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Radiation Therapy, Amifostine, and Chemotherapy in Treating Young Patients With Newly Diagnosed Nasopharyngeal Cancer
Not Recruiting
Trial ID: NCT00274937
Purpose
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.
Official Title
Treatment of Childhood Nasopharyngeal Carcinoma With Neoadjuvant Chemotherapy and Concomitant Chemoradiotherapy: A Groupwide Phase III Study
Stanford Investigator(s)
Eligibility
Inclusion Criteria:
- 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
Intervention(s):
radiation: radiation therapy
drug: cisplatin
drug: fluorouracil
other: laboratory biomarker analysis
drug: Amifostine
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Peds Hem/Onc CRAs
650-723-5535