April 9, 2020 Head and Neck
Clinical Trial Information
PROTOCOL: RTOG-1008
Please Note: Below is a brief description of eligibility, please contact GHCI Research Department to discuss full eligibility requirements.
ELIGIBILITY:
- 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. - 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.
- intermediate-grade adenocarcinoma or intermediate-grade mucoepidermoid
- Surgical resection with curative intent within 8 weeks prior to registration.
- 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:- 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.
- History/physical examination within 8 weeks prior to registration;
- Zubrod Performance Status 0-1.
- Age ≥ 18.
- No residual macroscopic disease after surgery.
- 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).
- No prior systemic chemotherapy or radiation therapy for salivary gland malignancy; note that prior chemotherapy for a different cancer is allowable.
- No prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields.