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A Phase II Trial of Chemoradiotherapy Alone or with Vandetanib for High-Risk Advanced Squamous Cell Carcinoma of the Head and Neck
[Protocol 09-103]
- Full Title :
- A RANDOMIZED PHASE II TRIAL OF CHEMORADIOTHERAPY VERSUS CHEMORADIOTHERAPY AND VANDETANIB FOR HIGH-RISK POSTOPERATIVE ADVANCED SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK (RTOG 0619)
- Purpose :
Chemotherapy plus radiation therapy is often given to patients with advanced head and neck cancer after surgery to increase the chance of a cure and reduce the risk of recurrence. Nevertheless, these tumors frequently recur despite these treatments.
The purpose of this study is to see if adding an investigational drug called vandetanib to chemoradiotherapy is more effective than chemoradiotherapy alone. Vandetanib kills tumor cells in a different way than standard chemotherapy and radiation therapy. It interferes with cell communication and growth and reduces the growth of new blood vessels. Vandetanib may delay the growth of tumor cells.
Patients in this study will be randomly assigned to receive chemoradiotherapy alone or in combination with vandetanib.
- 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 squamous cell carcinoma of the head and neck that has not metastasized to distant sites and has been surgically removed.
- Patients may not have received prior chemotherapy or radiation therapy for head and neck cancer.
- At least 3 weeks must have passed since major surgery and entry into the study.
- 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.
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