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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01575548
Other study ID # NCI-2012-00723
Secondary ID NCI-2012-00723CD
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date August 8, 2012
Est. completion date February 22, 2025

Study information

Verified date May 2024
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This randomized phase III trial studies how well pazopanib hydrochloride works compared to placebo in treating patients with kidney cancer that has spread to other parts of the body and have no evidence of disease after surgery. Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.


Description:

PRIMARY OBJECTIVES: I. To evaluate disease-free survival with pazopanib (pazopanib hydrochloride) as compared to placebo, defined as the time from randomization to the development of recurrent disease, second primary cancer (other than localized breast, localized prostate, or non-melanoma skin cancer) or death from any cause for patients with metastatic renal cell carcinoma (RCC) with no evidence of disease following metastasectomy. SECONDARY OBJECTIVES: I. To describe the overall survival of patients with advanced RCC randomly assigned to receive placebo or pazopanib for one year following metastasectomy to no evidence of disease (NED). II. To describe treatment and (at recurrence) disease-related adverse events in the two treatment arms. III. To analyze quality-adjusted time without symptoms of disease or treatment (Q-TWiST) for subjects in the two treatment arms. IV. To characterize changes in patient-reported fatigue and (at recurrence) kidney cancer-related symptoms during and following treatment with pazopanib compared to placebo. V. To explore the association between plasma trough levels of pazopanib and disease-free and overall survival. VI. To prospectively bank preserved tissue from primary tumors and associated metastatic sites in patients with RCC. OUTLINE: Patients are randomized to 1of 2 treatment arms. ARM A: Patients receive pazopanib hydrochloride orally (PO) once daily (QD) on days 1-28. Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity. ARM B: Patients receive placebo PO QD on days 1-28. Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo computed tomography (CT) or magnetic resonance imaging (MRI) throughout the study. After completion of study treatment, patients are followed up every 3 months for the first two years, every 6 months for the next 3 years, and then annually up to 10 years.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 129
Est. completion date February 22, 2025
Est. primary completion date July 17, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patient must be at least 18 years of age at the time of randomization - Patient must have pathologically confirmed renal cell carcinoma with a clear cell component; pure papillary and chromophobe histologies are excluded; there must be pathologic confirmation of metastatic disease in the resected metastasectomy specimen - Patient must have undergone nephrectomy or partial nephrectomy to remove primary renal cell carcinoma (at any time in the past) - Patient must have undergone surgical resection to remove one or more sites of metastatic disease, with successful removal of all known sites 2-12 weeks prior to randomization. Any number of prior metastasectomies may have been performed in the past, so long as the most recent procedure was within the 12 weeks of registration. The most recent procedure may be nephrectomy for a renal primary tumor - Patients with synchronous disease at initial diagnosis must have metastatic (M1) disease (American Joint Committee on Cancer [AJCC] 7th edition T1-4N0-1M1) - Positive surgical margins are permitted if the surgeon confirms complete resection of gross metastatic disease, and post-operative scans are negative - Patients presenting with metachronous disease may have distant metastases, regional lymph node or renal bed recurrence. Recurrences at a partial nephrectomy resection site are not eligible if it is the only site of disease - Patient must have no evidence of disease on post-operative imaging: - A computed tomography (CT) of the chest must be obtained within 4 weeks prior to randomization with or without contrast - A CT of the abdomen/pelvis must be obtained within 4 weeks prior to randomization with intravenous (IV) contrast (oral contrast may be added at the radiologist's discretion); an magnetic resonance imaging (MRI) of the abdomen/pelvis with gadolinium may be substituted for the CT if the CT with IV contrast is contra-indicated - An MRI of the brain with and without gadolinium must be done within 8 weeks prior to randomization; a CT of the brain with and without IV contrast is permitted if MRI is contra-indicated (i.e., pacemaker) - Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at the time of randomization - Absolute granulocyte count > 1,500/mcL (within 2 weeks prior to randomization) - Platelets > 100,000/mcL (within 2 weeks prior to randomization) - Total bilirubin < 1.5 x institutional upper limit of normal (ULN) (within 2 weeks prior to randomization) - Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) < 2.5 x upper limit of normal (ULN) (within 2 weeks prior to randomization) - Calculated creatinine clearance (CrCl) > 30 mL/min (within 2 weeks prior to randomization) - Subjects must have a urine protein/creatinine (UPC) ratio < 1; if UPC >= 1, then a 24-hour urine total protein must be obtained; subjects must have a 24-hour urine protein value < 1 g to be eligible; use of urine dipstick for renal function assessment is not acceptable (within 2 weeks prior to randomization) - All females of childbearing potential must have a blood test or urine study within 2 weeks prior to randomization to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months) - Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception or to abstain from sexual intercourse for the duration of their participation in the study; 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 - Patient must be able to swallow pills and have no significant impairment in gastrointestinal absorption including history of gastric bypass surgery - Patient must have a corrected QT (QTc) interval on electrocardiogram (ECG) =< 0.48 seconds by Bazett's calculation (=< Common Terminology Criteria for Adverse Events [CTCAE] version [v.]4 grade 2) prior to randomization - Patient must have a systolic blood pressure =< 140 mmHg and diastolic blood pressure must be =< 90 mmHg, measured within 4 weeks prior to randomization; initiation or adjustment of anti-hypertensives prior to starting study treatment is allowed - Patient must have no history of cerebrovascular accident (CVA) within 6 months of randomization Exclusion Criteria: - Patients presenting with tumors within the kidneys (multiple synchronous or single/multiple metachronous) are not eligible if there are no extrarenal sites of disease (i.e. potential multifocal primary disease) - Patient must not have received any prior or concurrent systemic therapy for RCC. Adjuvant placebo administration is permitted - Patient must have no active peptic ulcer disease - Patient must have no active inflammatory bowel disease - Patient must have no New York Heart Association (NYHA) class II or greater congestive heart failure - Patient must have no prior history or current clinically apparent central nervous system metastases - Women must not be pregnant or breast-feeding due to the unknown effects of pazopanib on the developing fetus - Patient must have no history of allergic reactions attributed to compounds of similar chemical or biologic composition to pazopanib - Patient must have no uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements - Patient must not have serious or non-healing wound, ulcer, or bone fracture at the time of randomization - Patient must have no history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 4 weeks prior to randomization - Patient must have no history of myocardial infarction, hospital admission for unstable angina, cardiac angioplasty or stenting within 6 months of randomization - Patient must have no history venous thrombosis within 12 weeks of randomization - Patient cannot be taking strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors such as: - Antibiotics: clarithromycin, telithromycin, troleandomycin - Human immunodeficiency virus (HIV) antiviral protease inhibitors: ritonavir, indinavir, saquinavir, nelfinavir, amprenavir, lopinavir - Antifungals: itraconazole, ketoconazole, voriconazole, fluconazole - Antidepressants: nefazodone - Patient must not have history of hemoptysis in excess of 2.5 mL (1/2 teaspoon) within 8 weeks prior to randomization - Patient must not be taking drugs known to prolong the QTc interval; such drugs should be discontinued at least 5 half-lives prior to randomization - Patients must not have any history of other cancer within 3 years from time of randomization with the exception of basal cell skin cancer, squamous cell skin cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breast, or resected non-invasive (Ta) urothelial carcinoma

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Computed Tomography
Undergo CT
Magnetic Resonance Imaging
Undergo MRI
Drug:
Pazopanib Hydrochloride
Given PO
Other:
Placebo Administration
Given PO
Questionnaire Administration
Ancillary studies

Locations

Country Name City State
United States Lehigh Valley Hospital-Cedar Crest Allentown Pennsylvania
United States Mary Greeley Medical Center Ames Iowa
United States McFarland Clinic - Ames Ames Iowa
United States Community Hospital of Anaconda Anaconda Montana
United States Michigan Cancer Research Consortium NCORP Ann Arbor Michigan
United States Trinity Health Saint Joseph Mercy Hospital Ann Arbor Ann Arbor Michigan
United States University of Michigan Comprehensive Cancer Center Ann Arbor Michigan
United States PCR Oncology Arroyo Grande California
United States Randolph Hospital Asheboro North Carolina
United States AdventHealth Infusion Center Asheville Asheville North Carolina
United States Emory Saint Joseph's Hospital Atlanta Georgia
United States Emory University Hospital/Winship Cancer Institute Atlanta Georgia
United States MultiCare Auburn Medical Center Auburn Washington
United States Harold Alfond Center for Cancer Care Augusta Maine
United States Rush - Copley Medical Center Aurora Illinois
United States Virginia Mason Bainbridge Island Medical Center Bainbridge Island Washington
United States Saint Alphonsus Medical Center-Baker City Baker City Oregon
United States Saint Louis Cancer and Breast Institute-Ballwin Ballwin Missouri
United States Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore Maryland
United States Eastern Maine Medical Center Bangor Maine
United States Flaget Memorial Hospital Bardstown Kentucky
United States Bronson Battle Creek Battle Creek Michigan
United States Overlake Medical Center Bellevue Washington
United States Strecker Cancer Center-Belpre Belpre Ohio
United States Lehigh Valley Hospital - Muhlenberg Bethlehem Pennsylvania
United States Spectrum Health Big Rapids Hospital Big Rapids Michigan
United States Billings Clinic Cancer Center Billings Montana
United States Montana Cancer Consortium NCORP Billings Montana
United States Saint Vincent Frontier Cancer Center Billings Montana
United States Saint Vincent Healthcare Billings Montana
United States Illinois CancerCare-Bloomington Bloomington Illinois
United States OSF Saint Joseph Medical Center Bloomington Illinois
United States Saint Alphonsus Cancer Care Center-Boise Boise Idaho
United States Central Care Cancer Center - Bolivar Bolivar Missouri
United States Parkland Health Center-Bonne Terre Bonne Terre Missouri
United States McFarland Clinic - Boone Boone Iowa
United States Bozeman Health Deaconess Hospital Bozeman Montana
United States Cox Cancer Center Branson Branson Missouri
United States Harrison HealthPartners Hematology and Oncology-Bremerton Bremerton Washington
United States Lafayette Family Cancer Center-EMMC Brewer Maine
United States Trinity Health IHA Medical Group Hematology Oncology - Brighton Brighton Michigan
United States Trinity Health Medical Center - Brighton Brighton Michigan
United States Bristol Regional Medical Center Bristol Tennessee
United States Wellmont Medical Associates Oncology and Hematology-Bristol Bristol Tennessee
United States Wellmont Medical Associates-Bristol Bristol Virginia
United States Montefiore Medical Center - Moses Campus Bronx New York
United States Montefiore Medical Center-Einstein Campus Bronx New York
United States Montefiore Medical Center-Weiler Hospital Bronx New York
United States Ascension Southeast Wisconsin Hospital - Elmbrook Campus Brookfield Wisconsin
United States Henry Ford Cancer Institute-Downriver Brownstown Michigan
United States Saint Joseph Regional Cancer Center Bryan Texas
United States Highline Medical Center-Main Campus Burien Washington
United States Aurora Cancer Care-Southern Lakes VLCC Burlington Wisconsin
United States Cone Health Cancer Center at Alamance Regional Burlington North Carolina
United States Saint James Community Hospital and Cancer Treatment Center Butte Montana
United States Saint Alphonsus Cancer Care Center-Caldwell Caldwell Idaho
United States Cooper Hospital University Medical Center Camden New Jersey
United States Illinois CancerCare-Canton Canton Illinois
United States Saint Joseph Mercy Canton Canton Michigan
United States Trinity Health IHA Medical Group Hematology Oncology - Canton Canton Michigan
United States Saint Francis Medical Center Cape Girardeau Missouri
United States Southeast Cancer Center Cape Girardeau Missouri
United States Memorial Hospital of Carbondale Carbondale Illinois
United States Caro Cancer Center Caro Michigan
United States Carson Tahoe Regional Medical Center Carson City Nevada
United States SIH Cancer Institute Carterville Illinois
United States Illinois CancerCare-Carthage Carthage Illinois
United States Rocky Mountain Oncology Casper Wyoming
United States Dayton Physicians LLC-Miami Valley South Centerville Ohio
United States Miami Valley Hospital South Centerville Ohio
United States Centralia Oncology Clinic Centralia Illinois
United States Providence Regional Cancer System-Centralia Centralia Washington
United States Cancer Center of Kansas - Chanute Chanute Kansas
United States Bon Secours Saint Francis Hospital Charleston South Carolina
United States Charleston Oncology - Roper Charleston South Carolina
United States Charleston Oncology - Saint Francis Charleston South Carolina
United States Lowcountry Hematology Oncology PA-North Charleston Charleston South Carolina
United States Lowcountry Hematology Oncology PA-West Ashley Charleston South Carolina
United States Roper Hospital Charleston South Carolina
United States West Virginia University Charleston Division Charleston West Virginia
United States Erlanger Medical Center Chattanooga Tennessee
United States Memorial Hospital Chattanooga Tennessee
United States Saint Joseph Mercy Chelsea Chelsea Michigan
United States Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital Chelsea Michigan
United States Saint Luke's Hospital Chesterfield Missouri
United States Hematology and Oncology Associates Chicago Illinois
United States Northwestern University Chicago Illinois
United States Presence Resurrection Medical Center Chicago Illinois
United States Adena Regional Medical Center Chillicothe Ohio
United States Marshfield Clinic-Chippewa Center Chippewa Falls Wisconsin
United States Bethesda North Hospital Cincinnati Ohio
United States Good Samaritan Hospital - Cincinnati Cincinnati Ohio
United States Oncology Hematology Care Inc-Anderson Cincinnati Ohio
United States Oncology Hematology Care Inc-Blue Ash Cincinnati Ohio
United States Oncology Hematology Care Inc-Eden Park Cincinnati Ohio
United States Oncology Hematology Care Inc-Kenwood Cincinnati Ohio
United States Oncology Hematology Care Inc-Mercy West Cincinnati Ohio
United States TriHealth Cancer Institute-Anderson Cincinnati Ohio
United States TriHealth Cancer Institute-Westside Cincinnati Ohio
United States Hematology Oncology Consultants-Clarkston Clarkston Michigan
United States Newland Medical Associates-Clarkston Clarkston Michigan
United States MetroHealth Medical Center Cleveland Ohio
United States Sampson Radiation Oncology Clinton North Carolina
United States Southeastern Medical Oncology Center-Clinton Clinton North Carolina
United States Henry Ford Macomb Hospital-Clinton Township Clinton Township Michigan
United States Mercy Cancer Center-West Lakes Clive Iowa
United States Mission Cancer and Blood - West Des Moines Clive Iowa
United States Big Horn Basin Cancer Center Cody Wyoming
United States Billings Clinic-Cody Cody Wyoming
United States Kootenai Health - Coeur d'Alene Coeur d'Alene Idaho
United States Penrose-Saint Francis Healthcare Colorado Springs Colorado
United States Rocky Mountain Cancer Centers-Penrose Colorado Springs Colorado
United States MU Health - University Hospital/Ellis Fischel Cancer Center Columbia Missouri
United States Columbus NCI Community Oncology Research Program Columbus Ohio
United States Columbus Oncology and Hematology Associates Inc Columbus Ohio
United States Doctors Hospital Columbus Ohio
United States Grant Medical Center Columbus Ohio
United States John B Amos Cancer Center Columbus Georgia
United States Mount Carmel Health Center West Columbus Ohio
United States Riverside Methodist Hospital Columbus Ohio
United States The Mark H Zangmeister Center Columbus Ohio
United States Commonwealth Cancer Center-Corbin Corbin Kentucky
United States Alegent Health Mercy Hospital Council Bluffs Iowa
United States Greater Regional Medical Center Creston Iowa
United States Oncology Hematology Care Inc-Crestview Crestview Hills Kentucky
United States Carle at The Riverfront Danville Illinois
United States Dayton NCI Community Oncology Research Program Dayton Ohio
United States Dayton Physician LLC - Englewood Dayton Ohio
United States Good Samaritan Hospital - Dayton Dayton Ohio
United States Grandview Hospital Dayton Ohio
United States Miami Valley Hospital Dayton Ohio
United States Miami Valley Hospital North Dayton Ohio
United States Beaumont Hospital - Dearborn Dearborn Michigan
United States Henry Ford Medical Center-Fairlane Dearborn Michigan
United States Cancer Care Specialists of Illinois - Decatur Decatur Illinois
United States Decatur Memorial Hospital Decatur Illinois
United States Heartland Cancer Research NCORP Decatur Illinois
United States Delaware Health Center-Grady Cancer Center Delaware Ohio
United States Delaware Radiation Oncology Delaware Ohio
United States Grady Memorial Hospital Delaware Ohio
United States Porter Adventist Hospital Denver Colorado
United States Mercy Medical Center - Des Moines Des Moines Iowa
United States Mission Cancer and Blood - Laurel Des Moines Iowa
United States Ascension Saint John Hospital Detroit Michigan
United States Henry Ford Hospital Detroit Michigan
United States Cancer Center of Kansas - Dodge City Dodge City Kansas
United States City of Hope Comprehensive Cancer Center Duarte California
United States Epic Care-Dublin Dublin California
United States Mercy Medical Center Durango Colorado
United States Southwest Oncology PC Durango Colorado
United States Duke University Medical Center Durham North Carolina
United States Great Lakes Cancer Management Specialists-Doctors Park East China Township Michigan
United States HSHS Sacred Heart Hospital Eau Claire Wisconsin
United States Marshfield Clinic Cancer Center at Sacred Heart Eau Claire Wisconsin
United States Carle Physician Group-Effingham Effingham Illinois
United States Crossroads Cancer Center Effingham Illinois
United States Cancer Center of Kansas - El Dorado El Dorado Kansas
United States Christiana Care - Union Hospital Elkton Maryland
United States Bay Area Breast Surgeons Inc Emeryville California
United States Epic Care Partners in Cancer Care Emeryville California
United States Walter Knox Memorial Hospital Emmett Idaho
United States Newman Regional Health Emporia Kansas
United States Saint Elizabeth Hospital Enumclaw Washington
United States Illinois CancerCare-Eureka Eureka Illinois
United States Providence Regional Cancer Partnership Everett Washington
United States Fairbanks Memorial Hospital Fairbanks Alaska
United States Oncology Hematology Care Inc-Healthplex Fairfield Ohio
United States Farmington Health Center Farmington Utah
United States Beaumont Hospital - Farmington Hills Farmington Hills Michigan
United States Saint Francis Hospital Federal Way Washington
United States Virginia Mason Federal Way Medical Center Federal Way Washington
United States Armes Family Cancer Center Findlay Ohio
United States Blanchard Valley Hospital Findlay Ohio
United States Orion Cancer Care Findlay Ohio
United States Genesee Cancer and Blood Disease Treatment Center Flint Michigan
United States Genesee Hematology Oncology PC Flint Michigan
United States Genesys Hurley Cancer Institute Flint Michigan
United States Hurley Medical Center Flint Michigan
United States McLeod Regional Medical Center Florence South Carolina
United States Aurora Health Center-Fond du Lac Fond Du Lac Wisconsin
United States McFarland Clinic - Trinity Cancer Center Fort Dodge Iowa
United States Cancer Center of Kansas - Fort Scott Fort Scott Kansas
United States Ascension Saint Francis - Reiman Cancer Center Franklin Wisconsin
United States Atrium Medical Center-Middletown Regional Hospital Franklin Ohio
United States Dayton Physicians LLC-Atrium Franklin Ohio
United States Northeast Georgia Medical Center-Gainesville Gainesville Georgia
United States Illinois CancerCare-Galesburg Galesburg Illinois
United States Western Illinois Cancer Treatment Center Galesburg Illinois
United States Saint Catherine Hospital Garden City Kansas
United States Northwestern Medicine Cancer Center Delnor Geneva Illinois
United States Aurora Health Care Germantown Health Center Germantown Wisconsin
United States MultiCare Gig Harbor Medical Park Gig Harbor Washington
United States Tacoma/Valley Radiation Oncology Centers-Gig Harbor Gig Harbor Washington
United States Mountain Blue Cancer Care Center Golden Colorado
United States Southeastern Medical Oncology Center-Goldsboro Goldsboro North Carolina
United States Wayne Memorial Hospital Goldsboro North Carolina
United States Wayne Radiation Oncology Goldsboro North Carolina
United States Aurora Cancer Care-Grafton Grafton Wisconsin
United States Nebraska Cancer Specialists/Oncology Hematology West PC Grand Island Nebraska
United States Grand Valley Oncology Grand Junction Colorado
United States Cancer Research Consortium of West Michigan NCORP Grand Rapids Michigan
United States Corewell Health Grand Rapids Hospitals - Butterworth Hospital Grand Rapids Michigan
United States Trinity Health Grand Rapids Hospital Grand Rapids Michigan
United States Three Rivers Community Hospital Grants Pass Oregon
United States Saint Rose Ambulatory and Surgery Center Great Bend Kansas
United States Benefis Sletten Cancer Institute Great Falls Montana
United States Great Falls Clinic Great Falls Montana
United States Aurora BayCare Medical Center Green Bay Wisconsin
United States Cone Health Cancer Center Greensboro North Carolina
United States Dayton Physicians LLC-Wayne Greenville Ohio
United States Saint Francis Cancer Center Greenville South Carolina
United States Saint Francis Hospital Greenville South Carolina
United States Wayne Hospital Greenville Ohio
United States William Beaumont Hospital-Grosse Pointe Grosse Pointe Michigan
United States Academic Hematology Oncology Specialists Grosse Pointe Woods Michigan
United States Great Lakes Cancer Management Specialists-Van Elslander Cancer Center Grosse Pointe Woods Michigan
United States Michigan Breast Specialists-Grosse Pointe Woods Grosse Pointe Woods Michigan
United States Smilow Cancer Hospital Care Center at Saint Francis Hartford Connecticut
United States HaysMed Hays Kansas
United States Saint Peter's Community Hospital Helena Montana
United States Cancer and Blood Specialists-Henderson Henderson Nevada
United States Comprehensive Cancer Centers of Nevada - Henderson Henderson Nevada
United States Comprehensive Cancer Centers of Nevada-Southeast Henderson Henderson Nevada
United States GenesisCare USA - Henderson Henderson Nevada
United States Las Vegas Cancer Center-Henderson Henderson Nevada
United States AdventHealth Hendersonville Hendersonville North Carolina
United States Hematology Oncology Associates of Illinois-Highland Park Highland Park Illinois
United States Pulmonary Medicine Center of Chattanooga-Hixson Hixson Tennessee
United States CHI Saint Vincent Cancer Center Hot Springs Hot Springs Arkansas
United States Edwards Comprehensive Cancer Center Huntington West Virginia
United States Cancer Center of Kansas-Independence Independence Kansas
United States Franciscan Health Indianapolis Indianapolis Indiana
United States Indiana University/Melvin and Bren Simon Cancer Center Indianapolis Indiana
United States University of Iowa/Holden Comprehensive Cancer Center Iowa City Iowa
United States Allegiance Health Jackson Michigan
United States University of Mississippi Medical Center Jackson Mississippi
United States Onslow Memorial Hospital Jacksonville North Carolina
United States Southeastern Medical Oncology Center-Jacksonville Jacksonville North Carolina
United States McFarland Clinic - Jefferson Jefferson Iowa
United States MU Health Care Goldschmidt Cancer Center Jefferson City Missouri
United States Wellmont Medical Associates Oncology and Hematology-Johnson City Johnson City Tennessee
United States Freeman Health System Joplin Missouri
United States Mercy Hospital Joplin Joplin Missouri
United States Borgess Medical Center Kalamazoo Michigan
United States Bronson Methodist Hospital Kalamazoo Michigan
United States West Michigan Cancer Center Kalamazoo Michigan
United States Kalispell Medical Oncology Kalispell Montana
United States Kalispell Regional Medical Center Kalispell Montana
United States Presence Saint Mary's Hospital Kankakee Illinois
United States The University of Kansas Cancer Center-South Kansas City Missouri
United States University Health Truman Medical Center Kansas City Missouri
United States University of Kansas Cancer Center Kansas City Kansas
United States University of Kansas Cancer Center - North Kansas City Missouri
United States University of Kansas Cancer Center-West Kansas City Kansas
United States CHI Health Good Samaritan Kearney Nebraska
United States Heartland Hematology and Oncology Kearney Nebraska
United States Northwest Cancer Clinic Kennewick Washington
United States Aurora Cancer Care-Kenosha South Kenosha Wisconsin
United States First Dayton Cancer Care Kettering Ohio
United States Greater Dayton Cancer Center Kettering Ohio
United States Kettering Medical Center Kettering Ohio
United States Illinois CancerCare-Kewanee Clinic Kewanee Illinois
United States Cancer Center of Kansas-Kingman Kingman Kansas
United States Ballad Health Cancer Care - Kingsport Kingsport Tennessee
United States Wellmont Holston Valley Hospital and Medical Center Kingsport Tennessee
United States ECU Health Oncology Kinston Kinston North Carolina
United States University of Tennessee - Knoxville Knoxville Tennessee
United States Gundersen Lutheran Medical Center La Crosse Wisconsin
United States UC San Diego Moores Cancer Center La Jolla California
United States Providence Regional Cancer System-Lacey Lacey Washington
United States Marshfield Clinic - Ladysmith Center Ladysmith Wisconsin
United States Rocky Mountain Cancer Centers-Lakewood Lakewood Colorado
United States Saint Anthony Hospital Lakewood Colorado
United States Saint Clare Hospital Lakewood Washington
United States Fairfield Medical Center Lancaster Ohio
United States Lancaster Radiation Oncology Lancaster Ohio
United States University of Michigan Health - Sparrow Lansing Lansing Michigan
United States Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas Nevada
United States Ann M Wierman MD LTD Las Vegas Nevada
United States Cancer and Blood Specialists-Shadow Las Vegas Nevada
United States Cancer and Blood Specialists-Tenaya Las Vegas Nevada
United States Cancer Therapy and Integrative Medicine Las Vegas Nevada
United States Comprehensive Cancer Centers of Nevada Las Vegas Nevada
United States Comprehensive Cancer Centers of Nevada - Central Valley Las Vegas Nevada
United States Comprehensive Cancer Centers of Nevada - Northwest Las Vegas Nevada
United States Comprehensive Cancer Centers of Nevada-Summerlin Las Vegas Nevada
United States GenesisCare USA - Fort Apache Las Vegas Nevada
United States GenesisCare USA - Las Vegas Las Vegas Nevada
United States GenesisCare USA - Vegas Tenaya Las Vegas Nevada
United States HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills Las Vegas Nevada
United States HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway Las Vegas Nevada
United States HealthCare Partners Medical Group Oncology/Hematology-San Martin Las Vegas Nevada
United States HealthCare Partners Medical Group Oncology/Hematology-Tenaya Las Vegas Nevada
United States Las Vegas Cancer Center-Medical Center Las Vegas Nevada
United States Nevada Cancer Research Foundation NCORP Las Vegas Nevada
United States OptumCare Cancer Care at Fort Apache Las Vegas Nevada
United States Radiation Oncology Centers of Nevada Central Las Vegas Nevada
United States Radiation Oncology Centers of Nevada Southeast Las Vegas Nevada
United States Summerlin Hospital Medical Center Las Vegas Nevada
United States University Cancer Center Las Vegas Nevada
United States University Medical Center of Southern Nevada Las Vegas Nevada
United States Lawrence Memorial Hospital Lawrence Kansas
United States Cancer Centers of Southwest Oklahoma Research Lawton Oklahoma
United States University of Kansas Cancer Center - Lee's Summit Lee's Summit Missouri
United States Beebe Medical Center Lewes Delaware
United States Saint Joseph Regional Medical Center Lewiston Idaho
United States Saint Joseph Hospital East Lexington Kentucky
United States Saint Joseph Radiation Oncology Resource Center Lexington Kentucky
United States Cancer Center of Kansas-Liberal Liberal Kansas
United States AMG Libertyville - Oncology Libertyville Illinois
United States Saint Elizabeth Regional Medical Center Lincoln Nebraska
United States Littleton Adventist Hospital Littleton Colorado
United States Hope Cancer Clinic Livonia Michigan
United States Trinity Health Saint Mary Mercy Livonia Hospital Livonia Michigan
United States Longmont United Hospital Longmont Colorado
United States Rocky Mountain Cancer Centers-Longmont Longmont Colorado
United States Los Angeles General Medical Center Los Angeles California
United States USC / Norris Comprehensive Cancer Center Los Angeles California
United States Jewish Hospital Louisville Kentucky
United States Saints Mary and Elizabeth Hospital Louisville Kentucky
United States UofL Health Medical Center Northeast Louisville Kentucky
United States Virginia Mason Lynnwood Medical Center Lynnwood Washington
United States Great Lakes Cancer Management Specialists-Macomb Medical Campus Macomb Michigan
United States Illinois CancerCare-Macomb Macomb Illinois
United States Michigan Breast Specialists-Macomb Township Macomb Michigan
United States Atrium Health Navicent Macon Georgia
United States Cancer Center of Kansas-Manhattan Manhattan Kansas
United States Marietta Memorial Hospital Marietta Ohio
United States Aurora Bay Area Medical Group-Marinette Marinette Wisconsin
United States Bay Area Medical Center Marinette Wisconsin
United States Saint Mary's Oncology/Hematology Associates of Marlette Marlette Michigan
United States McFarland Clinic - Marshalltown Marshalltown Iowa
United States Marshfield Medical Center Marshfield Wisconsin
United States Marshfield Medical Center-Marshfield Marshfield Wisconsin
United States Contra Costa Regional Medical Center Martinez California
United States Mercy Medical Center - North Iowa Mason City Iowa
United States Carle Physician Group-Mattoon/Charleston Mattoon Illinois
United States Loyola University Medical Center Maywood Illinois
United States Cancer Center of Kansas - McPherson McPherson Kansas
United States Cone Heath Cancer Center at Mebane Mebane North Carolina
United States Bon Secours Memorial Regional Medical Center Mechanicsville Virginia
United States Asante Rogue Regional Medical Center Medford Oregon
United States Providence Medford Medical Center Medford Oregon
United States Ascension Columbia Saint Mary's Hospital Ozaukee Mequon Wisconsin
United States Idaho Urologic Institute-Meridian Meridian Idaho
United States East Jefferson General Hospital Metairie Louisiana
United States Robert Veith MD LLC Metairie Louisiana
United States Franciscan Saint Anthony Health-Michigan City Michigan City Indiana
United States Woodland Cancer Care Center Michigan City Indiana
United States Dayton Physicians LLC-Signal Point Middletown Ohio
United States Garnet Health Medical Center Middletown New York
United States Bon Secours Saint Francis Medical Center Midlothian Virginia
United States Ascension Columbia Saint Mary's Hospital - Milwaukee Milwaukee Wisconsin
United States Ascension Southeast Wisconsin Hospital - Saint Joseph Campus Milwaukee Wisconsin
United States Aurora Cancer Care-Milwaukee Milwaukee Wisconsin
United States Aurora Saint Luke's Medical Center Milwaukee Wisconsin
United States Aurora Sinai Medical Center Milwaukee Wisconsin
United States Medical College of Wisconsin Milwaukee Wisconsin
United States Marshfield Clinic-Minocqua Center Minocqua Wisconsin
United States Memorial Regional Cancer Center Day Road Mishawaka Indiana
United States Community Medical Center Missoula Montana
United States Montana Cancer Specialists Missoula Montana
United States Saint Patrick Hospital - Community Hospital Missoula Montana
United States Holy Family Medical Center Monmouth Illinois
United States Illinois CancerCare-Monmouth Monmouth Illinois
United States Monroe Cancer Center Monroe Michigan
United States Lowcountry Hematology Oncology PA-Mount Pleasant Mount Pleasant South Carolina
United States Good Samaritan Regional Health Center Mount Vernon Illinois
United States Knox Community Hospital Mount Vernon Ohio
United States ProHealth D N Greenwald Center Mukwonago Wisconsin
United States Trinity Health Muskegon Hospital Muskegon Michigan
United States Saint Alphonsus Cancer Care Center-Nampa Nampa Idaho
United States Rutgers Cancer Institute of New Jersey New Brunswick New Jersey
United States Louisiana State University Health Science Center New Orleans Louisiana
United States Ochsner Medical Center Jefferson New Orleans Louisiana
United States University Medical Center New Orleans New Orleans Louisiana
United States Christiana Care Health System-Christiana Hospital Newark Delaware
United States Christiana Gynecologic Oncology LLC Newark Delaware
United States Delaware Clinical and Laboratory Physicians PA Newark Delaware
United States Helen F Graham Cancer Center Newark Delaware
United States Licking Memorial Hospital Newark Ohio
United States Medical Oncology Hematology Consultants PA Newark Delaware
United States Newark Radiation Oncology Newark Ohio
United States Cancer Center of Kansas - Newton Newton Kansas
United States Corewell Health Lakeland Hospitals - Niles Hospital Niles Michigan
United States Illinois Cancer Specialists-Niles Niles Illinois
United States Carle Cancer Institute Normal Normal Illinois
United States Cancer Care Associates-Norman Norman Oklahoma
United States Southwest VA Regional Cancer Center Norton Virginia
United States Henry Ford Medical Center-Columbus Novi Michigan
United States Alta Bates Summit Medical Center - Summit Campus Oakland California
United States Bay Area Tumor Institute Oakland California
United States ProHealth Oconomowoc Memorial Hospital Oconomowoc Wisconsin
United States Integris Cancer Institute of Oklahoma Oklahoma City Oklahoma
United States Mercy Hospital Oklahoma City Oklahoma City Oklahoma
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma
United States Olathe Health Cancer Center Olathe Kansas
United States Capital Medical Center Olympia Washington
United States Providence - Saint Peter Hospital Olympia Washington
United States Alegent Health Bergan Mercy Medical Center Omaha Nebraska
United States Alegent Health Immanuel Medical Center Omaha Nebraska
United States Alegent Health Lakeside Hospital Omaha Nebraska
United States Creighton University Medical Center Omaha Nebraska
United States Hematology and Oncology Consultants PC Omaha Nebraska
United States Nebraska Methodist Hospital Omaha Nebraska
United States Saint Alphonsus Medical Center-Ontario Ontario Oregon
United States Memorial GYN Plus Ooltewah Tennessee
United States Vince Lombardi Cancer Clinic - Oshkosh Oshkosh Wisconsin
United States Illinois CancerCare-Ottawa Clinic Ottawa Illinois
United States Ottawa Regional Hospital and Healthcare Center Ottawa Illinois
United States Radiation Oncology of Northern Illinois Ottawa Illinois
United States University of Kansas Cancer Center-Overland Park Overland Park Kansas
United States Midlands Community Hospital Papillion Nebraska
United States Parker Adventist Hospital Parker Colorado
United States Rocky Mountain Cancer Centers-Parker Parker Colorado
United States Cancer Center of Kansas - Parsons Parsons Kansas
United States Illinois CancerCare-Pekin Pekin Illinois
United States OSF Saint Francis Radiation Oncology at Pekin Pekin Illinois
United States Illinois CancerCare-Peoria Peoria Illinois
United States Methodist Medical Center of Illinois Peoria Illinois
United States OSF Saint Francis Medical Center Peoria Illinois
United States OSF Saint Francis Radiation Oncology at Peoria Cancer Center Peoria Illinois
United States Proctor Hospital Peoria Illinois
United States Illinois CancerCare-Peru Peru Illinois
United States Illinois Valley Hospital Peru Illinois
United States Valley Radiation Oncology Peru Illinois
United States University of Pennsylvania/Abramson Cancer Center Philadelphia Pennsylvania
United States Ascension Via Christi - Pittsburg Pittsburg Kansas
United States University of Pittsburgh Cancer Institute (UPCI) Pittsburgh Pennsylvania
United States Hope Cancer Center Pontiac Michigan
United States Michigan Healthcare Professionals Pontiac Pontiac Michigan
United States Newland Medical Associates-Pontiac Pontiac Michigan
United States Trinity Health Saint Joseph Mercy Oakland Hospital Pontiac Michigan
United States Lake Huron Medical Center Port Huron Michigan
United States Jefferson Healthcare Port Townsend Washington
United States Oregon Health and Science University Portland Oregon
United States Southern Ohio Medical Center Portsmouth Ohio
United States Kootenai Clinic Cancer Services - Post Falls Post Falls Idaho
United States Pottstown Hospital Pottstown Pennsylvania
United States Harrison HealthPartners Hematology and Oncology-Poulsbo Poulsbo Washington
United States Peninsula Cancer Center Poulsbo Washington
United States Cancer Center of Kansas - Pratt Pratt Kansas
United States Illinois CancerCare-Princeton Princeton Illinois
United States Princeton Community Hospital Princeton West Virginia
United States Rocky Mountain Cancer Centers - Pueblo Pueblo Colorado
United States Saint Mary Corwin Medical Center Pueblo Colorado
United States MultiCare Good Samaritan Hospital Puyallup Washington
United States Tacoma/Valley Radiation Oncology Centers-Puyallup Puyallup Washington
United States Aurora Cancer Care-Racine Racine Wisconsin
United States Rapid City Regional Hospital Rapid City South Dakota
United States Corewell Health Reed City Hospital Reed City Michigan
United States Beebe Health Campus Rehoboth Beach Delaware
United States Annie Penn Memorial Hospital Reidsville North Carolina
United States Renown Regional Medical Center Reno Nevada
United States Saint Mary's Regional Medical Center Reno Nevada
United States Ascension Saint Mary's Hospital Rhinelander Wisconsin
United States Saint Mary's Hospital Rhinelander Wisconsin
United States Lakeview Medical Center-Marshfield Clinic Rice Lake Wisconsin
United States Marshfield Medical Center-Rice Lake Rice Lake Wisconsin
United States Bon Secours Saint Mary's Hospital Richmond Virginia
United States Reid Health Richmond Indiana
United States Mayo Clinic in Rochester Rochester Minnesota
United States Great Lakes Cancer Management Specialists-Rochester Hills Rochester Hills Michigan
United States Penobscot Bay Medical Center Rockport Maine
United States Delbert Day Cancer Institute at PCRMC Rolla Missouri
United States Mercy Clinic-Rolla-Cancer and Hematology Rolla Missouri
United States Michigan Cancer Specialists Roseville Michigan
United States Cancer Care Associates PC Royal Oak Michigan
United States Comprehensive Medical Center PLLC Royal Oak Michigan
United States Hematology Oncology Consultants PC Royal Oak Michigan
United States Oakland Colon Rectal Associates Royal Oak Michigan
United States Oakland Medical Group Royal Oak Michigan
United States William Beaumont Hospital-Royal Oak Royal Oak Michigan
United States Ascension Saint Mary's Hospital Saginaw Michigan
United States Oncology Hematology Associates of Saginaw Valley PC Saginaw Michigan
United States Coborn Cancer Center at Saint Cloud Hospital Saint Cloud Minnesota
United States Saint Cloud Hospital Saint Cloud Minnesota
United States Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center Saint Joseph Michigan
United States Corewell Health Lakeland Hospitals - Saint Joseph Hospital Saint Joseph Michigan
United States Mercy Hospital Saint Louis Saint Louis Missouri
United States Missouri Baptist Medical Center Saint Louis Missouri
United States Saint Louis Cancer and Breast Institute-South City Saint Louis Missouri
United States Saint Louis-Cape Girardeau CCOP Saint Louis Missouri
United States Washington University School of Medicine Saint Louis Missouri
United States Sainte Genevieve County Memorial Hospital Sainte Genevieve Missouri
United States Cancer Center of Kansas - Salina Salina Kansas
United States Salina Regional Health Center Salina Kansas
United States Huntsman Cancer Institute/University of Utah Salt Lake City Utah
United States Kootenai Cancer Clinic Sandpoint Idaho
United States Lewis Cancer and Research Pavilion at Saint Joseph's/Candler Savannah Georgia
United States TidalHealth Nanticoke / Allen Cancer Center Seaford Delaware
United States Virginia Mason Medical Center Seattle Washington
United States Vince Lombardi Cancer Clinic-Sheboygan Sheboygan Wisconsin
United States Jewish Hospital Medical Center South Shepherdsville Kentucky
United States Welch Cancer Center Sheridan Wyoming
United States Dayton Physicians LLC-Wilson Sidney Ohio
United States Saint Michael Cancer Center Silverdale Washington
United States Mercy Medical Center-Sioux City Sioux City Iowa
United States Saint Luke's Regional Medical Center Sioux City Iowa
United States Siouxland Regional Cancer Center Sioux City Iowa
United States Hematology Oncology Associates of Illinois - Skokie Skokie Illinois
United States Memorial Hospital of South Bend South Bend Indiana
United States South Jordan Health Center South Jordan Utah
United States Central Illinois Hematology Oncology Center Springfield Illinois
United States CoxHealth South Hospital Springfield Missouri
United States Memorial Medical Center Springfield Illinois
United States Mercy Hospital Springfield Springfield Missouri
United States Southern Illinois University School of Medicine Springfield Illinois
United States Springfield Clinic Springfield Illinois
United States Springfield Regional Cancer Center Springfield Ohio
United States Springfield Regional Medical Center Springfield Ohio
United States Bhadresh Nayak MD PC-Sterling Heights Sterling Heights Michigan
United States Mitchell Folbe MD PC Sterling Heights Michigan
United States Premier Hematology Oncology Care Sterling Heights Michigan
United States Trinity's Tony Teramana Cancer Center Steubenville Ohio
United States Ascension Saint Michael's Hospital Stevens Point Wisconsin
United States Marshfield Medical Center-River Region at Stevens Point Stevens Point Wisconsin
United States Missouri Baptist Sullivan Hospital Sullivan Missouri
United States Aurora Medical Center in Summit Summit Wisconsin
United States BJC Outpatient Center at Sunset Hills Sunset Hills Missouri
United States Southwest Illinois Health Services LLP Swansea Illinois
United States ProMedica Flower Hospital Sylvania Ohio
United States Franciscan Research Center-Northwest Medical Plaza Tacoma Washington
United States MultiCare Allenmore Hospital Tacoma Washington
United States MultiCare Tacoma General Hospital Tacoma Washington
United States Northwest Medical Specialties PLLC Tacoma Washington
United States Northwest NCI Community Oncology Research Program Tacoma Washington
United States Saint Joseph Medical Center Tacoma Washington
United States Tacoma/Valley Radiation Oncology Centers-Jackson Hall Tacoma Washington
United States Tacoma/Valley Radiation Oncology Centers-Saint Joe's Tacoma Washington
United States Rocky Mountain Cancer Centers-Thornton Thornton Colorado
United States ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital Toledo Ohio
United States Cotton O'Neil Cancer Center / Stormont Vail Health Topeka Kansas
United States University of Kansas Health System Saint Francis Campus Topeka Kansas
United States Munson Medical Center Traverse City Michigan
United States Claudia BR Herke MD PC Troy Michigan
United States Dayton Physicians LLC - Troy Troy Ohio
United States Hematology Oncology Consultants PC-Troy Troy Michigan
United States Michigan Institute of Urology-Town Center Troy Michigan
United States Upper Valley Medical Center Troy Ohio
United States William Beaumont Hospital - Troy Troy Michigan
United States Banner University Medical Center - Tucson Tucson Arizona
United States University of Arizona Cancer Center-North Campus Tucson Arizona
United States University of Arizona Cancer Center-Orange Grove Campus Tucson Arizona
United States Natalie Warren Bryant Cancer Center at Saint Francis Tulsa Oklahoma
United States Warren Clinic Oncology-Tulsa Tulsa Oklahoma
United States Vince Lombardi Cancer Clinic-Two Rivers Two Rivers Wisconsin
United States Carle Cancer Center Urbana Illinois
United States The Carle Foundation Hospital Urbana Illinois
United States Advanced Breast Care Center PLLC Warren Michigan
United States Great Lakes Cancer Management Specialists-Macomb Professional Building Warren Michigan
United States Macomb Hematology Oncology PC Warren Michigan
United States Michigan Breast Specialists-Warren Warren Michigan
United States Saint John Macomb-Oakland Hospital Warren Michigan
United States Northwestern Medicine Cancer Center Warrenville Warrenville Illinois
United States MedStar Georgetown University Hospital Washington District of Columbia
United States Mercy Hospital Washington Washington Missouri
United States Aurora Cancer Care-Waukesha Waukesha Wisconsin
United States ProHealth Waukesha Memorial Hospital Waukesha Wisconsin
United States UW Cancer Center at ProHealth Care Waukesha Wisconsin
United States Marshfield Clinic-Wausau Center Wausau Wisconsin
United States Ascension Medical Group Southeast Wisconsin - Mayfair Road Wauwatosa Wisconsin
United States Aurora Cancer Care-Milwaukee West Wauwatosa Wisconsin
United States Cancer Center of Kansas - Wellington Wellington Kansas
United States Aurora West Allis Medical Center West Allis Wisconsin
United States Henry Ford West Bloomfield Hospital West Bloomfield Michigan
United States Saint Mary's Oncology/Hematology Associates of West Branch West Branch Michigan
United States Mercy Medical Center-West Lakes West Des Moines Iowa
United States Saint Ann's Hospital Westerville Ohio
United States Ascension Saint Clare's Hospital Weston Wisconsin
United States Diagnostic and Treatment Center Weston Wisconsin
United States Marshfield Medical Center - Weston Weston Wisconsin
United States Ascension Via Christi Hospitals Wichita Wichita Kansas
United States Cancer Center of Kansas - Wichita Wichita Kansas
United States Cancer Center of Kansas-Wichita Medical Arts Tower Wichita Kansas
United States Wichita NCI Community Oncology Research Program Wichita Kansas
United States Christiana Care Health System-Wilmington Hospital Wilmington Delaware
United States Cancer Center of Kansas - Winfield Winfield Kansas
United States Southeast Clinical Oncology Research Consortium NCORP Winston-Salem North Carolina
United States Marshfield Clinic - Wisconsin Rapids Center Wisconsin Rapids Wisconsin
United States Wright-Patterson Medical Center Wright-Patterson Air Force Base Ohio
United States University of Michigan Health - West Wyoming Michigan
United States Greene Memorial Hospital Xenia Ohio
United States Rush-Copley Healthcare Center Yorkville Illinois
United States Huron Gastroenterology PC Ypsilanti Michigan
United States Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus Ypsilanti Michigan
United States Genesis Healthcare System Cancer Care Center Zanesville Ohio

Sponsors (1)

Lead Sponsor Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other To Prospectively Bank Preserved Tissue From Primary Tumors and Associated Metastatic Sites in Patients With RCC Baseline
Primary Disease-free Survival (DFS) Disease-free survival (DFS) is defined as the time from randomization to the development of recurrent disease, second primary cancer (other than localized breast, localized prostate, or non-melanoma skin cancer) or death from any cause. Assessed every 3 months for the first 2 years, every 6 months for the next 3 years, and then annually up to 6 years
Secondary 3-year Overall Survival (OS) Rate Overall survival is defined as the time from randomization to death or date last known alive. Kaplan-Meier method was used to estimate 3-year overall survival rate. Assessed every 3 months for the first 2 years, and then every 6 months for the 3rd year.
Secondary Quality-adjusted Time Without Symptoms of Disease or Treatment (Q-TWiST) OS for each arm is divided into 3 health states: toxicity (TOX), time without symptoms of disease or toxicity (TWiST), and recurrence (REC). TOX is defined as the time spent with grade 3/4 adverse events (AEs) prior to disease recurrence. TWiST is defined as the time prior to disease recurrence when no AEs of grade 3/4 were experienced. REC health state is defined as the time from disease recurrence or second primary cancer until death. Patients alive will be censored at the date of last contact. For each health state, a patient-reported utility weight will be assigned. The mean amount of time in each state will be estimated using Kaplan and Meier method.
TWiST = mean recurrence-free survival (RFS) - mean time with toxicities REC = mean OS - mean RFS Q-TWiST = (uTOX x TOX) + (uTWiST x TWiST) + (uREC x REC) Where uTOX, uTWiST, and uREC represent the average group utility value for each state for that arm and TOX, TWiST and REC represent the mean duration of the state for that arm.
Assessed every 3 months for the first 2 years, every 6 months for the next 3 years, then annually up to 10 years
Secondary Change in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Score From Baseline to 6 Months FACIT-Fatigue subscale (13 items) was used to evaluate fatigue in this patient population. The score ranges between 0 and 52. The higher the score, the better the quality of life. The change in FACIT-Fatigue score from baseline to 6 months will be compared between the two arms. Assessed at baseline and 6 months
Secondary Change in Functional Assessment of Cancer Therapy-Kidney Symptom Index Score From Baseline to 6 Months Functional Assessment of Cancer Therapy Kidney Cancer Symptom Index - 15 Item Version (FKSI-15) will be used to evaluate the quality of life concerns among this patient population. The change in score from baseline to 6 months will be compared between the two arms. The score ranges between 0 and 60. A score of "0" is a severely symptomatic patient and the highest possible score is an asymptomatic patient. Assessed at baseline and 6 months
Secondary Change in Plasma Levels of Pazopanib From Baseline to Cycle 2 Day 1 Plasma concentration of pazopanib will be assessed at baseline and cycle 2 day 1. Assessed at baseline and cycle 2 day 1
See also
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