NCT00007930Unknown3 期
Randomized Trial of Wide Mesorectal Excision Versus Total Mesorectal Excision for Mid Rectal Cancer
National Medical Research Council (NMRC), Singapore4 个研究点 分布在 2 个国家目标入组 800 人开始时间: 1999年8月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 800
- 试验地点
- 4
- 主要终点
- Local recurrence at 3 years
研究概览
简要总结
RATIONALE: Surgery to remove the tumor may be an effective treatment for rectal cancer. It is not yet known whether one type of surgery is more effective than another for rectal cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of two types of surgery in treating patients who have rectal cancer.
详细描述
OBJECTIVES:
- Compare local and distant recurrences in patients with mid-rectal cancer treated with wide mesorectal surgical excision with straight colorectal anastomosis versus total mesorectal surgical excision with colonic J pouch coloanal anastomosis.
- Compare the functional, physiological, and anatomical outcomes in these patients treated with these two surgical procedures.
- Compare disease-free survival and overall survival in these patients treated with these two surgical procedures.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to treatment center. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo surgical resection with a wide mesorectal excision followed by a straight colorectal anastomosis.
- Arm II: Patients undergo surgical resection with a total mesorectal excision followed by a colonic J pouch coloanal anastomosis. Patients then receive a temporary ileostomy which is closed 6 weeks later.
Patients are followed at 6 weeks, every 4-6 months for 2 years, every 6 months for 2 years, and then annually thereafter.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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
- •DISEASE CHARACTERISTICS:
- •Clinical diagnosis of rectal cancer by colonoscopy or barium enema
- •Distal margin of tumor arises within 9-15 cm from the anal verge as measured by rigid sigmoidoscopy
- •No synchronous multiple adenocarcinomas
- •Candidate for low anterior surgical resection by laparoscopy or conventional open method
- •No evidence of gross metastatic disease
- •No evidence of peritoneal or pelvic metastases
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Not specified
- •Life expectancy:
- •At least 6 months
- •Hematopoietic:
- •Not specified
- •Not specified
- •Not specified
- •No other malignancy within the past 5 years
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •Neoadjuvant or adjuvant chemoradiotherapy allowed
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •See Chemotherapy
- •See Disease Characteristics
排除标准
- 未提供
结局指标
主要结局
Local recurrence at 3 years
次要结局
- Disease-free and overall survival at 5 years
研究者
研究点 (4)
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