CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 111 enrolled
Drug / intervention
Amifostine +4 moredrug
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/NCT00274937
NCT00274937Phase 3Completed

Treatment of Childhood Nasopharyngeal Carcinoma With Neoadjuvant Chemotherapy and Concomitant Chemoradiotherapy: A Groupwide Phase III Study

Children's Oncology Group·interventional·Posted Jan 11, 2006·Updated Oct 25, 2022

In Brief

A Phase 3 clinical trial evaluating Amifostine, Cisplatin, and 3 other interventions for Stage I Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7 and 7 related conditions. Completed, enrolled 111 participants across 109 sites in 3 countries.

Detailed Summary

This phase III trial is studying how well radiation therapy, amifostine, and chemotherapy work in treating young patients with newly diagnosed nasopharyngeal cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs, such as amifostine, may protect normal cells from the side effects of radiation therapy. Drugs used in chemotherapy, such as cisplatin and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with amifostine and chemotherapy may kill more tumor cells.

Study Details

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 11, 2006
Enrollment StartFeb 20, 2006
Primary CompletionDec 31, 2014
Study CompletionSep 30, 2022
TodayJul 2, 2026
Enrollment to primary: 8.9 yearsPosted 20.5 years ago

Interventions

Amifostinedrug

Given subcutaneously

Cisplatindrug

Given IV

Fluorouracildrug

Given IV

Laboratory Biomarker Analysisother

Correlative studies

Radiation Therapyradiation

Undergo radiotherapy