Chemotherapy and Radiation Therapy With or Without Surgery in Treating Patients With Head and Neck Cancer
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Intervention: cisplatin; Standard fractionation RT; Accelerated fractionation radiation therapy; Conventional surgery for select patients
Intervention description: 100 mg/m^2 intravenously on days 1, 22; Radiation will be delivered in 2 Gy per fraction, five fractions a week. The primary tumor and clinically/radiologically involved nodes will receive 70 Gy in 7 weeks and uninvolved nodes will receive 50 Gy in 5 weeks. The anterior lower neck field will be treated with 2 Gy per fraction at 3-cm depth to a total dose of 50 Gy.; Radiation to the initial target volume encompassing the gross and subclinical disease sites will be delivered in 1.8 Gy per fraction, five fractions a week to 54 Gy in 30 fractions over 6 weeks. At 32.4 Gy/18 Fx (i.e., latter part of week 4), the boost volume covering gross tumor and clinically/radiologically involved nodes will receive boost irradiation of 1.5 Gy/Fx as second daily fraction (at least 6 h interval) for a total of 12 treatment days (18 Gy total). The primary tumor and clinically/radiologically involved nodes will receive 72 Gy in 42 fractions over 6 weeks and uninvolved nodes will receive 54 Gy in 6 weeks. Clinically/radiologically negative posterior neck should receive a minimum dose of 50.4 Gy at 3 cm. The anterior lower neck field will be treated with 1.8 Gy per fraction at 3-cm depth to a total dose of 50.4 Gy in 28 fractions in 5.6 weeks.; Surgical removal (salvage resection) of the primary tumor should be performed if biopsy-proven cancer remains more than three months after completion of therapy. The nature of the surgical resection should be dictated by the extent of tumor at the initial evaluation. The operation should be conducted using accepted criteria for primary surgical treatment of the cancer.
A planned neck dissection for patients with multiple neck nodes or with lymph nodes exceeding 3 cm in diameter (N2a, N2b, N3) is mandatory, regardless of the clinical and/or radiographic response. A neck dissection is required for patients with N1 disease if a palpable or worrisome radiographic abnormality persists in the neck six weeks after completion of therapy. Surgery should be performed within 2 weeks once the decision for neck dissection is made.
Intervention MeSH terms: Cisplatin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 743.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stage III squamous cell carcinoma of the hypopharynx; stage III squamous cell carcinoma of the larynx; stage III squamous cell carcinoma of the lip and oral cavity; stage III squamous cell carcinoma of the oropharynx; stage IV squamous cell carcinoma of the hypopharynx; stage IV squamous cell carcinoma of the larynx; stage IV squamous cell carcinoma of the lip and oral cavity; stage IV squamous cell carcinoma of the oropharynx

Summary:

      RATIONALE: Radiation therapy (RT) uses high-energy x-rays to damage tumor cells. Giving
      radiation therapy in different ways and combining it with chemotherapy before surgery may
      kill more tumor cells. It is not yet known which radiation therapy regimen combined with
      chemotherapy with or without surgery is more effective for head and neck cancer.

      PURPOSE: Randomized phase III trial to compare two different radiation therapy regimens
      combined with cisplatin with or without surgery in treating patients who have stage III or
      stage IV head and neck cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx,
             hypopharynx, or larynx

               -  Stage III or IV (T2, N2-3, M0 or T3-4, any N, M0)

          -  No metastases below the clavicle or more distant by clinical exam or radiology

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Performance status

          -  Zubrod 0-1

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Absolute granulocyte count at least 2,000/mm^3

          -  Platelet count at least 100,000/mm^3

        Hepatic

          -  Bilirubin no greater than 1.5 mg/dL

          -  Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) no greater than 2
             times upper limit of normal

        Renal

          -  Creatinine no greater than 1.5 mg/dL

          -  Creatinine clearance at least 50 mL/min

          -  Calcium normal

        Cardiovascular

          -  No symptomatic coronary artery disease (angina)

          -  No myocardial infarction within the past 6 months

        Other

          -  No other invasive malignancy within the past 3 years except nonmelanoma skin cancer

          -  No simultaneous primary tumors

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  Not specified

        Chemotherapy

          -  No prior chemotherapy

        Endocrine therapy

          -  Not specified

        Radiotherapy

          -  No prior radiotherapy to the head and neck except radioactive iodine therapy

        Surgery

          -  No prior surgery to the primary tumor or nodes except diagnostic biopsy or nodal
             sampling of neck disease

               -  No radical or modified neck dissection