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.

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Key information

Conditions

Esophagitis Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Digestive System Diseases Esophageal Diseases Gastroenteritis Gastrointestinal Diseases Infections Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Non-small Cell Lung Carcinoma Pneumonia Pneumonitis Respiratory Tract Diseases Respiratory Tract Infections Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cedars Sanai, Los Angeles, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Amifostine

Drug

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.

Sponsors and collaborators

Lead sponsor

MedImmune LLC

Industry

Registry information

Official study 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

Important dates

Study start: 2003
Study completion: 2006
First posted: Apr 9, 2004
Registry last updated: Aug 21, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed