Head and Neck Cancer Clinical Trial
Official title:
A Phase III Study to Test the Efficacy and Safety of GM-CSF to Reduce the Severity and Duration of Mucosal Injury and Pain (Mucositis) Associated With Curative Radiation Therapy in Head and Neck Cancer Patients
RATIONALE: Sargramostim may lessen symptoms of mucositis in patients receiving radiation
therapy for head and neck cancer. It is not yet known if sargramostim is more effective than
no treatment in reducing mucositis caused by radiation therapy.
PURPOSE: Randomized phase III trial to determine the effectiveness of sargramostim in
decreasing mucositis in patients who are receiving radiation therapy for head and neck
cancer.
OBJECTIVES:
- Determine the efficacy of sargramostim (GM-CSF) in terms of reducing the severity and
expected duration of radiotherapy-induced oral mucositis in patients with head and neck
cancer receiving radiotherapy.
- Determine the correlation between reduced mucosal injury and quality of life
improvement in patients treated with this drug.
OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are
stratified according to concurrent cisplatin chemotherapy (yes vs no). Patients are
randomized to 1 of 2 treatment arms.
- Arm I: Patients receive radiotherapy once daily five days a week for 6-7 weeks.
Patients also receive sargramostim (GM-CSF) subcutaneously (SC) three times a week
(except on days if receiving concurrent cisplatin) beginning 1 week prior to
radiotherapy and continuing until 2 weeks after completion of radiotherapy for a total
of approximately 9 weeks.
- Arm II: Patients receive radiotherapy as in arm I. Patients also receive placebo SC on
the same schedule as GM-CSF in arm I.
Quality of life is assessed at baseline, and then at 3, 6, and 12 months.
Patients are followed at 3, 6 and 11 months.
PROJECTED ACCRUAL: A total of 126 patients (63 per arm) will be accrued within 1.2-1.4
years.
;
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
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