CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 243 enrolled
Drug / intervention
filgrastim +4 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00003313
NCT00003313Phase 3Completed

A Phase III Randomized Study of Amifostine Mucosal Protection for Patients With Favorable Performance Inoperable Stage II-III A/B Non-Small Cell Lung Cancer (NSCLC) Receiving Sequential Induction and Concurrent Hyperfractionated Radiotherapy With Paclitaxel and Carboplatin

Radiation Therapy Oncology Group·interventional·Posted Nov 26, 2003·Updated Nov 21, 2014

In Brief

A Phase 3 clinical trial evaluating filgrastim, amifostine trihydrate, and 3 other interventions for Drug/Agent Toxicity by Tissue/Organ and 3 related conditions. Completed, enrolled 243 participants across 264 sites in 2 countries.

Detailed Summary

RATIONALE: Amifostine may be an effective treatment for the toxic side effects caused by radiation therapy and chemotherapy. It is not yet known whether chemotherapy and radiation therapy are more effective with or without amifostine for non-small cell lung cancer. PURPOSE: Randomized phase III trial to determine the effectiveness of amifostine in treating patients who have stage II or stage III non-small cell lung cancer that cannot be surgically removed and who are undergoing chemotherapy and radiation therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, United States

Timeline

Phase 3CompletedFinished
199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 26, 2003
Enrollment StartSep 1, 1998
Primary CompletionJul 1, 2002
Study CompletionJun 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 22.6 years ago

Interventions

filgrastimbiological

amifostine trihydratedrug

carboplatindrug

paclitaxeldrug

radiation therapyradiation