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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
33
250 mg/m2 on Day 1 after the first dose of radiation was administered to all patients
500 mg orally every 12 hours with the morning dose administered 2 hours before radiation
continuous-infusion 5-FU at a dose of 600 mg/m2 daily for 120 hours
Radiotherapy was administered at 1.5 Gy per fraction twice daily with treatments separated by at least 6 hours on Days 1 through 5 on an alternating week schedule. Radiation was delivered with intensity-modulated radiation therapy (IMRT) planning for all patients.
Mount Sinai School of Medicine
New York, New York, United States
Llocoregional Recurrence
Percentage of Participants with Loco-regional recurrence.
Time frame: 2 years
Survival
Overall Survival - Percentage of Participants who survived Disease-Free Survival - measured from the initiation of nonsurgical treatment to either the last follow-up, disease progression, or death using intent-to-treat methodology
Time frame: 2 years
Long- Term Toxicity
Grade 3 toxicities events
Time frame: 2 years
UW-QOLR: Quality of Life Score
University of Washington Quality of Life (UW-QOLR) questionnaire - covers 12 domains - pain, appearance, activity, recreation, swallowing, chewing, speech, shoulder function, taste, saliva, mood and anxiety. Each domain have between 3 and 6 response options that are scaled evenly from 0 (worst) to 100 (best) according to the hierarchy of response and reported as one composite score from 0 (worst) to 100 (best).
Time frame: 2 years
Distant Metastases
Percentage of participants who did not have distant control
Time frame: 2 years
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