Radiation Therapy With or Without Chemotherapy in Reducing Mouth Dryness in Patients With Nasopharyngeal Cancer
Condition: Head and Neck Cancer; Oral Complications of Radiation Therapy; Radiation Toxicity
MeSH terms: Nasopharyngeal Neoplasms; Nasopharyngeal Carcinoma
Intervention: cisplatin; fluorouracil; Intensity modulated radiation therapy
Intervention description: 100 mg/m^2 intravenously on days 1, 22, and 43 and 80 mg/m^2 intravenously on days 71, 99, and 127; 1000 mg/m^2/day as 96-hour continuous infusion on days 71-74, 99-102, and 127-130; The gross tumor and lymph node metastasis, Planning Target Volume (PTV) 70 (Clinical Target Volume [CTV] 70 with a 5 mm margin) will receive 70 Gy in 33 fractions at 2.12 Gy per fraction. Treatment will be delivered once daily, 5 fractions per week, over 6 weeks and 3 days.
Intervention MeSH terms: Fluorouracil
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 68.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: oral complications of radiation therapy; radiation toxicity; stage I squamous cell carcinoma of the nasopharynx; stage II squamous cell carcinoma of the nasopharynx; stage III squamous cell carcinoma of the nasopharynx; stage IV squamous cell carcinoma of the nasopharynx

Summary:

      RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation
      therapy in different ways may cause less damage to normal tissue, prevent or lessen mouth
      dryness, and may help patients live more comfortably. Drugs used in chemotherapy use
      different ways to stop tumor cells from dividing so they stop growing or die. Combining
      chemotherapy with radiation therapy may kill more tumor cells.

      PURPOSE: Phase II trial to study the effectiveness of specialized radiation therapy
      techniques with or without chemotherapy in reducing mouth dryness in patients who have
      nasopharyngeal cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed stage I-IVB squamous cell carcinoma of the nasopharynx

               -  WHO I-III

               -  No stage IVC disease

               -  No evidence of distant metastasis

          -  Measurable or evaluable disease

          -  Must have been treated with primary radiotherapy

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Performance status

          -  Zubrod 0-1

        Life expectancy

          -  Not specified

        Hematopoietic

          -  White blood cell count (WBC) at least 4,000/mm^3

          -  Platelet count at least 100,000/mm^3

        Hepatic

          -  Not specified

        Renal

          -  Creatinine no greater than 1.6 mg/dL

          -  Creatinine clearance at least 60 mL/min

        Other

          -  Not pregnant (If stage T2b or greater or node-positive disease)

          -  Negative pregnancy test (If stage T2b or greater or node-positive disease)

          -  No other prior head and neck cancer

          -  No other malignancy within the past 5 years except nonmelanoma skin cancer

          -  No active untreated infection

          -  No other major medical or psychiatric illness that would preclude study entry

          -  Nutritional and general physical condition compatible with radiotherapy NOTE: *If
             stage T2b or greater or node-positive disease

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  Not specified

        Chemotherapy

          -  More than 6 months since prior chemotherapy

        Endocrine therapy

          -  Not specified

        Radiotherapy

          -  See Disease Characteristics

          -  More than 6 months since prior radiotherapy for head and neck cancer

        Surgery

          -  No prior head and neck surgery to the primary tumor or lymph nodes except incisional
             or excisional biopsies

        Other

          -  No other concurrent experimental therapy for cancer

          -  No amifostine or pilocarpine during or for 3 months after radiotherapy