Phase III Study of Postoperative Radiation Therapy (IMRT) +/- Cetuximab for Locally-Advanced Resected Head and Neck Cancer (RTOG 0920) (CIRB)


Head and Neck Cancer | Larynx | Lip, Oral Cavity and Pharynx

Trial Phase

Phase III

Trial Purpose and Description

Trial Purpose

Participation Guidelines

18 Years and older

Eligibility Criteria


Histologically confirmed squamous cell carcinoma (including variants, such as verrucous carcinoma, spindle cell carcinoma, or carcinoma not otherwise specified) of the head and neck, including the following subtypes:

  • Oral cavity
  • Oropharynx
  • Larynx

Clinical stage T1, N1-2, M0 OR T2-4a, N0-2, M0 disease based on the following diagnostic workup within the past 8 weeks:

  • General history and physical examination by a Radiation Oncologist and/or Medical Oncologist
  • Chest x-ray or chest CT scan (with or without contrast) or chest CT/PET scan (with or without contrast)

Must have undergone gross total resection of the primary tumor with curative intent within the past 7 weeks with surgical pathology demonstrating = 1 of the following
criteria for "intermediate" risk of recurrence:

  • Perineural invasion
  • Lymphovascular invasion
  • Single lymph node > 3 cm or = 2 lymph nodes (all < 6 cm) (no extracapsular extension)
  • Close margin(s) of resection, defined as cancer extending to within 5 mm of a surgical margin, and/or an initially focally positive margin that is subsequently superseded by intraoperative negative margins (similarly, patients whose tumors had focally positive margins in the main specimen but negative margins from re-excised samples in the region of the positive margin are eligible)
  • Pathologically confirmed T3 or T4a primary tumor
  • T2 oral cavity cancer with > 5 mm depth of invasion
  • No positive margin(s) (defined as tumor present at the cut or inked edge of the tumor), nodal extracapsular extension, and/or gross residual disease after surgery


  • Zubrod performance status 0-1
  • Absolute granulocyte count = 1,500/mm³
  • Platelet co
Radiation Therapy Oncology Group
Last Updated:
Study HIC#: