A Phase II Study of Amifostine for the Prevention of Acute Radiation-Induced Rectal Toxicity
This study is currently recruiting participants.
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.
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 firstname.lastname@example.org |
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 December 08, 2013
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Physiological Effects of Drugs