Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Advanced Cancer of the Oropharynx or Hypopharynx
Condition: Head and Neck Cancer
MeSH terms: Oropharyngeal Neoplasms
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. Combining chemotherapy with radiation therapy may kill more tumor cells and allow
      doctors to preserve the part of the body where the cancer started. It is not yet known
      whether radiation therapy with combination chemotherapy is more effective than radiation
      therapy alone in treating cancer of the oropharynx or hypopharynx that cannot be surgically
      removed.

      PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy plus
      cisplatin and fluorouracil with radiation therapy alone in treating patients who have
      advanced cancer of the oropharynx or hypopharynx that cannot be surgically removed.
    

Detailed description: 
      OBJECTIVES:

        -  Compare the overall survival and survival without relapse for 1, 3, and 5 years of
           patients with squamous cell cancer of the oropharynx or hypopharynx after treatment with
           twice a day radiotherapy with or without cisplatin and fluorouracil.

        -  Compare the presence of distant metastases at 1, 3, and 5 years in these patients after
           these treatments.

        -  Compare the local control and duration of control in these patients after these
           treatments.

        -  Compare the clinical changes and histological changes at 6 months in these patients
           after these treatments.

        -  Determine the rate of complete response in these patients after these treatments.

        -  Determine the early and late toxic effects of these regimens in these patients.

        -  Determine the quality of life of these patients.

        -  Determine the pharmacokinetics of fluorouracil and tolerability of this regimen in these
           patients.

      OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center
      and primary site of disease (oropharynx vs hypopharynx)

      Patients are randomized to one of two treatment arms.

        -  Arm I: Patients undergo radiotherapy twice a day, 6 hours apart, 5 days a week, for 7
           weeks.

        -  Arm II: Patients undergo radiotherapy as in arm I, plus concurrent chemotherapy
           consisting of cisplatin IV on day 1 and fluorouracil by continuous infusion over 24
           hours on days 1-5. Courses are repeated every 3 weeks for 3 courses.

      Patients are followed every month for 1 year, every 2-3 months for 2 years, then every 6
      months for at least 2 years.

      PROJECTED ACCRUAL: A total of 160 patients (80/arm) will be accrued for this study within 4.5
      years.
    

Intervention name(s): cisplatin; fluorouracil; radiation therapy
Intervention type(s): Drug; Drug; Radiation
Intervention MeSH terms: Fluorouracil
Allocation: Randomized
Primary purpose: Treatment
Keywords: 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