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

Description

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.

Phase

Phase 2 - takes the treatment one step further, assessing the activity of a particular therapy in a disease, often building upon leads from the Phase I trial. While patients are generally required to be previously untreated, participation in a Phase II trial doesn't usually preclude the patient from getting the standard treatment after they've received the investigational agent. At best they are allowed to get a new drug they wouldn't be able to get otherwise that may turn out to be better for their disease.

Inclusion and Exclusion Criteria

  • 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

Sites

  • California

    • UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California, 94115
  • Idaho

    • Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center, Boise, Idaho, 83706
  • Colorado

    • Penrose Cancer Center at Penrose Hospital, Colorado Springs, Colorado, 80933
    • Swedish Medical Center, Englewood, Colorado, 80110
    • Porter Adventist Hospital, Denver, Colorado, 80210
    • North Suburban Medical Center, Thornton, Colorado, 80229
    • Rocky Mountain Cancer Centers - Aurora, Aurora, Colorado, 80012
    • McKee Medical Center, Loveland, Colorado, 80539
  • Oregon

    • Clackamas Radiation Oncology Center, Clackamas, Oregon, 97015
    • Providence St. Vincent Medical Center, Portland, Oregon, 97225
  • Washington

    • Northwest Cancer Specialists at Vancouver Cancer Center, Vancouver, Washington, 98684
  • South Dakota

    • Rapid City Regional Hospital, Rapid City, South Dakota, 57701
  • Oklahoma

    • Oklahoma University Cancer Institute, Oklahoma City, Oklahoma, 73104
  • Texas

    • Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas, Dallas, Texas, 75390
  • Nebraska

    • Methodist Estabrook Cancer Center, Omaha, Nebraska, 68114
  • Iowa

    • Siouxland Hematology-Oncology Associates, LLP, Sioux City, Iowa, 51101
    • John Stoddard Cancer Center at Iowa Methodist Medical Center, Des Moines, Iowa, 50309
    • McFarland Clinic, PC, Ames, Iowa, 50010
  • Louisiana

    • Mary Bird Perkins Cancer Center - Baton Rouge, Baton Rouge, Louisiana, 70809
  • Illinois

    • Cancer Institute at St. John's Hospital, Springfield, Illinois, 62702
  • Mississippi

    • University of Mississippi Cancer Clinic, Jackson, Mississippi, 39216
  • Wisconsin

    • Medical College of Wisconsin Cancer Center, Milwaukee, Wisconsin, 53226
    • St. Mary's Hospital Medical Center - Green Bay, Green Bay, Wisconsin, 54303
    • Bay Area Cancer Care Center at Bay Area Medical Center, Marinette, Wisconsin, 54143
  • Kentucky

    • James Graham Brown Cancer Center at University of Louisville, Louisville, Kentucky, 40202
  • Indiana

    • Center for Cancer Care at Goshen General Hospital, Goshen, Indiana, 46526
  • Ohio

    • Charles M. Barrett Cancer Center at University Hospital, Cincinnati, Ohio, 45267
    • Precision Radiotherapy at University Pointe, West Chester, Ohio, 45069
  • Georgia

    • Winship Cancer Institute of Emory University, Atlanta, Georgia, 30322
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