NCT00190541已完成3 期
Mesorectal Excision With Lateral Lymph Node Dissection Versus Without Lateral Lymph Node Dissection for Clinical Stage II, III Lower Rectal Cancer (JCOG0212)
Haruhiko Fukuda96 个研究点 分布在 1 个国家目标入组 700 人开始时间: 2003年6月最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 700
- 试验地点
- 96
- 主要终点
- Relapse-free survival
研究概览
简要总结
The purpose of this study is to evaluate the of international standard operation, mesorectal excision (ME alone) compared to Japanese standard operation, ME with lateral lymph node dissection for clinical stage II, III lower rectal cancer
详细描述
Total mesorectal excision (TME) or mesorectal excision (ME) with lateral lymph node dissection for advanced rectal cancer is widely performed in Japan. In other countries, TME or ME without lateral lymph node dissection is the standard. In order to determine which is the better rectal cancer surgery, relapse-free survivals of these are compared as the primary endpoint.
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 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preoperative criteria:
- •Histologically confirmed adenocarcinoma
- •Clinical stage II or III
- •Preoperative findings:
- •Main lesion of the tumor is located at the rectum
- •Lower tumor margin is below the peritoneal reflection
- •No extramesorectal lymph node swelling (Shorter diameter is less than 10 mm)
- •No invasion to other organ (s)
- •Patient age is more than 20 and less than 75
- •No past history of chemotherapy, pelvic surgery or radiation
- •Written informed consent
- •Operative criteria:
- •Mesorectal excision is performed
- •Operative findings:
- •Main lesion of the tumor is located at the rectum
- •Lower tumor margin is below the peritoneal reflection
- •R0 after resection
排除标准
- •Multiple cancer patients
- •Pregnant patients
- •Psychological disorder
- •Steroid administration
- •Cardiac infarction within six months
- •Severe pulmonary emphysema and pulmonary fibrosis
- •Doctor's decision for exclusion
结局指标
主要结局
Relapse-free survival
时间窗: Until relapsing
次要结局
- Local-recurrence-free survival(Until local-recurrence)
- Incidence of adverse events(5 years)
- Incidence of major adverse events(5 years)
- Operative time(Operation day)
- Blood loss(Operation day)
- Overall survival(Overall)
- Incidence of sexual and urinary dysfunction(1 year)
研究者
Haruhiko Fukuda
JCOG Data Center
Japan Clinical Oncology Group
研究点 (96)
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