Combination Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer (Paradigm Trial)

• Survival [ Time Frame: 3-years ] [ Designated as safety issue: No ]
  To compare the 3-year survival achieved by docetaxel/cisplatin/5-FU based sequential therapy with platinum based chemo radiotherapy in patients with locally advanced SCCHN
  
  

• Progression-free survival and disease-specific survival as assessed by disease progression or death and log rank tests at the median, and 2, 3, and 5 years [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  
• Response as assessed by RECIST criteria after completion of induction chemotherapy and chemoradiotherapy [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  
• Quality of life as assessed by longitudinal data analysis at baseline, 6 and 12 months, and then every 6 and 12 months for 5 years [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  
• Toxicity as assessed by the Chi-square or Fischer's exact test [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  
• Organ preservation rate as assessed by the Chi-square or Fischer's exact test [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  

OBJECTIVES:

Primary

• Compare 3-year survival of patients with previously untreated stage III or IV squamous cell carcinoma of the head and neck treated with induction chemotherapy comprising docetaxel, cisplatin, and fluorouracil followed by radiotherapy and carboplatin or docetaxel vs radiotherapy and cisplatin only.

Secondary

• Compare 2-year progression-free status in patients treated with these regimens.
• Compare 5-year survival of patients treated with these regimens.
• Compare 3- and 5-year progression-free survival of patients treated with these regimens.
• Compare the complete response rate in patients treated with these regimens.
• Compare tumor site-specific survival in patients treated with these regimens.
• Compare functional organ preservation in patients treated with these regimens.
• Compare the toxicity of these regimens in these patients.
• Compare the quality of life of patients treated with these regimens.
• Correlate tissue and germline markers with response, local/regional control, and the development of distant metastases in patients treated with these regimens.

OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive induction chemotherapy comprising docetaxel, cisplatin, and fluorouracil. Treatment repeats every 21 days for 3 courses. Patients achieving a pathologic complete response at the primary site and a clinical complete response in the neck then receive carboplatin once weekly and undergo concurrent radiotherapy once daily, 5 days a week, for 7 weeks. Patients with a partial response at the primary site (i.e., positive biopsy), stable disease, or radiographic evidence of persistent disease in the neck receive docetaxel once weekly for 4 weeks and undergo concurrent radiotherapy once or twice daily, 5 days a week, for 6 weeks.
• Arm II: Patients receive cisplatin IV on weeks 1 and 4 and undergo concurrent radiotherapy once or twice daily, 5 days a week, for 6 weeks.

Quality of life is assessed at baseline and then at 3, 12, and 24 months.

Patients are followed monthly for 1 year, every 2 months for 1 year, every 3 months for 1 year, and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 330 patients will be accrued for this study.