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

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Pathologically proven diagnosis of a malignant major salivary gland tumor of the
following histologic subtypes:

- High-grade mucoepidermoid carcinoma

- Salivary duct carcinoma

- High-grade adenocarcinoma

- 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 patients with salivary gland malignancies originating from the minor salivary
glands

- No patients with histologies other than high-grade mucoepidermoid carcinoma,
high-grade adenocarcinoma, or salivary duct carcinoma

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