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
Data Collection
Bronchial Neoplasms+15
+ Carcinoma, Bronchogenic
+ Carcinoma, Non-Small-Cell Lung
Prevention Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.130 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
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
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
Radiation Oncology Center
Sacramento, United StatesThe Center for Cancer Care
Torrington, United StatesFlorida Wellcare Alliance
Inverness, United States