Preventing Mucositis in Head and Neck Cancer Patients
Name of the Trial
Phase III Randomized Study of Palifermin for Reducing Oral Mucositis in Patients with Locally Advanced Squamous Cell Carcinoma of the Oral Cavity, Oropharynx, Hypopharynx, or Larynx Undergoing Concurrent Radiotherapy and Chemotherapy (RTOG-0435). See the protocol summary at http://cancer.gov/clinicaltrials/RTOG-0435.
 Principal Investigator
Dr. David I. Rosenthal, Radiation Therapy Oncology Group
Why This Trial Is Important
Nonsurgical treatment of locally advanced head and neck cancer usually involves a combination of radiotherapy and chemotherapy (chemoradiotherapy). Unfortunately, both the disease and its treatment are associated with serious oral complications. A common side effect of chemoradiotherapy is oral mucositis, inflammation of the mucous membranes in the mouth and throat that can cause painful sores. Severe oral mucositis can lead to delays in treatment, difficulty in eating and speaking, and life-threatening infections.
Palifermin has been approved by the FDA to prevent and treat mucositis in patients undergoing high-dose chemotherapy and radiotherapy for leukemia or lymphoma. It promotes the growth of mucosal cells lining the mouth and gastrointestinal tract and helps replace cells damaged by cancer treatment.
In this trial, patients undergoing chemoradiotherapy for advanced head and neck cancer will receive intravenous palifermin or placebo before and during cancer treatment.
"Chemoradiotherapy for head and neck cancer has led to significant improvements in survival, but those improvements have come at the cost of greater incidence of oropharyngeal mucositis, the most common reason for unplanned treatment interruptions," said Dr. Rosenthal. "Based on preclinical data and its proven efficacy in leukemia and lymphoma, palifermin is the most promising agent for reducing the burden of mucositis for head and neck cancer patients."
Who Can Join This Trial
Researchers will enroll 298 patients with stage III or IV squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx. See the list of eligibility criteria at http://cancer.gov/clinicaltrials/RTOG-0435.
Study Sites and Contact Information
Study sites in the United States are recruiting patients for this trial. See the list of study contacts at http://www.cancer.gov/clinicaltrials/RTOG-0435 or call NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237) for more information. The toll-free call is confidential.
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