A Phase II Study of Amifostine for the Prevention of Acute Radiation-Induced Rectal Toxicity
NCT ID: NCT01586117
Last Updated: 2013-08-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
40 participants
INTERVENTIONAL
2012-02-29
2014-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Amifostine
intrarectal Amifostine assign to the Amifostine arm
Amifostine
intrarectal Amifostine administration 1500mg QD x 5 weeks
Interventions
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Amifostine
intrarectal Amifostine administration 1500mg QD x 5 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Chinese Academy of Medical Sciences
OTHER
Responsible Party
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Jing Jin, M.D.
M.D. Cancer Hospital, CAMS
Principal Investigators
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Jing Jin, M.D
Role: PRINCIPAL_INVESTIGATOR
Chinese Acedemy of Medical Scinences
Locations
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Radiation Oncology Depratment, Cancer Hospital, CAMS
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Ning Li, MD
Role: primary
Other Identifiers
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CH-GI-022
Identifier Type: -
Identifier Source: org_study_id