Short-course Preoperative Chemoradiotherapy Followed by Delayed Operation for Locally Advanced Rectal Cancer: Phase II Multi-institutional Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 2
- 主要终点
- To evaluate the pathologic response
研究概览
简要总结
Concurrent chemoradiotherapy (CRT)
-
Radiotherapy 25 ㏉/5 fractions (start concomitantly at D1)
-
↓ ↓ ↓ ↓ ↓
-
Radical surgery 6 weeks after completion of chemoradiotherapy
-
↑ ↑ ↑ ↑ ↑ D1 - - - - - D5
-
5-Fluorouracil 400㎎/㎡/day + LV 20㎎/㎡/day IV bolus during the radiotherapy
详细描述
Radiotherapy using tomotherapy is delivered in 5 Gy daily fractions for a total of 25 Gy in 5 fractions.
A bolus injection of 5-fluorouracil (400 mg/m2/d)and leucovorin (20 mg/m2/d) is delivered concurrently on day 1-5 during radiotherapy.
Total mesorectal excision is performed within 6±2 weeks. The pathological response of downstaing is the study endpoint.
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 —（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
To evaluate the pathologic response
时间窗: After surgery with pathology data
downstaging(ypT0-2N0M0)rate
次要结局
- Tumor regression grade & MR volumetry(After surgery with pathology data for TRG, at the pretreatment work-up and 1-4 days befor surgery)
- Acute/ late toxicities(preoperative CCRT to 3 months after surgery)
研究者
DAE YONG KIM
Principal Investigator
National Cancer Center, Korea