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

Information source: Chinese Academy of Medical Sciences
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rectal Cancer

Intervention: Amifostine (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Chinese Academy of Medical Sciences

Official(s) and/or principal investigator(s):
Jing Jin, M.D, Principal Investigator, Affiliation: Chinese Acedemy of Medical Scinences

Overall contact:
Ning Li, MD, Phone: 86-13810381399, Email: lee_ak@163.com

Summary

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.

Clinical Details

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

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

Primary outcome: Acute radiation-induced toxicity: daily diarrhea frequency

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

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Ning Li, MD, Phone: 86-13810381399, Email: lee_ak@163.com

Radiation Oncology Depratment, Cancer Hospital, CAMS, Beijing, Beijing 100021, China; Recruiting
Ning Li, MD, Phone: 86-13810381399, Email: lee_ak@163.com
Additional Information

Starting date: February 2012
Last updated: August 14, 2013

Page last updated: August 20, 2015

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