Completed

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Data Collection

Who is being recruted

Bronchial Neoplasms+15

+ Carcinoma, Bronchogenic

+ Carcinoma, Non-Small-Cell Lung

Over 18 Years
See all eligibility criteria
How is the trial designed

Prevention Study

Phase 2
Interventional
Study Start: November 2003
See protocol details

Summary

Principal SponsorMedImmune LLC
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2003

Actual date on which the first participant was enrolled.

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.

Official TitlePhase 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 
NCT00081315
Principal SponsorMedImmune LLC
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

130 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bronchial NeoplasmsCarcinoma, BronchogenicCarcinoma, Non-Small-Cell LungDigestive System DiseasesEsophageal DiseasesEsophagitisGastroenteritisGastrointestinal DiseasesInfectionsLung DiseasesLung NeoplasmsNeoplasmsNeoplasms by SitePneumoniaRespiratory Tract DiseasesRespiratory Tract InfectionsRespiratory Tract NeoplasmsThoracic Neoplasms

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)

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 24 locations

Suspended

Cedars Sanai

Los Angeles, United StatesSee the location
Suspended

Radiation Oncology Center

Sacramento, United States
Suspended

The Center for Cancer Care

Torrington, United States
Suspended

Florida Wellcare Alliance

Inverness, United States
Completed24 Study Centers