Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

Een onderzoek naar de geneesmiddelen Selumetinib vs. Carboplatine en Vincristine bij patiënten met laaggradig glioom

5 november 2026 bijgewerkt door: National Cancer Institute (NCI)

Een gerandomiseerde fase 3-studie naar non-inferioriteit van carboplatine en vincristine versus selumetinib (NSC# 748727) bij nieuw gediagnosticeerde of eerder onbehandelde laaggradige glioom (LGG) die niet verband houdt met BRAFV600E-mutaties of systemische neurofibromatose type 1 (NF1)

This phase III trial compares the effect of selumetinib versus the standard of care treatment with carboplatin and vincristine (CV) in treating patients with newly diagnosed or previously untreated low-grade glioma (LGG) that does not have a genetic abnormality called BRAFV600E mutation and is not associated with systemic neurofibromatosis type 1. Selumetinib works by blocking some of the enzymes needed for cell growth and may kill tumor cells. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Vincristine is in a class of medications called vinca alkaloids. It works by stopping tumor cells from growing and dividing and may kill them. The overall goal of this study is to see if selumetinib works just as well as the standard treatment of CV for patients with LGG. Another goal of this study is to compare the effects of selumetinib versus CV in subjects with LGG to find out which is better. Additionally, this trial will also examine if treatment with selumetinib improves the quality of life for subjects who take it.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

PRIMARY OBJECTIVE:

I. To demonstrate that the efficacy of treatment with selumetinib as measured by event-free survival (EFS) is non-inferior compared to treatment with carboplatin/vincristine (CV) in previously-untreated low-grade glioma (LGG) not associated with BRAFV600E mutations or systemic neurofibromatosis type 1 (NF1).

SECONDARY OBJECTIVES:

I. To estimate tumor response rates to each regimen of chemotherapy. II. To evaluate visual acuity (VA) outcomes utilizing Teller Acuity Cards (TAC) and HOTV letter acuity testing in previously-untreated optic pathway gliomas (OPGs).

III. To describe the improvement in motor function as measured by the Vineland Scale in children with previously-untreated LGG that have motor deficits at enrollment.

IV. To estimate the difference in EFS and tumor response rate between BRAF rearranged and non-BRAF rearranged patients treated on each chemotherapy regimen.

V. To prospectively evaluate the quality of life of children with LGG not associated with BRAFV600E or systemic NF1 treated with either CV or selumetinib.

VI. To prospectively evaluate the cognitive, social, emotional, and behavioral functioning of children with LGG not associated with BRAFV600E or systemic NF1 treated with either CV or selumetinib.

EXPLORATORY OBJECTIVE:

I. To obtain paired blood and tumor specimens for future biology studies as well as data from Molecular Characterization Initiative (MCI) testing, to correlate genomic drivers to efficacy outcomes.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I:

INDUCTION: Patients receive vincristine sulfate intravenously (IV) on days 1, 8, 15, 22, 29, 36, 43, 50, 57, and 64, and carboplatin IV over 60 minutes on days 1, 8, 15, 22, 43, 50, 57, and 64 in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood and magnetic resonance imaging (MRI) throughout the trial.

MAINTENANCE: Patients receive vincristine sulfate IV on days 1, 8, and 15, and carboplatin IV over 60 minutes on days 1, 8, 15, and 22 of each cycle. Cycles repeat every 42 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood and MRI throughout the trial.

ARM II: Patients receive selumetinib sulfate orally (PO) twice daily (BID) on days 1-28 of each cycle. Cycles repeat every 28 days for up to 27 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo echocardiography (ECHO) at baseline and undergo collection of blood and MRI throughout the trial.

After completion of study treatment, patients are followed up every 3 months for year 1, every 6 months for years 2-3, and then annually for years 4-10.

Studietype

Ingrijpend

Inschrijving (Geschat)

170

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Canada
      • Québec, Canada, G1V 4G2
        • Werving
        • CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL)
        • Hoofdonderzoeker:
          • Bruno Michon
        • Contact:
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H 3V4
        • Werving
        • British Columbia Children's Hospital
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 6477 604-875-2345
        • Hoofdonderzoeker:
          • Rebecca J. Deyell
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
        • Werving
        • Janeway Child Health Centre
        • Hoofdonderzoeker:
          • Lisa A. Goodyear
        • Contact:
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3K 6R8
        • Werving
        • IWK Health Centre
        • Contact:
        • Hoofdonderzoeker:
          • Chelsea Ash
    • Quebec
      • Montreal, Quebec, Canada, H3H 1P3
        • Werving
        • The Montreal Children's Hospital of the MUHC
        • Contact:
        • Hoofdonderzoeker:
          • Stephanie Mourad
      • Montreal, Quebec, Canada, H3T 1C5
        • Werving
        • Centre Hospitalier Universitaire Sainte-Justine
        • Hoofdonderzoeker:
          • Monia Marzouki
        • Contact:
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Werving
        • Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
        • Contact:
        • Hoofdonderzoeker:
          • Stephanie Vairy
  • Puerto Rico
      • Caguas, Puerto Rico, 00726
        • Actief, niet wervend
        • HIMA San Pablo Oncologic Hospital
  • Verenigde Staten
    • Alabama
      • Birmingham, Alabama, Verenigde Staten, 35233
        • Werving
        • Children's Hospital of Alabama
        • Contact:
        • Hoofdonderzoeker:
          • Laura K. Metrock
    • Arizona
      • Mesa, Arizona, Verenigde Staten, 85202
        • Werving
        • Banner Children's at Desert
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 480-412-3100
        • Hoofdonderzoeker:
          • Joseph C. Torkildson
      • Phoenix, Arizona, Verenigde Staten, 85016
        • Werving
        • Phoenix Childrens Hospital
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 602-546-0920
        • Hoofdonderzoeker:
          • Kazuhiro Sabet
    • Arkansas
      • Little Rock, Arkansas, Verenigde Staten, 72202-3591
        • Werving
        • Arkansas Children's Hospital
        • Hoofdonderzoeker:
          • Michael W. Bishop
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 501-364-7373
    • California
      • Loma Linda, California, Verenigde Staten, 92354
        • Werving
        • Loma Linda University Medical Center
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 909-558-4050
        • Hoofdonderzoeker:
          • Albert Kheradpour
      • Long Beach, California, Verenigde Staten, 90806
        • Werving
        • Miller Children's and Women's Hospital Long Beach
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 562-933-5600
        • Hoofdonderzoeker:
          • Jacqueline N. Casillas
      • Los Angeles, California, Verenigde Staten, 90027
        • Werving
        • Children's Hospital Los Angeles
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 323-361-4110
        • Hoofdonderzoeker:
          • Nathan J. Robison
      • Los Angeles, California, Verenigde Staten, 90048
        • Werving
        • Cedars-Sinai Medical Center
        • Hoofdonderzoeker:
          • Fataneh (Fae) Majlessipour
        • Contact:
      • Los Angeles, California, Verenigde Staten, 90095
        • Werving
        • Mattel Children's Hospital UCLA
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 310-825-6708
        • Hoofdonderzoeker:
          • Satiro N. De Oliveira
      • Oakland, California, Verenigde Staten, 94611
        • Werving
        • Kaiser Permanente-Oakland
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 877-642-4691
          • E-mail: Kpoct@kp.org
        • Hoofdonderzoeker:
          • Aarati V. Rao
      • Orange, California, Verenigde Staten, 92868
        • Werving
        • Children's Hospital of Orange County
        • Contact:
        • Hoofdonderzoeker:
          • Elyssa M. Rubin
      • Palo Alto, California, Verenigde Staten, 94304
        • Werving
        • Lucile Packard Children's Hospital Stanford University
        • Contact:
        • Hoofdonderzoeker:
          • Jay Michael S. Balagtas
      • San Diego, California, Verenigde Staten, 92123
        • Werving
        • Rady Children's Hospital - San Diego
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 858-966-5934
        • Hoofdonderzoeker:
          • William D. Roberts
      • San Francisco, California, Verenigde Staten, 94158
        • Werving
        • UCSF Medical Center-Mission Bay
        • Contact:
        • Hoofdonderzoeker:
          • Alyssa T. Reddy
    • Colorado
      • Aurora, Colorado, Verenigde Staten, 80045
        • Werving
        • Children's Hospital Colorado
        • Hoofdonderzoeker:
          • Jean M. Mulcahy Levy
        • Contact:
    • Connecticut
      • Hartford, Connecticut, Verenigde Staten, 06106
        • Werving
        • Connecticut Children's Medical Center
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 860-545-9981
        • Hoofdonderzoeker:
          • Michael S. Isakoff
      • New Haven, Connecticut, Verenigde Staten, 06520
        • Werving
        • Yale University
        • Hoofdonderzoeker:
          • Asher M. Marks
        • Contact:
    • Delaware
      • Wilmington, Delaware, Verenigde Staten, 19803
        • Werving
        • Alfred I duPont Hospital for Children
        • Contact:
        • Hoofdonderzoeker:
          • Sridhi Patel
    • District of Columbia
      • Washington D.C., District of Columbia, Verenigde Staten, 20010
        • Werving
        • Children's National Medical Center
        • Hoofdonderzoeker:
          • Jeffrey S. Dome
        • Contact:
    • Florida
      • Fort Myers, Florida, Verenigde Staten, 33908
        • Werving
        • Golisano Children's Hospital of Southwest Florida
        • Contact:
        • Hoofdonderzoeker:
          • Emad K. Salman
      • Gainesville, Florida, Verenigde Staten, 32610
        • Actief, niet wervend
        • UF Health Cancer Institute - Gainesville
      • Hollywood, Florida, Verenigde Staten, 33021
        • Werving
        • Memorial Regional Hospital/Joe DiMaggio Children's Hospital
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 954-265-1847
          • E-mail: OHR@mhs.net
        • Hoofdonderzoeker:
          • Iftikhar Hanif
      • Jacksonville, Florida, Verenigde Staten, 32207
        • Werving
        • Nemours Children's Clinic-Jacksonville
        • Contact:
        • Hoofdonderzoeker:
          • Sridhi Patel
      • Miami, Florida, Verenigde Staten, 33155
        • Werving
        • Nicklaus Children's Hospital
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 888-624-2778
        • Hoofdonderzoeker:
          • Ziad A. Khatib
      • Miami, Florida, Verenigde Staten, 33136
        • Ingetrokken
        • University of Miami Miller School of Medicine-Sylvester Cancer Center
      • Orlando, Florida, Verenigde Staten, 32806
        • Werving
        • Arnold Palmer Hospital for Children
        • Contact:
        • Hoofdonderzoeker:
          • Zhongbo Hu
      • Orlando, Florida, Verenigde Staten, 32827
        • Werving
        • Nemours Children's Hospital
        • Contact:
        • Hoofdonderzoeker:
          • Sridhi Patel
      • Orlando, Florida, Verenigde Staten, 32803
        • Werving
        • AdventHealth Orlando
        • Contact:
        • Hoofdonderzoeker:
          • Fouad M. Hajjar
      • Pensacola, Florida, Verenigde Staten, 32504
        • Geschorst
        • Sacred Heart Hospital
      • Pensacola, Florida, Verenigde Staten, 32504
      • St. Petersburg, Florida, Verenigde Staten, 33701
        • Werving
        • Johns Hopkins All Children's Hospital
        • Contact:
        • Hoofdonderzoeker:
          • Stacie L. Stapleton
      • Tampa, Florida, Verenigde Staten, 33607
        • Werving
        • Saint Joseph's Hospital/Children's Hospital-Tampa
        • Contact:
        • Hoofdonderzoeker:
          • Don E. Eslin
    • Georgia
      • Atlanta, Georgia, Verenigde Staten, 30329
        • Werving
        • Children's Healthcare of Atlanta - Arthur M Blank Hospital
        • Hoofdonderzoeker:
          • Jason R. Fangusaro
        • Contact:
    • Hawaii
      • Honolulu, Hawaii, Verenigde Staten, 96826
        • Werving
        • Kapiolani Medical Center for Women and Children
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 808-983-6090
        • Hoofdonderzoeker:
          • Wade T. Kyono
    • Idaho
      • Boise, Idaho, Verenigde Staten, 83712
        • Werving
        • Saint Luke's Cancer Institute - Boise
        • Hoofdonderzoeker:
          • Martha M. Pacheco
        • Contact:
    • Illinois
      • Chicago, Illinois, Verenigde Staten, 60611
        • Werving
        • Lurie Children's Hospital-Chicago
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 773-880-4562
        • Hoofdonderzoeker:
          • Angela J. Waanders
      • Chicago, Illinois, Verenigde Staten, 60637
        • Werving
        • University of Chicago Comprehensive Cancer Center
        • Contact:
        • Hoofdonderzoeker:
          • Wendy S. Darlington
      • Chicago, Illinois, Verenigde Staten, 60612
        • Werving
        • University of Illinois
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 312-355-3046
        • Hoofdonderzoeker:
          • Dipti S. Dighe
      • Peoria, Illinois, Verenigde Staten, 61637
      • Springfield, Illinois, Verenigde Staten, 62702
        • Werving
        • Southern Illinois University School of Medicine
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 217-545-7929
        • Hoofdonderzoeker:
          • Gregory P. Brandt
    • Indiana
      • Indianapolis, Indiana, Verenigde Staten, 46202
        • Werving
        • Riley Hospital for Children
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 800-248-1199
        • Hoofdonderzoeker:
          • Sandeep Batra
      • Indianapolis, Indiana, Verenigde Staten, 46260
        • Werving
        • Ascension Saint Vincent Indianapolis Hospital
        • Contact:
        • Hoofdonderzoeker:
          • Jessica F. Goodman
    • Iowa
      • Des Moines, Iowa, Verenigde Staten, 50309
        • Werving
        • Blank Children's Hospital
        • Contact:
        • Hoofdonderzoeker:
          • Samantha L. Mallory
      • Iowa City, Iowa, Verenigde Staten, 52242
        • Werving
        • University of Iowa/Holden Comprehensive Cancer Center
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 800-237-1225
        • Hoofdonderzoeker:
          • Andrew P. Groves
    • Kentucky
      • Lexington, Kentucky, Verenigde Staten, 40536
        • Werving
        • University of Kentucky/Markey Cancer Center
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 859-257-3379
        • Hoofdonderzoeker:
          • James T. Badgett
      • Louisville, Kentucky, Verenigde Staten, 40202
        • Werving
        • Norton Children's Hospital
        • Contact:
        • Hoofdonderzoeker:
          • Michael J. Ferguson
    • Louisiana
      • New Orleans, Louisiana, Verenigde Staten, 70118
        • Werving
        • Children's Hospital New Orleans
        • Hoofdonderzoeker:
          • Maria C. Velez-Yanguas
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 504-894-5377
    • Maine
      • Bangor, Maine, Verenigde Staten, 04401
        • Werving
        • Eastern Maine Medical Center
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 207-973-4274
        • Hoofdonderzoeker:
          • Daniel L. Callaway
      • Scarborough, Maine, Verenigde Staten, 04074
        • Werving
        • Maine Children's Cancer Program
        • Hoofdonderzoeker:
          • Stanley Chaleff
        • Contact:
    • Maryland
      • Baltimore, Maryland, Verenigde Staten, 21287
        • Werving
        • Johns Hopkins University/Sidney Kimmel Cancer Center
        • Contact:
        • Hoofdonderzoeker:
          • Kenneth J. Cohen
      • Bethesda, Maryland, Verenigde Staten, 20889-5600
        • Werving
        • Walter Reed National Military Medical Center
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 301-319-2100
        • Hoofdonderzoeker:
          • Kip R. Hartman
    • Massachusetts
      • Boston, Massachusetts, Verenigde Staten, 02215
        • Actief, niet wervend
        • Dana-Farber Cancer Institute
      • Boston, Massachusetts, Verenigde Staten, 02114
        • Actief, niet wervend
        • Massachusetts General Hospital Cancer Center
    • Michigan
      • Ann Arbor, Michigan, Verenigde Staten, 48109
        • Werving
        • C S Mott Children's Hospital
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 800-865-1125
        • Hoofdonderzoeker:
          • Andrea T. Franson
      • Detroit, Michigan, Verenigde Staten, 48201
      • Grand Rapids, Michigan, Verenigde Staten, 49503
        • Werving
        • Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
        • Contact:
        • Hoofdonderzoeker:
          • Kathleen Y. Butler
      • Royal Oak, Michigan, Verenigde Staten, 48073
        • Actief, niet wervend
        • Corewell Health Children's
    • Minnesota
      • Minneapolis, Minnesota, Verenigde Staten, 55404
        • Werving
        • Children's Hospitals and Clinics of Minnesota - Minneapolis
        • Hoofdonderzoeker:
          • Michael K. Richards
        • Contact:
      • Minneapolis, Minnesota, Verenigde Staten, 55455
        • Werving
        • University of Minnesota/Masonic Cancer Center
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 612-624-2620
        • Hoofdonderzoeker:
          • Clay M. Hoerig
      • Rochester, Minnesota, Verenigde Staten, 55905
        • Werving
        • Mayo Clinic in Rochester
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 855-776-0015
        • Hoofdonderzoeker:
          • Joseph Z. Wilson
    • Mississippi
      • Jackson, Mississippi, Verenigde Staten, 39216
        • Werving
        • University of Mississippi Medical Center
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 601-815-6700
        • Hoofdonderzoeker:
          • Amanda Strobel
    • Missouri
      • Kansas City, Missouri, Verenigde Staten, 64108
        • Werving
        • Children's Mercy Hospitals and Clinics
        • Hoofdonderzoeker:
          • Keith J. August
        • Contact:
      • St Louis, Missouri, Verenigde Staten, 63110
        • Werving
        • Washington University School of Medicine
        • Contact:
        • Hoofdonderzoeker:
          • Andrew S. Cluster
      • St Louis, Missouri, Verenigde Staten, 63104
        • Werving
        • Cardinal Glennon Children's Medical Center
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 314-268-4000
        • Hoofdonderzoeker:
          • William S. Ferguson
    • Nebraska
      • Omaha, Nebraska, Verenigde Staten, 68114
        • Werving
        • Children's Hospital and Medical Center of Omaha
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 402-955-3949
        • Hoofdonderzoeker:
          • Jill C. Beck
      • Omaha, Nebraska, Verenigde Staten, 68198
        • Werving
        • University of Nebraska Medical Center
        • Contact:
        • Hoofdonderzoeker:
          • Jill C. Beck
    • New Jersey
      • Morristown, New Jersey, Verenigde Staten, 07960
        • Werving
        • Morristown Medical Center
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 973-971-5900
        • Hoofdonderzoeker:
          • Kathryn L. Laurie
    • New York
      • Albany, New York, Verenigde Staten, 12208
        • Werving
        • Albany Medical Center
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 518-262-5513
        • Hoofdonderzoeker:
          • Lauren R. Weintraub
      • Buffalo, New York, Verenigde Staten, 14263
        • Werving
        • Roswell Park Cancer Institute
        • Contact:
        • Hoofdonderzoeker:
          • Matthew J. Barth
      • Mineola, New York, Verenigde Staten, 11501
        • Werving
        • NYU Langone Hospital - Long Island
        • Contact:
        • Hoofdonderzoeker:
          • Chana L. Glasser
      • New Hyde Park, New York, Verenigde Staten, 11040
        • Werving
        • The Steven and Alexandra Cohen Children's Medical Center of New York
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 718-470-3460
        • Hoofdonderzoeker:
          • Mark P. Atlas
      • New York, New York, Verenigde Staten, 10065
        • Werving
        • Memorial Sloan Kettering Cancer Center
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 212-639-7592
        • Hoofdonderzoeker:
          • Sameer Farouk Sait
      • New York, New York, Verenigde Staten, 10016
        • Werving
        • Laura and Isaac Perlmutter Cancer Center at NYU Langone
        • Hoofdonderzoeker:
          • Elizabeth A. Raetz
        • Contact:
      • Rochester, New York, Verenigde Staten, 14642
        • Actief, niet wervend
        • University of Rochester
      • Syracuse, New York, Verenigde Staten, 13210
        • Werving
        • State University of New York Upstate Medical University
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 315-464-5476
        • Hoofdonderzoeker:
          • Melanie A. Comito
      • Valhalla, New York, Verenigde Staten, 10595
        • Werving
        • New York Medical College
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 914-594-3794
        • Hoofdonderzoeker:
          • Andrew J. Bellantoni
    • North Carolina
      • Chapel Hill, North Carolina, Verenigde Staten, 27599
        • Werving
        • UNC Lineberger Comprehensive Cancer Center
        • Contact:
        • Hoofdonderzoeker:
          • David E. Kram
      • Charlotte, North Carolina, Verenigde Staten, 28203
        • Werving
        • Carolinas Medical Center/Levine Cancer Institute
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 800-804-9376
        • Hoofdonderzoeker:
          • Joel A. Kaplan
      • Durham, North Carolina, Verenigde Staten, 27710
        • Werving
        • Duke University Medical Center
        • Hoofdonderzoeker:
          • Jessica M. Sun
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 888-275-3853
      • Greenville, North Carolina, Verenigde Staten, 27834
        • Werving
        • East Carolina University
        • Contact:
        • Hoofdonderzoeker:
          • Andrea R. Whitfield
      • Winston-Salem, North Carolina, Verenigde Staten, 27157
        • Werving
        • Wake Forest University Health Sciences
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 336-713-6771
        • Hoofdonderzoeker:
          • Sarah Supples
    • North Dakota
      • Fargo, North Dakota, Verenigde Staten, 58122
    • Ohio
      • Akron, Ohio, Verenigde Staten, 44308
        • Werving
        • Children's Hospital Medical Center of Akron
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 330-543-3193
        • Hoofdonderzoeker:
          • Lauren R. Draper
      • Cincinnati, Ohio, Verenigde Staten, 45229
        • Werving
        • Cincinnati Children's Hospital Medical Center
        • Contact:
        • Hoofdonderzoeker:
          • Peter M. de Blank
      • Cleveland, Ohio, Verenigde Staten, 44106
        • Werving
        • Rainbow Babies and Childrens Hospital
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 216-844-5437
        • Hoofdonderzoeker:
          • Duncan S. Stearns
      • Columbus, Ohio, Verenigde Staten, 43205
      • Dayton, Ohio, Verenigde Staten, 45404
        • Werving
        • Dayton Children's Hospital
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 800-228-4055
        • Hoofdonderzoeker:
          • Jordan M. Wright
    • Oklahoma
      • Oklahoma City, Oklahoma, Verenigde Staten, 73104
        • Werving
        • University of Oklahoma Health Sciences Center
        • Contact:
        • Hoofdonderzoeker:
          • Rene Y. McNall-Knapp
    • Oregon
      • Portland, Oregon, Verenigde Staten, 97239
        • Werving
        • Oregon Health and Science University
        • Contact:
        • Hoofdonderzoeker:
          • Neha J. Patel
    • Pennsylvania
      • Danville, Pennsylvania, Verenigde Staten, 17822
        • Werving
        • Geisinger Medical Center
        • Hoofdonderzoeker:
          • Jagadeesh Ramdas
        • Contact:
      • Hershey, Pennsylvania, Verenigde Staten, 17033
        • Werving
        • Penn State Children's Hospital
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 717-531-6012
        • Hoofdonderzoeker:
          • Lisa M. McGregor
      • Philadelphia, Pennsylvania, Verenigde Staten, 19104
        • Werving
        • Children's Hospital of Philadelphia
        • Hoofdonderzoeker:
          • Michael J. Fisher
        • Contact:
      • Philadelphia, Pennsylvania, Verenigde Staten, 19134
        • Werving
        • Saint Christopher's Hospital for Children
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 215-427-8991
        • Hoofdonderzoeker:
          • Gregory E. Halligan
      • Pittsburgh, Pennsylvania, Verenigde Staten, 15224
        • Werving
        • Children's Hospital of Pittsburgh of UPMC
        • Contact:
        • Hoofdonderzoeker:
          • James T. Felker
    • Rhode Island
      • Providence, Rhode Island, Verenigde Staten, 02903
        • Werving
        • Rhode Island Hospital
        • Hoofdonderzoeker:
          • Bradley DeNardo
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 401-444-1488
    • South Carolina
      • Charleston, South Carolina, Verenigde Staten, 29425
        • Werving
        • Medical University of South Carolina
        • Contact:
        • Hoofdonderzoeker:
          • Jacqueline M. Kraveka
      • Columbia, South Carolina, Verenigde Staten, 29203
        • Werving
        • Prisma Health Richland Hospital
        • Hoofdonderzoeker:
          • Stuart L. Cramer
        • Contact:
      • Greenville, South Carolina, Verenigde Staten, 29605
        • Werving
        • BI-LO Charities Children's Cancer Center
        • Hoofdonderzoeker:
          • Aniket Saha
        • Contact:
    • Tennessee
      • Knoxville, Tennessee, Verenigde Staten, 37916
        • Werving
        • East Tennessee Childrens Hospital
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 865-541-8266
        • Hoofdonderzoeker:
          • Susan E. Spiller
      • Memphis, Tennessee, Verenigde Staten, 38105
        • Werving
        • Saint Jude Children's Research Hospital
        • Hoofdonderzoeker:
          • Anna Vinitsky
        • Contact:
      • Nashville, Tennessee, Verenigde Staten, 37232
        • Werving
        • Vanderbilt University/Ingram Cancer Center
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 800-811-8480
        • Hoofdonderzoeker:
          • Devang J. Pastakia
    • Texas
      • Austin, Texas, Verenigde Staten, 78723
      • Dallas, Texas, Verenigde Staten, 75390
        • Werving
        • UT Southwestern/Simmons Cancer Center-Dallas
        • Contact:
        • Hoofdonderzoeker:
          • Daniel C. Bowers
      • El Paso, Texas, Verenigde Staten, 79905
        • Werving
        • El Paso Children's Hospital
        • Contact:
        • Hoofdonderzoeker:
          • Benjamin Carcamo
      • Fort Worth, Texas, Verenigde Staten, 76104
      • Houston, Texas, Verenigde Staten, 77030
        • Werving
        • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
        • Hoofdonderzoeker:
          • Murali M. Chintagumpala
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 713-798-1354
          • E-mail: burton@bcm.edu
      • Houston, Texas, Verenigde Staten, 77030
        • Werving
        • UT MD Anderson Cancer Center
        • Contact:
        • Hoofdonderzoeker:
          • Najat C. Daw
      • Lubbock, Texas, Verenigde Staten, 79410
        • Werving
        • Covenant Children's Hospital
        • Hoofdonderzoeker:
          • Kishor M. Bhende
        • Contact:
      • Lubbock, Texas, Verenigde Staten, 79415
        • Werving
        • UMC Cancer Center / UMC Health System
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 806-775-8590
        • Hoofdonderzoeker:
          • Erin K. Barr
      • San Antonio, Texas, Verenigde Staten, 78207
        • Werving
        • Children's Hospital of San Antonio
        • Contact:
        • Hoofdonderzoeker:
          • Julie Voeller
      • San Antonio, Texas, Verenigde Staten, 78229
        • Werving
        • University of Texas Health Science Center at San Antonio
        • Contact:
        • Hoofdonderzoeker:
          • Shafqat Shah
      • San Antonio, Texas, Verenigde Staten, 78229
        • Werving
        • Methodist Children's Hospital of South Texas
        • Contact:
        • Hoofdonderzoeker:
          • Jose M. Esquilin
    • Utah
      • Salt Lake City, Utah, Verenigde Staten, 84113
        • Werving
        • Primary Children's Hospital
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 801-585-5270
        • Hoofdonderzoeker:
          • Priya Chan
    • Vermont
      • Burlington, Vermont, Verenigde Staten, 05405
        • Werving
        • University of Vermont and State Agricultural College
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 802-656-8990
          • E-mail: rpo@uvm.edu
        • Hoofdonderzoeker:
          • Jessica L. Heath
    • Virginia
      • Norfolk, Virginia, Verenigde Staten, 23507
        • Werving
        • Children's Hospital of The King's Daughters
        • Contact:
        • Hoofdonderzoeker:
          • Melissa S. Mark
      • Richmond, Virginia, Verenigde Staten, 23298
        • Werving
        • VCU Massey Comprehensive Cancer Center
        • Hoofdonderzoeker:
          • Christopher Park
        • Contact:
      • Roanoke, Virginia, Verenigde Staten, 24014
        • Werving
        • Carilion Children's
        • Contact:
        • Hoofdonderzoeker:
          • Erwood G. Edwards
    • Washington
      • Seattle, Washington, Verenigde Staten, 98105
        • Werving
        • Seattle Children's Hospital
        • Contact:
          • Site Public Contact
          • Telefoonnummer: 866-987-2000
        • Hoofdonderzoeker:
          • Sarah E. Leary
      • Spokane, Washington, Verenigde Staten, 99204
        • Werving
        • Providence Sacred Heart Medical Center and Children's Hospital
        • Contact:
        • Hoofdonderzoeker:
          • Judy L. Felgenhauer
      • Tacoma, Washington, Verenigde Staten, 98405
        • Werving
        • Mary Bridge Children's Hospital and Health Center
        • Contact:
        • Hoofdonderzoeker:
          • Robert G. Irwin
      • Tacoma, Washington, Verenigde Staten, 98431
        • Werving
        • Madigan Army Medical Center
        • Hoofdonderzoeker:
          • Melissa A. Forouhar
        • Contact:
    • West Virginia
      • Morgantown, West Virginia, Verenigde Staten, 26506
        • Werving
        • West Virginia University Healthcare
        • Contact:
        • Hoofdonderzoeker:
          • Ashley E. Meyer
    • Wisconsin
      • Madison, Wisconsin, Verenigde Staten, 53792
        • Werving
        • University of Wisconsin Carbone Cancer Center - University Hospital
        • Contact:
        • Hoofdonderzoeker:
          • Nicholas J. Pytel
      • Milwaukee, Wisconsin, Verenigde Staten, 53226
        • Werving
        • Children's Hospital of Wisconsin
        • Contact:
        • Hoofdonderzoeker:
          • Sarah Rumler

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

2 jaar tot 21 jaar (Kind, Volwassen)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Patients must be >= 2 years and =< 21 years at the time of enrollment

  • Patients must have a body surface area (BSA) of >= 0.5 m^2 at enrollment

  • Patients must have non-neurofibromatosis type 1 (non-NF1) low-grade glioma (LGG) without a BRAFV600E mutation as confirmed by Rapid Central Pathology and Molecular Screening Reviews performed on APEC14B1 (NCT02402244) Childhood Cancer Data Initiative (CCDI)-MCI, or accepted Clinical Laboratory Improvement Act (CLIA)-certified test and that has not been treated with any modality besides surgery. Note: Patients may be newly-diagnosed OR previously diagnosed, and there is no required time frame between biopsy/surgery and treatment initiation.

    • Patients with residual tumor after resection or progressive tumor after initial diagnosis (with or without surgery) who have not received treatment (chemotherapy and/or radiation) are eligible
    • Patients must have two-dimensional measurable tumor >= 1 cm^2 to be eligible
    • Patients with ependymoma are not eligible

  • Eligible histologies will include all tumors considered low-grade glioma or low-grade astrocytoma (World Health Organization [WHO] grade I and II) by 5th edition WHO classification of central nervous system (CNS) tumors with the exception of subependymal giant cell astrocytoma

  • Patients with metastatic disease or multiple independent primary LGG are eligible

  • Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 OR a serum creatinine based on age/sex as follows (performed within 7 days prior to enrollment):

    • Age: Maximum Serum Creatinine (mg/dL)
    • 2 to < 6 years: 0.8 mg/dL (male); 0.8 mg/dL (female)
    • 6 to < 10 years: 1 mg/dL (male); 1 mg/dL (female)
    • 10 to < 13 years: 1.2 mg/dL (male); 1.2 mg/dL (female)
    • 13 to < 16 years: 1.5 mg/dL (male); 1.4 mg/dL (female)
    • >= 16 years: 1.7 mg/dL (male); 1.4 mg/dL (female)

  • Total bilirubin =< 1.5 x upper limit of normal (ULN) for age (performed within 7 days prior to enrollment) (children with a diagnosis of Gilbert's syndrome will be allowed on study regardless of their total and indirect [unconjugated] bilirubin levels as long as their direct [conjugated] bilirubin is < 3.1 mg/dL)

  • Serum glutamic pyruvic transaminase (SGPT) (alanine aminotransferase [ALT]) =< 135 U/L (performed within 7 days prior to enrollment). For the purpose of this study, the ULN for SGPT is 45 U/L

  • Albumin >= 2 g/dL (performed within 7 days prior to enrollment)

  • Left ventricular ejection fraction (LVEF) >= 53% (or institutional normal; if the LVEF result is given as a range of values, then the upper value of the range will be used) by echocardiogram (performed within 4 weeks prior to enrollment)

  • Corrected QT (QTc) interval =< 450 msec by electrocardiography (EKG) (performed within 4 weeks prior to enrollment)

  • Absolute neutrophil count >= 1,000/uL (unsupported) (performed within 7 days prior to enrollment)

  • Platelets >= 100,000/uL (unsupported) (performed within 7 days prior to enrollment)

  • Hemoglobin >= 8 g/dL (may be supported) (performed within 7 days prior to enrollment)

  • Patients with a known seizure disorder must be stable and must not have experienced a significant increase in seizure frequency within 2 weeks prior to enrollment

  • Patients 2-17 years of age must have a blood pressure that is =< 95th percentile for age, height, and sex at the time of enrollment (with or without the use of anti-hypertensive medications)

  • Patients >= 18 years of age must have a blood pressure =< 130/80 mmHg at the time of enrollment (with or without the use of anti-hypertensive medications)

  • Note for patients of all ages: Adequate blood pressure can be achieved using medication for the treatment of hypertension

  • All patients must have ophthalmology toxicity assessments performed within 8 weeks prior to enrollment

  • For all patients, an MRI of the brain (with orbital cuts for optic pathway tumors) and/or spine (depending on the site(s) of primary disease) with and without contrast must be performed within 8 weeks prior to enrollment

  • Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, or 2. Use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age

  • Patients must have the ability to swallow whole capsules

  • 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

  • All patients have signed an appropriate consent form and Health Insurance Portability and Accountability Act (HIPAA) authorization form (if applicable)

  • All patients have been consented and enrolled on APEC14B1 (NCT02402244) Part A for Pre-Enrollment Eligibility Screening for ACNS1833

Exclusion Criteria:

  • Patients must not have received any prior tumor-directed therapy including chemotherapy, radiation therapy, immunotherapy, or bone marrow transplant. Prior surgical intervention (with the exclusion of laser interstitial thermal therapy [LITT]) is permitted

  • Patients with a concurrent malignancy or history of treatment (other than surgery) for another tumor within the last year are ineligible

  • Patients with diffuse intrinsic pontine tumors as seen on MRI (> 2/3 of pons involvement on imaging) are not eligible even if biopsy reveals grade I/II histology

  • Patients may not be receiving any other investigational agents

  • Patients with any serious medical or psychiatric illness/condition, including substance use disorders or ophthalmological conditions, likely in the judgment of the investigator to interfere or limit compliance with study requirements/treatment

  • Patients who, in the opinion of the investigator, are not able to comply with the study procedures are not eligible

  • Female patients who are pregnant are not eligible since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential

  • Lactating females who plan to breastfeed their infants are not eligible

  • Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation and for 1 week after stopping study therapy are not eligible.

    • Note: Women study participants of child-bearing potential must use acceptable contraception during the study and for 1 week (7 days) after the last dose of selumetinib. Men study participants with sexual partners who are pregnant or who are of child-bearing potential must use acceptable contraception during the study and for 1 week (7 days) after the last dose of study agent. Acceptable contraception includes implants, injectables, or oral contraceptives (all combined with barrier methods), some intrauterine devices (IUDs), vasectomy or abstinence

  • Known genetic disorder that increases risk for coronary artery disease. Note: The presence of dyslipidemia in a family with a history of myocardial infarction is not in itself an exclusion unless there is a known genetic disorder documented

  • Symptomatic heart failure

  • New York Health Association (NYHA) class II-IV prior or current cardiomyopathy

  • Severe valvular heart disease

  • History of atrial fibrillation

  • Current or past history of central serous retinopathy

  • Current or past history of retinal vein occlusion or retinal detachment

  • Patients with uncontrolled glaucoma

    • If checking pressure is clinically indicated, patients with intraocular pressure (IOP) > 22 mmHg or ULN adjusted by age are not eligible

  • Supplementation with vitamin E greater than 100% of the daily recommended dose. Any multivitamin containing vitamin E must be stopped prior to study enrollment even if less than 100% of the daily recommended dosing for vitamin E

  • Surgery within 2 weeks prior to enrollment, with the exception of surgical biopsy, placement of a vascular access device or cerebral spinal fluid (CSF) diverting procedure such as endoscopic third ventriculostomy (ETV) and ventriculoperitoneal (VP) shunt.

    • Note: Patients must have healed from any prior surgery

  • Patients who have an uncontrolled infection are not eligible

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: Arm I (vincristine sulfate, carboplatin)

INDUCTION: Patients receive vincristine sulfate IV on days 1, 8, 15, 22, 29, 36, 43, 50, 57, and 64, and carboplatin IV over 60 minutes on days 1, 8, 15, 22, 43, 50, 57, and 64 in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood and MRI throughout the trial.

MAINTENANCE: Patients receive vincristine sulfate IV on days 1, 8, and 15, and carboplatin IV over 60 minutes on days 1, 8, 15, and 22 of each cycle. Cycles repeat every 42 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood and MRI throughout the trial.
Geneesmiddel: Carboplatin

Given IV

Andere namen:
  • Blastocarb
  • Carboplat
  • Carboplatine Hexal
  • Carboplatino
  • Carboplatina
  • Carbosin
  • Carbosol
  • Carbotec
  • CBDCA
  • Displata
  • Ercar
  • JM-8
  • Nealorin
  • Novoplatina
  • Paraplatine
  • Paraplatina AQ
  • Platinawas
  • Ribocarbo
  • JM8
Procedure: Biospecimen Collection

Undergo blood sample collection

Andere namen:
  • Biologische monsterverzameling
  • Biospecimen verzameld
  • Specimenverzameling
  • Monsterverzameling
Geneesmiddel: Vincristine Sulfate

Given IV

Andere namen:
  • Oncovin
  • Kyocristine
  • Leurocristinesulfaat
  • Leurocristine, sulfaat
  • Vincasar
  • Vincosid
  • Vincrex
  • Vincristine, sulfaat
Procedure: Magnetic Resonance Imaging

Undergo MRI

Andere namen:
  • MRI
  • Magnetische resonantie
  • Magnetic Resonance Imaging-scan
  • Medische beeldvorming, magnetische resonantie / nucleaire magnetische resonantie
  • DHR
  • MR-beeldvorming
  • MRI scan
  • NMR-beeldvorming
  • NMRI
  • Nucleaire magnetische resonantie beeldvorming
  • Magnetische resonantiebeeldvorming (MRI)
  • sMRI
  • Magnetische resonantiebeeldvorming (procedure)
  • MRI's
  • Structurele MRI
Ander: Questionnaire Administration

Ancillary studies
Experimenteel: Arm II (selumetinib sulfate)

Patients receive selumetinib sulfate PO BID on days 1-28 of each cycle. Cycles repeat every 28 days for up to 27 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo ECHO at baseline and undergo collection of blood and MRI throughout the trial.
Procedure: Biospecimen Collection

Undergo blood sample collection

Andere namen:
  • Biologische monsterverzameling
  • Biospecimen verzameld
  • Specimenverzameling
  • Monsterverzameling
Procedure: Magnetic Resonance Imaging

Undergo MRI

Andere namen:
  • MRI
  • Magnetische resonantie
  • Magnetic Resonance Imaging-scan
  • Medische beeldvorming, magnetische resonantie / nucleaire magnetische resonantie
  • DHR
  • MR-beeldvorming
  • MRI scan
  • NMR-beeldvorming
  • NMRI
  • Nucleaire magnetische resonantie beeldvorming
  • Magnetische resonantiebeeldvorming (MRI)
  • sMRI
  • Magnetische resonantiebeeldvorming (procedure)
  • MRI's
  • Structurele MRI
Ander: Questionnaire Administration

Ancillary studies

Procedure: Echocardiography Test

Undergo ECHO

Andere namen:
  • Echocardiografie
  • EG
Geneesmiddel: Selumetinib Sulfate

Given PO

Andere namen:
  • AZD-6244 waterstofsulfaat
  • AZD6244 Waterstofsulfaat
  • Koselogo
  • Selumetinib sulfaat

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Event-free survival (EFS)
Tijdsspanne: Up to 10 years from date of randomization

The Kaplan-Meier method will be used to estimate EFS which is defined as the interval from randomization to first occurrence of clinical or radiographic disease progression, disease recurrence, second malignant neoplasm, or death from any cause, or to the date of last follow-up. Estimates with 95% confidence intervals will be reported by treatment arm. The hazard ratio with a confidence interval will also be reported to compare treatment arms based on a Cox proportional hazards model stratified by BRAF status, tumor location and size of residual tumor. Will also provide outcome estimates and their associated confidence intervals by sex, race and ethnicity, as descriptive summaries of outcome.
Up to 10 years from date of randomization

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Radiographic tumor response rate
Tijdsspanne: Up to 10 years

Percentages of patients with responses (complete or partial response) will be reported by treatment arm with 95% confidence intervals. The result of an exact binomial test to test for the difference in response rates between treatment arm will also be reported. Will also provide outcome estimates and their associated confidence intervals by sex, race and ethnicity, as descriptive summaries of outcome.
Up to 10 years
Overall survival (OS)
Tijdsspanne: Up to 10 years from date of randomization

The Kaplan-Meier method will be used to estimate OS by treatment arm, defined as the interval from randomization to death from any cause, or to the date of last follow-up. Estimates with confidence intervals will be reported by treatment arm. Will also provide outcome estimates and their associated confidence intervals by sex, race and ethnicity, as descriptive summaries of outcome.
Up to 10 years from date of randomization
Number of patients who experience an improvement in visual acuity (VA)
Tijdsspanne: After the first 12 months of treatment

Numbers of patients that show improvement in VA after 12 months of treatment will be reported by treatment arm. Patients with at least 1 impaired eye are evaluable. In a patient with a unilateral optic nerve glioma, only the affected eye is considered. In patients with bilateral visual impairment, if VA improves in 1 eye but worsens in the other, the patient will be coded as a treatment failure, whereas if 1 eye improves and the other is at least stable, the patient will be coded as a success.
After the first 12 months of treatment
Change in motor function
Tijdsspanne: After 48 weeks of therapy

Motor function is measured using the Vineland-3 Motor Scale. Only patients with motor function deficits at baseline are included. Magnitudes of change from baseline between the 2 treatment arms and provide a 90% 2-sided confidence interval for this difference.
After 48 weeks of therapy
Change in quality of life (QOL)
Tijdsspanne: Baseline and 9 months after treatment initiation

QOL will be measured using the PedsQL Total Scale Score as measured from the validated PedsQL Generic Module (for children 2-21 years old). Mean differences in the total scale score between 9 months and baseline will be reported by treatment arm. The results of 2-sample t-test comparing differences in the QOL scores between the 2 arms will also be reported. If change scores do not follow normal distributions, non-parametric alternatives may be employed for analysis.
Baseline and 9 months after treatment initiation
Processing speed function
Tijdsspanne: Up to 9 months post-treatment initiation

Measured by Wechsler Processing Speed Index (standard score). Scores at 9 months will be summarized by treatment arm and reported as means (with standard deviations) or medians (with ranges) depending on the data distribution.
Up to 9 months post-treatment initiation
Change in executive function
Tijdsspanne: Baseline and 9-months

Executive function will be measured by the Behavior Rating Inventory of Executive Function, Second Edition BRIEF Cognitive Regulation Index (CRI). Summary statistics for the differences in scores from baseline to 9 months will be reported by treatment arm.
Baseline and 9-months

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in QOL scores over time
Tijdsspanne: At baseline, 9 months, 30 months, and 60 months after treatment initiation

QOL scores for each domain of the PedsQL Generic module will be summarized by timepoint (4 timepoints) and treatment arm. Mean QOL scores will be reported with standard deviations. If scores do not follow normal distributions, medians and ranges will be reported instead.
At baseline, 9 months, 30 months, and 60 months after treatment initiation
Change in neurocognitive functioning scores over time
Tijdsspanne: At baseline, 9 months, 30 months, and 60 months after treatment initiation

Neurocognitive functioning scores for each index/scale of the Behavior Rating Inventory of Executive Function, Second Edition/Preschool Version/Adult will be summarized by timepoint (4 timepoints) and treatment arm. Mean scores will be reported with standard deviations. If scores do not follow normal distributions, medians and ranges will be reported instead.
At baseline, 9 months, 30 months, and 60 months after treatment initiation
EFS by sex
Tijdsspanne: Up to 10 years from date of randomization

Estimates of treatment effect and the corresponding 95% confidence intervals will be provided by sex.
Up to 10 years from date of randomization
EFS by race
Tijdsspanne: Up to 10 years from date of randomization

Estimates of treatment effect and the corresponding 95% confidence intervals will be provided by race.
Up to 10 years from date of randomization
EFS by ethnicity
Tijdsspanne: Up to 10 years from date of randomization

Estimates of treatment effect and the corresponding 95% confidence intervals will be provided by ethnicity.
Up to 10 years from date of randomization
OS by sex
Tijdsspanne: Up to 10 years from date of randomization

Estimates of treatment effect and the corresponding 95% confidence intervals will be provided by sex.
Up to 10 years from date of randomization
OS by race
Tijdsspanne: Up to 10 years from date of randomization

Estimates of treatment effect and the corresponding 95% confidence intervals will be provided by race.
Up to 10 years from date of randomization
OS by ethnicity
Tijdsspanne: Up to 10 years from date of randomization

Estimates of treatment effect and the corresponding 95% confidence intervals will be provided by ethnicity.
Up to 10 years from date of randomization
Neurocognitive outcomes by sex
Tijdsspanne: Up to 10 years from date of randomization

Estimates of treatment effect and the corresponding 95% confidence intervals will be provided by sex.
Up to 10 years from date of randomization
Neurocognitive outcomes by race
Tijdsspanne: Up to 10 years from date of randomization

Estimates of treatment effect and the corresponding 95% confidence intervals will be provided by race.
Up to 10 years from date of randomization
Neurocognitive outcomes by ethnicity
Tijdsspanne: Up to 10 years from date of randomization

Estimates of treatment effect and the corresponding 95% confidence intervals will be provided by ethnicity.
Up to 10 years from date of randomization
QOL by sex
Tijdsspanne: Up to 10 years from date of randomization

Estimates of treatment effect and the corresponding 95% confidence intervals will be provided by sex.
Up to 10 years from date of randomization
QOL by race
Tijdsspanne: Up to 10 years from date of randomization

Estimates of treatment effect and the corresponding 95% confidence intervals will be provided by race.
Up to 10 years from date of randomization
QOL by ethnicity
Tijdsspanne: Up to 10 years from date of randomization

Estimates of treatment effect and the corresponding 95% confidence intervals will be provided by ethnicity.
Up to 10 years from date of randomization

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

National Cancer Institute (NCI)

Onderzoekers

  • Hoofdonderzoeker: Peter M de Blank, Children's Oncology Group

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

31 januari 2020

Primaire voltooiing (Geschat)

31 december 2030

Studie voltooiing (Geschat)

31 december 2030

Studieregistratiedata

Eerst ingediend

15 november 2019

Eerst ingediend dat voldeed aan de QC-criteria

15 november 2019

Eerst geplaatst (Werkelijk)

18 november 2019

Updates van studierecords

Laatste update geplaatst (Werkelijk)

6 november 2026

Laatste update ingediend die voldeed aan QC-criteria

5 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • NCI-2019-07600
  • U10CA180886 (Subsidie/contract van de Amerikaanse NIH)
  • NCI-2019-07600 (Register-ID: CTRP (Clinical Trial Reporting Program))
  • ACNS1833 (Andere identificatie: CTEP)
  • ACNS1833 (Andere identificatie: Children's Oncology Group)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren