A Multicenter Noninferior Randomized Controlled Study Comparing the Efficacy of Laparoscopic Versus Abdominal Radical Hysterectomy for Cervical Cancer(Stage IB1,IB2,IIA1)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 780
- 试验地点
- 1
- 主要终点
- the rate of PFS at 5 years
研究概览
简要总结
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 IB1, IB2, IIA1).
详细描述
The purpose of this study is to compare LRH (or robotic-assisted) and ARH in patients with cervical cancer (Stage IB1, IB2, IIA1), by a multicenter stratified randomized controlled study, mainly including the following aspects:
- To compare the differences in PFS and OS between patients receiving LRH and ARH.
- 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).
- To assess postoperative complications and quality of survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of squamous carcinoma of the cervix, adenocarcinoma, squamous adenocarcinoma (Stage IB1,IB2,IIA1).
- •Age ≥ 21 years and ≤ 70 years.
- •Surgery type B and C (refer to Q-M surgical staging)
- •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.
- •No history of other malignancies.
- •Non-pregnancy.
- •Physical strength classification: Karnofsky score ≥ 60;
- •Subjects voluntarily joined the study, signed the informed consent form, were compliant and cooperated with the follow-up.
- •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)
排除标准
- •Those who are contraindicated for various surgeries and cannot undergo surgery.
- •Patients who have received pelvic/abdominal radiotherapy irradiation or neoadjuvant chemotherapy for cervical cancer.
- •Patients with recurrent cervical cancer
- •Patients with CT, MRI or PET-CT suggesting suspicious metastasis of pelvic lymph nodes with maximum diameter >2cm after further improvement of preoperative examination.
结局指标
主要结局
the rate of PFS at 5 years
时间窗: 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.
次要结局
- the rate of OS at 5 years(5 years from surgery)