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

August 14, 2013 updated by: Jing Jin, M.D., Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

To evaluate the different use way of intrarectal Amifostine administration on acute radiation-induced rectal toxicity in pre-operative chemo-radiotherapy.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Ning Li, MD
  • Phone Number: 86-13810381399
  • Email: lee_ak@163.com

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100021
        • Recruiting
        • Radiation Oncology Depratment, Cancer Hospital, CAMS
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Amifostine
intrarectal Amifostine assign to the Amifostine arm
Drug: Amifostine
intrarectal Amifostine administration 1500mg QD x 5 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Acute radiation-induced toxicity: daily diarrhea frequency
Time Frame: about 3 months from chemo-raditherapy to operation
about 3 months from chemo-raditherapy to operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Investigators

  • Principal Investigator: Jing Jin, M.D, Chinese Acedemy of Medical Scinences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Anticipated)

December 1, 2013

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

April 22, 2012

First Submitted That Met QC Criteria

April 24, 2012

First Posted (Estimate)

April 26, 2012

Study Record Updates

Last Update Posted (Estimate)

August 15, 2013

Last Update Submitted That Met QC Criteria

August 14, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CH-GI-022

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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