A Phase II Study of Amifostine for the Prevention of Acute Radiation-Induced Rectal Toxicity

This study is currently recruiting participants. (see Contacts and Locations)
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
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

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 July 20, 2014