NCT01586117Unknown2 期
A Phase II Study of Amifostine for the Prevention of Acute Radiation-Induced Rectal Toxicity
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Acute radiation-induced toxicity: daily diarrhea frequency
研究概览
简要总结
The purpose of this study is to evaluate the effect of intrarectal Amifostine administration on acute radiation-induced rectal toxicity in pre-operative chemo-radiotherapy.
详细描述
To evaluate the different use way of intrarectal Amifostine administration on acute radiation-induced rectal toxicity in pre-operative chemo-radiotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •pathologically confirmed rectal cancer, preoperative stage II / III (T3-4N0 or T1-4N + M0).
- •tumor distance from anus less than 12 cm.
- •KPS score not less than 70
- •can be tolerated chemotherapy and radiotherapy.
- •pelvic who had no history of radiation therapy.
- •Non-allergic history of fluorouracil or platinum-based chemotherapy drugs.
- •blood pressure can be controlled by drugs in the normal range (90 ≤ systolic blood pressure ≤ 140,60 ≤ diastolic blood pressure ≤ 90).
- •a full understanding of the study, the ability to complete all of the treatment plan, follow up the conditions and sign the informed consent.
排除标准
- •other malignancy (past or at the same time), does not include curable non-melanoma skin cancer and cervical carcinoma in situ; does not include resectable primary colon cancer (synchronous or metachronous).
- •pregnant or lactating patients.
- •fertility but did not use contraceptive measures.
- •existing active infection.
- •merge serious complications, can not tolerate the treatment, such as 6 months of myocardial infarction, mental illness, uncontrollable diabetes or uncontrollable hypertension or hypotension.
- •concurrent treatment with other anticancer drugs.
- •can not complete treatment or follow-up.
研究组 & 干预措施
Amifostine
Experimental
intrarectal Amifostine assign to the Amifostine arm
干预措施: Amifostine (Drug)
结局指标
主要结局
Acute radiation-induced toxicity: daily diarrhea frequency
时间窗: about 3 months from chemo-raditherapy to operation
次要结局
未报告次要终点
研究者
Jing Jin, M.D.
M.D. Cancer Hospital, CAMS
Chinese Academy of Medical Sciences
研究点 (1)
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