Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Advanced Head and Neck Cancer
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.
      Combining more than one drug and combining chemotherapy with radiation therapy may kill more
      tumor cells. It is not yet known which regimen of combination chemotherapy is more effective
      for advanced head and neck cancer.

      PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of
      combination chemotherapy plus radiation therapy in treating patients who have advanced head
      and neck cancer.
    

Detailed description: 
      OBJECTIVES: I. Compare the progression free survival of patients with locally advanced,
      inoperable squamous cell carcinoma of the head and neck treated with cisplatin plus
      fluorouracil with or without docetaxel as a neoadjuvant to radiotherapy. II. Compare the
      response rate, response duration, toxicity, local symptoms, and time to disease progression
      of these treatment regimens in this patient population. III. Evaluate the quality of life in
      these patients.

      OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
      primary tumor site (oral cavity vs oropharynx vs hypopharynx vs larynx) and institution.
      Patients are randomized to one of two treatment arms. Arm I: Patients receive docetaxel IV
      over 1 hour, immediately followed by cisplatin IV over 1 hour on day 1 and fluorouracil
      (5-FU) IV as a continuous infusion on days 1-5. Arm II: Patients receive cisplatin IV over 1
      hour on day 1 followed by 5-FU IV as a continuous infusion on days 1-5. Treatment continues
      every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.
      Patients receive radiotherapy following chemotherapy within 3-6 weeks of last course.
      Radiotherapy is administered 5 days a week for up to 7 weeks. Quality of life is assessed
      before treatment, at courses 2 and 4, and at 6 and 9 months. Patients are followed every 3
      months for the first 2 years and then every 6 months until death.

      PROJECTED ACCRUAL: A total of 348 patients will be accrued for this study within 24 months.
    

Intervention name(s): cisplatin; docetaxel; fluorouracil; radiation therapy
Intervention type(s): Drug; Drug; Drug; Radiation
Intervention MeSH terms: Docetaxel; Fluorouracil
Allocation: Randomized
Primary purpose: Treatment
Keywords: stage III squamous cell carcinoma of the lip and oral cavity; stage IV squamous cell carcinoma of the lip and oral cavity; stage III squamous cell carcinoma of the oropharynx; stage IV squamous cell carcinoma of the oropharynx; stage III squamous cell carcinoma of the hypopharynx; stage IV squamous cell carcinoma of the hypopharynx; stage III squamous cell carcinoma of the larynx; stage IV squamous cell carcinoma of the larynx