Subcutaneous Amifostine (Ethyol®) in the Prevention of Radiochemotherapy-Induced Esophagitis and Pneumonitis in Patients With Unresectable Non-Small Cell Lung Cancer

MedImmune LLC130 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

130

Conditions

Esophagitis Pneumonitis Non-Small Cell Lung Carcinoma

Interventions

AmifostineDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (24)

Cedars Sanai

Los Angeles, California, United States

Outcomes

Primary Outcomes

- Acute radiochemotherapy-induced esophagitis will be assessed from the time of randomization through up to 3 months after completion of radiochemotherapy treatment.

Secondary Outcomes

- Acute radiochemotherapy-induced pneumonitis will be assessed until 6 months after the last dose of XRT.

Data from ClinicalTrials.gov

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