Zoledronate in Preventing Skeletal (Bone)-Related Events in Patients Who Are Receiving Androgen Deprivation Therapy For Prostate Cancer and Bone Metastases
A total of 680 patients (340 per treatment arm) will be accrued for this study within 4 years.
This is a randomized, double-blind, placebo-controlled, multicenter study followed by an open-label study. Patients are stratified according to ECOG performance status (0-1 vs 2), prior skeletal-related event (no vs yes), and serum alkaline phosphatase (< upper limit of normal [ULN] vs ≥ ULN). Patients are randomized to 1 of 2 treatment arms.
In both arms, courses repeat every 4 weeks in the absence of disease progression or a skeletal-related event. All patients receive concurrent androgen deprivation therapy. Patients also receive oral calcium and cholecalciferol (vitamin D) supplements daily.
Patients progressing to androgen-independent prostate cancer proceed to open-label therapy comprising zoledronate IV over 15 minutes on day 1. Courses repeat every 3 weeks in the absence of disease progression or a skeletal-related event.
Patients are followed periodically for approximately 10 years after randomization.
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| U.S.A. |
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| Arkansas |
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Ft. Smith |
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| | Hembree Mercy Cancer Center at St. Edward Mercy Medical Center |
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| | John Wells, MD | |
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Little Rock |
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| | Arkansas Cancer Research Center at University of Arkansas for Medical Sciences |
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| | Clinical Trial Office - Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | |
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| California |
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Burbank |
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| | Providence Saint Joseph Medical Center - Burbank |
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| | Clinical Trials Office - Providence Saint Joseph Medical Center - Burbank | |
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Loma Linda |
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| | Veterans Affairs Medical Center - Loma Linda (Pettis) |
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| | Mark Reeves, MD, PhD | |
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Pomona |
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| | Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center |
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| | Clinical Trials Office - Robert and Beverly Lewis Family Cancer Care Center | |
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San Francisco |
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| | UCSF Helen Diller Family Comprehensive Cancer Center |
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| | Clinical Trials Office - UCSF Helen Diller Family Comprehensive Cancer Center | |
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| Colorado |
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Aurora |
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| | University of Colorado Cancer Center at UC Health Sciences Center |
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| | Clinical Trials Office - University of Colorado Cancer Center | |
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Montrose |
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| | Montrose Memorial Hospital Cancer Center |
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| | Clinical Trials Office - Montrose Memorial Hospital Cancer Center | |
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| Delaware |
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Lewes |
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| | Tunnell Cancer Center at Beebe Medical Center |
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| | Clinical Trials Office - Tunnell Cancer Center | |
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Newark |
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| | CCOP - Christiana Care Health Services |
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| | Clinical Trial Office - CCOP - Christiana Care Health Services | |
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| District of Columbia |
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Washington |
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| | Lombardi Comprehensive Cancer Center at Georgetown University Medical Center |
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| | Clinical Trials Office - Lombardi Comprehensive Cancer Center | |
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| Florida |
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Jacksonville |
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| | Mayo Clinic - Jacksonville |
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| | Clinical Trials Office - All Mayo Clinic Locations | |
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Leesburg |
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| | Cancer Centers of Central Florida, PA |
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| | Donald Elmajian, MD | |
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| Georgia |
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Augusta |
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| | MBCCOP - Medical College of Georgia Cancer Center |
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| | Anand Jillella, MD | |
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Savannah |
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| | Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler |
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| | Mark Taylor, MD | |
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| Idaho |
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Idaho Falls |
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| | Snake River Oncology of Eastern Idaho PLLC |
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| | Christian Shull | |
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| Illinois |
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Alton |
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| | Saint Anthony's Hospital at Saint Anthony's Health Center |
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| | Bethany Sleckman, MD | |
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Aurora |
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| | Rush-Copley Cancer Care Center |
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| | Kendrith Rowland, MD | |
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Chicago |
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| | University of Chicago Cancer Research Center |
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| | Clinical Trials Office - University of Chicago Cancer Research Center | |
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Elmhurst |
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| | Elmhurst Memorial Hospital |
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| | Gerald Kozuh, MD | |
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Hines |
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| | Veterans Affairs Medical Center - Hines |
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| | Nirmala Bhoopalam, MD | |
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Joliet |
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| | Joliet Oncology-Hematology Associates, Limited - West |
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| | Kendrith Rowland, MD | |
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Kankakee |
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| | Provena St. Mary's Regional Cancer Center - Kankakee |
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| | Riaz Elahi, MD | |
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La Grange |
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| | La Grange Memorial Hospital |
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| | Clinical Trials Office - La Grange Memorial Hospital | |
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Mt. Vernon |
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| | Good Samaritan Regional Health Center |
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| | Bethany Sleckman, MD | |
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Olympia Fields |
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| | Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields |
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| | Clinical Trials Office - Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields | |
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Urbana |
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| | Carle Cancer Center at Carle Foundation Hospital |
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| | Clinical Trials Office - Carle Cancer Center | |
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| | CCOP - Carle Cancer Center |
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| | Clinical Trials Office - CCOP - Carle Cancer Center | |
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| Indiana |
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Indianapolis |
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| | Indiana University Melvin and Bren Simon Cancer Center |
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| | Clinical Trials Office - Indiana University Cancer Center | |
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| | William N. Wishard Memorial Hospital |
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| | Noah Hahn | |
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Michigan City |
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| | Saint Anthony Memorial Health Centers |
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| | Kendrith Rowland, MD | |
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| Iowa |
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Council Bluffs |
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| | Alegent Health Mercy Hospital |
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| | Gamini Soori, MD, FACP, FRCP, MBA | |
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| | Heartland Oncology and Hematology |
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| | John Okerbloom, MD | |
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Waterloo |
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| | Cedar Valley Medical Specialists, PC - West Ridgeway Avenue |
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| | Boriana Kamenova | |
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| | Covenant Cancer Treatment Center |
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| | Clinical Trials Office - Covenant Cancer Treatment Center | |
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| Kansas |
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Kansas City |
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| | Providence Medical Center |
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| | Rakesh Gaur, MD | |
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Lawrence |
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| | Lawrence Memorial Hospital |
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| | Rakesh Gaur, MD | |
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Overland Park |
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| | Johnson County Radiation Therapy |
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| | Rakesh Gaur, MD | |
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| | Menorah Medical Center |
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| | Rakesh Gaur, MD | |
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Shawnee Mission |
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| | Shawnee Mission Medical Center |
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| | Rakesh Gaur, MD | |
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Topeka |
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| | Cotton-O'Neil Cancer Center |
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| | Clinical Trials Office - Cotton-O'Neil Cancer Center | |
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| | St. Francis Comprehensive Cancer Center |
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| | Michael Hurwitz, MD | |
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| Louisiana |
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Monroe |
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| | Louisiana State University Health Sciences Center - Monroe |
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| | Donald Elmajian, MD | |
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Shreveport |
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| | Feist-Weiller Cancer Center at Louisiana State University Health Sciences |
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| | Clinical Trials Office - Feist-Weiller Cancer Center at Louisiana State University Health Sciences | |
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| | Highland Clinic |
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| | Donald Elmajian, MD | |
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| | Veterans Affairs Medical Center - Shreveport |
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| | Donald Elmajian, MD | |
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| Maine |
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Lewiston |
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| | Central Maine Comprehensive Cancer Center at Central Maine Medical Center |
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| | Nicholette Erickson, MD | |
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Waterville |
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| | MaineGeneral Medical Center - Waterville |
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| | Clinical Trials Office - MaineGeneral Medical Center - Waterville | |
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| Maryland |
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Baltimore |
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| | Greenebaum Cancer Center at University of Maryland Medical Center |
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| | Clinical Trials Office - Greenebaum Cancer Center at University of Maryladn Medical Center | |
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| | Veterans Affairs Medical Center - Baltimore |
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| | Arif Hussain, MD | |
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Easton |
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| | Shore Regional Cancer Center at Memorial Hospital - Easton |
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| | John P. Foley, MD | |
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Elkton MD |
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| | Union Hospital Cancer Program at Union Hospital |
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| | Stephen Grubbs, MD | |
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Largo |
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| | Kaiser Permanente Mid-Atlantic Medical Group-Largo Medical Facility |
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| | Leon Hwang, MD | |
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Lutherville |
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| | Kaiser Permanente - Towson |
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| | Leon Hwang, MD | |
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Rockville |
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| | Kaiser Permanente Capital Area Medical Group - Shady Grove Facility |
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| | Leon Hwang, MD | |
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| Massachusetts |
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Boston |
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| | Boston University Cancer Research Center |
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| | Clinical Trials Office - Boston University Cancer Research Center | |
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| | Dana-Farber/Brigham and Women's Cancer Center |
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| | Clinical Trials Office | |
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| | Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute |
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| | Matthew Smith, MD | |
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| | Massachusetts General Hospital |
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| | Clinical Trials Office - Massachusetts General Hospital | |
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| Michigan |
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Adrian |
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| | Hickman Cancer Center at Bixby Medical Center |
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| | Clinical Trials Office - Hickman Cancer Center at Bixby Medical Center | |
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Detroit |
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| | Josephine Ford Cancer Center at Henry Ford Hospital |
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| | Robert Chapman, MD | |
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Escanaba |
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| | Green Bay Oncology, Limited - Escanaba |
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| | Thomas Saphner, MD, FACP | |
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Iron Mountain |
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| | Dickinson County Healthcare System |
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| | Thomas Saphner, MD, FACP | |
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Kalamazoo |
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| | Borgess Medical Center |
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| | Raymond Lord, MD | |
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| | Bronson Methodist Hospital |
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| | Raymond Lord, MD | |
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| | West Michigan Cancer Center |
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| | Clinical Trials Office - West Michigan Cancer Center | |
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Lambertville |
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| | Haematology-Oncology Associates of Ohio and Michigan, PC |
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| | Paul Schaefer, MD | |
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Monroe |
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| | Community Cancer Center of Monroe |
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| | Paul Schaefer, MD | |
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| | Mercy Memorial Hospital - Monroe |
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| | Paul Schaefer, MD | |
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| Minnesota |
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Burnsville |
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| | Fairview Ridges Hospital |
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| | Patrick Flynn, MD | |
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Coon Rapids |
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| | Mercy and Unity Cancer Center at Mercy Hospital |
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| | Patrick Flynn, MD | |
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Duluth |
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| | CCOP - Duluth |
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| | Daniel Nikcevich, MD, PhD | |
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| | Duluth Clinic Cancer Center - Duluth |
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| | Clinical Trials Office - Duluth Clinic Cancer Center - Duluth | |
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| | Miller - Dwan Medical Center |
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| | Daniel Nikcevich, MD, PhD | |
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Edina |
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| | Fairview Southdale Hospital |
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| | Clinical Trials Office - Fairview Southdale Hospital | |
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Fridley |
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| | Mercy and Unity Cancer Center at Unity Hospital |
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| | Patrick Flynn, MD | |
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Mankato |
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| | Immanuel St. Joseph's |
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| | Glenn Harman, MD | |
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Maplewood |
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| | Minnesota Oncology Hematology, PA - Maplewood |
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| | Patrick Flynn, MD | |
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Minneapolis |
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| | Masonic Cancer Center at University of Minnesota |
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| | Clinical Trials Office - Masonic Cancer Center at University of Minnesota | |
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| | Virginia Piper Cancer Institute at Abbott - Northwestern Hospital |
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| | Clinical Trials Office - Virginia Piper Cancer Institute | |
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Robbinsdale |
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| | Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center |
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| | Clinical Trials Office - Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center | |