Head and Neck Cancer Clinical Trial
Official title:
A Feasibility Study of Re-irradiation Using Stereotactic Body Radiation Therapy (SBRT) and Cetuximab for Recurrent Squamous Cell Carcinoma of the Head and Neck (SCCHN)
RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the
tumor and cause less damage to normal tissue. Monoclonal antibodies, such as cetuximab, can
block tumor growth in different ways. Some block the ability of tumor cells to grow and
spread. Others find tumor cells and help kill them or carry tumor-killing substances to
them. Giving stereotactic body radiation therapy together with cetuximab may kill more tumor
cells.
PURPOSE: This clinical trial is studying the side effects of radiation therapy given
together with cetuximab and to see how well it works in treating patients with recurrent
head and neck cancer.
OBJECTIVES:
Primary
- To assess the toxicity of stereotactic body radiotherapy delivered concurrently with
cetuximab in patients with recurrent squamous cell carcinoma of the head and neck.
Secondary
- To assess the feasibility of delivering this regimen in these patients.
- To assess the impact of this regimen on local control, distant control, and overall
survival of these patients.
OUTLINE: Patients receive cetuximab IV over 60-120 minutes once weekly in weeks 1-5.
Patients undergo 1 fraction of stereotactic-body radiotherapy (RT) in week 2. At 4 weeks
after RT completion, patients may receive additional cetuximab IV combined with a 28-day
chemotherapy regimen, per investigator discretion.
After completion of study treatment, patients are followed every 2 months for 1 year, every
3-4 months for 1 year, every 6 months for 2 years, and then annually thereafter.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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