Radiation Therapy With or Without Chemotherapy in Treating Patients With High-Risk Malignant Salivary Gland Tumors That Have Been Removed By Surgery

This randomized phase II 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.

Study phase (if other): II/III

Basic eligibility criteria:
Please contact the study coordinator for additional eligibility information.

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

Primary disease category: Cancer

Sponsor: NRG Oncology

Projected enrollment dates: May 2017 to September 2023

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