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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

Phase 3
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Head and Neck Cancer, Skin Reactions Secondary to Radiation Therapy

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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

Inclusion 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)

Type of Study:


Study Design:

Primary Purpose: Supportive Care

Principal Investigator

Elizabeth Elliott, MRT(T), MRT(R), CCRP

Investigator Role:

Study Chair

Investigator Affiliation:

Margaret and Charles Juravinski Cancer Centre


United States: Federal Government

Study ID:




Start Date:

October 2000

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • Skin Reactions Secondary to Radiation Therapy
  • stage III squamous cell carcinoma of the lip and oral cavity
  • stage IV squamous cell carcinoma of the lip and oral cavity
  • stage III squamous cell carcinoma of the oropharynx
  • stage IV squamous cell carcinoma of the oropharynx
  • stage III squamous cell carcinoma of the hypopharynx
  • stage IV squamous cell carcinoma of the hypopharynx
  • stage III squamous cell carcinoma of the larynx
  • stage IV squamous cell carcinoma of the larynx
  • skin reactions secondary to radiation therapy
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms



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