OBJECTIVES:
Primary
Phase II
* Determine the feasibility of conducting a cooperative group prospective clinical trial in patients with resected malignant salivary gland tumors.
* Acquire preliminary efficacy data comparing postoperative radiotherapy alone to concurrent chemotherapy and radiation using weekly cisplatin.
Phase III
\* Compare overall survival rates among patients receiving cisplatin and radiation to those receiving radiation alone.
Secondary
Phase II/III
* Compare the acute toxicities of these 2 adjuvant treatments.
* Compare late treatment-related adverse events in patients receiving postoperative radiation to those receiving concurrent chemoradiation.
* Compare progression-free survival rates among patients receiving cisplatin and radiation to those receiving radiation alone in both the cohort of patients with pathologically high-risk disease (high-grade adenocarcinoma, high-grade mucoepidermoid carcinoma, salivary duct carcinoma), and the patient cohort with pathologically intermediate-risk disease (all other eligible diagnoses).
* Investigate quality of life and patient-reported outcomes in patients enrolled in the study.
* Identify the histopathology and tumor marker expression from patients enrolled on this trial and assemble a tissue bank for future correlative studies.
* Establish a NRG Oncology baseline database for salivary gland malignancies to serve as a resource for future exploration of innovative and/or targeted approaches for this disease.
OUTLINE: This is a multicenter study. Patients are stratified according to histology (high-grade mucoepidermoid carcinoma vs salivary duct carcinoma vs high-grade adenocarcinoma) and nodal status (N0 vs N1-3). Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients undergo 3-dimensional conformal radiotherapy (3D-CRT) or intensity-modulated radiotherapy (IMRT) 5 days a week for 6-6.5 weeks. Patients also receive cisplatin IV over 60 minutes on days 1, 8, 15, 22, 29, 36, and 43 during radiotherapy.
* Arm II: Patients undergo 3D-CRT or IMRT as in Arm I. Tissue and blood samples may be collected for translational research studies. Patients may complete quality-of-life assessments periodically.
After completion of study treatment, patients are followed up at 3, 6, 9, 12, and 24 months, every 6 months for 2 years, and then annually thereafter.
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
Lip, Oral Cavity and Pharynx