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NCT00081315 · ClinicalTrials.gov registry record · Phase 2
Subcutaneous Amifostine (Ethyol®) in the Prevention of Radiochemotherapy-Induced Esophagitis and Pneumonitis in Patients With Unresectable Non-Small Cell Lung Cancer
A Phase 2 study of Non-Small-Cell Lung Carcinoma and Esophagitis, sponsored by MedImmune.
- Completed
- Registry status
- Phase 2
- Development phase
- 130
- Enrollment target
- 20
- Study locations
NCT00081315: Completed Phase 2 study of Non-Small-Cell Lung Carcinoma and Esophagitis, sponsored by MedImmune.
NCT00081315 is a Phase 2 study of Non-Small-Cell Lung Carcinoma and Esophagitis that has completed, run by MedImmune. The registered enrollment target is 130 participants, below the 231-participant average among 30 other Non-Small-Cell Lung Carcinoma trials with a reported enrollment target (44% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00081315, a Phase 2 study of Non-Small-Cell Lung Carcinoma and Esophagitis, has completed, sponsored by MedImmune.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 130 participants
- Enrollment target
- 20
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG Amifostine
Study Locations (20)
Florida
- Florida Wellcare Alliance - Inverness
- Florida Community Cancer Center - New Port Richey
- Ormand Memorial Cancer Center - Ormand Beach
- Sarasota Memorial Hospital - Sarasota
- University Community Hospital-Center for Cancer Care - Tampa
Maryland
- St. Agnes Health Care - Baltimore
- Center for Cancer & Blood Disorders - Bethesda
- Chesapeake Oncology-Hematology Associates - Glen Burnie
New York
- Long Island Jewish Medical Center - New Hyde Park
- Beth Israel Hospital - New York
- Upstate NY Cancer R&E Foundation - Rochester
California
- Cedars Sanai - Los Angeles
- Radiation Oncology Center - Sacramento
Pennsylvania
- Cancer Center of Upper Delaware Valley - Milford
- Montgomery Cancer Center - Norristown
Connecticut
- The Center for Cancer Care - Torrington
Kentucky
- University of Kentucky - Lexington
Missouri
- St. John's Medical Research - Springfield
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 130 participants |
| Start Date | 2003-11 |
| Est. Completion | 2006-08 |
| Phase | Phase 2 |
What the finished NCT00081315 record still lists
NCT00081315 is an interventional study that assigns participants to a tested intervention. The registered 130 participants enrollment target is mid-sized for trials with a published cap, below the 231-participant average among 30 other Non-Small-Cell Lung Carcinoma trials with a reported enrollment target (44% lower).
The record links to 3 conditions, with Non-Small-Cell Lung Carcinoma appearing as the primary indexed condition, and to 1 intervention - of which Amifostine is the first listed.
NCT00081315 names 20 study sites across 10 states, led by Florida, Maryland, New York.
Frequently Asked Questions
What is clinical trial NCT00081315 about?
NCT00081315 is a clinical study titled "Subcutaneous Amifostine (Ethyol®) in the Prevention of Radiochemotherapy-Induced Esophagitis and Pneumonitis in Patients With Unresectable Non-Small Cell Lung Cancer". 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.
What is the current status of trial NCT00081315?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 130 participants. The study started on 2003-11. Estimated completion is 2006-08.
What conditions does trial NCT00081315 study?
This clinical trial studies the following conditions: Non-Small-Cell Lung Carcinoma, Esophagitis, Pneumonitis.
What interventions are being tested in trial NCT00081315?
The interventions under investigation include: Amifostine (DRUG).
Who is sponsoring clinical trial NCT00081315?
This trial is sponsored by MedImmune, which has 210 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00081315 being conducted?
This trial has 20 study locations across California, Connecticut, Florida, Kentucky, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT00081315's enrollment target sits among peer trials
130 15th of 30 higher than 16 of 30 other Non-Small-Cell Lung Carcinoma trials
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