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A Phase III Study of Postoperative Radiation Therapy (IMRT) +/- Cetuximab for Locally-Advanced Resected Head and Neck Cancer

Primary Objective Test whether the addition of cetuximab to radiation therapy will improve overall survival (OS) in postoperative patients with intermediate risk following surgery Secondary Objectives (6/4/10) Assess the impact of the addition of cetuximab to postoperative radiation therapy on the following: Disease-free survival (DFS); Acute dysphagia, dry mouth, skin toxicity, and other toxicities (CTCAE, v. 4) and their relationships to patient-reported outcomes at 3 months; Late dysphagia, dry mouth, skin toxicity, and other toxicities (CTCAE, v. 4) and their relationships to patient-reported outcomes at 12 and 24 months. Tumor analysis of EGFR, specifically extent of EGFR overexpression by immunohistochemical (IHC) and FISH analysis, EGFRvIII expression, as well as association of these assay data with OS and DFS; Tumor analysis of HPV infection (as defined by in situ hybridization), specifically, within the cohort of patients with oropharynx cancer, to perform an exploratory analysis of the impact of HPV on DFS and OS in this patient subset; Tumor DNA analyses of TP53 mutations for response prediction to cetuximab and prognosis; Germline DNA analyses of polymorphic variants in EGFR intron repeats for response prediction to cetuximab. Tertiary Objectives (Exploratory) Assess the impact of the addition of cetuximab to postoperative radiation therapy on the following: Local-regional control; Patient-reported quality of life (QOL), swallowing, xerostomia, and skin toxicity based on head and neck specific instruments, including: the Performance Status Scale for Head and Neck Cancer (PSS-HN), the Functional Assessment of Cancer Therapy-Head & Neck (FACT-H&N), the University of Michigan Xerostomia-Related Quality of Life Scale (XeQOLS), and the Dermatology Life Quality Index (DLQI); Cost-utility analysis using the EuroQol (EQ-5D). To evaluate the utility of IGRT as a means of enhancing the efficacy (i.e., local-regional control) of IMRT while reducing the acute and/or late toxicity (particularly xerostomia) and improving patient-reported outcomes (particularly scores with the XeQOLS); To retrospectively compare the local regional control rate for patients treated with IMRT alone (no IGRT or cetuximab) with similar patients treated with external beam radiation alone in the postoperative trial, RTOG 95-01.

Primary Objective Test whether the addition of cetuximab to radiation therapy will improve overall survival (OS) in postoperative patients with intermediate risk following surgery Secondary Objectives (6/4/10) Assess the impact of the addition of cetuximab to postoperative radiation therapy on the following: Disease-free survival (DFS); Acute dysphagia, dry mouth, skin toxicity, and other toxicities (CTCAE, v. 4) and their relationships to patient-reported outcomes at 3 months; Late dysphagia, dry mouth, skin toxicity, and other toxicities (CTCAE, v. 4) and their relationships to patient-reported outcomes at 12 and 24 months. Tumor analysis of EGFR, specifically extent of EGFR overexpression by immunohistochemical (IHC) and FISH analysis, EGFRvIII expression, as well as association of these assay data with OS and DFS; Tumor analysis of HPV infection (as defined by in situ hybridization), specifically, within the cohort of patients with oropharynx cancer, to perform an exploratory analysis of the impact of HPV on DFS and OS in this patient subset; Tumor DNA analyses of TP53 mutations for response prediction to cetuximab and prognosis; Germline DNA analyses of polymorphic variants in EGFR intron repeats for response prediction to cetuximab. Tertiary Objectives (Exploratory) Assess the impact of the addition of cetuximab to postoperative radiation therapy on the following: Local-regional control; Patient-reported quality of life (QOL), swallowing, xerostomia, and skin toxicity based on head and neck specific instruments, including: the Performance Status Scale for Head and Neck Cancer (PSS-HN), the Functional Assessment of Cancer Therapy-Head & Neck (FACT-H&N), the University of Michigan Xerostomia-Related Quality of Life Scale (XeQOLS), and the Dermatology Life Quality Index (DLQI); Cost-utility analysis using the EuroQol (EQ-5D). To evaluate the utility of IGRT as a means of enhancing the efficacy (i.e., local-regional control) of IMRT while reducing the acute and/or late toxicity (particularly xerostomia) and improving patient-reported outcomes (particularly scores with the XeQOLS); To retrospectively compare the local regional control rate for patients treated with IMRT alone (no IGRT or cetuximab) with similar patients treated with external beam radiation alone in the postoperative trial, RTOG 95-01.