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

Phase 2
Completed
Conditions
Esophagitis
Pneumonitis
Non-Small Cell Lung Carcinoma
Registration Number
NCT00081315
Lead Sponsor
MedImmune LLC
Brief Summary

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

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
130
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
- 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
NameTimeMethod
- Acute radiochemotherapy-induced pneumonitis will be assessed until 6 months after the last dose of XRT.

Trial Locations

Locations (24)

St. Agnes Health Care

🇺🇸

Baltimore, Maryland, United States

Long Island Jewish Medical Center

🇺🇸

New Hyde Park, New York, United States

Center for Cancer & Blood Disorders

🇺🇸

Bethesda, Maryland, United States

Beth Israel Hospital

🇺🇸

New York, New York, United States

Montgomery Cancer Center

🇺🇸

Norristown, Pennsylvania, United States

Cedars Sanai

🇺🇸

Los Angeles, California, United States

Upstate NY Cancer R&E Foundation

🇺🇸

Rochester, New York, United States

New Hanover Radiation

🇺🇸

Wilmington, North Carolina, United States

Sarasota Memorial Hospital

🇺🇸

Sarasota, Florida, United States

Valley Medical Center

🇺🇸

Renton, Washington, United States

Radiation Oncology Center

🇺🇸

Sacramento, California, United States

Providence Everett Medical Center

🇺🇸

Everett, Washington, United States

The Center for Radiation Oncology

🇺🇸

Danville, Virginia, United States

University of Kentucky

🇺🇸

Lexington, Kentucky, United States

Cooper University Hospital

🇺🇸

Camden, New Jersey, United States

University Community Hospital-Center for Cancer Care

🇺🇸

Tampa, Florida, United States

Florida Community Cancer Center

🇺🇸

New Port Richey, Florida, United States

The Center for Cancer Care

🇺🇸

Torrington, Connecticut, United States

Ormand Memorial Cancer Center

🇺🇸

Ormand Beach, Florida, United States

Charleston Cancer Center

🇺🇸

Charleston, South Carolina, United States

Chesapeake Oncology-Hematology Associates

🇺🇸

Glen Burnie, Maryland, United States

St. John's Medical Research

🇺🇸

Springfield, Missouri, United States

Cancer Center of Upper Delaware Valley

🇺🇸

Milford, Pennsylvania, United States

Florida Wellcare Alliance

🇺🇸

Inverness, Florida, United States

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