NCT00309517终止3 期
A Prospectively Randomized Study on Neoadjuvant Radio-Chemotherapy in Patients With Operated Rectal Carcinoma Dukes B and C (pT2, pN1-3; pT3-4, pN0-3; M0.
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 700
- 试验地点
- 16
- 主要终点
- Local recurrence-free survival
研究概览
简要总结
This clinical investigation examined the influence of preoperative radiotherapy in combination with postoperative 5-fluorouracil + leucovorin chemotherapy vs. 5-fluorouracil + leucovorin + MAb 17-1A chemo-immunotherapy on patients' local recurrence rate and overall survival time following surgery for rectal carcinoma Dukes B or C (T2-4, N0-3, M0).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically verified operable rectal cancer Dukes B and C (Stage II, T2-4, N0-3, M0), R0
- •Age: 18-80 years
- •Karnofsky Performance Status > 80
- •Adequate bone marrow reserve (leukocytes > 4,000, thrombocytes > 105/mm3, Hb > 10g %), renal and hepatic functions (total bilirubin and creatinine < 1.25 x ULN)
排除标准
- •Colon cancer
- •R1, R2; carcinosis peritonei
- •Start of treatment > 42 days postop; other adjuvant radiotherapy, chemotherapy or immunotherapy
- •Previous application of a murine or chimeric monoclonal antibody or antibody fragment
- •Medical therapy with steroids, cyclosporin or antithymocyte globulin within 3 months pre-study
- •Known hypersensitivity to animal protein
- •Serious concomitant disease: HIV, chronically inflammatory intestine, diabetes mell. gravis, cerebral seizure disorder, et al.
- •Pregnancy or lactation
结局指标
主要结局
Local recurrence-free survival
Overall survival
次要结局
未报告次要终点
研究者
研究点 (16)
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