Multicenter Phase II Study of Short Course Radiotherapy Followed by Intensive Chemotherapy With Delayed Surgery for Rectal Cancer With Synchronous Distant Metastasis
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- R0 resection rate
研究概览
简要总结
Radical treatment of primary rectal cancer with synchronous distant metastases includes surgical resection of primary and metastatic lesion. However, primary rectal cancer in case of metastasized disease are often locally advanced disease and need downsizing before surgery. It is reported that pelvic recurrence rates and distant metastasis rates outside liver are 30~35% and 60%, respectively. Therefore, combined treatment with radiotherapy and chemotherapy is used. However, the sequence of treatment modalities is not yet definitely established and preoperative chemoradiotherapy and surgical resection is accepted as an option of treatment. Conventional long course chemoradiotherapy delays administration of full-dose chemotherapy, and metastatic lesion can be progressed during chemoradiotherapy. In present study, we evaluate the efficacy of short course radiotherapy (SCRT) followed by full-dose chemotherapy with delayed surgical resection of the primary tumor and metastases.
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
- •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 function.
- •Over 18 years
- •Eastern Cooperative Oncology Group performance status 0-2
- •Proper organ function (Hemoglobin ≥ 10 g/dl, Absolute neutrophil count (ANC) ≥ 1,500/mm3, Platelet ≥ 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 (Aspartate aminotransferase/Alanine transaminase/Alkaline phosphatase) ≤ 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
研究组 & 干预措施
SCRT/ChemoTx with Delayed Surgery
Short course radiotherapy (25 Gy in 5 fractions) followed by intensive chemotherapy, compromising of FOLFOX of FOLFIRI (+-Bevacizumab or Cetuximab), with delayed surgery for rectal cancer with synchronous distant metastasis
干预措施: Short Course Radiotherapy (Radiation)
SCRT/ChemoTx with Delayed Surgery
Short course radiotherapy (25 Gy in 5 fractions) followed by intensive chemotherapy, compromising of FOLFOX of FOLFIRI (+-Bevacizumab or Cetuximab), with delayed surgery for rectal cancer with synchronous distant metastasis
干预措施: Chemotherapy (Drug)
SCRT/ChemoTx with Delayed Surgery
Short course radiotherapy (25 Gy in 5 fractions) followed by intensive chemotherapy, compromising of FOLFOX of FOLFIRI (+-Bevacizumab or Cetuximab), with delayed surgery for rectal cancer with synchronous distant metastasis
干预措施: Delayed Surgery (Procedure)
结局指标
主要结局
R0 resection rate
时间窗: Expected average of 12 weeks (after resection)
R0 resection rate of primary and metastatic lesions
次要结局
- Overall survival rate(2 years)
- Progression free survival rate(2 years)
- Tumor regression grade(Just after resection & pathologic report)
- Toxicity(1 year)
研究者
Sun Mi Moon
Korea Cancer Center Hospital
Korea Cancer Center Hospital