Combination Chemotherapy Plus Radiation Therapy To Preserve the Larynx in Patients With Cancer of the Hypopharynx or Larynx
Condition: Head and Neck Cancer
MeSH terms: Laryngeal Diseases
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 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 which regimen of
      cisplatin and fluorouracil combined with radiation therapy is more effective in treating
      resectable cancer of the hypopharynx or larynx.

      PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of cisplatin
      and fluorouracil combined with radiation therapy in preserving the larynx in patients who
      have resectable cancer of the hypopharynx or larynx.
    

Detailed description: 
      OBJECTIVES:

        -  Compare relapse-free survival and larynx preservation in patients with resectable
           hypopharyngeal or laryngeal cancer treated with sequential vs alternating cisplatin and
           fluorouracil and radiotherapy.

        -  Compare the health-related quality of life in patients treated with these regimens.

        -  Compare the cost-effectiveness of these regimens.

      OUTLINE: This is a randomized, multicenter study. Patients are stratified by performance
      status, disease site, tumor stage, node stage, and center.

      Patients are randomized to one of two treatment arms. Both groups may receive either
      conventional radiotherapy in single daily fractions, 5 days per week, for 7 weeks (option 1)
      or hyperfractionated radiotherapy in 2 daily fractions, 5 days per week, for 4-5 weeks
      (option 2), according to institutional policy.

        -  Arm I: Patients receive cisplatin and fluorouracil every 3 weeks. Patients with a
           complete or partial response on day 42 receive 2 additional courses of chemotherapy
           followed by 7 weeks of radiotherapy beginning on day 80. After radiotherapy, patients
           with a complete remission enter follow-up; those with a partial remission proceed to
           surgery. Patients with stable or progressive disease proceed immediately to surgery with
           or without postoperative radiotherapy.

        -  Arm II: Patients receive cisplatin and fluorouracil every 3 weeks for 4 courses.
           Patients treated on radiotherapy option 1 are evaluated 2 months after completion of
           radiotherapy; those with a complete remission enter follow-up while all others proceed
           to surgery. Patients treated on option 2 are evaluated on day 42; those with a partial
           or complete response complete chemoradiotherapy and are then evaluated and treated like
           option 1 patients. Patients with stable or progressive disease on day 42 proceed to
           surgery with or without a third course of chemotherapy on week 7.

      Patients are followed every 3 months for 3 years and at least every 6 months thereafter.

      PROJECTED ACCRUAL: A total of 564 patients will be accrued for this study within 4 years.
    

Intervention name(s): cisplatin; fluorouracil; conventional surgery; neoadjuvant therapy; radiation therapy
Intervention type(s): Drug; Drug; Procedure; Procedure; Radiation
Intervention MeSH terms: Fluorouracil
Allocation: Randomized
Primary purpose: Treatment
Keywords: stage II squamous cell carcinoma of the hypopharynx; 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