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Sponsored by: |
MedImmune LLC |
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Information provided by: | MedImmune LLC |
ClinicalTrials.gov Identifier: | NCT00081315 |
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.
Condition | Intervention | Phase |
---|---|---|
Esophagitis Pneumonitis Non-Small Cell Lung Carcinoma |
Drug: Amifostine |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Active Control, Single Group Assignment |
Official Title: | 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 |
Estimated Enrollment: | 130 |
Study Start Date: | November 2003 |
Study Completion Date: | August 2006 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
You may be eligible for this study if you are 18 years of age or older and:
United States, California | |
Radiation Oncology Center | |
Sacramento, California, United States, 95816 | |
Cedars Sanai | |
Los Angeles, California, United States, 90048 | |
United States, Connecticut | |
The Center for Cancer Care | |
Torrington, Connecticut, United States, 06790 | |
United States, Florida | |
Ormand Memorial Cancer Center | |
Ormand Beach, Florida, United States, 32174 | |
Sarasota Memorial Hospital | |
Sarasota, Florida, United States, 34239 | |
Florida Wellcare Alliance | |
Inverness, Florida, United States, 34452 | |
Florida Community Cancer Center | |
New Port Richey, Florida, United States, 34652 | |
University Community Hospital-Center for Cancer Care | |
Tampa, Florida, United States, 33613 | |
United States, Kentucky | |
University of Kentucky | |
Lexington, Kentucky, United States, 40536-0293 | |
United States, Maryland | |
Center for Cancer & Blood Disorders | |
Bethesda, Maryland, United States, 20817 | |
St. Agnes Health Care | |
Baltimore, Maryland, United States, 21229 | |
Chesapeake Oncology-Hematology Associates | |
Glen Burnie, Maryland, United States, 21061 | |
United States, Missouri | |
St. John's Medical Research | |
Springfield, Missouri, United States, 65807 | |
United States, New Jersey | |
Cooper University Hospital | |
Camden, New Jersey, United States, 08103 | |
United States, New York | |
Upstate NY Cancer R&E Foundation | |
Rochester, New York, United States, 14623 | |
Long Island Jewish Medical Center | |
New Hyde Park, New York, United States, 11040 | |
Beth Israel Hospital | |
New York, New York, United States, 10003 | |
United States, North Carolina | |
New Hanover Radiation | |
Wilmington, North Carolina, United States, 28401 | |
United States, Pennsylvania | |
Cancer Center of Upper Delaware Valley | |
Milford, Pennsylvania, United States, 18337 | |
Montgomery Cancer Center | |
Norristown, Pennsylvania, United States, 19401 | |
United States, South Carolina | |
Charleston Cancer Center | |
Charleston, South Carolina, United States, 29406 | |
United States, Virginia | |
The Center for Radiation Oncology | |
Danville, Virginia, United States, 24541 | |
United States, Washington | |
Valley Medical Center | |
Renton, Washington, United States, 98055 | |
Providence Everett Medical Center | |
Everett, Washington, United States, 98201 |
Principal Investigator: | Luz Hammershaimb, M.D. | MedImmune LLC |
Study ID Numbers: | MI-CP079 |
Study First Received: | April 7, 2004 |
Last Updated: | August 20, 2007 |
ClinicalTrials.gov Identifier: | NCT00081315 |
Health Authority: | United States: Food and Drug Administration |
- Non-Small cell lung cancer |
Thoracic Neoplasms Non-small cell lung cancer Amifostine Esophageal disorder Gastrointestinal Diseases Carcinoma Esophagitis Digestive System Diseases Respiratory Tract Infections |
Respiratory Tract Diseases Lung Neoplasms Lung Diseases Esophageal Diseases Gastroenteritis Carcinoma, Non-Small-Cell Lung Pneumonia Neoplasms, Glandular and Epithelial |
Respiratory Tract Neoplasms Radiation-Protective Agents Neoplasms Neoplasms by Site |
Neoplasms by Histologic Type Physiological Effects of Drugs Protective Agents Pharmacologic Actions |