A PHASE III PROSPECTIVE RANDOMIZED TRIAL COMPARING LAPAROSCOPIC-ASSISTED COLECTOMY VERSUS OPEN COLECTOMY FOR COLON CANCER
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 810
- 试验地点
- 316
- 主要终点
- Overall survival
研究概览
简要总结
RATIONALE: Less invasive types of surgery may help reduce the number of side effects and improve recovery. It is not yet known which type of surgery is more effective for colon cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of laparoscopic-assisted colectomy with open colectomy in treating patients who have colon cancer.
详细描述
OBJECTIVES:
- Compare the disease-free and overall survival rates of patients with colon cancer treated with laparoscopic-assisted colectomy vs open colectomy.
- Compare the safety of these regimens in terms of early and late morbidity and 30-day mortality of these patients.
- Compare the differences in costs and cost effectiveness between these treatments in this patient population.
- Compare the differences in quality of life of patients treated with these regimens. (closed as of 4/30/99)
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, primary surgeon, site of primary tumor (right vs left vs sigmoid), and American Society of Anesthesiologists disease classification (I and II vs III). Patients are randomized to one of two treatment arms.
The extent of colon resection is identical for both arms.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Overall survival
时间窗: Up to 8 years
Disease-free survival
时间窗: Up to 8 years
* Compare the disease-free and overall survival rates of patients with colon cancer treated with laparoscopic-assisted colectomy vs open colectomy. * Compare the safety of these regimens in terms of early and late morbidity and 30-day mortality of these patients. * Compare the differences in costs and cost effectiveness between these treatments in this patient population. * Compare the differences in quality of life of patients treated with these regimens. (closed as of 4/30/99)
次要结局
- Morbidity(Up to 8 years)
- Mortality(At 30 days)
- Costs and cost effectiveness between these treatments in this patient population(Up to 8 years)
- Compare the differences in quality of life of patients treated with these regimens(Up to 8 years)