NCT01431599Unknown2 期
Two Week-course Preoperative Chemoradiotherapy Followed by Delayed Operation for Rectal Cancer: Phase II Multicenter Clinical Trial (KROG 11-02)
适应症
干预措施
试验速览
- 阶段
- 2 期
- 入组人数
- 80
- 试验地点
- 3
- 主要终点
- downstaging effect of tumor
研究概览
简要总结
The purpose of this study is to evaluate the early clinical outcome of the short-course preoperative chemoradiotherapy, 33Gy/10 fx and delayed operation after chemoradiation, the investigators initiated the clinical trial of KROG 11-02.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •histologically confirmed adenocarcinoma
- •distal margin of the tumor located < 8 cm above the anal verge
- •cT3-4 or cN+ classification as determined by endorectal ultrasonography (EUS) and CT
- •patient older than age 18 years
- •Karnofsky performance score >= 70
排除标准
- •distant metastasis identified during staging workup
- •previous or concurrent malignancy
- •pregnant or breast-feeding women
- •impending rectal obstruction
- •familial adenomatous polyposis
研究组 & 干预措施
short-course
Experimental
干预措施: short-course radiation (Radiation)
结局指标
主要结局
downstaging effect of tumor
时间窗: an expected average of 6 weeks after chemoradiation
Comparison of clinical T staging and pathologic T staging example\> cT4 --\> pT1 after chemoradiation: down staging (+)
次要结局
- bladder and small bowel toxicity after chemoradiation(Participants will be followed for an expected average of 3 months after chemoradiation)
研究者
研究点 (3)
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