Randomized Controlled Trial to Evaluate Laparoscopic Versus Open Surgery for Colorectal Cancer（JCOG 0404,CRC Surg-LAP/OPEN)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,050
- 试验地点
- 52
- 主要终点
- Overall survival
研究概览
简要总结
The purpose of this study is to evaluate oncological outcome of patients for T3 and T4 colorectal cancer undergoing laparoscopic versus open surgery.
详细描述
The benefits of laparoscopic surgery (LAP) in comparison to open surgery (OPEN) have been suggested with respect to decreased morbidity, decreased pain, faster recovery, and shorter hospital stay.1-4 However, the long-term survival of LAP for colorectal cancer is still unclear, especially for advanced colorectal cancer requiring extended lymphadenectomy. Thus, the investigators designed a study which investigates whether LAP is suitable for advanced colorectal cancer with respect to survival and post-operative morbidity.
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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically proven colorectal carcinoma
- •Tumor located in the cecum, ascending colon, sigmoid colon, or rectosigmoid colon
- •T3 or deeper lesion without involvement of other organs
- •Without multiple lesion other than carcinoma in situ
- •Cancer classified as N0-2 and M0, according to the TNM classification system
- •Tumor size < 8 cm
- •No bowel obstruction
- •Age 20 < and > 75 years
- •Sufficient organ function
- •No history of gastrointestinal surgery
- •No history of chemotherapy or radiotherapy
- •Provided written informed consent
排除标准
- •Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ
- •Severe pulmonary emphysema, interstitial pneumonitis, or ischemic heart disease
- •Pregnant or lactating women
- •Severe mental disease
- •Continuous systemic steroid therapy
结局指标
主要结局
Overall survival
时间窗: During the study conduct
次要结局
- The proportion of conversion from LAP to OPEN(operation day)
- The proportion of completion of LAP(operation day)
- Short-term clinical outcomes(time to 1st discharge after operation)
- Relapse-free survival(During the study conduct)
- Adverse events(During the study conduct)
研究者
Haruhiko Fukuda
JCOG Data Center
Japan Clinical Oncology Group