April 9, 2020 Head and Neck

Clinical Trial Information

Schema RTOG 1008

PROTOCOL: RTOG-1008

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

ELIGIBILITY:

  1. Pathologically proven diagnosis of a malignant major salivary gland tumor or malignant minor salivary gland tumor of the head and neck of the following histologic subtypes:
    1.  intermediate-grade adenocarcinoma or intermediate-grade mucoepidermoid
      carcinoma;
       high-grade adenocarcinoma or high-grade mucoepidermoid carcinoma or salivary
      duct carcinoma;
       high-grade acinic cell carcinoma or high-grade (>30% solid component) adenoid
      cystic carcinoma.
    2. Pathologic interpretation of salivary gland malignancies can be very difficult. Patients with diagnoses such as “undifferentiated or poorly differentiated carcinoma”, “carcinoma-ex pleomorphic adenoma”, “carcinoma NOS” and others should be considered for this trial.
  2. Surgical resection with curative intent within 8 weeks prior to registration.
  3. Pathologic stage T3-4 or N1-3 or T1-2, N0 with a close (≤1mm) or microscopically positive surgical margin. Patients must be free of
    distant metastases based upon the following minimum diagnostic workup:

    1.  History/physical examination within 8 weeks prior to registration;
       Radiologic confirmation of the absence of hematogenous metastasis within 12 weeks prior to registration; at a minimum, contrast CT imaging of the chest is required; PET/CT is acceptable.
  4. Zubrod Performance Status 0-1.
  5. Age ≥ 18.
  6.  No residual macroscopic disease after surgery.
  7.  No prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible).
  8.  No prior systemic chemotherapy or radiation therapy for salivary gland malignancy; note that prior chemotherapy for a different cancer is allowable.
  9.  No prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields.


April 9, 2020 Head and Neck

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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