Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Radiation Therapy Oncology Group
With
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.
Age
Any age
Sex
ALL
Healthy volunteers
Not accepted