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Clinical Trials

Head and Neck Protocols

Please check with your physician for additional protocols and/or information.

1.  E1305:  A Phase III Randomized Trial of Cisplatin & Docetaxel with or without Bevacizumab in Patients with Recurrent or Metastatic Head and Neck Cancer

The purpose of this study is to compare the effects (good and bad) of the addition of a drug called bevacizumab to the standard chemotherapy to see which works better. We will determine if the combination of standard chemotherapy (cisplatin and docetaxel, cisplatin and 5-FU, carboplatin and docetaxel, or carboplatin and 5-FU) and bevacizumab can increase the effectiveness of treatment for head and neck cancer. This combination is experimental. We will determine if adding bevacizumab to standard therapy produces results that are better than those we would ordinarily expect. Currently, we do not know whether using bevacizumab will be effective.  This is a subject of this study. Bevacizumab is approved by the Food and Drug Administration (FDA) for another type of cancer, colorectal cancer, but is not approved for head and neck cancer.

2.  RTOG 0920:  A Phase III Study of Radiation Therapy +/- Cetuximab for Intermediate Risk Resected Head and Neck Cancer

The purpose of this study is to compare the effects, good and/or bad, of radiation therapy alone with radiation therapy and cetuximab on you and your cancer to find out which is better.  In this study, you will get either radiation therapy alone OR radiation therapy and cetuximab.

3.  RTOG 1016:  A Phase III Trial of Radiotherapy + Cetuximab vs. Chemoradiotherapy in HPV- Associated Oropharynx Cancer

The purpose of this study is to compare the effects, good and/or bad, of two standard treatments for head and neck cancer: radiation therapy and cisplatin or radiation therapy and cetuximab. The two treatments may be comparable in treating your cancer, but radiation and cetuximab may result in less severe side effects.

4.  RTOG 1216:  A Randomized Phase II/III Trial of Surgery and Postoperative RT Delivered with Concurrent Cisplatin vs. Docetaxel vs. Docetaxel and Cetuximab for High-Risk Squamous Cell Cancer of the Head and Neck

The purpose of the this part of this study is to find out what effects, good and/or bad, one of the following treatments has on you and your cancer. In this part of the study, you will receive one of the following treatments:

  • Standard treatment: radiation therapy and cisplatin
  • Experimental treatment: radiation therapy and docetaxel
  • Experimental treatment: radiation therapy, docetaxel, and cetuximab

Cisplatin and docetaxel are standard chemotherapy drugs. The dose and schedule of docetaxel given in this part of the study is considered experimental.

Cetuximab is a drug that blocks the epidermal growth factor receptor, a protein that affects cancer growth and many other functions.

5.  E1311:  A Randomized Placebo Controlled Phase II Trial of Afatinib as Adjuvant Therapy Following Chemoradiation in Patients with Head and Neck Squamous Cell Carcinoma at High Risk of Recurrence

The purpose of this study is to find out whether afatinib can improve survival after completion of your initial therapy using chemoradiation and neck surgery. Afatinib is investigational and has not been approved by the FDA for use in this cancer.

For more information on these protocols or any other research, please contact your physician or our clinical research coordinator, Jessica Gerlach, CCRP at 845-333-1133.

Orange Regional Medical Center
707 East Main Street
Middletown, NY 10940
845-333-1000

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Orange Regional Medical Pavilion
75 Crystal Run Road
Middletown, NY 10940
845-695-5800

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