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
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Esophagitis, Pneumonitis, Non-Small Cell Lung Carcinoma
Both
Esophagitis, Pneumonitis, Non-Small Cell Lung Carcinoma
Trial Information
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
Inclusion Criteria
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)
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Outcome Measure:
- Acute radiochemotherapy-induced esophagitis will be assessed from the time of randomization through up to 3 months after completion of radiochemotherapy treatment.
Principal Investigator
Luz Hammershaimb, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
MedImmune LLC
Authority:
United States: Food and Drug Administration
Study ID:
MI-CP079
NCT ID:
NCT00081315
Start Date:
November 2003
Completion Date:
August 2006
Related Keywords:
- Esophagitis
- Pneumonitis
- Non-Small Cell Lung Carcinoma
- - Non-Small cell lung cancer
- Carcinoma
- Carcinoma, Non-Small-Cell Lung
- Esophagitis
- Lung Neoplasms
- Pneumonia
Name | Location |
|---|---|
| Sarasota Memorial Hospital | Sarasota, Florida 34239 |
| Cooper University Hospital | Camden, New Jersey 08103 |
| Long Island Jewish Medical Center | New Hyde Park, New York 11040 |
| Valley Medical Center | Renton, Washington 98055 |
| Florida Community Cancer Center | Hudson, Florida 34667 |
| Charleston Cancer Center | Charleston, South Carolina 29406 |
| University of Kentucky | Lexington, Kentucky 40536-0098 |
| Chesapeake Oncology-Hematology Associates | Baltimore, Maryland 21225 |
| Center for Cancer & Blood Disorders | Bethesda, Maryland 20817 |
| Cedars Sanai | Los Angeles, California 90048 |
| Radiation Oncology Center | Sacramento, California 95816 |
| The Center for Cancer Care | Torrington, Connecticut 06790 |
| Florida Wellcare Alliance | Inverness, Florida 34452 |
| Ormand Memorial Cancer Center | Ormand Beach, Florida 32174 |
| University Community Hospital-Center for Cancer Care | Tampa, Florida 33613 |
| St. Agnes Health Care | Baltimore, Maryland 21229 |
| St. John's Medical Research | Springfield, Missouri 65807 |
| Beth Israel Hospital | New York, New York 10003 |
| Upstate NY Cancer R&E Foundation | Rochester, New York 14623 |
| New Hanover Radiation | Wilmington, North Carolina 28401 |
| Cancer Center of Upper Delaware Valley | Milford, Pennsylvania 18337 |
| Montgomery Cancer Center | Norristown, Pennsylvania 19401 |
| The Center for Radiation Oncology | Danville, Virginia 24541 |
| Providence Everett Medical Center | Everett, Washington 98201 |
