Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in
chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells,
either by killing the cells or by stopping them from dividing. It is not yet known whether
radiation therapy is more effective when given together with chemotherapy or alone after
surgery in treating salivary gland tumors.
PURPOSE: This randomized phase II/III trial is studying radiation therapy with or without
chemotherapy to see how well it works in treating patients with high-risk malignant salivary
gland tumors that have been removed by surgery.
Phase
Phase 2
Funding Agency/Sponsor
National Cooperative Group
Disease
Head and Neck Cancer
Enrollment Eligibility
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