At a glance
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Phase II Trial of Post-operative or Definitive Concurrent Radiation and Cetuximab for Locally Advanced Cutaneous Squamous Cell Carcinoma of the Head and Neck
In Brief
A Phase 2 clinical trial evaluating Cetuximab and Radiation Therapy for Head and Neck Cancer. Completed, enrolled 24 participants across 1 site.
Detailed Summary
The standard treatment of surgery followed by radiation therapy can stop tumors from growing in the head and neck region in most patients. However, the cancer can recur or can spread to other parts of the body. Cetuximab is a drug that may delay or prevent tumor growth by blocking certain cellular chemical pathways that lead to tumor development. It was approved by the United States Food and Drug Administration (FDA) in 2006 for the treatment of head and neck cancer. The purpose of this study is to determine how easily cetuximab can be added to treatment with radiation therapy in patients with cutaneous cancer of the head and neck. This study will also look at how well cetuximab added to radiation therapy works over time and how well this treatment is tolerated.
Study Details
Timeline
Interventions
400 mg/m2 IV over 120 minutes week 1; 250 mg/m2 IV over 60 minutes weekly weeks 2-7
Radiation Therapy 60-66 Gy in 2 Gy fractions starting week 2 of Cetuximab