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

NCT ID: NCT00081315

Last Updated: 2007-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-11-30

Study Completion Date

2006-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Esophagitis Pneumonitis Non-Small Cell Lung Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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Amifostine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MedImmune LLC

INDUSTRY

Sponsor Role lead

Principal Investigators

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Luz Hammershaimb, M.D.

Role: PRINCIPAL_INVESTIGATOR

MedImmune LLC

Locations

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Cedars Sanai

Los Angeles, California, United States

Site Status

Radiation Oncology Center

Sacramento, California, United States

Site Status

The Center for Cancer Care

Torrington, Connecticut, United States

Site Status

Florida Wellcare Alliance

Inverness, Florida, United States

Site Status

Florida Community Cancer Center

New Port Richey, Florida, United States

Site Status

Ormand Memorial Cancer Center

Ormand Beach, Florida, United States

Site Status

Sarasota Memorial Hospital

Sarasota, Florida, United States

Site Status

University Community Hospital-Center for Cancer Care

Tampa, Florida, United States

Site Status

University of Kentucky

Lexington, Kentucky, United States

Site Status

St. Agnes Health Care

Baltimore, Maryland, United States

Site Status

Center for Cancer & Blood Disorders

Bethesda, Maryland, United States

Site Status

Chesapeake Oncology-Hematology Associates

Glen Burnie, Maryland, United States

Site Status

St. John's Medical Research

Springfield, Missouri, United States

Site Status

Cooper University Hospital

Camden, New Jersey, United States

Site Status

Long Island Jewish Medical Center

New Hyde Park, New York, United States

Site Status

Beth Israel Hospital

New York, New York, United States

Site Status

Upstate NY Cancer R&E Foundation

Rochester, New York, United States

Site Status

New Hanover Radiation

Wilmington, North Carolina, United States

Site Status

Cancer Center of Upper Delaware Valley

Milford, Pennsylvania, United States

Site Status

Montgomery Cancer Center

Norristown, Pennsylvania, United States

Site Status

Charleston Cancer Center

Charleston, South Carolina, United States

Site Status

The Center for Radiation Oncology

Danville, Virginia, United States

Site Status

Providence Everett Medical Center

Everett, Washington, United States

Site Status

Valley Medical Center

Renton, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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MI-CP079

Identifier Type: -

Identifier Source: org_study_id