A Phase II/III Study of Surgery Followed by Radiation Therapy plus either Cisplatin, Docetaxel, or Both Drugs for High-Risk Squamous Cell Cancer of the Head and Neck

Protocol
13-115
Full Title
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 (RTOG 1216)
Phase
II/III
Purpose

Giving radiation therapy and chemotherapy after surgery reduces the chance that a head and neck cancer may return. Cisplatin is the standard chemotherapy drug that is commonly used and can sensitize tumor cells to radiation therapy. In this study, researchers are comparing the effectiveness of three different treatment regimens for patients with squamous cell carcinoma of the head and neck that has a high chance of returning.

All patients will have had their tumors surgically removed. Patients will then be randomly assigned to one of three therapies: radiation therapy plus cisplatin; radiation plus docetaxel; or radiation plus docetaxel and cetuximab. Docetaxel and cetuximab are approved chemotherapy drugs, but the way they are being given in this study is considered investigational.

Eligibility

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

  • Patients must have stage III or IV high-risk squamous cell cancer of the mouth, oropharynx, larynx, or hypopharynx that was surgically removed within 49 days of entering the study.
  • Patients may not have received radiation therapy or chemotherapy for their cancer.
  • This study is open to patients age 18 and older.

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

Disease(s)
Head & Neck Cancer
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