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

Phase 2
18 Years
75 Years
Open (Enrolling)
Rectal Cancer

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Trial Information

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

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

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.

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Acute radiation-induced toxicity: daily diarrhea frequency

Outcome Time Frame:

about 3 months from chemo-raditherapy to operation

Safety Issue:


Principal Investigator

Jing Jin, M.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

Chinese Acedemy of Medical Scinences


China: Ministry of Health

Study ID:




Start Date:

February 2012

Completion Date:

December 2014

Related Keywords:

  • Rectal Cancer
  • rectal cancer
  • amifostine
  • pre-operative chemo-radiation
  • Rectal Neoplasms