Head and Neck Cancer Clinical Trial
Official title:
Multi-Institutional Phase II Study of Weekly Docetaxel and Concurrent Radiotherapy for Laryngeal and Hypopharyngeal Cancer in the Group of Elderly and/or Patients With Medical Illness
RATIONALE: Drugs used in chemotherapy, such as docetaxel work in different ways to stop the
growth of tumor cells, either by killing the cells or by stopping them from dividing.
Radiation therapy uses high-energy x-rays to kill tumor cells. Giving docetaxel together
with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving docetaxel together with radiation
therapy works in treating patients with stage II or stage III cancer of the larynx or
hypopharynx.
OBJECTIVES:
Primary
- Determine the objective response of the primary tumor in patients with stage II or III
squamous cell carcinoma of the larynx or hypopharynx treated with docetaxel and
radiotherapy.
Secondary
- Determine the local relapse-free survival of patients treated with this regimen.
- Determine the larynx-preservation survival of patients treated with this regimen.
- Determine the overall survival of patients treated with this regimen.
- Determine the protocol completion rate in patients treated with this regimen.
- Determine the adverse effects of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive docetaxel IV over 1 hour on days 1, 8, 15, 22, and 29 and undergo
radiotherapy on days 1-5, 8-12, 15-19, 22-26, and 29-33.
PROJECTED ACCRUAL: A total of 25-50 patients will be accrued for this study.
;
Masking: Open Label, Primary Purpose: Treatment
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