Head and Neck Cancer Clinical Trial
Official title:
Randomised Phase II Study of GM-CSF to Reduce Severity of Mucositis Caused by Accelerated Radiotherapy of Laryngeal Cancer
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as
sargramostim may protect normal cells from the side effects of radiation therapy.
PURPOSE: Randomized phase II trial to determine the effectiveness of sargramostim in
preventing mucositis in patients who are receiving radiation therapy for laryngeal cancer.
OBJECTIVES:
- Determine the efficacy of sargramostim (GM-CSF) in reducing the duration and severity
of mucositis resulting from accelerated radiotherapy in patients with laryngeal
carcinoma.
- Determine the effect of GM-CSF on quality of life aspects of these patients as assessed
by nutritional status, analgesic use, and days in the hospital.
OUTLINE: This is a randomized study.
Patients receive radiotherapy in 16 fractions over 21 days. Patients are randomly allocated
to one of two treatment arms before scheduled radiotherapy begins.
- Arm I: Patients receive sargramostim (GM-CSF) SC daily for 14 days beginning on day 14
of the course of radiotherapy.
- Arm II: Patients do not receive GM-CSF. Patients are followed weekly until mucositis is
healed, as well as at weeks 2 and 6 following the end of radiotherapy.
PROJECTED ACCRUAL: A total of 34 patients (17 per arm) will be accrued for this study.
;
Allocation: Randomized, Primary Purpose: Supportive Care
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