Maintenance of Chemotherapy Following Neoadjuvant Chemoradiation Therapy for Distal Rectal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- To assess the complete clinical response rate following neoadjuvant chemoradiation in patients with distal rectal cancer.
研究概览
简要总结
This study will assess the complete clinical response (no clinical evidence of remaining disease or recurrence of disease)in rectal cancer that arises within 3 inches of the anal opening after radiation therapy given at the same time as chemotherapy over a 6 week period, followed by chemotherapy alone given three times over an additional 9 weeks. Follow-up begins with an examination at the end of treatment (at 15 weeks), with ongoing follow-up every 4-6 weeks for one year.
详细描述
Research has shown that low rectal cancer treated with neoadjuvant chemoradiation (54Gy concurrent with 3 cycles of 5-FU/Leucovorin) followed by 3 additional cycles of 5FU/Leucovorin, followed by close follow-up (every 4-6 weeks for one year)has had good success in achieving complete clinical response, avoiding surgical intervention. If at follow-up remaining disease is found or if there is recurrent disease, surgery can be performed.
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
- •over 18 years old
- •tumor potentially resectable en bloc; tumors tethered or fixed to a structure that can be removed
- •clinical/radiological stages T2,T3,or T4, N0-1
- •ANC >1500, PLT>100,000
- •AST and alkaline phosphatase < 2.5 X ULN
- •bilirubin < 1.5 X ULN
- •CrCl > 50 ml/min using Cockcroft-Gault formula
- •ECOG Performance Scale 0-2
- •No malignancies within previous 5 years other than non-melanoma skin cancer, in-situ cervical cancer, in-situ ductal breast cancer
- •no evidence of metastatic disease
排除标准
- •initial tumor fixation to pelvic bone or side wide; technically unresectable disease
- •any evidence of distant metastasis
- •perforation
- •obstruction
- •hereditary non-polyposis colorectal cancer
- •synchronous primary colon carcinomas except T1 lesions
- •known dihydropyrimidine dehydrogenase deficiency
- •prior radiation therapy to the pelvis
- •prior chemotherapy for malignancies
- •known existing uncontrolled coagulopathy
- •pregnancy or lactation
- •women of childbearing potential not using reliable and appropriate contraceptive method
- •serious, uncontrolled concurrent infection(s)
- •participation in any investigational drug study within 4 weeks preceding the start of study treatment
- •clinically significant heart disease
- •other serious uncontrolled medical conditions that might compromise study participation (in the investigator's opinion)
- •major surgery within 4 weeks prior to the study treatment
- •lack of physical integrity of the upper GI tract or malabsorption syndrome
研究组 & 干预措施
5FU/Leucovorin- post distal rectal srgy
Assess complete clinical response rate following neoadjuvant chemoradiation in patients with distal rectal cancer
干预措施: 5FU/Leucovorin (Drug)
结局指标
主要结局
To assess the complete clinical response rate following neoadjuvant chemoradiation in patients with distal rectal cancer.
时间窗: One year from the time of chemoradiation
Primary endpoints are the proportion of subjects with complete clinical response to chemoradiation therapy at no sooner than 9 weeks from treatment completion, and maintenance of continuous freedom from local failure for one year.
次要结局
- The proportion of subjects with complete pathological response at surgical resection(One year from chemoradiation therapy)