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

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