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
Not Enrolling
Both
Esophagitis, Pneumonitis, Non-Small Cell Lung Carcinoma

Thank you

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