A Phase II Study of Amifostine for the Prevention of Acute Radiation-Induced Rectal Toxicity
Information source: Chinese Academy of Medical Sciences
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Rectal Cancer
Intervention: Amifostine (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Chinese Academy of Medical Sciences Official(s) and/or principal investigator(s): Jing Jin, M.D, Principal Investigator, Affiliation: Chinese Acedemy of Medical Scinences
Overall contact: Ning Li, MD, Phone: 86-13810381399, Email: lee_ak@163.com
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.
Clinical Details
Official title: A Phase II Study of Amifostine for the Prevention of Acute Radiation-Induced Rectal Toxicity
Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: Acute radiation-induced toxicity: daily diarrhea frequency
Detailed description:
To evaluate the different use way of intrarectal Amifostine administration on acute
radiation-induced rectal toxicity in pre-operative chemo-radiotherapy.
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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.
Locations and Contacts
Ning Li, MD, Phone: 86-13810381399, Email: lee_ak@163.com
Radiation Oncology Depratment, Cancer Hospital, CAMS, Beijing, Beijing 100021, China; Recruiting Ning Li, MD, Phone: 86-13810381399, Email: lee_ak@163.com
Additional Information
Starting date: February 2012
Last updated: August 14, 2013
|