Radiation Therapy Cisplatin With or Without Fluorouracil Patients With Stage III or Stage IV Head and Neck Cancer
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Intervention: cisplatin; fluorouracil; radiation therapy
Intervention description: Given IV; Given IV; Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks
Intervention MeSH terms: Fluorouracil
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 69.0
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 lip and oral cavity; stage III squamous cell carcinoma of the oropharynx; stage III squamous cell carcinoma of the larynx; stage IV squamous cell carcinoma of the hypopharynx; stage IV squamous cell carcinoma of the lip and oral cavity; stage IV squamous cell carcinoma of the oropharynx; stage IV squamous cell carcinoma of the larynx

Summary:

      RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. 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 cisplatin and fluorouracil may kill more tumor cells. It is
      not yet known whether radiation therapy and cisplatin are more effective with or without
      fluorouracil in treating patients with head and neck cancer.

      PURPOSE: This randomized phase III trial is studying radiation therapy and cisplatin to
      compare how well they work with or without fluorouracil in treating patients with stage III
      or stage IV head and neck cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx,
             larynx, or hypopharynx

               -  No histologic diagnosis other than squamous cell carcinoma

               -  A primary site must be identified

          -  Must have locoregionally confined stage III (excluding T1-2, N1) or stage IV disease

               -  No evidence of nodal disease below the clavicles or distant hematogenous
                  metastases (M0)

               -  No stage IVC disease (stage IVB disease allowed)

          -  Deemed appropriate for definitive non-operative management with curative intent

               -  Resectable disease is not required

          -  No primary cancer of the nasopharynx, paranasal sinus, or salivary gland

        PATIENT CHARACTERISTICS:

          -  ECOG performance status 0-1

          -  WBC > 3,500/mm³

          -  Platelet count > 100,000/mm³

          -  Serum creatinine < 2.0 mg/dL

          -  Alkaline phosphatase < 2 times normal

          -  AST < 2 times normal

          -  Bilirubin ≤ 2.0 mg/dL

          -  Serum calcium normal

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No unstable or uncontrolled angina

          -  No clinically apparent jaundice

          -  No active infection

          -  No history of any other malignancy (except squamous cell or basal cell skin cancer or
             cervical carcinoma in situ), unless the patient has been continuously disease-free for
             at least 5 years

          -  Not a poor compliance risk

          -  Able to withstand the rigors of intensive treatment

          -  Available for and compliant with adequate long-term follow-up

        PRIOR CONCURRENT THERAPY:

          -  No prior definitive surgery or radiotherapy for this malignancy

          -  No prior chemotherapy, immunotherapy, or epidermal growth factor receptor inhibitors
             for any disease Patients who have had previous definitive surgery, or radiation
             therapy for this malignancy, and patients who have had any previous chemotherapy,
             immunotherapy, or EGF receptor inhibition for any disease are ineligible.

        Exclusion Criteria Patients with primary cancers of the nasopharynx, paranasal sinus or
        salivary gland are ineligible.

        Patients with unstable or uncontrolled angina, clinically apparent jaundice, or active
        infection are ineligible.

        Patients with a history of any other malignancy (except squamous or basal cell skin cancer
        or cervical carcinoma in-situ) are ineligible, unless the patient has been continuously
        disease-free for at least 5 years.

        Patients with any histologic diagnosis other than squamous cell carcinoma are ineligible.

        Patients who might be a poor-compliance risk are ineligible.

        Pregnant or breastfeeding women are ineligible. Women/men of reproductive potential must be
        willing to practice acceptable methods of birth control to prevent pregnancy.