Radiation Therapy and Chemotherapy in Treating Patients With Head and Neck Cancer
Condition: Carcinoma of Unknown Primary; Head and Neck Cancer
MeSH terms: Carcinoma; Head and Neck Neoplasms; Neoplasms, Unknown Primary
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in
      chemotherapy use different ways to stop tumor cells from dividing so they stop growing or
      die. It is not yet known whether combining mitomycin or porfiromycin with radiation therapy
      is more effective in treating patients with head and neck cancer.

      PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy plus
      either mitomycin or porfiromycin in treating patients with head and neck cancer.
    

Detailed description: 
      OBJECTIVES: I. Compare the efficacy of mitomycin vs. porfiromycin as an adjunct to
      radiotherapy for the treatment of epidermoid carcinomas of the head and neck.

      OUTLINE: Randomized study. Arm I: Radiotherapy plus Single-Agent Chemotherapy. Irradiation of
      involved head and neck sites by external-beam radiotherapy (EBRT) alone (source not
      specified), brachytherapy alone (using permanent or removable radiation sources), or both;
      plus Mitomycin, MITO, NSC-26980. Arm II: Radiotherapy plus Single-Agent Chemotherapy.
      Radiotherapy as in Arm I; plus Porfiromycin, NSC-56410.

      PROJECTED ACCRUAL: Approximately 200 patients will be entered over 3-4 years.
    

Intervention name(s): mitomycin C; porfiromycin; brachytherapy; radiation therapy
Intervention type(s): Drug; Drug; Radiation; Radiation
Intervention MeSH terms: Mitomycins; Mitomycin; Porfiromycin
Primary purpose: Treatment
Keywords: stage I squamous cell carcinoma of the lip and oral cavity; stage I adenoid cystic carcinoma of the oral cavity; stage II squamous cell carcinoma of the lip and oral cavity; stage II adenoid cystic carcinoma of the oral cavity; stage III squamous cell carcinoma of the lip and oral cavity; stage III adenoid cystic carcinoma of the oral cavity; stage IV squamous cell carcinoma of the lip and oral cavity; stage IV adenoid cystic carcinoma of the oral cavity; recurrent squamous cell carcinoma of the lip and oral cavity; recurrent adenoid cystic carcinoma of the oral cavity; stage I squamous cell carcinoma of the oropharynx; stage I lymphoepithelioma of the oropharynx; stage II squamous cell carcinoma of the oropharynx; stage II lymphoepithelioma of the oropharynx; stage III squamous cell carcinoma of the oropharynx; stage III lymphoepithelioma of the oropharynx; stage IV squamous cell carcinoma of the oropharynx; stage IV lymphoepithelioma of the oropharynx; recurrent squamous cell carcinoma of the oropharynx; recurrent lymphoepithelioma of the oropharynx; stage I squamous cell carcinoma of the nasopharynx; stage I lymphoepithelioma of the nasopharynx; stage II squamous cell carcinoma of the nasopharynx; stage II lymphoepithelioma of the nasopharynx; stage III squamous cell carcinoma of the nasopharynx; stage III lymphoepithelioma of the nasopharynx; stage IV squamous cell carcinoma of the nasopharynx; stage IV lymphoepithelioma of the nasopharynx; recurrent squamous cell carcinoma of the nasopharynx; recurrent lymphoepithelioma of the nasopharynx; stage I squamous cell carcinoma of the hypopharynx; stage II squamous cell carcinoma of the hypopharynx; stage III squamous cell carcinoma of the hypopharynx; stage IV squamous cell carcinoma of the hypopharynx; recurrent squamous cell carcinoma of the hypopharynx; stage I squamous cell carcinoma of the larynx; stage II squamous cell carcinoma of the larynx; stage III squamous cell carcinoma of the larynx; stage IV squamous cell carcinoma of the larynx; recurrent squamous cell carcinoma of the larynx; newly diagnosed carcinoma of unknown primary; recurrent carcinoma of unknown primary