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
Sponsor:
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: August 14, 2013
Last verified: August 2013
  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: December 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: August 14, 2013
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 April 17, 2014