RTOG 0920: A Phase III Study of Postoperative Radiation Therapy (IMRT) +/- Cetuximab for Locally-Advanced Resected Head and Neck Cancer

Summary:
The standard of care for head and neck cancer is surgery and/or radiation therapy.  In the last several years, randomized trials have shown that the addition of concurrent chemotherapy (chemotherapy at the same time as radiation) improves outcomes for selected subjects.  We will determine the effects of concurrent chemo-radiation therapy by comparing the results to subjects who only receive radiation therapy.  In this study, patients will either get radiation therapy alone or radiation with chemotherapy. Cetuximab (Erbitux) is an approved drug that may delay or prevent tumor growth by blocking certain pathways that lead to tumor development and will be used for this study.

Eligibility and Treatment Plan:

• Diagnosis of squamous cell carcinoma of the head/neck.
• Adequate hepatic (liver) and renal (kidney) function.
• Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control.

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