Biafine Cream to Reduce Side Effects of Radiation Therapy in Patients Receiving Treatment for Advanced Head and Neck Cancer
Launched by RADIATION THERAPY ONCOLOGY GROUP · Dec 30, 2003
Trial Information
Current as of July 04, 2025
Completed
Keywords
ClinConnect Summary
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: T...
Gender
ALL
Eligibility criteria
- • DISEASE CHARACTERISTICS: Histologically confirmed stage III or IV squamous cell carcinoma of the head and neck, including: Oral cavity Oropharyngeal Hypopharyngeal Laryngeal Radiotherapy indicated as primary treatment or treatment after primary surgical resection Primary field to receive at least 50 Gy No skin rash, ulceration, or open wound in treatment field No tumor involvement of the skin
- • PATIENT CHARACTERISTICS: Age: Not specified Performance status: Zubrod 0-1 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No known skin allergy or sensitivity to Biafine No inflammatory or connective tissue disorders of the skin No history of mental incompetence, including psychological disorders or drug dependency disorders, that would preclude study compliance
- • PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Concurrent chemotherapy allowed Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics No prior radiotherapy to treatment field Surgery: See Disease Characteristics Prior surgery allowed Other: No other concurrent investigational therapy No concurrent participation on other RTOG clinical trials No concurrent amifostine (concurrent pilocarpine allowed)
About Radiation Therapy Oncology Group
The Radiation Therapy Oncology Group (RTOG) is a leading clinical trial sponsor dedicated to advancing the field of radiation oncology through rigorous research and collaboration. Established to improve patient outcomes, RTOG conducts multicenter clinical trials that evaluate innovative radiation treatment techniques, assess the efficacy of combined modality therapies, and enhance quality of life for cancer patients. Committed to scientific excellence, RTOG fosters partnerships among academic institutions, healthcare providers, and industry stakeholders, ensuring that findings translate into clinical practice to optimize cancer care and improve survival rates.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Marshfield, Wisconsin, United States
Cleveland, Ohio, United States
Milwaukee, Wisconsin, United States
Tucson, Arizona, United States
New York, New York, United States
Calgary, Alberta, Canada
Fleurimont, Quebec, Canada
Bronx, New York, United States
Houston, Texas, United States
Ann Arbor, Michigan, United States
Rochester, Minnesota, United States
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Grand Junction, Colorado, United States
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Patients applied
Trial Officials
Elizabeth Elliott, MRT(T), MRT(R), CCRP
Study Chair
Margaret and Charles Juravinski Cancer Centre
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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