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Research & Trial Information

SCHEMA RTOG-1008

Protocol#: RTOG – 1008

Cancer Type: Head & Neck

Patient 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:
    •     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. 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.
  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
  8. for a minimum of 3 years (for example, carcinoma in situ of the breast, oral cavity, or
  9. cervix are all permissible).
  10. No prior systemic chemotherapy or radiation therapy for salivary gland malignancy; note that prior chemotherapy for a different cancer is allowable.
  11. No prior radiotherapy to the region of the study cancer that would result in overlap ofradiation therapy fields.


Research & Trial Information

SCHEMA EA3132

Protocol#: ECOG – EA3132

Cancer Type: Head & Neck

Patient 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.
  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and/or pathology report, positive margin(s) [tumor present at the cut or inked edge of the tumor] which is not superceded by an additional margin of tumor-negative tissue, nodal extracapsular extension, and/or gross residual disease after surgery are not eligible.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.
  9. Per the operative report, the gross total resection of the primary tumor with curative intent was completed within 8 weeks prior to randomization.
  10. Patient has ECOG Performance Status 0-1 within 2 weeks prior to randomization

Genesys Hurley Cancer Institute

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Flint, MI 48503

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