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.
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Locations near you
Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Full eligibility criteria for NCT01586117
Ages eligible for Study
18 Years to 75 Years
Genders eligible for Study
Accepts Healthy Volunteers
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.
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.
All locations for NCT01586117
Radiation Oncology Depratment, Cancer Hospital, CAMS
Beijing, Beijing, China, 100021
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View full eligibility
Tris trial is registered with FDA with number: NCT01586117. The sponsor of the trial is Chinese Academy of Medical Sciences and it is looking for 40 volunteers for the current phase.
Official trial title: A Phase II Study of Amifostine for the Prevention of Acute Radiation-Induced Rectal Toxicity
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