Comparison of Class II and Class III Hysterectomy in Early Stage Cervical Cancer Cervical Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 500
- 主要终点
- 3-year disease-free survival (DFS) rate
研究概览
简要总结
Based on the value-based medicine, a randomized clinical trial was conducted to compare the role of class II and class III hysterectomy in patients with low risk early staged cervical cancer (defined as tumor lesions less than 2cm with less than 50% stromal invasion).
详细描述
This is a 1:1 multi-center randomized trial with class II hysterectomy plus node dissection as the experimental arm, and class III hysterectomy plus pelvic node dissection as the control arm. Primary endpoints are: (1). 3-year diseases-free survival (DFS) rate; (2) the rates of treatment-related toxicity; (3) post-operation QoL (including sexual function) and (4) treatment costs. Secondary endpoints are：(1) the rates of pelvic and/or extra-pelvic relapse; (2) overall survival(OS) rate; (3) the numbers of retroperitoneal node dissection, and (4) the rates of parametrial, margins and pelvic/para-aortic nodes involvement.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Stage IA2 and small IB1 <2 cm
- •Less than 50% stromal invasion based on MRI OR 10mm stromal invasion based on the pathology measurement of the LEEP/cone specimen
- •Squamous OR adenocarcinoma OR adenosquamous
- •Grade 1, 2 and 3
- •Lymph-vascular space invasion (LVSI): presence or absence
- •Diagnosis confirmed by LEEP/cone/cervical biopsy
- •Pelvic MRI in patients with involved cone/LEEP margins and those who had cervical biopsy only
- •Abdomino-pelvic CT scan in patients with negative LEEP-cone margins
- •No contraindications to surgery
- •No desire to preserve fertility
- •Informed consent
排除标准
- •High-risk histology types (clear cell, small cell etc)
- •Evidence of lymph node metastasis on preoperative imaging
- •Neo-adjuvant chemotherapy
- •Desire to preserve fertility
结局指标
主要结局
3-year disease-free survival (DFS) rate
时间窗: up to 4 years
次要结局
- Post-operation quality of life(up to 4 years)
- Node number involved in retroperitoneal node dissection(up to 4 years)
- Pelvic and/or extra-pelvic relapse rate(up to 4 years)
- Overall survival(up to 4 years)
- Rates of parametrial, margins and pelvic/para-aortic nodes involvement(up to 4 years)
- Treatment-related toxicity(up to 4 years)
- Cost effective(up to 4 years)