A Randomized Phase II/Phase III Study of Adjuvant Concurrent Radiation and Chemotherapy Versus Radiation Alone in Resected High-Risk Malignant Salivary Gland Tumors

• DISEASE CHARACTERISTICS:

• 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 acinic cell carcinoma or high-grade (>30% solid component) adenoid cystic carcinoma

• Surgical resection with curative intent within 8 weeks prior to registration

• All patients must have a Medical Oncology evaluation within 4 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)

• No patients with residual macroscopic disease after surgery

• No prior systemic chemotherapy or radiation therapy for salivary gland malignancy

• PATIENT CHARACTERISTICS:

• Zubrod performance status 0-1

• Absolute neutrophil count (ANC) ≥ 1,800 cells/mm^3

• Platelets ≥ 100,000 cells/mm^3

• Hemoglobin ≥ 8.0 g/dL (the use of transfusion or other intervention to achieve hemoglobin ≥ 8.0 g/dL is acceptable)

• Serum creatinine < 2.0 mg/dL

• Total bilirubin < 2 x the institutional upper limit of normal (ULN)

• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 3 x the institutional ULN

• Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential

• Women of childbearing potential and male participants who are sexually active must practice adequate contraception during treatment and for 6 weeks following treatment

• Not pregnant or nursing

• Patients must be deemed able to comply with the treatment plan and follow-up schedule

• Patients must provide study specific informed consent prior to study entry, including consent for mandatory tissue submission for central review

• 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 severe, active co-morbidity, defined as follows:

• Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months

• Transmural myocardial infarction within the last 6 months

• Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration

• Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration

• Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects (coagulation parameters are not required for entry into this protocol)

• Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control (CDC) definition (HIV testing is not required for entry into this protocol)

• Protocol-specific requirements may also exclude immunocompromised patients

• Pre-existing ≥ grade 2 neuropathy

• No significant pre-existing hearing loss, as defined by the patient or treating physician

• PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No prior systemic chemotherapy or radiation therapy for salivary gland malignancy (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

• No prior organ transplant

• No concurrent hematopoietic growth factors (e.g., G-CSF or pegfilgrastim) during radiotherapy

• No concurrent erythropoiesis-stimulating agents