A Phase Ⅱ Study of Pre-Operative Concurrent Chemoradiotherapy With Capecitabine Plus Irinotecan in Resectable Rectal Cancer.
试验速览
- 阶段
- 2 期
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Pathologic stage Tumor regression grade
研究概览
简要总结
This study is to evaluate the pathologic complete response rate to pre-operative concurrent chemoradiotherapy with capecitabine plus irinotecan in resectable rectal cancer
详细描述
This study is an open-label, single center, nonrandomized phase II study. Daily fractions of radiotherapy at 1.8 Gy to total of 45 Gy to tumor and draining lymph nodes and followed by a coned-down boost of 5.4 Gy to the tumor were delivered concurrently with chemotherapy.
Chemotherapy starts at day 1 of radiotherapy. Capecitabine is administered orally at a dose of 825 mg/m2 twice daily during weekdays (Monday to Friday) every week during radiotherapy. Irinotecan 40 mg/m2 is given intravenously once a week (D 1, 8, 15, 22 & 29).
Six ± 2 weeks after completion of chemoradiotherapy, curative surgery is performed.
Post-operative chemotherapy with capecitabine will be given to all patients 3-6 weeks after surgery. Capecitabine 1,250 mg/m2 twice daily on days 1-14 every 21 days will be administered for 18 weeks.
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
- 否
入选标准
- •Histologically confirmed adenocarcinoma of the rectum
- •Distal margin of tumor located from 0 to 8 cm from anal verge
- •Tumor must be clinically resectable by surgery and R0 resection must be most likely
- •ECOG performance status 0-2
- •No prior chemotherapy, radiotherapy to pelvis, and immunotherapy
- •Adequate organ functions
- •Patients must sign an informed consent
排除标准
- •Malignant disease of the rectum other than adenocarcinoma or arisen from chronic inflammatory bowel disease
- •Any unresected synchronous colon cancer
- •Any distant metastasis
- •Intestinal obstruction or impending obstruction, but decompressing colostomy is permitted
- •Any previous or concurrent malignancy other than non-melanoma skin cancer or in situ cancer of uterine cervix
- •Any other morbidity or situation with contraindication for chemoradiotherapy
- •Patients have history of significant gastric or small bowel resection, or malabsorption syndrome, or other lack of integrity of the upper gastrointestinal tract that may compromise the absorption of capecitabine
- •Pregnant or lactating women or patients of childbearing potential not practicing adequate contraception
结局指标
主要结局
Pathologic stage Tumor regression grade
时间窗: After operation
次要结局
- Toxicity(During chemoradiation)