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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00081315

Enrollment

130

Registered

2004-04-09

Start date

2003-11-30

Completion date

2006-08-31

Last updated

2007-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophagitis, Pneumonitis, Non-Small Cell Lung Carcinoma

Keywords

- Non-Small cell lung cancer

Brief 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.

Interventions

DRUGAmifostine

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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)

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026