Trial Information

A Phase III Comparison of Biafine to Declared Institutional Preference for Radiation Induced Skin Toxicity in Patients Undergoing Radiation Therapy for Advanced Squamous Cell Carcinomas of the Head and Neck

OBJECTIVES: I. Compare the efficacy of prophylactic Biafine cream vs standard best
supportive care in reducing grade 2 or higher radiation-induced skin toxicity observed
during radiotherapy in patients with advanced squamous cell carcinoma of the head and neck.
II. Determine if prophylactic or interventional use of Biafine cream is more effective based
on a reduction in maximum skin toxicity resulting from radiation treatment in this patient
population. III. Compare quality of life of these patients with this treatment. IV. Assess
the toxicity of Biafine cream in these patients.

OUTLINE: This is a randomized study. Patients are stratified according to lymph node status
(negative vs positive), type of treatment (radiation plus chemotherapy vs radiation alone),
radiation fractionation (standard vs concurrent boost), and radiation dose (50-60 Gy vs
greater than 60 Gy). Patients are randomized to 1 of 3 treatment arms. Arm I: Patients
receive radiotherapy once daily 5 days a week for 5-8 weeks, with or without standard skin
cream application (no Biafine cream) to irradiated skin. Arm II: Patients receive
radiotherapy as in arm I, with Biafine cream applied to skin 3 times daily 7 days a week at
the initiation of radiotherapy and continuing for 2 weeks after the last radiation
treatment. Biafine cream is applied no fewer than 4 hours before treatment and no fewer than
4 hours between applications. Arm III: Patients receive radiotherapy as in arms I and II,
with Biafine cream applied as in arm II only after skin becomes symptomatic (i.e., redness,
dryness, itching, or tenderness). Quality of life is assessed before treatment, weekly
during treatment, and then weekly for 4 weeks after treatment completion. Patients are
followed weekly for 4 weeks.

PROJECTED ACCRUAL: Approximately 500 patients will be accrued for this study within 17
months.