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

Conditions

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

Trial Phase

Phase III

Trial Purpose and Description

Trial Purpose


Participation Guidelines

Age:
18 Years and older
Gender:
Both

Eligibility Criteria

DISEASE CHARACTERISTICS:

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cancer extending to within 5 mm of a surgical margin, and/or an initially focally positive margin that is subsequently superseded by intraoperative negative margins (similarly, patients whose tumors had focally positive margins in the main specimen but negative margins from re-excised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

PATIENT CHARACTERISTICS:

  • Zubrod performance status 0-1
  • Absolute granulocyte count = 1,500/mm³
  • Platelet co
Sponsor:
Radiation Therapy Oncology Group
Dates:
08/05/2011
Last Updated:
Study HIC#:
1106008671