This is a non-randomized phase II study of targeted radiotherapy (RT) administered concurrently with panitumumab in patients with locally advanced squamous carcinoma of the head and neck.
This is a non-randomized phase II trial of targeted radiotherapy (RT) administered concurrently with panitumumab in patients with locally advanced squamous cell carcinoma of the head and neck. This protocol addresses patients with medical comorbidities that make them poor candidates for concurrent chemotherapy. Radiotherapy treatment will be directed at disease visible on diagnostic imaging modalities and the ipsilateral hemi-neck, sparing elective regions in the contralateral N0 hemi-neck with less than 20% chance of microscopic involvement. We explore the following hypothesis: Can acceptable locoregional disease control be obtained with less treatment-related morbidity by focusing RT on regions of gross disease, sparing regions with a low risk of harboring subclinical disease from elective RT?
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Weekly panitumumab intravenously at a dosage of 2.5 mg/kg started one week prior to RT until RT is completed. No more than 8 treatments.
The dose per fraction will be 2 Gy per day. Thus, the total number of fractions will be 35. Five days a week for 7 weeks.
Recurrence Rate of Locally Advanced Head & Neck Cancer
Imaging for recurrence via CT scan will occur at 8 weeks (+/-5 days) post-RT, and will be repeated at 6, 9, 12, and 24 months from start of treatment.
Time frame: 2 Years
Patterns of Failure
Evaluate locoregional recurrences to see if they arise in regions that were spared vs. treated, and assess long-term control after salvage therapy.
Time frame: 2 Years
Time to Relapse
Imaging for recurrence via CT scan will occur at 8 weeks (+/-5 days) post-RT, and will be repeated at 6, 9, 12, and 24 months from start of treatment.
Time frame: first day of therapy to the first sign of progressive disease
Morbidity of Treatment
Toxicity will be assessed according to the NCI CTCAE v4.
Time frame: From screening until 30 days after treatment
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