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

Rectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01586117
• Other study ID #: CH-GI-022
• Status: Recruiting
• Phase: Phase 2
• First received: April 22, 2012
• Last updated: August 14, 2013
• Start date: February 2012
• Est. completion date: December 2014

Study information

• Verified date: August 2013
• Source: Chinese Academy of Medical Sciences
• Contact: Ning Li, MD
• Phone: 86-13810381399
• Email: lee_ak[@]163.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Rectal Cancer

Intervention

Drug:
• Amifostine
intrarectal Amifostine administration 1500mg QD x 5 weeks

Locations

Country	Name	City	State
China	Radiation Oncology Depratment, Cancer Hospital, CAMS	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute radiation-induced toxicity: daily diarrhea frequency		about 3 months from chemo-raditherapy to operation	No