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)
- To assess the toxicity of stereotactic body radiotherapy delivered concurrently with
cetuximab in patients with recurrent squamous cell carcinoma of the head and neck.
- 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
Grade 4-5 toxicity as assessed by NCI CTCAE v.30
Daily while on Treatment
Anurag K. Singh, MD
Roswell Park Cancer Institute
United States: Food and Drug Administration
|Roswell Park Cancer Institute||Buffalo, New York 14263|