NCT00008398

Sargramostim in Decreasing Mucositis in Patients Receiving Radiation Therapy for Head and Neck Cancer

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: —
• Sponsor: Radiation Therapy Oncology Group · Network
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Head and Neck Cancer
• Oral Complications
• Radiation Toxicity

Interventions

Type	Name	Description
BIOLOGICAL	sargramostim
PROCEDURE	quality-of-life assessment
RADIATION	radiation therapy

Timeline

• Start date: 2000-10-01
• Primary completion: 2004-03-01
• First posted: 2003-06-05
• Last updated: 2013-11-19

Locations

236 sites across 2 countries: United States, Canada