Phase II Randomized Trial of Radiotherapy with or without Cisplatin for Surgically Resected Squamous Cell Carcinomas of the Head and Neck with TP53 Sequencing

April 9, 2020


Schema – EA3132

Please Note: Below is partial eligibility, for full eligibility requirement’s, please contact GHCI Research Department at (810) 762-8181, (810) 762-8079 and/or (810) 762-8038. Thank you!


  1. Pathologically proven diagnosis of squamous cell carcinoma (including variants such as verrucous carcinoma, spindle cell carcinoma, carcinoma NOS) of the head/neck (oral cavity, oropharynx, hypopharynx or larynx); pathologic stage III or IVA (AJCC 8): T3-T4a, N0-3, M0 or T1-T2, N1-3, M0.
  2. Patient has undergone total resection of the primary tumor with curative intent.
  3. For oropharynx primary tumors, the patient must have negative HPV status of the tumor as determined by p16 protein expression using immunohistochemistry (IHC).
  4. Patients with, per the operative and/or pathology report, positive margin(s) [tumor present at the cut or inked edge of the tumor] which is not superseded by an additional margin of tumor-negative tissue, nodal extracapsular extension, and/or gross residual disease after surgery are not eligible.
  5. At least 18 years of age.
  6. Patients with a history of a curatively treated malignancy must be disease-free for at least two years except for carcinoma in situ of cervix and/or non-melanomatous skin cancer. Patients must not have received chemotherapy or investigational therapy within two years of surgical resection of the primary tumor.
  7. Patient must not have had previous irradiation to the head and neck that would result in overlap in radiation fields for the current disease.
  8. Patients with recurrent disease or multiple primaries are ineligible.
  9. ECOG Performance Status 0-2.

Genesys Hurley Cancer Institute

302 Kensington Avenue (Print a Map)
Flint, MI 48503

810-762-8226 | 888-762-8675

Ascension Genesys Hospital
Hurley Medical Center
Michigan Cancer Consortium


Ⓒ 2020 Genesys Hurley Cancer Institute | All Rights Reserved.