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NCT01096368CompletedPhase 3

Maintenance Chemotherapy or Observation Following Induction Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Ependymoma

Phase III Randomized Trial of Post-Radiation Chemotherapy in Patients With Newly Diagnosed Ependymoma Ages 1 to 21 Years

Source: ClinicalTrials.gov · Last updated 30 Apr 2026

Brief summary (registry, in English)

The primary aim of this randomized phase III trial was to study whether the addition of maintenance chemotherapy delivered after surgical resection and focal radiation would be better than surgery and focal radiation alone. The trial also studied if patients who received induction chemotherapy and then either achieved a complete response or went on to have a complete resection would also benefit from maintenance chemotherapy. Children ages 1-21 years with newly diagnosed intracranial ependymoma were included. There were 2 arms that were not randomized. One arm studied patients with Grade II tumors located in the supratentorial compartment that were completely resected. One arm studied patients with residual tumor and those patients all received maintenance chemotherapy after focal radiation. Chemotherapy drugs, such as vincristine sulfate, carboplatin, cyclophosphamide, etoposide, and cisplatin, 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. Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving chemotherapy in combination with radiation therapy may kill more tumor cells and allow doctors to save the part of the body where the cancer started.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
479 (actual)
First submitted
30 Mar 2010
Start date
May 2010
Primary completion date
Dec 2021
Lead sponsor
Children's Oncology Group
NCT number
NCT01096368

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 479
  • From May 2010 to the primary completion date, Dec 2021
  • 209 sites in 4 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.

Prior treatment

  • No prior treatment other than surgical intervention and corticosteroids; patients are allowed to have had more than one attempt at resection prior to enrollment

Other illness

  • Patients with evidence of metastatic disease will be excluded; any evidence of non-contiguous spread beyond the primary site as determined by pre or post-operative magnetic resonance (MR) imaging of brain, pre or post-operative MR imaging of the spine, and post-operative cerebrospinal fluid (CSF) cytology obtained from the lumbar CSF space (the requirement for lumbar CSF examination may be waived if deemed to be medically contraindicated); CSF cytology from a ventriculostomy or permanent ventriculoperitoneal (VP) shunt that reveals the presence of tumor cells is indicative of metastatic disease

Other

  • Patients with a diagnosis of spinal cord ependymoma, myxopapillary ependymoma, subependymoma, ependymoblastoma, or mixed glioma are NOT eligible
  • Pregnant female patients are not eligible for this study
  • Post-menarchal females may not participate unless a pregnancy test with a negative result has been obtained
  • Males and females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method
  • Lactating females may not participate unless they have agreed not to breastfeed a child while on this study

Who the study is looking for

  • Patients must be newly diagnosed with histologically confirmed intracranial ependymoma; patients with classic ependymoma (WHO II) or anaplastic ependymoma (WHO III) are eligible, as are various subtypes described as clear cell, papillary, cellular or a combination of the above
  • There is no minimum performance level; children with ependymoma may suffer neurologic sequelae as a result of their tumor or surgical measures taken to establish a diagnosis and resect the tumor; in the majority of cases, there is neurologic recovery; neurologic recovery is not likely to be impeded by protocol therapy
  • REGULATORY: All patients and/or their parents or legal guardians must sign a written informed consent
  • REGULATORY: All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Age in the registry: 12 months to 21 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (209)

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

SiteCityCountrySite status
Monash Medical Center-Clayton Campus
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ClaytonAustraliaUnknown status
Royal Brisbane and Women's Hospital
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HerstonAustraliaUnknown status
Royal Children's Hospital-Brisbane
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HerstonAustraliaUnknown status
John Hunter Children's Hospital
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Hunter Regional Mail CentreAustraliaUnknown status
Women's and Children's Hospital-Adelaide
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North AdelaideAustraliaUnknown status
Royal Children's Hospital
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ParkvilleAustraliaUnknown status
Perth Children's Hospital
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PerthAustraliaUnknown 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
University of Alberta Hospital
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EdmontonCanadaUnknown 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
Children's Hospital
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LondonCanadaUnknown status
Centre Hospitalier Universitaire Sainte-Justine
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MontrealCanadaUnknown status
The Montreal Children's Hospital of the MUHC
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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
Janeway Child Health Centre
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St. John'sCanadaUnknown 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
Christchurch Hospital
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ChristchurchNew ZealandUnknown status
Starship Children's Hospital
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GraftonNew ZealandUnknown status
Children's Hospital Medical Center of Akron
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AkronUnited StatesUnknown status
Albany Medical Center
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AlbanyUnited StatesUnknown status
University of New Mexico Cancer Center
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AlbuquerqueUnited StatesUnknown status
Lehigh Valley Hospital-Cedar Crest
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AllentownUnited StatesUnknown status
C S Mott Children's Hospital
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Ann ArborUnited 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
Dell Children's Medical Center of Central Texas
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AustinUnited StatesUnknown status
Johns Hopkins University/Sidney Kimmel Cancer Center
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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
Massachusetts General Hospital Cancer Center
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BostonUnited StatesUnknown status
Dana-Farber Cancer Institute
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BostonUnited StatesUnknown status
Tufts Children's Hospital
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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
Medical University of South Carolina
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CharlestonUnited StatesUnknown status
West Virginia University Charleston Division
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CharlestonUnited StatesUnknown status
Carolinas Medical Center/Levine Cancer Institute
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CharlotteUnited StatesUnknown status
Novant Health Presbyterian Medical Center
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CharlotteUnited StatesUnknown status
T C Thompson Children's Hospital
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ChattanoogaUnited StatesUnknown status
University of Chicago Comprehensive Cancer Center
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ChicagoUnited StatesUnknown status
Lurie Children's Hospital-Chicago
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ChicagoUnited StatesUnknown status
University of Illinois
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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
University of Missouri Children's Hospital
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ColumbiaUnited 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
Geisinger Medical Center
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DanvilleUnited StatesUnknown status
Dayton Children's Hospital
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DaytonUnited StatesUnknown status
Blank Children's Hospital
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Des MoinesUnited StatesUnknown status
Henry Ford Health Saint John Hospital
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DetroitUnited 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
City of Hope Comprehensive Cancer Center
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DuarteUnited StatesUnknown status
Michigan State University
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East LansingUnited StatesUnknown status
Inova Fairfax Hospital
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Falls ChurchUnited StatesUnknown status
Sanford Broadway Medical Center
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FargoUnited StatesUnknown status
Hurley Medical Center
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FlintUnited StatesUnknown status
Broward Health Medical Center
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Fort LauderdaleUnited StatesUnknown status
Lee Memorial Health System
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Fort MyersUnited StatesUnknown status
Golisano Children's Hospital of Southwest Florida
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Fort MyersUnited StatesUnknown status
Cook Children's Medical Center
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Fort WorthUnited StatesUnknown status
UF Health Cancer Institute - Gainesville
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GainesvilleUnited 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
Kapiolani Medical Center for Women and Children
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HonoluluUnited 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
Ascension Saint Vincent Indianapolis Hospital
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IndianapolisUnited StatesUnknown status
University of Iowa/Holden Comprehensive Cancer Center
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Iowa CityUnited 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
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
Sunrise Hospital and Medical Center
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Las VegasUnited StatesUnknown status
Summerlin Hospital Medical Center
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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
University Medical Center of Southern Nevada
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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
Cedars-Sinai Medical Center
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Los AngelesUnited 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
UMC Cancer Center / UMC Health System
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LubbockUnited StatesUnknown status
Valley Children's Hospital
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MaderaUnited StatesUnknown status
University of Wisconsin Carbone Cancer Center - University Hospital
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MadisonUnited StatesUnknown status
Marshfield Medical Center-Marshfield
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MarshfieldUnited StatesUnknown status
Loyola University Medical Center
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MaywoodUnited StatesUnknown status
Saint Jude Children's Research Hospital
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MemphisUnited StatesUnknown status
Banner Children's at Desert
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MesaUnited StatesUnknown status
Nicklaus Children's Hospital
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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
University of Minnesota/Masonic Cancer Center
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MinneapolisUnited StatesUnknown status
Children's Hospitals and Clinics of Minnesota - Minneapolis
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MinneapolisUnited StatesUnknown status
West Virginia University Healthcare
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MorgantownUnited StatesUnknown status
Morristown Medical Center
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MorristownUnited StatesUnknown status
Vanderbilt University/Ingram Cancer Center
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NashvilleUnited StatesUnknown status
The Children's Hospital at TriStar Centennial
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NashvilleUnited StatesUnknown status
Newark Beth Israel Medical Center
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NewarkUnited StatesUnknown status
Saint Peter's University Hospital
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New BrunswickUnited StatesUnknown status
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
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New BrunswickUnited StatesUnknown status
Yale University
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New HavenUnited StatesUnknown status
The Steven and Alexandra Cohen Children's Medical Center of New York
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New Hyde ParkUnited StatesUnknown status
Ochsner Medical Center Jefferson
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New OrleansUnited 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
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
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New YorkUnited StatesUnknown status
Mount Sinai Hospital
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New YorkUnited StatesUnknown status
Laura and Isaac Perlmutter Cancer Center at NYU Langone
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New YorkUnited StatesUnknown status
Memorial Sloan-Kettering 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
UCSF Benioff Children's Hospital Oakland
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OaklandUnited StatesUnknown status
Kaiser Permanente-Oakland
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OaklandUnited StatesUnknown status
Advocate Children's Hospital-Oak Lawn
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Oak LawnUnited StatesUnknown status
University of Oklahoma Health Sciences Center
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Oklahoma CityUnited StatesUnknown status
Children's Hospital and Medical Center of Omaha
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OmahaUnited StatesUnknown status
University of Nebraska Medical Center
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OmahaUnited StatesUnknown status
Children's Hospital of Orange County
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OrangeUnited 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
Nemours Children's Clinic - Orlando
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OrlandoUnited StatesUnknown status
AdventHealth Orlando
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OrlandoUnited StatesUnknown status
Nemours Children's Hospital
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OrlandoUnited StatesUnknown status
Lucile Packard Children's Hospital Stanford University
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Palo AltoUnited StatesUnknown status
Saint Joseph's Regional Medical Center
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PatersonUnited 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 Children's Hospital
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PortlandUnited StatesUnknown status
Naval Medical Center - Portsmouth
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PortsmouthUnited StatesUnknown status
Rhode Island Hospital
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ProvidenceUnited StatesUnknown status
VCU Massey Comprehensive Cancer Center
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RichmondUnited StatesUnknown status
Carilion Children's
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RoanokeUnited StatesUnknown status
Mayo Clinic in Rochester
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RochesterUnited StatesUnknown status
University of Rochester
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RochesterUnited StatesUnknown status
Sutter Medical Center Sacramento
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SacramentoUnited 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
Children's Hospital of San Antonio
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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-Mission Bay
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San FranciscoUnited StatesUnknown status
UCSF Medical Center-Parnassus
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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
Southern Illinois University School of Medicine
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SpringfieldUnited StatesUnknown status
Baystate Medical Center
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SpringfieldUnited StatesUnknown status
Washington University School of Medicine
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St LouisUnited StatesUnknown status
Mercy Hospital Saint Louis
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St LouisUnited StatesUnknown status
Cardinal Glennon Children's Medical Center
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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
Mary Bridge Children's Hospital and Health Center
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TacomaUnited StatesUnknown status
Madigan Army Medical Center
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TacomaUnited StatesUnknown status
Saint Joseph's Hospital/Children's Hospital-Tampa
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TampaUnited StatesUnknown status
Scott and White Memorial Hospital
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TempleUnited 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
New York Medical College
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ValhallaUnited 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.