A Phase II Study of Amifostine for the Prevention of Acute Radiation-Induced Rectal Toxicity
Verified August 2013 by Chinese Academy of Medical Sciences
Information provided by (Responsible Party):
Jing Jin, M.D., Chinese Academy of Medical Sciences
First received: April 22, 2012
Last updated: August 14, 2013
Last verified: August 2013
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.
||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
||A Phase II Study of Amifostine for the Prevention of Acute Radiation-Induced Rectal Toxicity
Primary Outcome Measures:
- Acute radiation-induced toxicity: daily diarrhea frequency [ Time Frame: about 3 months from chemo-raditherapy to operation ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2013 (Final data collection date for primary outcome measure)
intrarectal Amifostine assign to the Amifostine arm
intrarectal Amifostine administration 1500mg QD x 5 weeks
To evaluate the different use way of intrarectal Amifostine administration on acute radiation-induced rectal toxicity in pre-operative chemo-radiotherapy.
|Ages Eligible for Study:
||18 Years to 75 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01586117
|Radiation Oncology Depratment, Cancer Hospital, CAMS
|Beijing, Beijing, China, 100021 |
|Contact: Ning Li, MD 86-13810381399 email@example.com |
Chinese Academy of Medical Sciences
||Jing Jin, M.D
||Chinese Acedemy of Medical Scinences
No publications provided
||Jing Jin, M.D., M.D. Cancer Hospital, CAMS, Chinese Academy of Medical Sciences
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 22, 2012
||August 14, 2013
||China: Ministry of Health
Keywords provided by Chinese Academy of Medical Sciences:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 01, 2014
Physiological Effects of Drugs