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COMPLETED

NCT00326898

PHASE3

Sunitinib Malate or Sorafenib Tosylate in Treating Patients With Kidney Cancer That Was Removed By Surgery

Sponsor: National Cancer Institute (NCI)

View on ClinicalTrials.gov

Summary

This randomized phase III trial studies sunitinib malate to see how well it works compared to sorafenib tosylate or placebo in treating patients with kidney cancer that has been removed by surgery. Sunitinib malate and sorafenib tosylate 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. Giving sunitinib malate or sorafenib tosylate after surgery may kill any tumor cells that remain after surgery. It is not yet known whether sunitinib malate is more effective than sorafenib tosylate or placebo in treating kidney cancer.

Official title: ASSURE: Adjuvant Sorafenib or Sunitinib for Unfavorable Renal Carcinoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1943

Start Date

2006-04-24

Completion Date

2021-09-01

Last Updated

2026-06-23

Healthy Volunteers

Conditions

Clear Cell Renal Cell Carcinoma Stage I Renal Cell Cancer AJCC v6 and v7 Stage II Renal Cell Cancer AJCC v7 Stage III Renal Cell Cancer AJCC v7

Interventions

OTHER

Laboratory Biomarker Analysis

Correlative studies

OTHER

Placebo

Given PO

OTHER

Quality-of-Life Assessment

Ancillary studies

DRUG

Sorafenib Tosylate

Given PO

DRUG

Sunitinib Malate

Given PO

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

Locations (987)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, United States

Clearview Cancer Institute

Huntsville, Alabama, United States

Mobile Infirmary Medical Center

Mobile, Alabama, United States

Providence Hospital

Mobile, Alabama, United States

University of South Alabama Mitchell Cancer Institute

Mobile, Alabama, United States

Providence Alaska Medical Center

Anchorage, Alaska, United States

Fairbanks Memorial Hospital

Fairbanks, Alaska, United States

Banner Thunderbird Medical Center

Glendale, Arizona, United States

Banner-University Medical Center Phoenix

Phoenix, Arizona, United States

Western Regional CCOP

Phoenix, Arizona, United States

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Banner University Medical Center - Tucson

Tucson, Arizona, United States

Sparks Regional Medical Center

Fort Smith, Arkansas, United States

CHI Saint Vincent Cancer Center Hot Springs

Hot Springs, Arkansas, United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Highlands Oncology Group-Rogers

Rogers, Arkansas, United States

Alta Bates Summit Medical Center-Herrick Campus

Berkeley, California, United States

Providence Saint Joseph Medical Center/Disney Family Cancer Center

Burbank, California, United States

Mills-Peninsula Medical Center

Burlingame, California, United States

East Bay Radiation Oncology Center

Castro Valley, California, United States

Eden Hospital Medical Center

Castro Valley, California, United States

Valley Medical Oncology Consultants-Castro Valley

Castro Valley, California, United States

John Muir Medical Center-Concord Campus

Concord, California, United States

City of Hope Comprehensive Cancer Center

Duarte, California, United States

Bay Area Breast Surgeons Inc

Emeryville, California, United States

Kaiser Permanente-Fremont

Fremont, California, United States

Valley Medical Oncology Consultants-Fremont

Fremont, California, United States

Washington Hospital

Fremont, California, United States

Saint Jude Medical Center

Fullerton, California, United States

Glendale Memorial Hospital and Health Center

Glendale, California, United States

Marin Cancer Care Inc

Greenbrae, California, United States

Marin General Hospital

Greenbrae, California, United States

Saint Rose Hospital

Hayward, California, United States

Loma Linda University Medical Center

Loma Linda, California, United States

Veterans Affairs Loma Linda Healthcare System

Loma Linda, California, United States

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States

Contra Costa Regional Medical Center

Martinez, California, United States

Fremont - Rideout Cancer Center

Marysville, California, United States

Memorial Medical Center

Modesto, California, United States

Community Hospital of Monterey Peninsula

Monterey, California, United States

El Camino Hospital

Mountain View, California, United States

Palo Alto Medical Foundation-Camino Division

Mountain View, California, United States

Northridge Hospital Medical Center

Northridge, California, United States

Sutter Cancer Research Consortium

Novato, California, United States

Highland General Hospital

Oakland, California, United States

Alta Bates Summit Medical Center - Summit Campus

Oakland, California, United States

Bay Area Tumor Institute

Oakland, California, United States

Hematology and Oncology Associates-Oakland

Oakland, California, United States

Tom K Lee Inc

Oakland, California, United States

Kaiser Permanente-Oakland

Oakland, California, United States

Saint Joseph Hospital - Orange

Orange, California, United States

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, United States

Palo Alto Medical Foundation Health Care

Palo Alto, California, United States

Stanford Cancer Institute Palo Alto

Palo Alto, California, United States

VA Palo Alto Health Care System

Palo Alto, California, United States

Valley Care Health System - Pleasanton

Pleasanton, California, United States

Valley Medical Oncology Consultants

Pleasanton, California, United States

Eisenhower Medical Center

Rancho Mirage, California, United States

Shasta Regional Medical Center

Redding, California, United States

Kaiser Permanente-Redwood City

Redwood City, California, United States

Kaiser Permanente-Richmond

Richmond, California, United States

Kaiser Permanente-Roseville

Roseville, California, United States

Sutter Roseville Medical Center

Roseville, California, United States

Sutter Medical Center Sacramento

Sacramento, California, United States

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

Mercy General Hospital

Sacramento, California, United States

Kaiser Permanente-South Sacramento

Sacramento, California, United States

Kaiser Permanente - Sacramento

Sacramento, California, United States

Salinas Valley Memorial

Salinas, California, United States

University of California San Diego

San Diego, California, United States

Kaiser Permanente-San Diego Mission

San Diego, California, United States

Veterans Administration-San Diego Medical Center

San Diego, California, United States

California Pacific Medical Center-Pacific Campus

San Francisco, California, United States

Kaiser Permanente-San Francisco

San Francisco, California, United States

UCSF Medical Center-Mount Zion

San Francisco, California, United States

Kaiser Permanente-Santa Teresa-San Jose

San Jose, California, United States

Kaiser Permanente San Leandro

San Leandro, California, United States

Doctors Medical Center- JC Robinson Regional Cancer Center

San Pablo, California, United States

Kaiser Permanente-San Rafael

San Rafael, California, United States

Kaiser Permanente Medical Center - Santa Clara

Santa Clara, California, United States

Kaiser Permanente-Santa Rosa

Santa Rosa, California, United States

Kaiser Permanente-South San Francisco

South San Francisco, California, United States

Kaiser Permanente-Stockton

Stockton, California, United States

Gene Upshaw Memorial Tahoe Forest Cancer Center

Truckee, California, United States

Northbay Cancer Center

Vacaville, California, United States

Kaiser Permanente-Vallejo

Vallejo, California, United States

Sutter Solano Medical Center/Cancer Center

Vallejo, California, United States

Kaiser Permanente-Walnut Creek

Walnut Creek, California, United States

John Muir Medical Center-Walnut Creek

Walnut Creek, California, United States

The Medical Center of Aurora

Aurora, Colorado, United States

Rocky Mountain Regional VA Medical Center

Aurora, Colorado, United States

Boulder Community Hospital

Boulder, Colorado, United States

Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, United States

UCHealth Memorial Hospital Central

Colorado Springs, Colorado, United States

Denver Health Medical Center

Denver, Colorado, United States

Kaiser Permanente-Franklin

Denver, Colorado, United States

Porter Adventist Hospital

Denver, Colorado, United States

University of Colorado

Denver, Colorado, United States

Presbyterian - Saint Lukes Medical Center - Health One

Denver, Colorado, United States

SCL Health Saint Joseph Hospital

Denver, Colorado, United States

Rose Medical Center

Denver, Colorado, United States

Colorado Cancer Research Program NCORP

Denver, Colorado, United States

Shaw Cancer Center

Edwards, Colorado, United States

Swedish Medical Center

Englewood, Colorado, United States

Poudre Valley Hospital

Fort Collins, Colorado, United States

Valley View Hospital Cancer Center

Glenwood Springs, Colorado, United States

Saint Mary's Hospital and Regional Medical Center

Grand Junction, Colorado, United States

North Colorado Medical Center

Greeley, Colorado, United States

Kaiser Permanente-Rock Creek

Lafayette, Colorado, United States

Saint Anthony Hospital

Lakewood, Colorado, United States

Sky Ridge Medical Center

Lone Tree, Colorado, United States

Longmont United Hospital

Longmont, Colorado, United States

McKee Medical Center

Loveland, Colorado, United States

Montrose Memorial Hospital

Montrose, Colorado, United States

Saint Mary Corwin Medical Center

Pueblo, Colorado, United States

North Suburban Medical Center

Thornton, Colorado, United States

SCL Health Lutheran Medical Center

Wheat Ridge, Colorado, United States

Saint Vincent's Medical Center

Bridgeport, Connecticut, United States

Danbury Hospital

Danbury, Connecticut, United States

Hartford Hospital

Hartford, Connecticut, United States

Smilow Cancer Hospital Care Center at Saint Francis

Hartford, Connecticut, United States

Manchester Memorial Hospital

Manchester, Connecticut, United States

Yale University

New Haven, Connecticut, United States

Norwalk Hospital

Norwalk, Connecticut, United States

Eastern Connecticut Hematology and Oncology Associates

Norwich, Connecticut, United States

Bayhealth Hospital Kent Campus

Dover, Delaware, United States

Beebe Medical Center

Lewes, Delaware, United States

Christiana Care Health System-Christiana Hospital

Newark, Delaware, United States

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, United States

MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States

Sibley Memorial Hospital

Washington D.C., District of Columbia, United States

George Washington University Medical Center

Washington D.C., District of Columbia, United States

Boca Raton Regional Hospital

Boca Raton, Florida, United States

Holy Cross Hospital

Fort Lauderdale, Florida, United States

Broward Health Medical Center

Fort Lauderdale, Florida, United States

Lee Memorial Health System

Fort Myers, Florida, United States

Southwest Florida Regional Medical Center

Fort Myers, Florida, United States

Florida Cancer Specialists-Gainesville Cancer Center

Gainesville, Florida, United States

University of Florida Health Science Center - Gainesville

Gainesville, Florida, United States

Memorial Regional Hospital/Joe DiMaggio Children's Hospital

Hollywood, Florida, United States

Baptist MD Anderson Cancer Center

Jacksonville, Florida, United States

Mayo Clinic in Florida

Jacksonville, Florida, United States

Jupiter Medical Center

Jupiter, Florida, United States

Lakeland Regional Health Hollis Cancer Center

Lakeland, Florida, United States

Cancer Centers of Central Florida PA

Leesburg, Florida, United States

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, United States

Mount Sinai Medical Center

Miami Beach, Florida, United States

21st Century Oncology-Orange Park

Orange Park, Florida, United States

AdventHealth Orlando

Orlando, Florida, United States

UF Cancer Center at Orlando Health

Orlando, Florida, United States

Sacred Heart Hospital

Pensacola, Florida, United States

Florida Cancer Specialists - Sarasota Downtown

Sarasota, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

Cleveland Clinic-Weston

Weston, Florida, United States

Phoebe Putney Memorial Hospital

Albany, Georgia, United States

University Cancer and Blood Center LLC

Athens, Georgia, United States

Piedmont Hospital

Atlanta, Georgia, United States

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

Atlanta Regional CCOP

Atlanta, Georgia, United States

Emory Saint Joseph's Hospital

Atlanta, Georgia, United States

Northside Hospital

Atlanta, Georgia, United States

Augusta University Medical Center

Augusta, Georgia, United States

WellStar Cobb Hospital

Austell, Georgia, United States

John B Amos Cancer Center

Columbus, Georgia, United States

Atlanta VA Medical Center

Decatur, Georgia, United States

Dekalb Medical Center

Decatur, Georgia, United States

Northeast Georgia Medical Center-Gainesville

Gainesville, Georgia, United States

Gwinnett Medical Center

Lawrenceville, Georgia, United States

Medical Center of Central Georgia

Macon, Georgia, United States

Wellstar Kennestone Hospital

Marietta, Georgia, United States

Southern Regional Medical Center

Riverdale, Georgia, United States

Harbin Clinic Medical Oncology and Clinical Research

Rome, Georgia, United States

Memorial Health University Medical Center

Savannah, Georgia, United States

Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

Savannah, Georgia, United States

South Georgia Medical Center/Pearlman Cancer Center

Valdosta, Georgia, United States

Hawaii Cancer Care Inc-POB II

Honolulu, Hawaii, United States

Queen's Medical Center

Honolulu, Hawaii, United States

Straub Clinic and Hospital

Honolulu, Hawaii, United States

University of Hawaii Cancer Center

Honolulu, Hawaii, United States

Hawaii Oncology Inc-Kuakini

Honolulu, Hawaii, United States

The Cancer Center of Hawaii-Liliha

Honolulu, Hawaii, United States

Kaiser Permanente Moanalua Medical Center

Honolulu, Hawaii, United States

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, United States

Tripler Army Medical Center

Honolulu, Hawaii, United States

Maui Memorial Medical Center

Wailuku, Hawaii, United States

Pacific Cancer Institute of Maui

Wailuku, Hawaii, United States

Pali Momi Medical Center

‘Aiea, Hawaii, United States

Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho, United States

Portneuf Medical Center

Pocatello, Idaho, United States

Kootenai Cancer Center

Post Falls, Idaho, United States

Saint Anthony's Health

Alton, Illinois, United States

Rush - Copley Medical Center

Aurora, Illinois, United States

Saint Joseph Medical Center

Bloomington, Illinois, United States

Illinois CancerCare-Bloomington

Bloomington, Illinois, United States

Graham Hospital Association

Canton, Illinois, United States

Illinois CancerCare-Canton

Canton, Illinois, United States

Illinois CancerCare-Carthage

Carthage, Illinois, United States

Memorial Hospital

Carthage, Illinois, United States

Mount Sinai Hospital Medical Center