Hospital of Fudan University; 🇨🇳 Shanghai, Shanghai, China