Non-Small Cell Lung Carcinoma Clinical Trial
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
| Verified date | August 2007 |
| Source | MedImmune LLC |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 130 |
| Est. completion date | August 2006 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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) |
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| United States | St. Agnes Health Care | Baltimore | Maryland |
| United States | Center for Cancer & Blood Disorders | Bethesda | Maryland |
| United States | Cooper University Hospital | Camden | New Jersey |
| United States | Charleston Cancer Center | Charleston | South Carolina |
| United States | The Center for Radiation Oncology | Danville | Virginia |
| United States | Providence Everett Medical Center | Everett | Washington |
| United States | Chesapeake Oncology-Hematology Associates | Glen Burnie | Maryland |
| United States | Florida Wellcare Alliance | Inverness | Florida |
| United States | University of Kentucky | Lexington | Kentucky |
| United States | Cedars Sanai | Los Angeles | California |
| United States | Cancer Center of Upper Delaware Valley | Milford | Pennsylvania |
| United States | Long Island Jewish Medical Center | New Hyde Park | New York |
| United States | Florida Community Cancer Center | New Port Richey | Florida |
| United States | Beth Israel Hospital | New York | New York |
| United States | Montgomery Cancer Center | Norristown | Pennsylvania |
| United States | Ormand Memorial Cancer Center | Ormand Beach | Florida |
| United States | Valley Medical Center | Renton | Washington |
| United States | Upstate NY Cancer R&E Foundation | Rochester | New York |
| United States | Radiation Oncology Center | Sacramento | California |
| United States | Sarasota Memorial Hospital | Sarasota | Florida |
| United States | St. John's Medical Research | Springfield | Missouri |
| United States | University Community Hospital-Center for Cancer Care | Tampa | Florida |
| United States | The Center for Cancer Care | Torrington | Connecticut |
| United States | New Hanover Radiation | Wilmington | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| MedImmune LLC |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | - Acute radiochemotherapy-induced esophagitis will be assessed from the time of randomization through up to 3 months after completion of radiochemotherapy treatment. | |||
| Secondary | - Acute radiochemotherapy-induced pneumonitis will be assessed until 6 months after the last dose of XRT. |
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