Randomized Phase II/III Trial of Surgery and Postoperative Radiation Delivered With Concurrent Cisplatin Versus Docetaxel Versus Docetaxel and Cetuximab for High-Risk Squamous Cell Cancer of the Head and Neck

This randomized phase II/III trial studies how well radiation therapy works when given together with cisplatin compared to docetaxel or cetuximab and docetaxel after surgery in treating patients with stage III-IV squamous cell head and neck cancer. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. 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 transmit tumor killing molecules to them. It is not yet known whether radiation therapy is more effective when given with cisplatin, docetaxel, or cetuximab and docetaxel.

Key Eligibility:

• Pathologically (histologically or cytologically) proven diagnosis of head and neck squamous cell carcinoma (HNSCC) involving the oral cavity, oropharynx (p16 negative), larynx, or hypopharynx within 63 days of registration

• Patients must have undergone gross total surgical resection within 63 days prior to registration

• Patients must have at least 1 of the following high-risk pathologic features: extracapsular nodal extension or invasive cancer at the primary tumor resection margin (tumor or ink)

• Pathologic stage III or IV head and neck squamous cell carcinoma (HNSCC), including no distant metastases, based upon the minimum diagnostic workup listed on Clinicaltrials.gov.
Phase II/III
Oral, Head and Neck
Paul Montgomery, M.D.
Brenda Fisher

The Pacific Cancer Research Consortium clinical trials are offered at multiple locations throughout Oregon, Washington, Alaska, California, and Idaho. To find a location near you, please contact the Patient Engagement Center at 844-552-2734.