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

Clinical Trial Information

Schema EA3132

PROTOCOL: ECOG-EA3132

Please Note: Below is a brief description of eligibility, please contact GHCI Research Department to discuss full eligibility requirements.

ELIGIBILITY:

  1. Age ≥ 18 years.
  2. 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.
  3. Patient has undergone total resection of the primary tumor with curative intent.
    1. NOTE: Patient is to be pre-registered to screening (Step 0) and tissue submitted to Foundation Medicine as soon as possible after surgery in order to meet the 8 week deadline to register the patient to Step 1 after surgery. Full assay minimum turn-around time is 17-24 days.
  4. For oropharynx primary tumors, the patient must have negative HPV status of the tumor as determined by p16 protein expression using immunohistochemistry (IHC).
  5. 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and/or pathology report, positive margin(s) [tumor present at the cut or inked edge of the tumor] which is not superceded by an additional margin of tumor-negative tissue, nodal extracapsular extension, and/or gross residual disease after surgery are not eligible.
  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.

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