A Randomized Phase II/Phase III Study of Adjuvant Concurrent Radiation and Chemotherapy Versus Radiation Alone in Resected High-Risk Malignant Salivary Gland Tumors
A Randomized Phase II/Phase III Study of Adjuvant Concurrent Radiation and Chemotherapy Versus Radiation Alone in Resected High-Risk Malignant Salivary Gland Tumors
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.
OBJECTIVES:
Primary
Phase II
Phase III
* Compare overall survival rates among patients receiving cisplatin and radiation to those receiving radiation alone.
Secondary
Phase II/III
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.
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:
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:
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)
Pre-existing ≥ grade 2 neuropathy
No significant pre-existing hearing loss, as defined by the patient or treating physician
PRIOR CONCURRENT THERAPY:
Cameron Park, California 95682, United States
Roseville, California 95661, United States
Sacramento, California 95817, United States
Vacaville, California 95687, United States
Deerfield Beach, Florida 33442, United States
Jacksonville, Florida 32209, United States
Miami, Florida 33136, United States
Louisville, Kentucky 40202, United States
Brownstown, Michigan 48183, United States
Harrisburg, Pennsylvania 17109, United States
American Fork, Utah 84003, United States
Sturgeon Bay, Wisconsin 54235-1495, United States
Summit, Wisconsin 53066, United States
Montreal, Quebec H3H 2R9, Canada