Radiation Therapy, Amifostine, and Chemotherapy in Treating Young Patients With Newly Diagnosed Nasopharyngeal Cancer
Condition: 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
MeSH terms: Carcinoma; Carcinoma, Squamous Cell
Intervention: Amifostine; Cisplatin; Fluorouracil; Laboratory Biomarker Analysis; Radiation Therapy
Intervention description: Given subcutaneously; Given IV; Given IV; Correlative studies; Undergo radiotherapy
Intervention MeSH terms: Cisplatin; Fluorouracil; Amifostine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 111.0
Sex: All
Maximum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        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