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NCT00274937 · ClinicalTrials.gov registry record · Phase 3

Radiation Therapy, Amifostine, and Chemotherapy in Treating Young Patients With Newly Diagnosed Nasopharyngeal Cancer

A Phase 3 study of Stage IV Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7 and Stage IV Nasopharyngeal Undifferentiated Carcinoma AJCC v7, sponsored by Children's Oncology Group.

Completed
Registry status
Phase 3
Development phase
111
Enrollment target
20
Study locations

NCT00274937: Completed Phase 3 study of Stage IV Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7 and Stage IV Nasopharyngeal Undifferentiated Carcinoma AJCC v7, sponsored by Children's Oncology Group.

NCT00274937 is a Phase 3 study of Stage IV Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7 and Stage IV Nasopharyngeal Undifferentiated Carcinoma AJCC v7 that has completed, run by Children's Oncology Group. The registered enrollment target is 111 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (86% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00274937, a Phase 3 study of Stage IV Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7 and Stage IV Nasopharyngeal Undifferentiated Carcinoma AJCC v7, has completed, sponsored by Children's Oncology Group.

COMPLETED
Registry status
Phase 3
Development phase
111 participants
Enrollment target
20
Study locations

Study 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.

Primary Outcome

The two-year event-free survival will be compared with a standard established from adult oncology data and the results of POG-9486. The two-year Kaplan-Meier estimate of event-free survival will be compared with 70% using a 1-sided test of size 0.05 using the asymptotic distribution of the complementary log-log distribution of the estimate.

Interventions

  • DRUG Cisplatin
  • DRUG Fluorouracil
  • OTHER Laboratory Biomarker Analysis
  • RADIATION Radiation Therapy
  • DRUG Amifostine

Study Locations (20)

California

  • Kaiser Permanente Downey Medical Center - Downey
  • Children's Hospital Los Angeles - Los Angeles
  • Mattel Children's Hospital UCLA - Los Angeles
  • UCLA / Jonsson Comprehensive Cancer Center - Los Angeles
  • Valley Children's Hospital - Madera
  • Kaiser Permanente-Oakland - Oakland
  • Lucile Packard Children's Hospital Stanford University - Palo Alto
  • UCSF Medical Center-Mount Zion - San Francisco
  • UCSF Medical Center-Parnassus - San Francisco
  • UCSF Medical Center-Mission Bay - San Francisco

Alabama

  • Children's Hospital of Alabama - Birmingham
  • University of Alabama at Birmingham Cancer Center - Birmingham

Arkansas

  • Arkansas Children's Hospital - Little Rock
  • University of Arkansas for Medical Sciences - Little Rock

Connecticut

  • University of Connecticut - Farmington
  • Connecticut Children's Medical Center - Hartford

District of Columbia

  • MedStar Georgetown University Hospital - Washington D.C.
  • Children's National Medical Center - Washington D.C.

Arizona

  • Banner University Medical Center - Tucson - Tucson

Colorado

  • Children's Hospital Colorado - Aurora

Trial Details

FieldValue
Enrollment Target 111 participants
Start Date 2006-02-20
Est. Completion 2022-09-30
Phase Phase 3
Children's Oncology Group

342 total trials

What the finished NCT00274937 record still lists

NCT00274937 is an interventional study that assigns participants to a tested intervention. The registered 111 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (86% lower).

The record links to 8 conditions, with Stage IV Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7 appearing as the primary indexed condition, and to 5 interventions - of which Cisplatin is the first listed.

NCT00274937 names 20 study sites across 7 states, led by California, Alabama, Arkansas.

Frequently Asked Questions

What is clinical trial NCT00274937 about?

NCT00274937 is a clinical study titled "Radiation Therapy, Amifostine, and Chemotherapy in Treating Young Patients With Newly Diagnosed Nasopharyngeal Cancer". 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 effec...

What is the current status of trial NCT00274937?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 111 participants. The study started on 2006-02-20. Estimated completion is 2022-09-30.

What conditions does trial NCT00274937 study?

This clinical trial studies the following conditions: Stage IV Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7, Stage IV Nasopharyngeal Undifferentiated Carcinoma AJCC v7, Stage I Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7, Stage I Nasopharyngeal Undifferentiated Carcinoma AJCC v7, Stage II Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7.

What interventions are being tested in trial NCT00274937?

The interventions under investigation include: Cisplatin (DRUG), Fluorouracil (DRUG), Laboratory Biomarker Analysis (OTHER), Radiation Therapy (RADIATION), Amifostine (DRUG).

Who is sponsoring clinical trial NCT00274937?

This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00274937 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Stage IV Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00274937's enrollment target sits among peer trials

111 1655th of 2000 higher than 344 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00274937, the US trial registry maintained by the National Library of Medicine. NCT00274937 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.