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

Completed · Phase 3

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT00274937

Run by

Children's Oncology Group

People needed

111

Starts

2006-02-20

Expected to finish

2022-09-30

Last updated by the study team

2022-10-25

Who can join

Age: any, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histological diagnosis of nasopharyngeal carcinoma WHO type II or III
• Stage I-IV disease
• Newly diagnosed disease
• Performance status
• Patients ≤ 16 years of age: Lansky 60-100%
• Patients > 16 years of age: Karnofsky 60-100%
• Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min
• Creatinine based on age/gender as follows:
• No greater than 0.4 mg/dL (for patients 1 month to < 6 months of age)
• No greater than 0.5 mg/dL (for patients 6 months to < 1 year of age)
• No greater than 0.6 mg/dL (for patients 1-2 years of age)
• No greater than 0.8 mg/dL (for patients < 6 years of age)
• No greater than 1.0mg/dL (for patients 6 to < 10 years of age)
• No greater than 1.2 mg/dL (for patients 10 to < 13 years of age)
• No greater than 1.4 mg/dL (for female patients 13 to ≥ 16 years of age)
• No greater than 1.5 mg/dL (for male patients 13 to < 16 years of age)
• No greater than 1.7 mg/dL (for male patients ≥ 16 years of age)
• Bilirubin ≤ 1.5 times upper limit of normal (ULN) for age
• AST or ALT < 2.5 times ULN for age
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No prior chemotherapy or radiotherapy to the nasopharynx or neck for the treatment of nasopharyngeal carcinoma

Where it is running

• University of Alabama at Birmingham Cancer Center — Birmingham, Alabama, United States
• Banner University Medical Center - Tucson — Tucson, Arizona, United States
• Arkansas Children's Hospital — Little Rock, Arkansas, United States
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• Kaiser Permanente Downey Medical Center — Downey, California, United States
• Children's Hospital Los Angeles — Los Angeles, California, United States
• Mattel Children's Hospital UCLA — Los Angeles, California, United States
• UCLA / Jonsson Comprehensive Cancer Center — Los Angeles, California, United States
• Valley Children's Hospital — Madera, California, United States
• Kaiser Permanente-Oakland — Oakland, California, United States
• Lucile Packard Children's Hospital Stanford University — Palo Alto, California, United States
• UCSF Medical Center-Mount Zion — San Francisco, California, United States
• UCSF Medical Center-Parnassus — San Francisco, California, United States
• UCSF Medical Center-Mission Bay — San Francisco, California, United States
• Children's Hospital Colorado — Aurora, Colorado, United States
• University of Connecticut — Farmington, Connecticut, United States
• Connecticut Children's Medical Center — Hartford, Connecticut, United States
• MedStar Georgetown University Hospital — Washington D.C., District of Columbia, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• Lee Memorial Health System — Fort Myers, Florida, United States
• Memorial Regional Hospital/Joe DiMaggio Children's Hospital — Hollywood, Florida, United States
• Nemours Children's Clinic-Jacksonville — Jacksonville, Florida, United States
• University of Miami Miller School of Medicine-Sylvester Cancer Center — Miami, Florida, United States
• Nicklaus Children's Hospital — Miami, Florida, United States
• Children's Hospital of Alabama — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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