Subcutaneous Amifostine (Ethyol®) in the Prevention of Radiochemotherapy-Induced Esophagitis and Pneumonitis in Patients With Unresectable Non-Small Cell Lung Cancer

August 20, 2007 updated by: MedImmune LLC

Phase II, Randomized, Double-Blind, Multicenter Trial of Subcutaneous Amifostine (Ethyol®) Versus Placebo in the Prevention of Radiochemotherapy-Induced Esophagitis and Pneumonitis in Patients With Unresectable Non-Small Cell Lung Cancer

The primary objective of this study is to assess the activity of subcutaneous (SC) amifostine on the incidence and severity of acute radiochemotherapy-induced esophagitis in patients with unresectable Stage IIIA or IIIB non-small cell lung cancer (NSCLC) receiving combined modality therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

130

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 Locations

  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Cedars Sanai
      • Sacramento, California, United States, 95816
        • Radiation Oncology Center
    • Connecticut
      • Torrington, Connecticut, United States, 06790
        • The Center for Cancer Care
    • Florida
      • Inverness, Florida, United States, 34452
        • Florida Wellcare Alliance
      • New Port Richey, Florida, United States, 34652
        • Florida Community Cancer Center
      • Ormand Beach, Florida, United States, 32174
        • Ormand Memorial Cancer Center
      • Sarasota, Florida, United States, 34239
        • Sarasota Memorial Hospital
      • Tampa, Florida, United States, 33613
        • University Community Hospital-Center for Cancer Care
    • Kentucky
      • Lexington, Kentucky, United States, 40536-0293
        • University of Kentucky
    • Maryland
      • Baltimore, Maryland, United States, 21229
        • St. Agnes Health Care
      • Bethesda, Maryland, United States, 20817
        • Center for Cancer & Blood Disorders
      • Glen Burnie, Maryland, United States, 21061
        • Chesapeake Oncology-Hematology Associates
    • Missouri
      • Springfield, Missouri, United States, 65807
        • St. John's Medical Research
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Cooper University Hospital
    • New York
      • New Hyde Park, New York, United States, 11040
        • Long Island Jewish Medical Center
      • New York, New York, United States, 10003
        • Beth Israel Hospital
      • Rochester, New York, United States, 14623
        • Upstate NY Cancer R&E Foundation
    • North Carolina
      • Wilmington, North Carolina, United States, 28401
        • New Hanover Radiation
    • Pennsylvania
      • Milford, Pennsylvania, United States, 18337
        • Cancer Center of Upper Delaware Valley
      • Norristown, Pennsylvania, United States, 19401
        • Montgomery Cancer Center
    • South Carolina
      • Charleston, South Carolina, United States, 29406
        • Charleston Cancer Center
    • Virginia
      • Danville, Virginia, United States, 24541
        • The Center for Radiation Oncology
    • Washington
      • Everett, Washington, United States, 98201
        • Providence Everett Medical Center
      • Renton, Washington, United States, 98055
        • Valley Medical Center

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

You may be eligible for this study if you are 18 years of age or older and:

  • Have UnResectable Stage IIIA or IIIB Non Small Cell Lung Cancer
  • Have never had prior chemotherapy with Paclitaxel or Carboplatin
  • Have never had prior thoracic radiation therapy (XRT)

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: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
- Acute radiochemotherapy-induced esophagitis will be assessed from the time of randomization through up to 3 months after completion of radiochemotherapy treatment.

Secondary Outcome Measures

Outcome Measure
- Acute radiochemotherapy-induced pneumonitis will be assessed until 6 months after the last dose of XRT.

Collaborators and Investigators

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

Sponsor

MedImmune LLC

Investigators

  • Principal Investigator: Luz Hammershaimb, M.D., MedImmune LLC

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

November 1, 2003

Study Completion (ACTUAL)

August 1, 2006

Study Registration Dates

First Submitted

April 7, 2004

First Submitted That Met QC Criteria

April 8, 2004

First Posted (ESTIMATE)

April 9, 2004

Study Record Updates

Last Update Posted (ESTIMATE)

August 21, 2007

Last Update Submitted That Met QC Criteria

August 20, 2007

Last Verified

August 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MI-CP079

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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