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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Progression-free survival (PFS), defined by the events of local-regional progression or recurrence, distant metastasis, or death from any cause, primarily at 2 years — From randomization to 2 years.
Trial sites (268)
Facility
City
Region
Status
University of Alabama at Birmingham Cancer Center
Birmingham
Alabama
The Kirklin Clinic at Acton Road
Birmingham
Alabama
Arizona Breast Cancer Specialists-Gilbert
Gilbert
Arizona
Arizona Center for Cancer Care-Peoria
Peoria
Arizona
Cancer Center at Saint Joseph's
Phoenix
Arizona
Arizona Breast Cancer Specialists-Phoenix
Phoenix
Arizona
Arizona Oncology-Deer Valley Center
Phoenix
Arizona
Arizona Breast Cancer Specialists
Scottsdale
Arizona
Arizona Breast Cancer Specialists-Scottsdale
Scottsdale
Arizona
Arizona Oncology Services Foundation
Scottsdale
Arizona
Arizona Center for Cancer Care-Surprise
Surprise
Arizona
University of Arizona Cancer Center-Orange Grove Campus
Tucson
Arizona
Banner University Medical Center - Tucson
Tucson
Arizona
University of Arizona Cancer Center-North Campus
Tucson
Arizona
Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn
California
AIS Cancer Center at San Joaquin Community Hospital
Bakersfield
California
Mills-Peninsula Medical Center
Burlingame
California
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Cameron Park
California
Mercy San Juan Medical Center
Carmichael
California
City of Hope Comprehensive Cancer Center
Duarte
California
UC San Diego Moores Cancer Center
La Jolla
California
Los Angeles County-USC Medical Center
Los Angeles
California
USC / Norris Comprehensive Cancer Center
Los Angeles
California
Fremont - Rideout Cancer Center
Marysville
California
Memorial Medical Center
Modesto
California
Hoag Memorial Hospital
Newport Beach
California
Saint Joseph Hospital - Orange
Orange
California
Stanford Cancer Institute Palo Alto
Palo Alto
California
Sutter Cancer Centers Radiation Oncology Services-Roseville
Roseville
California
Sutter Medical Center Sacramento
Sacramento
California
University of California Davis Comprehensive Cancer Center
Sacramento
California
UCSF Medical Center-Mount Zion
San Francisco
California
UCSF Medical Center-Mission Bay
San Francisco
California
Sutter Cancer Centers Radiation Oncology Services-Vacaville
Vacaville
California
Rocky Mountain Cancer Centers-Aurora
Aurora
Colorado
University of Colorado Hospital
Aurora
Colorado
Boulder Community Hospital
Boulder
Colorado
Penrose-Saint Francis Healthcare
Colorado Springs
Colorado
Porter Adventist Hospital
Denver
Colorado
Swedish Medical Center
Englewood
Colorado
+ 228 more sites — see the full list on the official registry below.
More Radiation Therapy Oncology Group trials in Canada
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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