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NCT00945009CompletedPhase 3

Combination Chemotherapy and Surgery in Treating Young Patients With Wilms Tumor

Treatment for Patients With Bilateral, Multicentric, or Bilaterally-Predisposed Unilateral Wilms Tumor

Source: ClinicalTrials.gov · Last updated 3 Jun 2026

Brief summary (registry, in English)

This phase III trial studies how well combination chemotherapy and surgery work in treating young patients with Wilms tumor. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving it after surgery may kill any tumor cells that remain after surgery.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
249 (actual)
First submitted
22 Jul 2009
Start date
24 Aug 2009
Primary completion date
31 Dec 2016
Lead sponsor
Children's Oncology Group
NCT number
NCT00945009

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 249
  • From 24 Aug 2009 to the primary completion date, 31 Dec 2016
  • 169 sites in 6 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

  • The patient must have one of the following conditions to be eligible:
    • Synchronous bilateral Wilms tumors\*\*; or
    • Unilateral Wilms tumor and aniridia, Beckwith-Wiedemann Syndrome, idiopathic hemihypertrophy, Simpson-Golabi-Behmel-Syndrome, Denys-Drash Syndrome or other associated genitourinary anomalies associated with bilateral Wilms tumor, such as hypospadias and undescended testis (to be eligible, these patients must not undergo any nephrectomy at diagnosis; note-horseshoe kidney is not associated with bilateral Wilms tumor and these patients should go on the appropriate unilateral Wilms tumor study); or
    • Multicentric Wilms tumor (any age) (to be eligible, these patients must not undergo any nephrectomy at diagnosis); or
    • Unilateral Wilms tumor with contralateral nephrogenic rest(s) (any size) in a child under one year of age (to be eligible, these patients must not undergo any nephrectomy at diagnosis); or
    • Diffuse hyperplastic perilobar nephroblastomatosis (unilateral or bilateral) defined by central radiological review; or
    • Wilms tumor arising in a solitary kidney (patients with metachronous Wilms tumor are not eligible)
    • The AREN0534 study uses the guideline that Wilms tumor with a single lesion 1 cm or greater in the contralateral kidney or multiple lesions (of any size) in the contralateral kidney should be treated on the synchronous bilateral Wilms tumor stratum; patients with an isolated lesion less than 1 cm in the contralateral kidney should be treated on the appropriate study for unilateral Wilms tumor OR on the unilateral Wilms tumor/contralateral nephrogenic rest stratum of this study if they have not undergone nephrectomy and are under one year of age
    • Loss of heterozygosity (LOH) results-which are used in the unilateral Wilms tumor studies-are not a requirement for enrollment on AREN0534; blood samples can be submitted but will not be used to direct AREN0534 therapy
  • Specimens/materials must be submitted for central review by day 7; for enrollment on AREN0534, unless a biopsy was done, the submission requirements at enrollment on AREN03B2 refer to imaging studies; tissue samples are only required if a surgical procedure (biopsy or nephrectomy) was performed at the time of enrollment on AREN03B2
  • Patients must begin protocol therapy on AREN0534 by day 14 following surgery or diagnosis by initial computed tomography (CT)/magnetic resonance imaging (MRI), unless medically contraindicated
  • Karnofsky performance status must be \>= 50% for patients \> 16 years of age and Lansky performance status must be \>= 50% (for patients =\< 16 years of age
  • Patients must not have received systemic chemotherapy or radiation therapy prior to treatment on this study
  • Patients with unilateral Wilms tumor and aniridia, Beckwith-Wiedemann Syndrome, idiopathic hemihypertrophy, Simpson-Golabi-Behmel-Syndrome, Denys-Drash Syndrome or other associated genitourinary anomalies; or multicentric or unilateral Wilms tumor with contralateral nephrogenic rest(s) (any size) in a child under 1 year of age who undergo a nephrectomy at diagnosis are not eligible for this study and should be directed to a unilateral Wilms tumor study
  • Total bilirubin =\< 1.5 times upper limit of normal (ULN) for age
  • Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) \< 2.5 times upper limit of normal (ULN) for age
  • Shortening fraction \>= 27% by echocardiogram, OR ejection fraction \>= 50% by radionuclide angiogram
    • (Cardiac function does not need to be assessed in patients who will not receive doxorubicin as part of their initial therapy on this study \[i.e., patients who start on regimen EE-4A\])
  • Female patients of childbearing age must have a negative pregnancy test
  • Female patients who are lactating must agree to stop breastfeeding
  • Sexually active patients of childbearing potential must agree to use effective contraception
  • All patients and/or their parents or legal guardians must sign a written informed consent
  • All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
  • No concurrent aprepitant

Age in the registry: - to 29 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (169)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Royal Brisbane and Women's Hospital
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HerstonAustraliaUnknown status
Royal Children's Hospital-Brisbane
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HerstonAustraliaUnknown status
Women's and Children's Hospital-Adelaide
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North AdelaideAustraliaUnknown status
Princess Margaret Hospital for Children
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PerthAustraliaUnknown status
Sydney Children's Hospital
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RandwickAustraliaUnknown status
Queensland Children's Hospital
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South BrisbaneAustraliaUnknown status
The Children's Hospital at Westmead
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WestmeadAustraliaUnknown status
Alberta Children's Hospital
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CalgaryCanadaUnknown status
IWK Health Centre
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HalifaxCanadaUnknown status
McMaster Children's Hospital at Hamilton Health Sciences
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HamiltonCanadaUnknown status
Kingston Health Sciences Centre
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KingstonCanadaUnknown status
The Montreal Children's Hospital of the MUHC
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MontrealCanadaUnknown status
Centre Hospitalier Universitaire Sainte-Justine
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MontrealCanadaUnknown status
Children'S Hospital Of Eastern Ontario
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OttawaCanadaUnknown status
CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL)
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QuébecCanadaUnknown status
Saskatoon Cancer Centre
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SaskatoonCanadaUnknown status
Hospital for Sick Children
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TorontoCanadaUnknown status
British Columbia Children's Hospital
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VancouverCanadaUnknown status
CancerCare Manitoba
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WinnipegCanadaUnknown status
Schneider Children's Medical Center of Israel
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Petah TikuaIsraelUnknown status
Christchurch Hospital
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ChristchurchNew ZealandUnknown status
Starship Children's Hospital
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GraftonNew ZealandUnknown status
San Jorge Children's Hospital
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San JuanPuerto RicoUnknown status
Children's Hospital Medical Center of Akron
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AkronUnited StatesUnknown status
University of New Mexico Cancer Center
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AlbuquerqueUnited StatesUnknown status
Texas Tech University Health Sciences Center-Amarillo
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AmarilloUnited StatesUnknown status
C S Mott Children's Hospital
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Ann ArborUnited StatesUnknown status
Mission Hospital
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AshevilleUnited StatesUnknown status
Children's Healthcare of Atlanta - Arthur M Blank Hospital
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AtlantaUnited StatesUnknown status
Augusta University Medical Center
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AugustaUnited StatesUnknown status
Children's Hospital Colorado
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AuroraUnited StatesUnknown status
Sinai Hospital of Baltimore
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BaltimoreUnited StatesUnknown status
University of Maryland/Greenebaum Cancer Center
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BaltimoreUnited StatesUnknown status
Eastern Maine Medical Center
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BangorUnited StatesUnknown status
Walter Reed National Military Medical Center
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BethesdaUnited StatesUnknown status
Lehigh Valley Hospital - Muhlenberg
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BethlehemUnited StatesUnknown status
Children's Hospital of Alabama
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BirminghamUnited StatesUnknown status
University of Alabama at Birmingham Cancer Center
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BirminghamUnited StatesUnknown status
Saint Luke's Cancer Institute - Boise
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BoiseUnited StatesUnknown status
Tufts Children's Hospital
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BostonUnited StatesUnknown status
Dana-Farber Cancer Institute
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BostonUnited StatesUnknown status
Roswell Park Cancer Institute
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BuffaloUnited StatesUnknown status
University of Vermont and State Agricultural College
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BurlingtonUnited StatesUnknown status
UNC Lineberger Comprehensive Cancer Center
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Chapel HillUnited StatesUnknown status
West Virginia University Charleston Division
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CharlestonUnited StatesUnknown status
Novant Health Presbyterian Medical Center
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CharlotteUnited StatesUnknown status
Carolinas Medical Center/Levine Cancer Institute
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CharlotteUnited StatesUnknown status
University of Virginia Cancer Center
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CharlottesvilleUnited StatesUnknown status
Lurie Children's Hospital-Chicago
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ChicagoUnited StatesUnknown status
Cincinnati Children's Hospital Medical Center
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CincinnatiUnited StatesUnknown status
Rainbow Babies and Childrens Hospital
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ClevelandUnited StatesUnknown status
Cleveland Clinic Foundation
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ClevelandUnited StatesUnknown status
Prisma Health Richland Hospital
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ColumbiaUnited StatesUnknown status
Nationwide Children's Hospital
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ColumbusUnited StatesUnknown status
Driscoll Children's Hospital
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Corpus ChristiUnited StatesUnknown status
Medical City Dallas Hospital
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DallasUnited StatesUnknown status
UT Southwestern/Simmons Cancer Center-Dallas
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DallasUnited StatesUnknown status
Dayton Children's Hospital
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DaytonUnited StatesUnknown status
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
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DenverUnited StatesUnknown status
Blank Children's Hospital
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Des MoinesUnited StatesUnknown status
Wayne State University/Karmanos Cancer Institute
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DetroitUnited StatesUnknown status
Kaiser Permanente Downey Medical Center
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DowneyUnited StatesUnknown status
Duke University Medical Center
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DurhamUnited StatesUnknown status
Michigan State University
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East LansingUnited StatesUnknown status
Sanford Broadway Medical Center
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FargoUnited StatesUnknown status
Broward Health Medical Center
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Fort LauderdaleUnited StatesUnknown status
Golisano Children's Hospital of Southwest Florida
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Fort MyersUnited StatesUnknown status
Lee Memorial Health System
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Fort MyersUnited StatesUnknown status
Brooke Army Medical Center
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Fort Sam HoustonUnited StatesUnknown status
Cook Children's Medical Center
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Fort WorthUnited StatesUnknown status
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
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Grand RapidsUnited StatesUnknown status
Saint Vincent Hospital Cancer Center Green Bay
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Green BayUnited StatesUnknown status
BI-LO Charities Children's Cancer Center
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GreenvilleUnited StatesUnknown status
Greenville Cancer Treatment Center
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GreenvilleUnited StatesUnknown status
Hackensack University Medical Center
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HackensackUnited StatesUnknown status
Connecticut Children's Medical Center
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HartfordUnited StatesUnknown status
Penn State Children's Hospital
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HersheyUnited StatesUnknown status
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
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HollywoodUnited StatesUnknown status
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
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HoustonUnited StatesUnknown status
Riley Hospital for Children
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IndianapolisUnited StatesUnknown status
University of Mississippi Medical Center
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JacksonUnited StatesUnknown status
Nemours Children's Clinic-Jacksonville
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JacksonvilleUnited StatesUnknown status
Kalamazoo Center for Medical Studies
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KalamazooUnited StatesUnknown status
Bronson Methodist Hospital
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KalamazooUnited StatesUnknown status
Children's Mercy Hospitals and Clinics
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Kansas CityUnited StatesUnknown status
East Tennessee Childrens Hospital
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KnoxvilleUnited StatesUnknown status
Nevada Cancer Research Foundation NCORP
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Las VegasUnited StatesUnknown status
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
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Las VegasUnited StatesUnknown status
Summerlin Hospital Medical Center
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Las VegasUnited StatesUnknown status
Sunrise Hospital and Medical Center
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Las VegasUnited StatesUnknown status
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
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LebanonUnited StatesUnknown status
University of Kentucky/Markey Cancer Center
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LexingtonUnited StatesUnknown status
Arkansas Children's Hospital
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Little RockUnited StatesUnknown status
University of Arkansas for Medical Sciences
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Little RockUnited StatesUnknown status
Saint Barnabas Medical Center
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LivingstonUnited StatesUnknown status
Loma Linda University Medical Center
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Loma LindaUnited StatesUnknown status
Miller Children's and Women's Hospital Long Beach
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Long BeachUnited StatesUnknown status
Children's Hospital Los Angeles
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Los AngelesUnited StatesUnknown status
Norton Children's Hospital
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LouisvilleUnited StatesUnknown status
Covenant Children's Hospital
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LubbockUnited StatesUnknown status
Valley Children's Hospital
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MaderaUnited StatesUnknown status
Marshfield Medical Center-Marshfield
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MarshfieldUnited StatesUnknown status
Saint Jude Children's Research Hospital
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MemphisUnited StatesUnknown status
Miami Cancer Institute
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MiamiUnited StatesUnknown status
University of Miami Miller School of Medicine-Sylvester Cancer Center
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MiamiUnited StatesUnknown status
Children's Hospital of Wisconsin
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MilwaukeeUnited StatesUnknown status
NYU Langone Hospital - Long Island
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MineolaUnited StatesUnknown status
Children's Hospitals and Clinics of Minnesota - Minneapolis
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MinneapolisUnited StatesUnknown status
University of Minnesota/Masonic Cancer Center
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MinneapolisUnited StatesUnknown status
Morristown Medical Center
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MorristownUnited StatesUnknown status
Newark Beth Israel Medical Center
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NewarkUnited StatesUnknown status
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
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New BrunswickUnited StatesUnknown status
Saint Peter's University Hospital
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New BrunswickUnited StatesUnknown status
Tulane University School of Medicine
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New OrleansUnited StatesUnknown status
Children's Hospital New Orleans
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New OrleansUnited StatesUnknown status
Mount Sinai Hospital
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New YorkUnited StatesUnknown status
Memorial Sloan-Kettering Cancer Center
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New YorkUnited StatesUnknown status
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
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New YorkUnited StatesUnknown status
Children's Hospital of The King's Daughters
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NorfolkUnited StatesUnknown status
Kaiser Permanente-Oakland
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OaklandUnited StatesUnknown status
UCSF Benioff Children's Hospital Oakland
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OaklandUnited StatesUnknown status
University of Oklahoma Health Sciences Center
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Oklahoma CityUnited StatesUnknown status
Children's Hospital of Orange County
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OrangeUnited StatesUnknown status
Nemours Children's Hospital
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OrlandoUnited StatesUnknown status
Nemours Children's Clinic - Orlando
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OrlandoUnited StatesUnknown status
Arnold Palmer Hospital for Children
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OrlandoUnited StatesUnknown status
Orlando Health Cancer Institute
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OrlandoUnited StatesUnknown status
AdventHealth Orlando
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OrlandoUnited StatesUnknown status
Lucile Packard Children's Hospital Stanford University
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Palo AltoUnited StatesUnknown status
Nemours Children's Clinic - Pensacola
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PensacolaUnited StatesUnknown status
Saint Jude Midwest Affiliate
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PeoriaUnited StatesUnknown status
Saint Christopher's Hospital for Children
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PhiladelphiaUnited StatesUnknown status
Children's Hospital of Philadelphia
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PhiladelphiaUnited StatesUnknown status
Phoenix Childrens Hospital
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PhoenixUnited StatesUnknown status
Children's Hospital of Pittsburgh of UPMC
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PittsburghUnited StatesUnknown status
Legacy Emanuel Hospital and Health Center
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PortlandUnited StatesUnknown status
Legacy Emanuel Children's Hospital
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PortlandUnited StatesUnknown status
VCU Massey Comprehensive Cancer Center
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RichmondUnited StatesUnknown status
Mayo Clinic in Rochester
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RochesterUnited StatesUnknown status
University of Rochester
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RochesterUnited StatesUnknown status
University of California Davis Comprehensive Cancer Center
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SacramentoUnited StatesUnknown status
Primary Children's Hospital
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Salt Lake CityUnited StatesUnknown status
Methodist Children's Hospital of South Texas
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San AntonioUnited StatesUnknown status
University of Texas Health Science Center at San Antonio
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San AntonioUnited StatesUnknown status
Rady Children's Hospital - San Diego
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San DiegoUnited StatesUnknown status
UCSF Medical Center-Parnassus
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San FranciscoUnited StatesUnknown status
UCSF Medical Center-Mission Bay
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San FranciscoUnited StatesUnknown status
Memorial Health University Medical Center
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SavannahUnited StatesUnknown status
Maine Children's Cancer Program
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ScarboroughUnited StatesUnknown status
Seattle Children's Hospital
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SeattleUnited StatesUnknown status
Sanford USD Medical Center - Sioux Falls
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Sioux FallsUnited StatesUnknown status
Providence Sacred Heart Medical Center and Children's Hospital
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SpokaneUnited StatesUnknown status
Mercy Hospital Saint Louis
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St LouisUnited StatesUnknown status
Washington University School of Medicine
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St LouisUnited StatesUnknown status
Johns Hopkins All Children's Hospital
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St. PetersburgUnited StatesUnknown status
Overlook Hospital
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SummitUnited StatesUnknown status
State University of New York Upstate Medical University
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SyracuseUnited StatesUnknown status
Madigan Army Medical Center
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TacomaUnited StatesUnknown status
Mary Bridge Children's Hospital and Health Center
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TacomaUnited StatesUnknown status
Saint Joseph's Hospital/Children's Hospital-Tampa
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TampaUnited StatesUnknown status
Montefiore Medical Center - Moses Campus
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The BronxUnited StatesUnknown status
Mercy Children's Hospital
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ToledoUnited StatesUnknown status
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
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ToledoUnited StatesUnknown status
Banner University Medical Center - Tucson
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TucsonUnited StatesUnknown status
Children's National Medical Center
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Washington D.C.United StatesUnknown status
MedStar Georgetown University Hospital
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Washington D.C.United StatesUnknown status
Saint Mary's Medical Center
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West Palm BeachUnited StatesUnknown status
Alfred I duPont Hospital for Children
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WilmingtonUnited StatesUnknown status
Wake Forest University Health Sciences
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Winston-SalemUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.