Clinical Trial: Fluorouracil, Hydroxyurea, Cetuximab and Twice-daily Intensity Radiation Therapy for Advanced Head and Neck Cancer
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Phase II Study of Concomitant Fluorouracil, Hydroxyurea, Cetuximab and Hyperfractionated Intensity Modulated Radiation Therapy for Locally Advanced Head and Neck Cancer
Brief Summary: For advanced head and neck cancer, combined radiation and chemotherapy prevents recurrences and for many patients, improves survival. While combined cisplatin and radiation or cetuximab and radiation is more effective than radiation alone, approximately 50% of these patients will still recur. A more aggressive approach may be needed for these patients to prevent recurrence and death. The strategy of using multiple chemotherapy drugs with radiation given twice a day has been tested at Mount Sinai and University of Chicago. Approximately 80% of patients are cured with this strategy. While cure rates are higher than standard chemotherapy and radiation and the treatment is tolerable, side effects during treatment are common. We propose replacing a chemotherapy drug with a less toxic, targeted therapy called cetuximab. Our goal is to reduce toxicity while maintaining or improving cure rates for these patients.
Detailed Summary:
Sponsor: Icahn School of Medicine at Mount Sinai
Current Primary Outcome:
- locoregional control
- survival
Original Primary Outcome: Same as current
Current Secondary Outcome:
- acute and late toxicity
- quality of life
- distant metastases
Original Secondary Outcome: Same as current
Information By: Icahn School of Medicine at Mount Sinai
Dates:
Date Received: April 18, 2007
Date Started: February 2007
Date Completion:
Last Updated: October 12, 2010
Last Verified: June 2008
