A Phase II Study of Amifostine for the Prevention of Acute Radiation-Induced Rectal Toxicity

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase

Unknown

Phase 2

Conditions

Rectal Cancer

Treatments

Drug: Amifostine

Study type

Interventional

Funder types

Other

Identifiers

NCT01586117

CH-GI-022

Details and patient eligibility

About

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.

Full description

To evaluate the different use way of intrarectal Amifostine administration on acute radiation-induced rectal toxicity in pre-operative chemo-radiotherapy.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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.