RTOG 920: A Phase III Study of Postoperative Radiation Therapy (IMRT) +/- Cetuximab for Locally-Advanced Resected Head and Neck Cancer
Aims: The purpose of this study is to compare the good and/or bad effects of adding the drug cetuximab to radiation therapy versus radiation therapy alone in patients with advanced head and neck cancer who are at risk of having their cancer return. The standard treatment for this type of cancer is surgery followed by radiation therapy with the goal of stopping tumors from growing.  However, the cancer can come back or spread to other parts of the body. Cetuximab is a drug that may delay or prevent tumor growth by blocking chemical pathways in cells that lead to tumor development. The chemical pathway that is blocked by cetuximab is known as EGFR or epidermal growth factor receptor.
Diagnosis: Locally-Advanced Resected Head and Neck Cancer
Principal Investigator: Bruce Brockstein, MD
IRB Approval Number: EH10-189
Sponsor: Radiation Therapy Oncology Group
Contact: Interested patients should contact study coordinator Sabina Omercajic, CCRP at 847.570.1066
Open to Enrollment: Yes

E1305: A Phase III Randomized Trial of Chemotherapy with or without Bevacizumab In Patients with Recurrent or Metastatic Head and Neck Cancer
Aims: The purpose of this study is to compare the good and/or bad effects of adding an investigational drug known as bevacizumab to the standard chemotherapy for head and neck cancer. Bevacizumab has been shown to make chemotherapy more effective in several other types of cancer. It is used in the treatment of lung, colorectal, and some breast cancers, but is considered investigational in this study because it has not been approved by the FDA for use in head and neck cancer.
Diagnosis: Metastatic or Recurrent Head and Neck Cancer
Principal Investigator: Bruce Brockstein, MD
IRB Approval Number: EH09-354
Sponsor: Eastern Cooperative Oncology Group
Contact: Interested patients should contact study coordinator Sabina Omercajic, CCRP at 847.570.1066
Open to Enrollment: Yes

RTOG 1016: Phase III Trial of Radiotherapy Plus Cetuximab versus Chemoradiotherapy in HPV-Associated Oropharynx Cancer
Aims: 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 plus the drug cisplatin or radiation therapy plus the drug cetuximab. The two treatments may be comparable in treating head and neck cancer, but radiation and cetuximab may result in less severe side effects. This study is being done in patients whose head and neck cancer was caused by Human Papillomavirus Virus (HPV). Some studies have found that patients with HPV-positive oropharynx cancer have a better response to treatment and live longer. Thus, this study aims to see if treatment with radiation plus cetuximab has less side effects and is as effective as radiation plus cisplatin.
Diagnosis: HPV-Associated Oropharynx Cancer
Principal Investigator: Bruce Brockstein, MD
IRB Approval Number: EH12-288
Sponsor: Radiation Therapy Oncology Group
Contact: Interested patients should contact study coordinator Sabina Omercajic, CCRP at 847.570.1066
Open to Enrollment: Yes

UC10-428B: A T1 Translational Multicenter Randomized Phase II Study of Temsirolimus Versus Cetuximab Plus Temsirolimus in Patients with Recurrent / Metastatic Head and Neck Cancer, Who Failed Prior EGFR-Based Therapy
Aims: The purpose of this study is learn if the drug temsirolimus alone, or in combination with the drug cetuximab, can potentially treat head and neck cancers in patients who previously were treated with cetuximab or another agent in the same class (EGFR inhibitors). The use of temsirolimus alone or in combination with other drugs for head and neck cancer is considered investigational and this is the first full study of this drug in head and neck cancer. Cetuximab is approved for head and neck cancers.
Diagnosis: Recurrent or Metastatic Head and Neck Cancer
Principal Investigator: Bruce Brockstein, MD
IRB Approval Number: EH12-016
Sponsor: University of Chicago
Contact: Interested patients should contact study coordinator Sabina Omercajic, CCRP at 847.570.1066
Open to Enrollment: Yes

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