A Phase II Study of Amifostine for the Prevention of Acute Radiation-Induced Rectal Toxicity
Primary Purpose
Rectal Cancer
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Amifostine
Sponsored by
About this trial
This is an interventional prevention trial for Rectal Cancer focused on measuring rectal cancer, amifostine, pre-operative chemo-radiation
Eligibility 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.
Sites / Locations
- Radiation Oncology Depratment, Cancer Hospital, CAMSRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Amifostine
Arm Description
intrarectal Amifostine assign to the Amifostine arm
Outcomes
Primary Outcome Measures
Acute radiation-induced toxicity: daily diarrhea frequency
Secondary Outcome Measures
Full Information
NCT ID
NCT01586117
First Posted
April 22, 2012
Last Updated
August 14, 2013
Sponsor
Chinese Academy of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01586117
Brief Title
A Phase II Study of Amifostine for the Prevention of Acute Radiation-Induced Rectal Toxicity
Official Title
A Phase II Study of Amifostine for the Prevention of Acute Radiation-Induced Rectal Toxicity
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Unknown status
Study Start Date
February 2012 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
December 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer
Keywords
rectal cancer, amifostine, pre-operative chemo-radiation
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Amifostine
Arm Type
Experimental
Arm Description
intrarectal Amifostine assign to the Amifostine arm
Intervention Type
Drug
Intervention Name(s)
Amifostine
Intervention Description
intrarectal Amifostine administration 1500mg QD x 5 weeks
Primary Outcome Measure Information:
Title
Acute radiation-induced toxicity: daily diarrhea frequency
Time Frame
about 3 months from chemo-raditherapy to operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ning Li, MD
Phone
86-13810381399
Email
lee_ak@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jing Jin, M.D
Organizational Affiliation
Chinese Acedemy of Medical Scinences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Radiation Oncology Depratment, Cancer Hospital, CAMS
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ning Li, MD
Phone
86-13810381399
Email
lee_ak@163.com
12. IPD Sharing Statement
Learn more about this trial
A Phase II Study of Amifostine for the Prevention of Acute Radiation-Induced Rectal Toxicity
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