NCT04939831招募中不适用
A Multicenter Noninferior Randomized Controlled Study Comparing the Efficacy of Laparoscopic Versus Abdominal Radical Hysterectomy for Cervical Cancer(Stage IB3,IIA2)
Obstetrics & Gynecology Hospital of Fudan University1 个研究点 分布在 1 个国家目标入组 1,104 人开始时间: 2021年5月12日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,104
- 试验地点
- 1
- 主要终点
- the rate of OS 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 IB3, IIA2).
详细描述
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:
- 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 IB3,IIA2).
- •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 OS at 5 years
时间窗: 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.)
次要结局
- the rate of PFS at 5 years(5 years from surgery)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
不适用
Laparoscopic or Abdominal Radical Hysterectomy for Cervical Cancer(Stage IA1 With LVSI, IA2)Cervical CancerNCT04934982Hua Jiang690
招募中
不适用
Laparoscopic or Abdominal Radical Hysterectomy for Cervical Cancer(Stage IB1,IB2,IIA1)Cervical CancerNCT04929769Obstetrics & Gynecology Hospital of Fudan University780
已完成
3 期
LVHR Multicenter StudyVentral and Ventral Insicional HerniaNCT00455299Oslo University Hospital156
Unknown
不适用
Colectomy for Cancer in the Elderly by Laparoscopy or LaparotomyColonic CancerNCT03033719Assistance Publique - Hôpitaux de Paris276
招募中
3 期
IRA vs IPOM Plus in Anterior Abdominal Wall Hernia Repair in terms of early post operative complicationsCTRI/2024/01/061886ABVIMS and Dr RML Hospital New Delhi