A Phase 2 Randomized Trial of Radiotherapy Plus Panitumumab Compared to Chemoradiotherapy With Unresected, Locally Advanced Squamous Cell Carcinoma of the Head and Neck
Inclusion Criteria:
Histologically or cytologically confirmed SCC of the oral cavity, oropharynx, hypopharynx
or larynx Stage III or Stage IVa-b (M0) disease according to the American Joint Committee
on Cancer staging manual 6th edition (locally advanced) ECOG performance status of 0 or 1
Bidimensionally measurable disease >/= 10 mm in at least 1 dimension
Exclusion Criteria:
NO Primary tumor of the nasopharynx, sinuses, salivary gland, or skin NO Subjects
requiring prophylactic tracheostomy NO Prior (or concomitant) malignancy (except
non-melanomatous skin cancer or in situ cervical cancer), other than the study disease
(SCCHN), unless treated with curative intent with no evidence of disease for >/= 3 years
NO Prior treatment for locally advanced SSCHN NO Prior surgery for SCCHN (except nodal
sampling or biopsy for study disease) NO Major surgery = 28 days before randomization or
minor surgery = 14 days before randomization with the exception of feeding tube
placement, dental extractions, central venous catheter placement, biopsies and nodal
sampling