Clinical trial NCT00081315: Subcutaneous Amifostine (Ethyol®) in the Prevention of Radiochemotherapy-Induced Esophagitis and Pneumonitis in Patients With Unresectable Non-Small Cell Lung Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Esophagitis
Pneumonitis
Non-Small Cell Lung Carcinoma
Keywords: - Non-Small cell lung cancer
Lead sponsor: MedImmune LLC
Sponsor class: INDUSTRY
First posted: 2004-04-09
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility 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)

Primary outcomes:
measure: - Acute radiochemotherapy-induced esophagitis will be assessed from the time of randomization through up to 3 months after completion of radiochemotherapy treatment.
Secondary outcomes:
measure: - Acute radiochemotherapy-induced pneumonitis will be assessed until 6 months after the last dose of XRT.
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars Sanai
state: California
city: Sacramento
country: United States
facility: Radiation Oncology Center
state: California
city: Torrington
country: United States
facility: The Center for Cancer Care
state: Connecticut
city: Inverness
country: United States
facility: Florida Wellcare Alliance
state: Florida
city: New Port Richey
country: United States
facility: Florida Community Cancer Center
state: Florida
city: Ormand Beach
country: United States
facility: Ormand Memorial Cancer Center
state: Florida
city: Sarasota
country: United States
facility: Sarasota Memorial Hospital
state: Florida
city: Tampa
country: United States
facility: University Community Hospital-Center for Cancer Care
state: Florida
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Baltimore
country: United States
facility: St. Agnes Health Care
state: Maryland
city: Bethesda
country: United States
facility: Center for Cancer & Blood Disorders
state: Maryland
city: Glen Burnie
country: United States
facility: Chesapeake Oncology-Hematology Associates
state: Maryland
city: Springfield
country: United States
facility: St. John's Medical Research
state: Missouri
city: Camden
country: United States
facility: Cooper University Hospital
state: New Jersey
city: New Hyde Park
country: United States
facility: Long Island Jewish Medical Center
state: New York
city: New York
country: United States
facility: Beth Israel Hospital
state: New York
city: Rochester
country: United States
facility: Upstate NY Cancer R&E Foundation
state: New York
city: Wilmington
country: United States
facility: New Hanover Radiation
state: North Carolina
city: Milford
country: United States
facility: Cancer Center of Upper Delaware Valley
state: Pennsylvania
city: Norristown
country: United States
facility: Montgomery Cancer Center
state: Pennsylvania
city: Charleston
country: United States
facility: Charleston Cancer Center
state: South Carolina
city: Danville
country: United States
facility: The Center for Radiation Oncology
state: Virginia
city: Everett
country: United States
facility: Providence Everett Medical Center
state: Washington
city: Renton
country: United States
facility: Valley Medical Center
state: Washington
Study officials:
affiliation: MedImmune LLC
name: Luz Hammershaimb, M.D.
role: PRINCIPAL_INVESTIGATOR
References: