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| Sponsor: | MedImmune LLC |
|---|---|
| Information provided by: | MedImmune LLC |
| ClinicalTrials.gov Identifier: | NCT00081315 |
Purpose
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 |
Eligibility| 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:
Contacts and Locations| 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 |
More Information
| Study ID Numbers: | MI-CP079 |
| Study First Received: | April 7, 2004 |
| Last Updated: | August 20, 2007 |
| ClinicalTrials.gov Identifier: | NCT00081315 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
- Non-Small cell lung cancer |
|
Thoracic Neoplasms Respiratory Tract Neoplasms Radiation-Protective Agents Neoplasms by Histologic Type Amifostine Gastrointestinal Diseases Physiological Effects of Drugs Protective Agents Pharmacologic Actions Carcinoma Esophagitis Neoplasms |
Digestive System Diseases Neoplasms by Site Respiratory Tract Infections Respiratory Tract Diseases Lung Neoplasms Lung Diseases Esophageal Diseases Gastroenteritis Carcinoma, Non-Small-Cell Lung Pneumonia Neoplasms, Glandular and Epithelial |
