A Phase II Study of Amifostine for the Prevention of Acute Radiation-Induced Rectal Toxicity
This study is currently recruiting participants.
Verified April 2012 by Chinese Academy of Medical Sciences
Sponsor:
Chinese Academy of Medical Sciences
Information provided by (Responsible Party):
Jing Jin, M.D., Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01586117
First received: April 22, 2012
Last updated: April 24, 2012
Last verified: April 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Rectal Cancer |
Drug: Amifostine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | A Phase II Study of Amifostine for the Prevention of Acute Radiation-Induced Rectal Toxicity |
Resource links provided by NLM:
Further study details as provided by Chinese Academy of Medical Sciences:
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: | 40 |
| Study Start Date: | February 2012 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Amifostine
intrarectal Amifostine assign to the Amifostine arm
|
Drug: Amifostine
intrarectal Amifostine administration 1500mg QD x 5 weeks
|
Detailed Description:
To evaluate the different use way of intrarectal Amifostine administration on acute radiation-induced rectal toxicity in pre-operative chemo-radiotherapy.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01586117
Contacts
| Contact: Ning Li, MD | 86-13810381399 | lee_ak@163.com |
Locations
| China, Beijing | |
| Radiation Oncology Depratment, Cancer Hospital, CAMS | Recruiting |
| Beijing, Beijing, China, 100021 | |
| Contact: Ning Li, MD 86-13810381399 lee_ak@163.com | |
Sponsors and Collaborators
Chinese Academy of Medical Sciences
Investigators
| Principal Investigator: | Jing Jin, M.D | Chinese Acedemy of Medical Scinences |
More Information
No publications provided
| Responsible Party: | Jing Jin, M.D., M.D. Cancer Hospital, CAMS, Chinese Academy of Medical Sciences |
| ClinicalTrials.gov Identifier: | NCT01586117 History of Changes |
| Other Study ID Numbers: | CH-GI-022 |
| Study First Received: | April 22, 2012 |
| Last Updated: | April 24, 2012 |
| Health Authority: | China: Ministry of Health |
Keywords provided by Chinese Academy of Medical Sciences:
|
rectal cancer amifostine pre-operative chemo-radiation |
Additional relevant MeSH terms:
|
Rectal Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases |
Gastrointestinal Diseases Intestinal Diseases Rectal Diseases Amifostine Radiation-Protective Agents Protective Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013