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低级别胶质瘤患者药物 Selumetinib 与卡铂和长春新碱的研究

2026年11月5日 更新者：National Cancer Institute (NCI)

卡铂和长春新碱与 Selumetinib (NSC# 748727) 在新诊断或以前未治疗的低级别胶质瘤 (LGG) 中的 3 期随机非劣效性研究，与 BRAFV600E 突变或系统性神经纤维瘤病 1 型 (NF1) 无关

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.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

170

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

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

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

2年 至 21年 (孩子、成人)

接受健康志愿者

不

有资格学习的性别

全部

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
有源比较器：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.
药品：Carboplatin

Given IV

其他名称：
  • 芽生威
  • 卡宝
  • 卡铂六醇
  • 卡铂
  • 卡布辛
  • 卡波索尔
  • 卡博泰克
  • CBDCA
  • 迪普拉塔
  • 埃卡尔
  • JM-8
  • 内洛林
  • 新铂金
  • 副铂
  • 副铂 AQ
  • 对铂
  • 铂金瓦斯
  • 核糖体
  • JM8
程序：Biospecimen Collection

Undergo blood sample collection

其他名称：
  • 生物样本采集
  • 收集的生物样本
  • 标本采集
  • 样本收集
药品：Vincristine Sulfate

Given IV

其他名称：
  • 致癌素
  • 基克里斯汀
  • 硫酸亮绿新碱
  • 硫酸白新碱
  • 长春
  • 长春甙
  • 万可乐
  • 硫酸长春新碱
程序：Magnetic Resonance Imaging

Undergo MRI

其他名称：
  • 核磁共振
  • 磁共振
  • 磁共振成像扫描
  • 医学影像、磁共振/核磁共振
  • 先生
  • 磁共振成像
  • 核磁共振成像扫描
  • 核磁共振成像
  • 磁共振成像 (MRI)
  • 磁共振成像（程序）
  • 结构核磁共振
其他：Questionnaire Administration

Ancillary studies
实验性的：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.
程序：Biospecimen Collection

Undergo blood sample collection

其他名称：
  • 生物样本采集
  • 收集的生物样本
  • 标本采集
  • 样本收集
程序：Magnetic Resonance Imaging

Undergo MRI

其他名称：
  • 核磁共振
  • 磁共振
  • 磁共振成像扫描
  • 医学影像、磁共振/核磁共振
  • 先生
  • 磁共振成像
  • 核磁共振成像扫描
  • 核磁共振成像
  • 磁共振成像 (MRI)
  • 磁共振成像（程序）
  • 结构核磁共振
其他：Questionnaire Administration

Ancillary studies

程序：Echocardiography Test

Undergo ECHO

其他名称：
  • 超声心动图
  • 欧共体
药品：Selumetinib Sulfate

Given PO

其他名称：
  • AZD-6244 硫酸氢盐
  • AZD6244 硫酸氢盐
  • 科塞卢戈
  • 硫酸司美替尼

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Event-free survival (EFS)
大体时间：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

次要结果测量

结果测量
措施说明
大体时间
Radiographic tumor response rate
大体时间：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)
大体时间：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)
大体时间：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
大体时间：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)
大体时间：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
大体时间：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
大体时间：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

其他结果措施

结果测量
措施说明
大体时间
Change in QOL scores over time
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

National Cancer Institute (NCI)

调查人员

  • 首席研究员：Peter M de Blank、Children's Oncology Group

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2020年1月31日

初级完成 (估计的)

2030年12月31日

研究完成 (估计的)

2030年12月31日

研究注册日期

首次提交

2019年11月15日

首先提交符合 QC 标准的

2019年11月15日

首次发布 (实际的)

2019年11月18日

研究记录更新

最后更新发布 (实际的)

2026年11月6日

上次提交的符合 QC 标准的更新

2026年11月5日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • NCI-2019-07600
  • U10CA180886 (美国 NIH 拨款/合同)
  • NCI-2019-07600 (注册表标识符：CTRP (Clinical Trial Reporting Program))
  • ACNS1833 (其他标识符：CTEP)
  • ACNS1833 (其他标识符：Children's Oncology Group)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

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.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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