Sunitinib Malate or Sorafenib Tosylate in Treating Patients With Kidney Cancer That Was Removed By Surgery (ASSURE)
Clear Cell Renal Cell Carcinoma, Stage I Renal Cell Cancer AJCC v6 and v7, Stage II Renal Cell Cancer AJCC v7
About this trial
This is an interventional treatment trial for Clear Cell Renal Cell Carcinoma
Eligibility Criteria
Inclusion Criteria: Pre-surgical criteria: Patients must have primary-intact renal cell carcinoma, eligible for nephrectomy with curative intent Tumors >= 4 cm AND/OR macroscopic fully resectable nodes AND/OR surgically resectable renal vein thrombus AND/OR surgically resectable inferior vena caval thrombus by radiologic criteria to be clinically >= pT1bNany (resectable) M0 disease Multifocal ipsilateral renal cell carcinoma is allowed provided fully resectable and does not exceed inclusion criteria Patients must have no history of distant metastases No prior anti-cancer therapy for renal cell carcinoma is permitted in either the adjuvant or neoadjuvant setting; this includes metastectomy for renal cell carcinoma, or radiation therapy to the renal bed Patients must not have other current malignancies, other than basal cell skin cancer, squamous cell skin cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breast; patients with other malignancies are eligible if they have been continuously disease-free for >= 5 years prior to the time of registration Patients must have no serious intercurrent illness including, but not limited to, the following: clinically significant cardiovascular disease (e.g. uncontrolled hypertension, myocardial infarction, unstable angina); New York Heart Association grade II or greater congestive heart failure; serious cardiac arrhythmia requiring medication; grade II or greater peripheral vascular disease; or psychiatric illness/social situations that would limit compliance with study requirements Patients must not have any of the following within the 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism Patient must not have ongoing ventricular cardiac dysrhythmias of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0 grade >= 2; patients with a history of serious ventricular arrhythmia (ventricular tachycardia [VT] or ventricular fibrillation [VF] >= 3 beats in a row) are also excluded; additionally, patients with ongoing atrial fibrillation are not eligible Patients must have corrected QT (QTc) interval < 500 msec on baseline electrocardiogram (EKG) Patient must not have hypertension that cannot be controlled by medications (>= diastolic blood pressure 100 mm Hg despite optimal medical therapy) Patient must not have pre-existing thyroid abnormality with thyroid stimulating hormone that cannot be maintained in the normal range with medication If female, patient must not be pregnant or breastfeeding; all females of childbearing potential must have a blood test or urine study within 2 weeks prior to pre-registration to rule out pregnancy; if pre-registration occurs prior to surgery, the blood or urine study must be repeated within 2 weeks prior to randomization to rule out pregnancy; (note: should a woman become pregnant while participating in this study, she should inform her treating physician immediately) Women of child-bearing potential and men must agree to use an accepted and effective method of contraception prior to study entry and for the duration of study participation; should a woman become pregnant while participating in this study, she should inform her treating physician immediately; if a man impregnates a woman while participating in this study, he should inform his treating physician immediately as well Patients with known human immunodeficiency virus (HIV) are excluded ELIGIBILITY CRITERIA FOLLOWING RADICAL OR PARTIAL NEPHRECTOMY The date of randomization must be less than 12 weeks after the date of surgery; patients must have recovered from any surgical related complications Within 4 weeks prior to randomization, patients must meet preoperative eligibility requirements Patients must have histologically or cytologically confirmed renal cell carcinoma. Using 2002 (American Joint Committee on Cancer [AJCC] 6th edition) TNM Staging, patients must be one of the following: pT1b G3-4 N0 (or pNX where clinically N0) M0 pT2 G (any) N0 (or pNX where clinically N0) M0 pT3 G (any) N0 (or pNX where clinically N0) M0 pT4 G (any) N0 (or pNX where clinically N0) M0 or T (any) G (any) N+ (fully resected) M0 Patients with microvascular invasion of the renal vein of any grade or stage (as long as M0) are also eligible Patients must have undergone a full surgical resection (radical nephrectomy or partial nephrectomy) by either open or laparoscopic technique; clinical evidence of lymph node positivity requires removal of all clinically positive nodes; surgeons should designate extent of node dissection; all surgical specimens must have negative margins; patients with positive renal vein margins are eligible unless there is invasion of the renal vein wall at the margin (provided no other margins are positive) Patients must not have collecting duct carcinomas or medullary carcinomas Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 Patients must have an absolute baseline left ventricular ejection fraction (LVEF) of >= 50% by multigated acquisition (MUGA) scan within 4 weeks prior to randomization Patients must have paraffin-embedded tumor specimen available for central core review of tumor histology and other correlative studies; tumor samples will be shipped as specified Patients must have no evidence of residual or metastatic renal cell cancer as documented on computed tomography (CT) scans of the chest, abdomen, and pelvis, all with oral and intravenous (IV) contrast (magnetic resonance imaging [MRI] scans of the abdomen and pelvis with gadolinium and a non-contrast CT of the chest may be substituted if patient is not able to have CT scans with intravenous contrast); patients unable to tolerate either gadolinium or IV contrast should not participate in this study (limitations to a patient's renal function should be taken into consideration when screening for this study) Scans must be obtained within 4 weeks of randomization; changes on these scans that are felt to be post surgical must be documented Patients without reported lymph nodes in the resected surgical specimen and a reported pathologic stage (post-nephrectomy) of pNX MUST undergo a post-operative contrast-enhanced CT scan (or MRI with gadolinium) within 4 weeks of randomization to document that there is no evidence of residual disease Patients must not be taking cytochrome P450 enzyme-inducing antiepileptic drugs (phenytoin, carbamazepine or phenobarbital), St John's Wort, ketoconazole, dexamethasone, the dysrhythmic drugs (terfenadine, quinidine, procainamide, sotalol, probucol, bepridil, indapamide or flecainide), haloperidol, risperidone, rifampin, grapefruit, or grapefruit juice within two weeks of randomization and during the course of therapy; (medications are not prohibited unless listed above); topical and inhaled steroids are permitted Patients must not receive any other investigational anti-cancer agents during the period on study Patients must not have a serious intercurrent illness, including ongoing or active infection requiring parental antibiotics Absolute granulocyte count (AGC) >= 1,500/mm^3 Platelet count >= 100,000/mm^3 Serum creatinine =< 2.0 x upper limit of normal (ULN) or calculated creatinine clearance (CrCl) >= 30 mL/min (neither drug is cleared by the kidney) Total bilirubin =< 1.5 x upper limit of normal (ULN) Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) =< 2.5 x ULN Patients must be able to swallow pills
Sites / Locations
- University of Alabama at Birmingham Cancer Center
- Clearview Cancer Institute
- Mobile Infirmary Medical Center
- Providence Hospital
- University of South Alabama Mitchell Cancer Institute
- Providence Alaska Medical Center
- Fairbanks Memorial Hospital
- Banner Thunderbird Medical Center
- Banner-University Medical Center Phoenix
- Western Regional CCOP
- Mayo Clinic in Arizona
- Banner University Medical Center - Tucson
- Sparks Regional Medical Center
- CHI Saint Vincent Cancer Center Hot Springs
- University of Arkansas for Medical Sciences
- Highlands Oncology Group-Rogers
- Alta Bates Summit Medical Center-Herrick Campus
- Providence Saint Joseph Medical Center/Disney Family Cancer Center
- Mills-Peninsula Medical Center
- East Bay Radiation Oncology Center
- Eden Hospital Medical Center
- Valley Medical Oncology Consultants-Castro Valley
- John Muir Medical Center-Concord Campus
- City of Hope Comprehensive Cancer Center
- Bay Area Breast Surgeons Inc
- Kaiser Permanente-Fremont
- Valley Medical Oncology Consultants-Fremont
- Washington Hospital
- Saint Jude Medical Center
- Glendale Memorial Hospital and Health Center
- Marin Cancer Care Inc
- Marin General Hospital
- Saint Rose Hospital
- Loma Linda University Medical Center
- Veterans Affairs Loma Linda Healthcare System
- USC / Norris Comprehensive Cancer Center
- Contra Costa Regional Medical Center
- Fremont - Rideout Cancer Center
- Memorial Medical Center
- Community Hospital of Monterey Peninsula
- El Camino Hospital
- Palo Alto Medical Foundation-Camino Division
- Northridge Hospital Medical Center
- Sutter Cancer Research Consortium
- Highland General Hospital
- Alta Bates Summit Medical Center - Summit Campus
- Bay Area Tumor Institute
- Hematology and Oncology Associates-Oakland
- Tom K Lee Inc
- Kaiser Permanente-Oakland
- Saint Joseph Hospital - Orange
- UC Irvine Health/Chao Family Comprehensive Cancer Center
- Palo Alto Medical Foundation Health Care
- Stanford Cancer Institute Palo Alto
- VA Palo Alto Health Care System
- Valley Care Health System - Pleasanton
- Valley Medical Oncology Consultants
- Eisenhower Medical Center
- Shasta Regional Medical Center
- Kaiser Permanente-Redwood City
- Kaiser Permanente-Richmond
- Kaiser Permanente-Roseville
- Sutter Roseville Medical Center
- Sutter Medical Center Sacramento
- University of California Davis Comprehensive Cancer Center
- Mercy General Hospital
- Kaiser Permanente-South Sacramento
- Kaiser Permanente - Sacramento
- Salinas Valley Memorial
- University of California San Diego
- Kaiser Permanente-San Diego Mission
- Veterans Administration-San Diego Medical Center
- California Pacific Medical Center-Pacific Campus
- Kaiser Permanente-San Francisco
- UCSF Medical Center-Mount Zion
- Kaiser Permanente-Santa Teresa-San Jose
- Kaiser Permanente San Leandro
- Doctors Medical Center- JC Robinson Regional Cancer Center
- Kaiser Permanente-San Rafael
- Kaiser Permanente Medical Center - Santa Clara
- Kaiser Permanente-Santa Rosa
- Kaiser Permanente-South San Francisco
- Kaiser Permanente-Stockton
- Gene Upshaw Memorial Tahoe Forest Cancer Center
- Northbay Cancer Center
- Kaiser Permanente-Vallejo
- Sutter Solano Medical Center/Cancer Center
- Kaiser Permanente-Walnut Creek
- John Muir Medical Center-Walnut Creek
- The Medical Center of Aurora
- Rocky Mountain Regional VA Medical Center
- Boulder Community Hospital
- Penrose-Saint Francis Healthcare
- UCHealth Memorial Hospital Central
- Denver Health Medical Center
- Kaiser Permanente-Franklin
- Porter Adventist Hospital
- University of Colorado
- Presbyterian - Saint Lukes Medical Center - Health One
- SCL Health Saint Joseph Hospital
- Rose Medical Center
- Colorado Cancer Research Program NCORP
- Shaw Cancer Center
- Swedish Medical Center
- Poudre Valley Hospital
- Valley View Hospital Cancer Center
- Saint Mary's Hospital and Regional Medical Center
- North Colorado Medical Center
- Kaiser Permanente-Rock Creek
- Saint Anthony Hospital
- Sky Ridge Medical Center
- Longmont United Hospital
- McKee Medical Center
- Montrose Memorial Hospital
- Saint Mary Corwin Medical Center
- North Suburban Medical Center
- SCL Health Lutheran Medical Center
- Saint Vincent's Medical Center
- Danbury Hospital
- Hartford Hospital
- Smilow Cancer Hospital Care Center at Saint Francis
- Manchester Memorial Hospital
- Yale University
- Norwalk Hospital
- Eastern Connecticut Hematology and Oncology Associates
- Bayhealth Hospital Kent Campus
- Beebe Medical Center
- Christiana Care Health System-Christiana Hospital
- MedStar Georgetown University Hospital
- MedStar Washington Hospital Center
- Sibley Memorial Hospital
- George Washington University Medical Center
- Boca Raton Regional Hospital
- Holy Cross Hospital
- Broward Health Medical Center
- Lee Memorial Health System
- Southwest Florida Regional Medical Center
- Florida Cancer Specialists-Gainesville Cancer Center
- University of Florida Health Science Center - Gainesville
- Memorial Regional Hospital/Joe DiMaggio Children's Hospital
- Baptist MD Anderson Cancer Center
- Mayo Clinic in Florida
- Jupiter Medical Center
- Lakeland Regional Health Hollis Cancer Center
- Cancer Centers of Central Florida PA
- Mount Sinai Medical Center
- University of Miami Miller School of Medicine-Sylvester Cancer Center
- 21st Century Oncology-Orange Park
- AdventHealth Orlando
- UF Cancer Center at Orlando Health
- Sacred Heart Hospital
- Florida Cancer Specialists - Sarasota Downtown
- Moffitt Cancer Center
- Cleveland Clinic-Weston
- Phoebe Putney Memorial Hospital
- University Cancer and Blood Center LLC
- Piedmont Hospital
- Emory University Hospital/Winship Cancer Institute
- Atlanta Regional CCOP
- Emory Saint Joseph's Hospital
- Northside Hospital
- Augusta University Medical Center
- WellStar Cobb Hospital
- John B Amos Cancer Center
- Atlanta VA Medical Center
- Dekalb Medical Center
- Northeast Georgia Medical Center-Gainesville
- Gwinnett Medical Center
- Medical Center of Central Georgia
- Wellstar Kennestone Hospital
- Southern Regional Medical Center
- Harbin Clinic Medical Oncology and Clinical Research
- Memorial Health University Medical Center
- Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
- South Georgia Medical Center/Pearlman Cancer Center
- Pali Momi Medical Center
- Hawaii Cancer Care Inc-POB II
- Queen's Medical Center
- Straub Clinic and Hospital
- University of Hawaii Cancer Center
- Hawaii Oncology Inc-Kuakini
- The Cancer Center of Hawaii-Liliha
- Kaiser Permanente Moanalua Medical Center
- Kapiolani Medical Center for Women and Children
- Tripler Army Medical Center
- Maui Memorial Medical Center
- Pacific Cancer Institute of Maui
- Saint Alphonsus Cancer Care Center-Boise
- Portneuf Medical Center
- Kootenai Cancer Center
- Saint Anthony's Health
- Rush - Copley Medical Center
- Saint Joseph Medical Center
- Illinois CancerCare-Bloomington
- Graham Hospital Association
- Illinois CancerCare-Canton
- Illinois CancerCare-Carthage
- Memorial Hospital
- Mount Sinai Hospital Medical Center
- Hematology and Oncology Associates
- Northwestern University
- Jesse Brown Veterans Affairs Medical Center
- John H Stroger Jr Hospital of Cook County
- Rush University Medical Center
- Mercy Hospital and Medical Center
- Swedish Covenant Hospital
- Presence Resurrection Medical Center
- University of Chicago Comprehensive Cancer Center
- Decatur Memorial Hospital
- Heartland Cancer Research NCORP
- Advocate Sherman Hospital
- AMITA Health Alexian Brothers Medical Center
- Elmhurst Memorial Hospital
- Eureka Hospital
- Illinois CancerCare-Eureka
- NorthShore University HealthSystem-Evanston Hospital
- Saint Francis Hospital
- Galesburg Cottage Hospital
- Illinois CancerCare-Cottage
- Illinois CancerCare-Galesburg
- LaGrange Oncology Associates
- Northwestern Medicine Cancer Center Delnor
- Ingalls Memorial Hospital
- Illinois CancerCare-Havana
- Mason District Hospital
- Hematology Oncology Associates of Illinois-Highland Park
- Hinsdale Hematology Oncology Associates Incorporated
- Hopedale Medical Complex - Hospital
- Midwest Center for Hematology Oncology
- Joliet Oncology-Hematology Associates Limited
- Presence Saint Mary's Hospital
- Illinois CancerCare-Kewanee Clinic
- Kewanee Hospital
- AMITA Health Adventist Medical Center
- NorthShore Hematology Oncology-Libertyville
- Illinois CancerCare-Macomb
- Mcdonough District Hospital
- Loyola University Medical Center
- Garneau, Stewart C MD (UIA Investigator)
- Porubcin, Michael MD (UIA Investigator)
- Sharis, Christine M MD (UIA Investigator)
- Spector, David MD (UIA Investigator)
- Stoffel, Thomas J MD (UIA Investigator)
- Trinity Medical Center
- Vigliotti, Antonio, P.G. M.D. (UIA Investigator)
- Holy Family Medical Center
- Illinois CancerCare-Monmouth
- Good Samaritan Regional Health Center
- Edward Hospital/Cancer Center
- DuPage Medical Group-Ogden
- Illinois Cancer Specialists-Niles
- Bromenn Regional Medical Center
- Community Cancer Center Foundation
- Illinois CancerCare-Community Cancer Center
- Advocate Christ Medical Center
- Franciscan St. James Health-Olympia Fields Campus
- Illinois CancerCare-Ottawa Clinic
- Ottawa Regional Hospital and Healthcare Center
- Illinois CancerCare-Pekin
- OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
- Pekin Hospital
- Proctor Hospital
- Illinois CancerCare-Peoria
- Methodist Medical Center of Illinois
- OSF Saint Francis Medical Center
- Illinois CancerCare-Peru
- Illinois Valley Hospital
- Illinois CancerCare-Princeton
- Perry Memorial Hospital
- West Suburban Medical Center
- Swedish American Hospital
- OSF Saint Anthony Medical Center
- Edward H Kaplan MD and Associates
- Hematology Oncology Associates of Illinois - Skokie
- Illinois CancerCare-Spring Valley
- Saint Margaret's Hospital
- Memorial Medical Center
- Carle Cancer Center
- Northwestern Medicine Central DuPage Hospital
- Franciscan Saint Francis Health-Beech Grove
- Elkhart Clinic
- Elkhart General Hospital
- Fort Wayne Medical Oncology and Hematology Inc-Parkview
- Goshen Center for Cancer Care
- Indiana University/Melvin and Bren Simon Cancer Center
- Richard L. Roudebush Veterans Affairs Medical Center
- Sidney and Lois Eskenazi Hospital
- Saint Vincent Hospital and Health Care Center
- Community Howard Regional Health
- IU Health La Porte Hospital
- IU Health Arnett Cancer Care
- Horizon Oncology Research LLC
- Premier Oncology Hematology Associates
- Franciscan Saint Anthony Health-Michigan City
- Saint Joseph Regional Medical Center-Mishawaka
- The Community Hospital
- Reid Health
- Memorial Hospital of South Bend
- Michiana Hematology Oncology PC-South Bend
- South Bend Clinic
- Northern Indiana Cancer Research Consortium
- McFarland Clinic PC - Ames
- Constantinou, Costas L MD (UIA Investigator)
- University of Iowa Healthcare Cancer Services Quad Cities
- Saint Luke's Hospital
- Mercy Hospital
- Oncology Associates at Mercy Medical Center
- Medical Oncology and Hematology Associates-West Des Moines
- Alegent Health Mercy Hospital
- Heartland Oncology and Hematology LLP
- Genesis Medical Center - East Campus
- Genesis Cancer Care Institute
- Mercy Capitol
- Iowa Methodist Medical Center
- Iowa-Wide Oncology Research Coalition NCORP
- Medical Oncology and Hematology Associates-Des Moines
- Medical Oncology and Hematology Associates-Laurel
- Mercy Medical Center - Des Moines
- Iowa Lutheran Hospital
- University of Iowa/Holden Comprehensive Cancer Center
- Mercy Medical Center - North Iowa
- Ottumwa Regional Health Center
- Siouxland Regional Cancer Center
- Mercy Medical Center-Sioux City
- Saint Luke's Regional Medical Center
- Cedar Valley Medical Specialists
- MercyOne Waterloo Medical Center
- Hospital District Sixth of Harper County
- Cancer Center of Kansas - Chanute
- Cancer Center of Kansas - Dodge City
- Cancer Center of Kansas - El Dorado
- Cancer Center of Kansas - Fort Scott
- Hays Medical Center
- Hutchinson Regional Medical Center
- Cancer Center of Kansas-Independence
- Providence Medical Center
- University of Kansas Cancer Center
- Cancer Center of Kansas-Kingman
- Lawrence Memorial Hospital
- Southwest Medical Center
- Cancer Center of Kansas - Newton
- Olathe Cancer Center
- Menorah Medical Center
- Radiation Oncology Practice Corporation Southwest
- Saint Luke's South Hospital
- Cancer Center of Kansas - Parsons
- Cancer Center of Kansas - Pratt
- Cancer Center of Kansas - Salina
- Shawnee Mission Medical Center-KCCC
- Cotton O'Neil Cancer Center / Stormont Vail Health
- Saint Francis Hospital and Medical Center - Topeka
- Cancer Center of Kansas - Wellington
- Associates In Womens Health
- Cancer Center of Kansas-Wichita Medical Arts Tower
- Cancer Center of Kansas - Wichita
- Via Christi Regional Medical Center
- Wichita NCI Community Oncology Research Program
- Cancer Center of Kansas - Winfield
- University of Kentucky/Markey Cancer Center
- The James Graham Brown Cancer Center at University of Louisville
- Baptist Health Louisville
- Doctors Carrol, Sheth, Raghavan
- Baton Rouge General Medical Center
- Mary Bird Perkins Cancer Center
- Ochsner Health Center-Summa
- University Health-Conway
- Louisiana State University Health Science Center
- University Medical Center New Orleans
- Ochsner Medical Center Jefferson
- Louisiana State University Health Sciences Center Shreveport
- Highland Clinic
- Harold Alfond Center for Cancer Care
- Eastern Maine Medical Center
- Mercy Hospital
- Maine Center for Cancer Medicine-Scarborough
- Maine Medical Center- Scarborough Campus
- Maine General Medical Center-Thayer
- York Hospital
- Anne Arundel Medical Center
- University of Maryland/Greenebaum Cancer Center
- Greater Baltimore Medical Center
- Saint Agnes Hospital
- MedStar Franklin Square Medical Center/Weinberg Cancer Institute
- Johns Hopkins University/Sidney Kimmel Cancer Center
- Suburban Hospital
- Memorial Hospital at Easton - Shore Regional Cancer Center
- University of Maryland Shore Medical Center at Easton
- Union Hospital of Cecil County
- Frederick Memorial Hospital
- Peninsula Regional Medical Center
- UM Saint Joseph Medical Center
- Massachusetts General Hospital Cancer Center
- Boston Medical Center
- Beth Israel Deaconess Medical Center
- Dana-Farber Cancer Institute
- Steward Saint Elizabeth's Medical Center
- Lahey Hospital and Medical Center
- Addison Gilbert Hospital
- Cape Cod Hospital
- Holy Family Hospital
- Milford Regional Medical Center
- Berkshire Medical Center - Cancer Center
- Commonwealth Hematology Oncology PC-Worcester
- University of Massachusetts Medical School
- Bixby Medical Center
- Hickman Cancer Center
- Michigan Cancer Research Consortium NCORP
- Saint Joseph Mercy Hospital
- University of Michigan Comprehensive Cancer Center
- Bronson Battle Creek
- Spectrum Health Big Rapids Hospital
- Beaumont Hospital ? Dearborn
- Wayne State University/Karmanos Cancer Institute
- Henry Ford Hospital
- Ascension Saint John Hospital
- Green Bay Oncology - Escanaba
- Hurley Medical Center
- Genesys Regional Medical Center-West Flint Campus
- McLaren Cancer Institute-Flint
- Cancer Research Consortium of West Michigan NCORP
- Mercy Health Saint Mary's
- Spectrum Health at Butterworth Campus
- Holland Community Hospital
- Green Bay Oncology - Iron Mountain
- Allegiance Health
- Bronson Methodist Hospital
- West Michigan Cancer Center
- Borgess Medical Center
- Sparrow Hospital
- Saint Mary Mercy Hospital
- Mercy Memorial Hospital
- Toledo Clinic Cancer Centers-Monroe
- Mercy Health Partners-Hackley Campus
- Mercy Health Mercy Campus
- Saint Joseph Mercy Oakland
- Lake Huron Medical Center
- William Beaumont Hospital-Royal Oak
- Ascension Saint Mary's Hospital
- Lakeland Medical Center Saint Joseph
- Marie Yeager Cancer Center
- Oncology Care Associates PLLC
- Ascension Providence Hospitals - Southfield
- Munson Medical Center
- Saint John Macomb-Oakland Hospital
- Metro Health Hospital
- Harris, John Gilbert MD (UIA Investigator)
- Medini, Eitan MD (UIA Investigator)
- Sanford Joe Lueken Cancer Center
- Brainerd Medical Center Inc
- Essentia Health Saint Joseph's Medical Center
- Fairview Ridges Hospital
- Mercy Hospital
- Essentia Health Cancer Center
- Essentia Health Saint Mary's Medical Center
- Miller-Dwan Hospital
- Fairview-Southdale Hospital
- Etzell, Paul S MD (UIA Investigator)
- Lake Region Healthcare Corporation-Cancer Care
- Swenson, Wade II, MD (UIA Investigator)
- Unity Hospital
- Hutchinson Area Health Care
- Meeker County Memorial Hospital
- Minnesota Oncology Hematology PA-Maplewood
- Saint John's Hospital - Healtheast
- Abbott-Northwestern Hospital
- Virginia Piper Cancer Institute
- Hennepin County Medical Center
- Minneapolis VA Medical Center
- University of Minnesota/Masonic Cancer Center
- Chippewa County - Montevideo Hospital
- North Memorial Medical Health Center
- Mayo Clinic
- Coborn Cancer Center at Saint Cloud Hospital
- Saint Cloud Hospital
- Metro Minnesota Community Oncology Research Consortium
- Park Nicollet Clinic - Saint Louis Park
- Regions Hospital
- Saint Joseph's Hospital - Healtheast
- United Hospital
- Adult and Pediatric Urology PLLP
- Saint Francis Regional Medical Center
- Ridgeview Medical Center
- Rice Memorial Hospital
- Minnesota Oncology Hematology PA-Woodbury
- Woodwinds Health Campus
- University of Mississippi Medical Center
- Singing River Hospital
- Southeast Missouri Hospital
- Saint Francis Medical Center
- Saint Luke's Hospital
- Missouri Cancer Associates
- Veterans Administration
- University of Missouri - Ellis Fischel
- Centerpoint Medical Center LLC
- Freeman Health System
- Truman Medical Center
- Saint Luke's Hospital of Kansas City
- Radiation Oncology Practice Corporation South
- Saint Joseph Health Center
- North Kansas City Hospital
- Heartland Hematology and Oncology Associates Incorporated
- Research Medical Center
- Radiation Oncology Practice Corporation - North
- Saint Luke's East - Lee's Summit
- Liberty Radiation Oncology Center
- Heartland Regional Medical Center
- Saint Joseph Oncology Inc
- Saint Louis Cancer and Breast Institute-South City
- Saint Louis University Hospital
- Washington University School of Medicine
- Mercy Hospital South
- Missouri Baptist Medical Center
- Siteman Cancer Center at Christian Hospital
- Center for Cancer Care and Research
- Mercy Hospital Saint Louis
- Saint Louis-Cape Girardeau CCOP
- Cancer Research for the Ozarks NCORP
- Mercy Hospital Springfield
- CoxHealth South Hospital
- Billings Clinic Cancer Center
- Northern Rockies Radiation Oncology Center
- Saint Vincent Healthcare
- Montana Cancer Consortium NCORP
- Saint Vincent Frontier Cancer Center
- Deaconess Medical Center
- Bozeman Deaconess Hospital
- Saint James Community Hospital and Cancer Treatment Center
- Benefis Healthcare- Sletten Cancer Institute
- Berdeaux, Donald MD (UIA Investigator)
- Great Falls Clinic
- Northern Montana Hospital
- Saint Peter's Community Hospital
- Glacier Oncology PLLC
- Kalispell Medical Oncology
- Kalispell Regional Medical Center
- Montana Cancer Specialists
- Saint Patrick Hospital - Community Hospital
- Community Medical Hospital
- Guardian Oncology and Center for Wellness
- CHI Health Saint Francis
- CHI Health Good Samaritan
- Nebraska Cancer Research Center
- Great Plains Health Callahan Cancer Center
- Missouri Valley Cancer Consortium
- Nebraska Methodist Hospital
- Alegent Health Immanuel Medical Center
- Alegent Health Bergan Mercy Medical Center
- Alegent Health Lakeside Hospital
- Creighton University Medical Center
- University of Nebraska Medical Center
- Midlands Community Hospital
- Carson-Tahoe Specialty Medical Center
- University Medical Center of Southern Nevada
- Nevada Cancer Research Foundation CCOP
- Renown Regional Medical Center
- Cheshire Medical Center-Dartmouth-Hitchcock Keene
- Dartmouth Hitchcock Medical Center
- Frisbie Hospital
- Ocean Medical Center
- Cooper Hospital University Medical Center
- Veterans Adminstration New Jersey Health Care System
- Hunterdon Medical Center
- CentraState Medical Center
- Hackensack University Medical Center
- The Cancer Institute of New Jersey Hamilton
- Saint Barnabas Medical Center
- Monmouth Medical Center
- Mountainside Hospital
- Morristown Medical Center
- Virtua Memorial
- Saint Peter's University Hospital
- Rutgers Cancer Institute of New Jersey
- Rutgers New Jersey Medical School
- Capital Health Medical Center-Hopewell
- Riverview Medical Center/Booker Cancer Center
- Valley Hospital
- Robert Wood Johnson University Hospital Somerset
- Overlook Hospital
- Community Medical Center
- Inspira Medical Center Vineland
- Virtua Voorhees
- University of New Mexico Cancer Center
- Hematology Oncology Associates
- Presbyterian Kaseman Hospital
- Memorial Medical Center - Las Cruces
- Christus Saint Vincent Regional Cancer Center
- Christus Saint Vincent Regional Medical Center
- New York Oncology Hematology PC - Albany
- New York Oncology Hematology PC -Albany Medical Center
- New York Oncology Hematology PC - Amsterdam
- Montefiore Medical Center-Weiler Hospital
- Montefiore Medical Center-Wakefield Campus
- Montefiore Medical Center - Moses Campus
- Kings County Hospital
- State University of New York Downstate Medical Center
- Veteran Affairs New York Harbor Healthcare System-Brooklyn Campus
- Veterans Affairs Western New York Health Care System-Buffalo
- Roswell Park Cancer Institute
- New York Oncology Hematology PC - Clifton Park
- Mary Imogene Bassett Hospital
- Hematology Oncology Associates of Central New York-East Syracuse
- Adirondack Cancer Center
- Glens Falls Hospital
- New York Oncology Hematology PC-Hudson
- Northwell Health NCORP
- North Shore University Hospital
- Orange Regional Medical Center
- Northern Westchester Hospital
- Long Island Jewish Medical Center
- Mount Sinai Union Square
- Laura and Isaac Perlmutter Cancer Center at NYU Langone
- Mount Sinai West
- NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
- NYP/Weill Cornell Medical Center
- Nyack Hospital
- Champlain Valley Physicians Hospital Medical Center
- New York Oncology Hematology PC - Rexford
- Interlakes Foundation Inc-Rochester
- University of Rochester
- Staten Island University Hospital
- State University of New York Upstate Medical University
- New York Oncology Hematology PC - Troy
- Faxton-Saint Luke's Healthcare
- Mission Hospital Inc-Memorial Campus
- Cone Health Cancer Center at Alamance Regional
- Waverly Hematology Oncology
- Carolinas Medical Center/Levine Cancer Institute
- Novant Health Presbyterian Medical Center
- Atrium Health Cabarrus/LCI-Concord
- CaroMont Regional Medical Center
- Southeastern Medical Oncology Center-Goldsboro
- Wayne Memorial Hospital
- East Carolina University
- Margaret R Pardee Memorial Hospital
- High Point Regional Hospital
- Vidant Oncology-Kinston
- FirstHealth of the Carolinas-Moore Regional Hospital
- Rex Cancer Center
- Rutherford Hospital
- Novant Health Forsyth Medical Center
- Southeast Clinical Oncology Research (SCOR) Consortium NCORP
- Mid Dakota Clinic
- Saint Alexius Medical Center
- Sanford Bismarck Medical Center
- Essentia Health Cancer Center-South University Clinic
- Sanford Broadway Medical Center
- Sanford Clinic North-Fargo
- Trinity Cancer Care Center
- Summa Akron City Hospital/Cooper Cancer Center
- Cleveland Clinic Akron General
- Summa Barberton Hospital
- Cleveland Clinic Cancer Center Beachwood
- Mary Rutan Hospital
- Toledo Clinic Cancer Centers-Bowling Green
- Mercy Medical Center
- Aultman Health Foundation
- Adena Regional Medical Center
- The Christ Hospital
- University of Cincinnati/Barrett Cancer Center
- Oncology Hematology Care Inc-Blue Ash
- Case Western Reserve University
- MetroHealth Medical Center
- Cleveland Clinic Cancer Center/Fairview Hospital
- Cleveland Clinic Foundation
- North Coast Cancer Care-Clyde
- Ohio State University Comprehensive Cancer Center
- Riverside Methodist Hospital
- Columbus NCI Community Oncology Research Program
- Grant Medical Center
- Mount Carmel Health Center West
- Doctors Hospital
- Grandview Hospital
- Good Samaritan Hospital - Dayton
- Miami Valley Hospital
- Miami Valley Hospital North
- Dayton NCI Community Oncology Research Program
- Veteran Affairs Medical Center
- Grady Memorial Hospital
- Hematology Oncology Center Incorporated
- Mercy Cancer Center-Elyria
- Blanchard Valley Hospital
- Atrium Medical Center-Middletown Regional Hospital
- Fremont Memorial Hospital
- Wayne Hospital
- Cleveland Clinic Cancer Center Independence
- Kettering Medical Center
- Fairfield Medical Center
- Saint Rita's Medical Center
- Lima Memorial Hospital
- OhioHealth Mansfield Hospital
- Marietta Memorial Hospital
- Saint Luke's Hospital
- Toledo Clinic Cancer Centers-Maumee
- Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
- Hillcrest Hospital Cancer Center
- Licking Memorial Hospital
- Fisher-Titus Medical Center
- Saint Charles Hospital
- Toledo Clinic Cancer Centers-Oregon
- Firelands Regional Medical Center
- North Coast Cancer Care
- Springfield Regional Medical Center
- ProMedica Flower Hospital
- Mercy Hospital of Tiffin
- The Toledo Hospital/Toledo Children's Hospital
- Saint Vincent Mercy Medical Center
- University of Toledo
- Toledo Community Hospital Oncology Program CCOP
- Mercy Saint Anne Hospital
- Toledo Clinic Cancer Centers-Toledo
- Upper Valley Medical Center
- Fulton County Health Center
- Saint Ann's Hospital
- Clinton Memorial Hospital
- Cleveland Clinic Wooster Family Health and Surgery Center
- Greene Memorial Hospital
- Genesis Healthcare System Cancer Care Center
- Cancer Centers of Southwest Oklahoma Research
- University of Oklahoma Health Sciences Center
- Cancer Care Associates
- Natalie Warren Bryant Cancer Center at Saint Francis
- Bend Memorial Clinic
- Saint Charles Health System
- Bay Area Hospital
- Legacy Mount Hood Medical Center
- Providence Milwaukie Hospital
- Legacy Good Samaritan Hospital and Medical Center
- Providence Portland Medical Center
- Adventist Medical Center
- Providence Saint Vincent Medical Center
- Compass Oncology Rose Quarter
- Kaiser Permanente Northwest
- Legacy Emanuel Hospital and Health Center
- Oregon Health and Science University
- Salem Hospital
- Mid-Columbia Medical Center/Celilo Cancer Center
- Legacy Meridian Park Hospital
- Abington Memorial Hospital
- Lehigh Valley Hospital-Cedar Crest
- Saint Luke's University Hospital-Bethlehem Campus
- Bryn Mawr Hospital
- Geisinger Medical Center
- Doylestown Hospital
- Oncology Hematology Associates of Northern Pennsylvania
- Pocono Medical Center
- Ephrata Cancer Center
- Adams Cancer Center
- UPMC Pinnacle Cancer Center/Community Osteopathic Campus
- Geisinger Medical Center-Cancer Center Hazleton
- Penn State Milton S Hershey Medical Center
- Armstrong Center for Medicine and Health
- Lancaster General Hospital
- Central PA Hematology-Medical Oncology Associates PC
- Lewistown Hospital
- Riddle Memorial Hospital
- Paoli Memorial Hospital
- University of Pennsylvania/Abramson Cancer Center
- Pennsylvania Hospital
- Thomas Jefferson University Hospital
- Fox Chase Cancer Center
- Aria Health-Torresdale Campus
- Einstein Medical Center Philadelphia
- Allegheny General Hospital
- University of Pittsburgh Cancer Institute (UPCI)
- Pottstown Hospital
- Penn State Health Saint Joseph Medical Center
- Guthrie Medical Group PC-Robert Packer Hospital
- Mercy Hospital
- Hematology and Oncology Associates of North East Pennsylvania
- Scranton Hematology Oncology
- Grand View Hospital
- Geisinger Medical Group
- Mount Nittany Medical Center
- Associates In Hematology Oncology PC-Upland
- Chester County Hospital
- Reading Hospital
- Geisinger Wyoming Valley/Henry Cancer Center
- UPMC Susquehanna
- Lankenau Medical Center
- Main Line Health NCORP
- WellSpan Health-York Hospital
- Hematology and Oncology Associates of Rhode Island Inc
- Memorial Hospital of Rhode Island
- Rhode Island Hospital
- Miriam Hospital
- Kent Hospital
- AnMed Health Hospital
- Roper Hospital
- Medical University of South Carolina
- Greenville Health System Cancer Institute-Easley
- McLeod Regional Medical Center
- Greenville Health System Cancer Institute-Andrews
- Saint Francis Hospital
- Greenville Health System Cancer Institute-Butternut
- Greenville Health System Cancer Institute-Faris
- Greenville Memorial Hospital
- Greenville Health System Cancer Institute-Eastside
- Self Regional Healthcare
- Greenville Health System Cancer Institute-Greer
- Greenville Health System Cancer Institute-Seneca
- Spartanburg Medical Center
- Greenville Health System Cancer Institute-Spartanburg
- Avera Cancer Institute-Aberdeen
- Rapid City Regional Hospital
- Sanford Cancer Center Oncology Clinic
- Avera Cancer Institute
- Avera McKennan Hospital and University Health Center
- Medical X-Ray Center
- Sanford USD Medical Center - Sioux Falls
- Erlanger Medical Center
- Vanderbilt-Ingram Cancer Center Cool Springs
- Jones Clinic
- Jackson-Madison County General Hospital
- Wellmont Holston Valley Hospital and Medical Center
- Thompson Cancer Survival Center
- East Tennessee Baptist Hospital-Mercy Health Partners
- University of Tennessee - Knoxville
- University of Tennessee Health Science Center
- Nashville Oncology Associates PC
- Meharry Medical College
- Vanderbilt University/Ingram Cancer Center
- The Don and Sybil Harrington Cancer Center
- Texas Oncology-Austin Midtown
- Texas Oncology - Central Austin Cancer Center
- Texas Oncology - South Austin Cancer Center
- Texas Oncology-Austin North
- Texas Oncology Seton Northwest
- Medical City Dallas Hospital
- Texas Health Presbyterian Hospital Dallas
- Parkland Memorial Hospital
- Clements University Hospital
- UT Southwestern/Simmons Cancer Center-Dallas
- Dallas Oncology Consultants PA
- The Center for Integrative Cancer Medicine
- Brooke Army Medical Center
- Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
- Baylor Saint Luke's Medical Center
- Ben Taub General Hospital
- M D Anderson Cancer Center
- Michael E DeBakey VA Medical Center
- The Methodist Hospital System
- Wilford Hall Medical Center
- Texas Tech University Health Sciences Center-Lubbock
- Texas Oncology-Seton Williamson
- Texas Oncology - Round Rock Cancer Center
- Audie L Murphy VA Hospital
- Cancer Therapy and Research Center at The UT Health Science Center at San Antonio
- University Hospital
- University of Texas Health Science Center at San Antonio
- Texas Oncology- San Marcos
- Scott and White Memorial Hospital
- American Fork Hospital / Huntsman Intermountain Cancer Center
- Sandra L Maxwell Cancer Center
- Logan Regional Hospital
- Cottonwood Hospital Medical Center
- Intermountain Medical Center
- McKay-Dee Hospital Center
- Utah Valley Regional Medical Center
- Dixie Medical Center Regional Cancer Center
- Intermountain Health Care
- Utah Cancer Specialists-Salt Lake City
- Huntsman Cancer Institute/University of Utah
- LDS Hospital
- Southwestern Vermont Medical Center
- Central Vermont Medical Center/National Life Cancer Treatment
- University of Vermont and State Agricultural College
- University of Virginia Cancer Center
- Danville Regional Medical Center
- Fredericksburg Oncology Inc
- Peninsula Cancer Institute-Gloucester
- Centra Lynchburg Hematology-Oncology Clinic Inc
- Peninsula Cancer Institute-Newport News
- Southwest VA Regional Cancer Center
- Virginia Commonwealth University/Massey Cancer Center
- Peninsula Cancer Institute-Williamsburg
- MultiCare Auburn Medical Center
- PeaceHealth Saint Joseph Medical Center
- Harrison HealthPartners Hematology and Oncology-Bremerton
- Providence Regional Cancer System-Centralia
- Saint Francis Hospital
- Kadlec Clinic Hematology and Oncology
- EvergreenHealth Medical Center
- Saint Clare Hospital
- Skagit Valley Hospital
- Providence - Saint Peter Hospital
- Olympic Medical Center
- Harrison HealthPartners Hematology and Oncology-Poulsbo
- MultiCare Good Samaritan Hospital
- Valley Medical Center
- Virginia Mason Medical Center
- Minor and James Medical PLLC
- Pacific Medical Center-First Hill
- Kaiser Permanente Washington
- Swedish Medical Center-First Hill
- University of Washington Medical Center
- Cancer Care Northwest - Spokane South
- Providence Sacred Heart Medical Center and Children's Hospital
- Providence Holy Family Hospital
- Rockwood Clinic
- MultiCare Allenmore Hospital
- MultiCare Tacoma General Hospital
- Northwest NCI Community Oncology Research Program
- Saint Joseph Medical Center
- Madigan Army Medical Center
- PeaceHealth Southwest Medical Center
- Compass Oncology Vancouver
- Legacy Salmon Creek Hospital
- Wenatchee Valley Hospital and Clinics
- Cancer Institutes of Washington PLLC
- North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
- West Virginia University Charleston Division
- Edwards Comprehensive Cancer Center
- Saint Mary's Medical Center
- West Virginia University Healthcare
- Camden Clark Medical Center
- Wheeling Hospital/Schiffler Cancer Center
- Langlade Hospital and Cancer Center
- Fox Valley Hematology and Oncology SC-Appleton
- Aurora Cancer Care-Southern Lakes VLCC
- Marshfield Clinic-Chippewa Center
- HSHS Sacred Heart Hospital
- Marshfield Clinic Cancer Center at Sacred Heart
- Aurora Cancer Care-Franklin
- Aurora Health Care Germantown Health Center
- Aurora Cancer Care-Glendale
- Green Bay Oncology at Saint Vincent Hospital
- Saint Vincent Hospital Cancer Center Green Bay
- Green Bay Oncology Limited at Saint Mary's Hospital
- Saint Vincent Hospital Cancer Center at Saint Mary's
- Aurora BayCare Medical Center
- UW Cancer Center Johnson Creek
- Aurora Cancer Care-Kenosha South
- Gundersen Lutheran Medical Center
- Mayo Clinic Health System-Franciscan Healthcare
- UW Health Oncology-One South Park
- Dean Hematology and Oncology Clinic
- University of Wisconsin Hospital and Clinics
- Holy Family Memorial Hospital
- Aurora Bay Area Medical Group-Marinette
- Bay Area Medical Center
- Marshfield Medical Center-Marshfield
- Marshfield Medical Center
- Aurora Saint Luke's Medical Center
- Froedtert and the Medical College of Wisconsin
- Aurora Sinai Medical Center
- Marshfield Clinic-Minocqua Center
- Saint Vincent Hospital Cancer Center at Oconto Falls
- Vince Lombardi Cancer Clinic - Oshkosh
- Aurora Cancer Care-Racine
- Ascension Saint Mary's Hospital
- Marshfield Medical Center-Rice Lake
- Vince Lombardi Cancer Clinic-Sheboygan
- Ascension Saint Michael's Hospital
- Saint Michael's Hospital
- Green Bay Oncology - Sturgeon Bay
- Aurora Medical Center in Summit
- Vince Lombardi Cancer Clinic-Two Rivers
- Aurora Cancer Care-Waukesha
- Aspirus Regional Cancer Center
- Marshfield Clinic-Wausau Center
- Aurora Cancer Care-Milwaukee West
- Marshfield Clinic - Weston Center
- Aspirus UW Cancer Center
- Marshfield Clinic - Wisconsin Rapids Center
- Rocky Mountain Oncology
- Welch Cancer Center
- Tom Baker Cancer Centre
- Cross Cancer Institute
- Clinical Research Unit at Vancouver Coastal Health Authority
- CancerCare Manitoba
- The Moncton Hospital
- Atlantic Health Sciences Corporation-Saint John Regional Hospital
- QEII Health Sciences Centre/Nova Scotia Health Authority
- Juravinski Cancer Centre at Hamilton Health Sciences
- Grand River Regional Cancer Centre at Grand River Hospital
- London Regional Cancer Program
- Lakeridge Health Oshawa
- Ottawa Hospital and Cancer Center-General Campus
- Algoma District Cancer Program Sault Area Hospital
- Thunder Bay Regional Health Science Centre
- Odette Cancer Centre- Sunnybrook Health Sciences Centre
- University Health Network-Princess Margaret Hospital
- PEI Cancer Treatment Centre-Queen Elizabeth Hospital
- CHUM - Hopital Notre-Dame
- McGill University Department of Oncology
- CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ)
- San Juan City Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
Arm A (sunitinib malate, placebo)
Arm B (sorafenib tosylate, placebo)
Arm C (placebo)
Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sunitinib malate PO QD for 4 weeks and placebo sorafenib tosylate PO QD or BID for 6 weeks.
Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sorafenib tosylate PO QD or BID for 6 weeks and placebo sunitinib malate PO QD for 4 weeks followed.
Beginning 4-12 weeks following radical or partial nephrectomy, patients receive placebo sorafenib tosylate as in Arm A and placebo sunitinib malate as in Arm B.