A Phase III Study of Postoperative Radiation Therapy with and without Cetuximab for Locally Advanced Resected Head and Neck Cancer

Protocol
10-081
Full Title
A Phase III Study of Postoperative Radiation Therapy (IMRT) +/- Cetuximab For Locally-Advanced Resected Head and Neck Cancer (RTOG 0920)
Phase
III
Purpose

Surgery followed by radiation therapy is a standard treatment for head and neck cancer. Some cancers have a greater risk of returning. In this study, researchers want to determine if adding the drug cetuximab to radiation therapy after surgery to remove locally advanced head and neck cancer is more effective than surgery plus radiation therapy alone for patients whose tumors are determined to have an intermediate risk of recurring. Patients will be randomly assigned to receive one treatment regimen or the other.

Cetuximab may delay or prevent tumor growth by blocking certain cellular chemical pathways that trigger tumor development. It is already approved for the treatment of head and neck cancers.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have surgically removed stage I-III locally advanced head and neck cancer that is determined to be at intermediate risk of recurrence.
  • Patients may not have had prior chemotherapy or radiation therapy for head and neck cancer.
  • Patients must be age 18 or older.

For more information and to inquire about eligibility for this study, please contact Dr. Nancy Lee at 212-639-3341.

Disease(s)
Head & Neck Cancer
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