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

NCT00274937 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 111

Last updated 2022-10-25

Study results available
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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.

Conditions

  • 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
  • Stage II Nasopharyngeal Undifferentiated Carcinoma AJCC v7
  • Stage III Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7
  • Stage III Nasopharyngeal Undifferentiated Carcinoma AJCC v7
  • Stage IV Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7
  • Stage IV Nasopharyngeal Undifferentiated Carcinoma AJCC v7

Interventions

DRUG

Amifostine

Given subcutaneously

DRUG

Cisplatin

Given IV

DRUG

Fluorouracil

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

RADIATION

Radiation Therapy

Undergo radiotherapy

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Children's Oncology Group

    lead NETWORK

Principal Investigators

  • Carlos Rodriguez-Galindo · Children's Oncology Group

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-02-20
Primary Completion
2014-12-31
Completion
2022-09-30

Countries

  • United States
  • Australia
  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00274937 on ClinicalTrials.gov