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

Phase 2

• Conditions: Rectal Cancer
• Interventions: Drug: Amifostine

• Registration Number: NCT01586117
• Lead Sponsor: Chinese Academy of Medical Sciences

Brief 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.

Detailed Description

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

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-04-22
• Study First Submitted QC: 2012-04-24
• Study First Posted: 2012-04-26
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-14
• Last Update Posted: 2013-08-15
• Primary Completion: 2013-12
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Amifostine	Amifostine	intrarectal Amifostine assign to the Amifostine arm

Primary Outcome Measures

Name	Time	Method
Acute radiation-induced toxicity: daily diarrhea frequency	about 3 months from chemo-raditherapy to operation

Trial Locations

Locations (1)

Radiation Oncology Depratment, Cancer Hospital, CAMS; 🇨🇳 Beijing, Beijing, China