NCT02490709Unknown2 期
Local Excision of Clinical T3 Mid- or Low-Rectal Adenocarcinoma Showing Major Response(ycT0-1) After Neoadjuvant Chemoradiotherapy: Prospective Multicenter Single-arm Phase II Clinical Trial
适应症
试验速览
- 阶段
- 2 期
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- 3-year disease free survival
研究概览
简要总结
The purpose of this study is evaluation of the safety and the efficacy of transanal local excision in patients with cT3 rectal cancer which was downstaged into ycT0-1 after neoadjuvant chemoradiotherapy.
详细描述
This study is a prospective multicenter single-arm phase II clinical trial. Rectal cancer patients with cT3 stage will receive neoadjuvant chemoradiotherapy, and be evaluated the response of the tumor in 6 to 10 weeks after completion of neoadjuvant chemoradiotherapy. For those who have good response (ycT0-1) will underwent transanal local excision under the patients' agree.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age: more than 20 years
- •biopsy-proven adenocarcinoma of the rectum
- •clinical staging, cT3NxM0
- •Rectal cancer located 8 cm from the anal verge
- •Restaging in 6-10 weeks after completion of neoadjuvant chemoradiotherapy, ycT0-1N0M0
- •ECOG performance status 2 or less
排除标准
- •Synchronous colon cancer or other malignancy
- •Obstructing rectal cancer
- •Pregnant or breast-feeding
- •Receiving any other study agents
- •History of prior colorectal cancer or inflammatory bowel disease
- •Hereditary colorectal cancer (FAP, HNPCC)
结局指标
主要结局
3-year disease free survival
时间窗: 1-5 years
Death or recurrence as an event
次要结局
- Complete response rate(1-5 years)
- Overall survival rate(1-5 years)
研究者
Jae Hwan Oh
Director, Hospital
National Cancer Center, Korea
研究点 (2)
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