1. Test whether the addition of cetuximab to radiation therapy will improve overall
survival (OS) in postoperative patients with intermediate risk following surgery
2. Assess the impact of the addition of cetuximab to postoperative radiation therapy on
- Disease-free survival (DFS);
- Acute dysphagia, dry mouth, skin toxicity, and other toxicities (CTEP's
Active Version CTCAE) and their relationships to patient-reported outcomes at 3
- Late dysphagia, dry mouth, skin toxicity, and other toxicities (Active Version
CTCAE) and their relationships to patient-reported outcomes at 12 and 24 months.
3. Tumor analysis of EGFR, specifically extent of EGFR over expression by
immunohistochemical (IHC) and FISH analysis, EGFRvIII expression, as well as
association of these assay data with OS and DFS;
4. 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;
5. Tumor DNA analyses of TP53 mutations for response prediction to cetuximab and
6. Germline DNA analyses of polymorphic variants in EGFR intron repeat for response
prediction to cetuximab.
Tertiary Objectives (Exploratory)
1. Assess the impact of the addition of cetuximab to postoperative radiation therapy on
- 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).
2. 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);
3. 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.
Pathologically proven diagnosis of squamous cell carcinoma (including variants such as
verrucous carcinoma, spindle cell carcinoma, carcinoma NOS, etc.) of the head/neck (oral
cavity, oropharynx or larynx); clinical stage T2-3, N0-2, M0 or T1, N1-2, M0.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
RTOG 0920: A Phase III Study of Postoperative Radiation Therapy (IMRT) +/- Cetuximab for Locally-Advanced Resected Head and Neck Cancer
Primary Objective 1. Test whether the addition of cetuximab to radiation therapy will improve overall survival (OS) in postoperative patients with intermediate risk following surgery
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