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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 HospitalSarasota, Florida  34239
Cooper University HospitalCamden, New Jersey  08103
Long Island Jewish Medical CenterNew Hyde Park, New York  11040
Valley Medical CenterRenton, Washington  98055
Florida Community Cancer CenterHudson, Florida  34667
Charleston Cancer CenterCharleston, South Carolina  29406
University of KentuckyLexington, Kentucky  40536-0098
Chesapeake Oncology-Hematology AssociatesBaltimore, Maryland  21225
Center for Cancer & Blood DisordersBethesda, Maryland  20817
Cedars SanaiLos Angeles, California  90048
Radiation Oncology CenterSacramento, California  95816
The Center for Cancer CareTorrington, Connecticut  06790
Florida Wellcare AllianceInverness, Florida  34452
Ormand Memorial Cancer CenterOrmand Beach, Florida  32174
University Community Hospital-Center for Cancer CareTampa, Florida  33613
St. Agnes Health CareBaltimore, Maryland  21229
St. John's Medical ResearchSpringfield, Missouri  65807
Beth Israel HospitalNew York, New York  10003
Upstate NY Cancer R&E FoundationRochester, New York  14623
New Hanover RadiationWilmington, North Carolina  28401
Cancer Center of Upper Delaware ValleyMilford, Pennsylvania  18337
Montgomery Cancer CenterNorristown, Pennsylvania  19401
The Center for Radiation OncologyDanville, Virginia  24541
Providence Everett Medical CenterEverett, Washington  98201