KCT0000525招募中未知
Multicenter Phase II Study of Short Course Radiotherapy Followed by Intensive Chemotherapy With Delayed Surgery for Rectal Cancer With Synchronous Distant Metastasis
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 39
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 18(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •Pathologically confirmed adenocarcinoma of rectum
- •- Lower margin of tumor within 12 cm from anal verge
- •- Clinically locally advanced (T3-4 or N1-2) disease
- •- Potentially resectable and synchronous distant metastases in liver and/or lung
- •The resectability of metastatic lesions is determined by size, number, location, general condition, liver function, and lung funcion.
- •- Over 18 years
- •- ECOG 0-2
- •- Proper organ function (Hemoglobin = 10 g/dl, ANC = 1,500/mm3, Platent = 100,000/mm3, Creatinine = 1.5 mg/dl, Clearance of creatinine >50 ml/min using Cockcroft-Gault formula, Bilirubin = 1.5 x upper limit of normal (ULN), Liver enzyme (AST/ALT/ALP) = 2.5 x ULN)
- •- Subject who should sign on the informed consent form before participate the trial.
排除标准
- •- Metastases in other organ except liver or lung
- •- History of other type of malignancies within 3 years other than non-melanoma of the skin or carcinoma in situ of cervix
- •- Hereditary colorectal cancer (FAP, HNPCC, and etc)
- •- Bowel obstruction or impending bowel obstruction
- •- Uncontrolled severe illness, unsuitable to chemoradiotherapy (within 6 months, myocardial infarct, unstable angina, heart failure, uncontrolled arrhythmia, uncontrolled epilepsy, central nervous system disease, psychological disorder, and etc)
- •- Subject pregnant or breast feeding, or incapable of appropriate contraception
- •- Unresected synchronous colorectal cancer
- •- History of prior pelvic radiotherapy
- •- History of prior chemotherapy for colorectal cancer
- •- Great surgery within 4 week before study enrollment
- •- Participant in other trial within 4 week before study enrollment
研究者
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