Protocol: NRG – HN009

SCHEMA HN009

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!

Eligibility:

1. Pathologically (histologically or cytologically) proven diagnosis of SCCHN of the oropharynx, larynx, hypopharynx, or p16-positive unknown primary prior to registration;
   specimen from cervical lymph nodes with a well-defined primary site documented clinically or radiologically is acceptable; in patients with carcinoma of unknown primary
   this will be sufficient for pathologic confirmation without a clinically or radiographically defined primary site. For patients with oropharyngeal cancer (OPC)/cancer of unknown primary (CUP): P16 status based on local site immunohistochemical tissue staining is required. A cell block obtained from a fine needle aspiration (FNA) biopsy specimen may be used as the sole diagnostic tissue. Centers are encouraged to contact the pathology chair for clarification.  Note: Institutions must screen patients for p16 status by immunohistochemistry (IHC) in order to be eligible for the trial using a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory. A rigorous laboratory accreditation process similar to the U.S. CLIA certification, such as the provincial accreditation status offered by the Ontario Laboratory Accreditation (OLA) Program in Canada, the College of American Pathologists (CAP), or an equivalent accreditation in other countries, is acceptable. The p16 results must be reported on the pathology report being submitted. The p16 positivity is defined as > 70% of tumor cells showing strong nuclear and/or cytoplasmic immunostaining with p16 antibody.  For patients with laryngeal and hypopharyngeal primaries: Analysis of p16 status is NOT required.
2. Patients must have clinically or radiographically evident measurable disease at the primary site or at nodal stations. Simple tonsillectomy or local excision of the primary
   without removal of nodal disease is permitted, as is excision removing gross nodal disease but with intact primary site. Limited neck dissections retrieving ≤ 4 nodes are
   permitted and considered as non-therapeutic nodal excisions.
3. History/physical examination within 60 days prior to registration.
4. Age ≥ 18.
5. Zubrod (ECOG) performance status of 0-1 within 14 days prior to registration.

Ineligibility:

1. Patients with oral cavity cancer, nasopharynx cancer, or p16-negative cancer of unknown primary (CUP).
2. Recurrence of the study cancer.
3. Definitive clinical or radiologic evidence of distant metastatic disease.
4. Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable, however, any prior exposure to cisplatin is excluded.
5. Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields.

PROTOCOL: ECOG-EA3132

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!

ELIGIBILITY:

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.