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Armodafinil til at reducere kræftrelateret træthed hos patienter med højgradig gliom

14. januar 2025 opdateret af: Alliance for Clinical Trials in Oncology

En fase III randomiseret, dobbeltblind placebokontrolleret undersøgelse af Armodafinil (Nuvigil®) for at reducere kræftrelateret træthed hos patienter med højgradig gliom

Dette randomiserede fase III-studie undersøger armodafinil for at se, hvor godt det virker til at reducere kræftrelateret træthed hos patienter med højgradig gliom. Armodafinil kan hjælpe med at lindre træthed hos patienter med højgradig gliom.

Studieoversigt

Detaljeret beskrivelse

Patienter, der oplever træthed relateret til kræft, vil blive bedt om at deltage i denne undersøgelse. Kræftrelateret træthed er et meget almindeligt symptom hos patienter med kræft. Patienterne vil modtage armodafinil eller placebo. Se venligst afsnittet "Arme" for flere detaljer om behandlingsopgaverne. Det primære formål med denne undersøgelse er at bestemme den foreløbige effekt målt ved patientrapporteret træthed Brief Fatigue Inventory (BFI) efter 8 uger af to doser (150 mg og 250 mg) af armodafinil til behandling af moderat træthed sammenlignet med placebo hos patienter med højgradigt gliom .

Undersøgelsens sekundære mål er anført nedenfor.

  1. At evaluere tolerabiliteten efter 8 uger af 150 mg og 250 mg armodafinil i denne patientpopulation.
  2. At vurdere effekten af ​​armodafinil efter 8 uger på kognitiv funktion hos patienter med høj grad af gliom.
  3. At vurdere virkningen af ​​armodafinil på global livskvalitet og andre træthedsendepunkter i denne patientpopulation med højgradig gliom.
  4. Udforsk sammenhængen mellem BFI, Patient-Reported Outcomes Measurement Information System (PROMIS) og Patient-Reported Outcomes-versionen af ​​Common Terminology Criteria for Adverse Events (PRO-CTCAE) målinger, samt forholdet mellem træthed og kognitive vanskeligheder .

Patienterne vil modtage armodafinil eller placebo i i alt 8 uger.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

328

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Alaska
      • Anchorage, Alaska, Forenede Stater, 99508
        • Alaska Breast Care and Surgery LLC
      • Anchorage, Alaska, Forenede Stater, 99508
        • Alaska Women's Cancer Care
      • Anchorage, Alaska, Forenede Stater, 99508
        • Anchorage Oncology Centre
      • Anchorage, Alaska, Forenede Stater, 99508
        • Katmai Oncology Group
      • Anchorage, Alaska, Forenede Stater, 99508
        • Providence Alaska Medical Center
      • Fairbanks, Alaska, Forenede Stater, 99701
        • Fairbanks Memorial Hospital
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85027
        • Arizona Oncology-Deer Valley Center
      • Phoenix, Arizona, Forenede Stater, 85013
        • Saint Joseph's Hospital and Medical Center
      • Scottsdale, Arizona, Forenede Stater, 85259
        • Mayo Clinic in Arizona
      • Scottsdale, Arizona, Forenede Stater, 85260
        • Arizona Oncology Services Foundation
    • California
      • Berkeley, California, Forenede Stater, 94704
        • Alta Bates Summit Medical Center-Herrick Campus
      • Burbank, California, Forenede Stater, 91505
        • Providence Saint Joseph Medical Center/Disney Family Cancer Center
      • Burlingame, California, Forenede Stater, 94010
        • Mills-Peninsula Medical Center
      • Clovis, California, Forenede Stater, 93611
        • Community Cancer Institute
      • Clovis, California, Forenede Stater, 93611
        • University Oncology Associates
      • Concord, California, Forenede Stater, 94520
        • John Muir Medical Center-Concord Campus
      • La Jolla, California, Forenede Stater, 92093
        • UC San Diego Moores Cancer Center
      • Loma Linda, California, Forenede Stater, 92354
        • Loma Linda University Medical Center
      • Modesto, California, Forenede Stater, 95355
        • Memorial Medical Center
      • Orange, California, Forenede Stater, 92868
        • UC Irvine Health/Chao Family Comprehensive Cancer Center
      • Orange, California, Forenede Stater, 92868
        • Saint Joseph Hospital - Orange
      • Santa Clara, California, Forenede Stater, 95051
        • Kaiser Permanente Medical Center - Santa Clara
      • Vallejo, California, Forenede Stater, 94589
        • Kaiser Permanente-Vallejo
    • Colorado
      • Colorado Springs, Colorado, Forenede Stater, 80907
        • Penrose-Saint Francis Healthcare
      • Colorado Springs, Colorado, Forenede Stater, 80907
        • Rocky Mountain Cancer Centers-Penrose
      • Wheat Ridge, Colorado, Forenede Stater, 80033
        • SCL Health Lutheran Medical Center
    • Delaware
      • Newark, Delaware, Forenede Stater, 19713
        • Helen F Graham Cancer Center
      • Newark, Delaware, Forenede Stater, 19713
        • Medical Oncology Hematology Consultants PA
      • Newark, Delaware, Forenede Stater, 19718
        • Christiana Care Health System-Christiana Hospital
      • Newark, Delaware, Forenede Stater, 19713
        • Regional Hematology and Oncology PA
    • District of Columbia
      • Washington, District of Columbia, Forenede Stater, 20002
        • Kaiser Permanente-Capitol Hill Medical Center
    • Florida
      • Boca Raton, Florida, Forenede Stater, 33486
        • Boca Raton Regional Hospital
      • Daytona Beach, Florida, Forenede Stater, 32117
        • Florida Hospital Memorial Medical Center
      • Lakeland, Florida, Forenede Stater, 33805
        • Lakeland Regional Health Hollis Cancer Center
      • Miami, Florida, Forenede Stater, 33136
        • University of Miami Miller School of Medicine-Sylvester Cancer Center
      • Orlando, Florida, Forenede Stater, 32803
        • Florida Hospital Orlando
      • Pensacola, Florida, Forenede Stater, 32504
        • Sacred Heart Hospital
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30309
        • Piedmont Hospital
      • Atlanta, Georgia, Forenede Stater, 30342
        • Northside Hospital
      • Augusta, Georgia, Forenede Stater, 30912
        • Augusta University Medical Center
      • Gainesville, Georgia, Forenede Stater, 30501
        • Northeast Georgia Medical Center-Gainesville
    • Hawaii
      • 'Aiea, Hawaii, Forenede Stater, 96701
        • Pali Momi Medical Center
      • 'Aiea, Hawaii, Forenede Stater, 96701
        • The Cancer Center of Hawaii-Pali Momi
      • 'Aiea, Hawaii, Forenede Stater, 96701
        • Hawaii Oncology Inc-Pali Momi
      • Honolulu, Hawaii, Forenede Stater, 96813
        • Queen's Medical Center
      • Honolulu, Hawaii, Forenede Stater, 96817
        • The Cancer Center of Hawaii-Liliha
      • Honolulu, Hawaii, Forenede Stater, 96813
        • Straub Clinic and Hospital
      • Honolulu, Hawaii, Forenede Stater, 96813
        • University of Hawaii Cancer Center
      • Honolulu, Hawaii, Forenede Stater, 96817
        • Hawaii Cancer Care Inc-Liliha
      • Honolulu, Hawaii, Forenede Stater, 96813
        • Hawaii Cancer Care Inc-POB II
      • Honolulu, Hawaii, Forenede Stater, 96817
        • Hawaii Oncology Inc-Kuakini
    • Idaho
      • Boise, Idaho, Forenede Stater, 83706
        • Saint Alphonsus Cancer Care Center-Boise
      • Coeur d'Alene, Idaho, Forenede Stater, 83814
        • Kootenai Medical Center
      • Post Falls, Idaho, Forenede Stater, 83854
        • Kootenai Cancer Center
      • Sandpoint, Idaho, Forenede Stater, 83864
        • Kootenai Cancer Clinic
    • Illinois
      • Bloomington, Illinois, Forenede Stater, 61704
        • Illinois CancerCare-Bloomington
      • Canton, Illinois, Forenede Stater, 61520
        • Illinois CancerCare-Canton
      • Carthage, Illinois, Forenede Stater, 62321
        • Illinois CancerCare-Carthage
      • Centralia, Illinois, Forenede Stater, 62801
        • Centralia Oncology Clinic
      • Chicago, Illinois, Forenede Stater, 60611
        • Northwestern University
      • Danville, Illinois, Forenede Stater, 61832
        • Carle on Vermilion
      • Decatur, Illinois, Forenede Stater, 62526
        • Decatur Memorial Hospital
      • Decatur, Illinois, Forenede Stater, 62526
        • Cancer Care Specialists of Illinois - Decatur
      • Effingham, Illinois, Forenede Stater, 62401
        • Crossroads Cancer Center
      • Effingham, Illinois, Forenede Stater, 62401
        • Carle Physician Group-Effingham
      • Eureka, Illinois, Forenede Stater, 61530
        • Illinois CancerCare-Eureka
      • Evanston, Illinois, Forenede Stater, 60201
        • NorthShore University HealthSystem-Evanston Hospital
      • Galesburg, Illinois, Forenede Stater, 61401
        • Illinois CancerCare-Galesburg
      • Glenview, Illinois, Forenede Stater, 60026
        • NorthShore University HealthSystem-Glenbrook Hospital
      • Highland Park, Illinois, Forenede Stater, 60035
        • NorthShore University HealthSystem-Highland Park Hospital
      • Kewanee, Illinois, Forenede Stater, 61443
        • Illinois CancerCare-Kewanee Clinic
      • Macomb, Illinois, Forenede Stater, 61455
        • Illinois CancerCare-Macomb
      • Mattoon, Illinois, Forenede Stater, 61938
        • Carle Physician Group-Mattoon/Charleston
      • Moline, Illinois, Forenede Stater, 61265
        • Trinity Medical Center
      • Mount Vernon, Illinois, Forenede Stater, 62864
        • Good Samaritan Regional Health Center
      • Ottawa, Illinois, Forenede Stater, 61350
        • Illinois CancerCare-Ottawa Clinic
      • Pekin, Illinois, Forenede Stater, 61554
        • Illinois CancerCare-Pekin
      • Peoria, Illinois, Forenede Stater, 61636
        • Methodist Medical Center of Illinois
      • Peoria, Illinois, Forenede Stater, 61637
        • OSF Saint Francis Medical Center
      • Peoria, Illinois, Forenede Stater, 61615
        • Illinois CancerCare-Peoria
      • Peru, Illinois, Forenede Stater, 61354
        • Illinois CancerCare-Peru
      • Princeton, Illinois, Forenede Stater, 61356
        • Illinois CancerCare-Princeton
      • Springfield, Illinois, Forenede Stater, 62781
        • Memorial Medical Center
      • Springfield, Illinois, Forenede Stater, 62702
        • Southern Illinois University School of Medicine
      • Springfield, Illinois, Forenede Stater, 62702
        • Springfield Clinic
      • Urbana, Illinois, Forenede Stater, 61801
        • Carle Cancer Center
      • Urbana, Illinois, Forenede Stater, 61801
        • The Carle Foundation Hospital
      • Warrenville, Illinois, Forenede Stater, 60555
        • Northwestern Medicine Cancer Center Warrenville
    • Indiana
      • Crown Point, Indiana, Forenede Stater, 46307
        • Michiana Hematology Oncology PC-Crown Point
      • Elkhart, Indiana, Forenede Stater, 46515
        • Elkhart General Hospital
      • Elkhart, Indiana, Forenede Stater, 46514
        • Michiana Hematology Oncology PC-Elkhart
      • Elkhart, Indiana, Forenede Stater, 46514-2098
        • Elkhart Clinic
      • Kokomo, Indiana, Forenede Stater, 46904
        • Community Howard Regional Health
      • La Porte, Indiana, Forenede Stater, 46350
        • IU Health La Porte Hospital
      • Mishawaka, Indiana, Forenede Stater, 46545
        • Memorial Regional Cancer Center Day Road
      • Mishawaka, Indiana, Forenede Stater, 46545
        • Michiana Hematology Oncology PC-Mishawaka
      • Mishawaka, Indiana, Forenede Stater, 46545
        • Saint Joseph Regional Medical Center-Mishawaka
      • Plymouth, Indiana, Forenede Stater, 46563
        • Michiana Hematology Oncology PC-Plymouth
      • South Bend, Indiana, Forenede Stater, 46601
        • Memorial Hospital of South Bend
      • South Bend, Indiana, Forenede Stater, 46601
        • Michiana Hematology Oncology PC-South Bend
      • Westville, Indiana, Forenede Stater, 46391
        • Michiana Hematology Oncology PC-Westville
    • Iowa
      • Ames, Iowa, Forenede Stater, 50010
        • McFarland Clinic PC - Ames
      • Ames, Iowa, Forenede Stater, 50010
        • Mary Greeley Medical Center
      • Cedar Rapids, Iowa, Forenede Stater, 52403
        • Mercy Hospital
      • Cedar Rapids, Iowa, Forenede Stater, 52403
        • Oncology Associates at Mercy Medical Center
      • Clive, Iowa, Forenede Stater, 50325
        • Mercy Cancer Center-West Lakes
      • Clive, Iowa, Forenede Stater, 50325
        • Medical Oncology and Hematology Associates-West Des Moines
      • Creston, Iowa, Forenede Stater, 50801
        • Greater Regional Medical Center
      • Des Moines, Iowa, Forenede Stater, 50314
        • Mercy Medical Center - Des Moines
      • Des Moines, Iowa, Forenede Stater, 50314
        • Medical Oncology and Hematology Associates-Laurel
      • Mason City, Iowa, Forenede Stater, 50401
        • Mercy Medical Center - North Iowa
      • Sioux City, Iowa, Forenede Stater, 51101
        • Siouxland Regional Cancer Center
      • West Des Moines, Iowa, Forenede Stater, 50266
        • Mercy Medical Center-West Lakes
    • Kansas
      • Chanute, Kansas, Forenede Stater, 66720
        • Cancer Center of Kansas - Chanute
      • Dodge City, Kansas, Forenede Stater, 67801
        • Cancer Center of Kansas - Dodge City
      • El Dorado, Kansas, Forenede Stater, 67042
        • Cancer Center of Kansas - El Dorado
      • Fort Scott, Kansas, Forenede Stater, 66701
        • Cancer Center of Kansas - Fort Scott
      • Independence, Kansas, Forenede Stater, 67301
        • Cancer Center of Kansas-Independence
      • Kingman, Kansas, Forenede Stater, 67068
        • Cancer Center of Kansas-Kingman
      • Lawrence, Kansas, Forenede Stater, 66044
        • Lawrence Memorial Hospital
      • Liberal, Kansas, Forenede Stater, 67905
        • Cancer Center of Kansas-Liberal
      • Manhattan, Kansas, Forenede Stater, 66502
        • Cancer Center of Kansas-Manhattan
      • McPherson, Kansas, Forenede Stater, 67460
        • Cancer Center of Kansas - McPherson
      • Newton, Kansas, Forenede Stater, 67114
        • Cancer Center of Kansas - Newton
      • Parsons, Kansas, Forenede Stater, 67357
        • Cancer Center of Kansas - Parsons
      • Pratt, Kansas, Forenede Stater, 67124
        • Cancer Center of Kansas - Pratt
      • Salina, Kansas, Forenede Stater, 67401
        • Cancer Center of Kansas - Salina
      • Topeka, Kansas, Forenede Stater, 66606
        • Cotton O'Neil Cancer Center / Stormont Vail Health
      • Wellington, Kansas, Forenede Stater, 67152
        • Cancer Center of Kansas - Wellington
      • Wichita, Kansas, Forenede Stater, 67208
        • Cancer Center of Kansas-Wichita Medical Arts Tower
      • Wichita, Kansas, Forenede Stater, 67214
        • Cancer Center of Kansas - Wichita
      • Wichita, Kansas, Forenede Stater, 67208
        • Associates In Womens Health
      • Wichita, Kansas, Forenede Stater, 67214
        • Via Christi Regional Medical Center
      • Winfield, Kansas, Forenede Stater, 67156
        • Cancer Center of Kansas - Winfield
    • Kentucky
      • Corbin, Kentucky, Forenede Stater, 40701
        • Baptist Health Corbin
      • Lexington, Kentucky, Forenede Stater, 40536
        • University of Kentucky/Markey Cancer Center
      • Lexington, Kentucky, Forenede Stater, 40503
        • Baptist Health Lexington
      • Louisville, Kentucky, Forenede Stater, 40207
        • Baptist Health Louisville
      • Madisonville, Kentucky, Forenede Stater, 42431
        • Baptist Health Madisonville/Merle Mahr Cancer Center
      • Paducah, Kentucky, Forenede Stater, 42003
        • Baptist Health Paducah
    • Louisiana
      • Baton Rouge, Louisiana, Forenede Stater, 70810
        • The NeuroMedical Center-Clinic
      • Marrero, Louisiana, Forenede Stater, 70072
        • West Jefferson Medical Center
      • Marrero, Louisiana, Forenede Stater, 70072
        • Culicchia Neurological Clinic LLC
      • New Orleans, Louisiana, Forenede Stater, 70112
        • Louisiana State University Health Science Center
    • Maine
      • Lewiston, Maine, Forenede Stater, 04240
        • Central Maine Medical Center
    • Maryland
      • Gaithersburg, Maryland, Forenede Stater, 20879
        • Kaiser Permanente-Gaithersburg Medical Center
      • Largo, Maryland, Forenede Stater, 20774
        • Kaiser Permanente - Largo Medical Center
      • Rockville, Maryland, Forenede Stater, 20852
        • Unspecified Site
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02111
        • Tufts Medical Center
      • Boston, Massachusetts, Forenede Stater, 02118
        • Boston Medical Center
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48106
        • Saint Joseph Mercy Hospital
      • Battle Creek, Michigan, Forenede Stater, 49017
        • Bronson Battle Creek
      • Caro, Michigan, Forenede Stater, 48723
        • Caro Cancer Center
      • Detroit, Michigan, Forenede Stater, 48236
        • Ascension Saint John Hospital
      • Flint, Michigan, Forenede Stater, 48503
        • Hurley Medical Center
      • Flint, Michigan, Forenede Stater, 48503
        • Genesee Cancer and Blood Disease Treatment Center
      • Flint, Michigan, Forenede Stater, 48503
        • Genesee Hematology Oncology PC
      • Flint, Michigan, Forenede Stater, 48503
        • Genesys Hurley Cancer Institute
      • Grand Rapids, Michigan, Forenede Stater, 49503
        • Spectrum Health at Butterworth Campus
      • Grand Rapids, Michigan, Forenede Stater, 49503
        • Mercy Health Saint Mary's
      • Grand Rapids, Michigan, Forenede Stater, 49503
        • Cancer Research Consortium of West Michigan NCORP
      • Kalamazoo, Michigan, Forenede Stater, 49007
        • West Michigan Cancer Center
      • Marlette, Michigan, Forenede Stater, 48453
        • Saint Mary's Oncology/Hematology Associates of Marlette
      • Marquette, Michigan, Forenede Stater, 49855
        • UP Health System Marquette
      • Marquette, Michigan, Forenede Stater, 49855
        • UP Health System Hematology Oncology Marquette
      • Royal Oak, Michigan, Forenede Stater, 48073
        • William Beaumont Hospital-Royal Oak
      • Saginaw, Michigan, Forenede Stater, 48601
        • Ascension Saint Mary's Hospital
      • Saginaw, Michigan, Forenede Stater, 48604
        • Oncology Hematology Associates of Saginaw Valley PC
      • Saint Joseph, Michigan, Forenede Stater, 49085
        • Lakeland Medical Center Saint Joseph
      • Saint Joseph, Michigan, Forenede Stater, 49085
        • Marie Yeager Cancer Center
      • Southfield, Michigan, Forenede Stater, 48075
        • Ascension Providence Hospitals - Southfield
      • Troy, Michigan, Forenede Stater, 48085
        • William Beaumont Hospital - Troy
      • Warren, Michigan, Forenede Stater, 48093
        • Saint John Macomb-Oakland Hospital
      • West Branch, Michigan, Forenede Stater, 48661
        • Saint Mary's Oncology/Hematology Associates of West Branch
      • Wyoming, Michigan, Forenede Stater, 49519
        • Metro Health Hospital
    • Minnesota
      • Burnsville, Minnesota, Forenede Stater, 55337
        • Fairview Ridges Hospital
      • Coon Rapids, Minnesota, Forenede Stater, 55433
        • Mercy Hospital
      • Duluth, Minnesota, Forenede Stater, 55805
        • Essentia Health Cancer Center
      • Edina, Minnesota, Forenede Stater, 55435
        • Fairview-Southdale Hospital
      • Fridley, Minnesota, Forenede Stater, 55432
        • Unity Hospital
      • Maplewood, Minnesota, Forenede Stater, 55109
        • Saint John's Hospital - Healtheast
      • Maplewood, Minnesota, Forenede Stater, 55109
        • Minnesota Oncology Hematology PA-Maplewood
      • Minneapolis, Minnesota, Forenede Stater, 55415
        • Hennepin County Medical Center
      • Minneapolis, Minnesota, Forenede Stater, 55407
        • Abbott-Northwestern Hospital
      • Minneapolis, Minnesota, Forenede Stater, 55454
        • Health Partners Inc
      • Monticello, Minnesota, Forenede Stater, 55362
        • Monticello Cancer Center
      • Robbinsdale, Minnesota, Forenede Stater, 55422
        • North Memorial Medical Health Center
      • Rochester, Minnesota, Forenede Stater, 55905
        • Mayo Clinic
      • Saint Louis Park, Minnesota, Forenede Stater, 55416
        • Park Nicollet Clinic - Saint Louis Park
      • Saint Paul, Minnesota, Forenede Stater, 55101
        • Regions Hospital
      • Saint Paul, Minnesota, Forenede Stater, 55102
        • United Hospital
      • Woodbury, Minnesota, Forenede Stater, 55125
        • Minnesota Oncology Hematology PA-Woodbury
    • Missouri
      • Bolivar, Missouri, Forenede Stater, 65613
        • Central Care Cancer Center - Bolivar
      • Chesterfield, Missouri, Forenede Stater, 63017
        • Saint Luke's Hospital
      • Columbia, Missouri, Forenede Stater, 65212
        • University of Missouri - Ellis Fischel
      • Joplin, Missouri, Forenede Stater, 64804
        • Freeman Health System
      • Kansas City, Missouri, Forenede Stater, 64111
        • Saint Luke's Hospital of Kansas City
      • Saint Joseph, Missouri, Forenede Stater, 64507
        • Heartland Regional Medical Center
      • Saint Louis, Missouri, Forenede Stater, 63110
        • Washington University School of Medicine
      • Saint Louis, Missouri, Forenede Stater, 63141
        • Mercy Hospital Saint Louis
      • Springfield, Missouri, Forenede Stater, 65804
        • Mercy Hospital Springfield
    • Montana
      • Billings, Montana, Forenede Stater, 59101
        • Billings Clinic Cancer Center
      • Great Falls, Montana, Forenede Stater, 59405
        • Benefis Healthcare- Sletten Cancer Institute
      • Missoula, Montana, Forenede Stater, 59802
        • Saint Patrick Hospital - Community Hospital
    • Nebraska
      • Grand Island, Nebraska, Forenede Stater, 68803
        • CHI Health Saint Francis
      • Kearney, Nebraska, Forenede Stater, 68847
        • CHI Health Good Samaritan
      • Lincoln, Nebraska, Forenede Stater, 68510
        • Nebraska Cancer Research Center
      • Omaha, Nebraska, Forenede Stater, 68124
        • Alegent Health Bergan Mercy Medical Center
      • Omaha, Nebraska, Forenede Stater, 68130
        • Alegent Health Lakeside Hospital
      • Omaha, Nebraska, Forenede Stater, 68131
        • Creighton University Medical Center
    • Nevada
      • Henderson, Nevada, Forenede Stater, 89052
        • Comprehensive Cancer Centers of Nevada - Henderson
      • Henderson, Nevada, Forenede Stater, 89052
        • OptumCare Cancer Care at Seven Hills
      • Henderson, Nevada, Forenede Stater, 89052
        • Cancer and Blood Specialists-Henderson
      • Henderson, Nevada, Forenede Stater, 89052
        • Las Vegas Cancer Center-Henderson
      • Henderson, Nevada, Forenede Stater, 89074
        • Comprehensive Cancer Centers of Nevada-Southeast Henderson
      • Henderson, Nevada, Forenede Stater, 89074
        • 21st Century Oncology-Henderson
      • Las Vegas, Nevada, Forenede Stater, 89106
        • Radiation Oncology Centers of Nevada Central
      • Las Vegas, Nevada, Forenede Stater, 89119
        • Radiation Oncology Centers of Nevada Southeast
      • Las Vegas, Nevada, Forenede Stater, 89128
        • Comprehensive Cancer Centers of Nevada - Northwest
      • Las Vegas, Nevada, Forenede Stater, 89144
        • Comprehensive Cancer Centers of Nevada-Summerlin
      • Las Vegas, Nevada, Forenede Stater, 89148
        • Comprehensive Cancer Centers of Nevada
      • Las Vegas, Nevada, Forenede Stater, 89148
        • OptumCare Cancer Care at Fort Apache
      • Las Vegas, Nevada, Forenede Stater, 89169
        • Comprehensive Cancer Centers of Nevada - Central Valley
      • Las Vegas, Nevada, Forenede Stater, 89106
        • Cancer and Blood Specialists-Shadow
      • Las Vegas, Nevada, Forenede Stater, 89109
        • HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
      • Las Vegas, Nevada, Forenede Stater, 89113
        • HealthCare Partners Medical Group Oncology/Hematology-San Martin
      • Las Vegas, Nevada, Forenede Stater, 89121
        • Cancer Therapy and Integrative Medicine
      • Las Vegas, Nevada, Forenede Stater, 89128
        • HealthCare Partners Medical Group Oncology/Hematology-Tenaya
      • Las Vegas, Nevada, Forenede Stater, 89148-2405
        • Las Vegas Cancer Center-Medical Center
      • Las Vegas, Nevada, Forenede Stater, 89109
        • 21st Century Oncology
      • Las Vegas, Nevada, Forenede Stater, 89128
        • 21st Century Oncology-Vegas Tenaya
      • Las Vegas, Nevada, Forenede Stater, 89148
        • 21st Century Oncology-Fort Apache
      • Las Vegas, Nevada, Forenede Stater, 89128
        • Ann M Wierman MD LTD
    • New Hampshire
      • Concord, New Hampshire, Forenede Stater, 03301
        • New Hampshire Oncology Hematology PA-Concord
      • Hooksett, New Hampshire, Forenede Stater, 03106
        • New Hampshire Oncology Hematology PA-Hooksett
      • Laconia, New Hampshire, Forenede Stater, 03246
        • LRGHealthcare-Lakes Region General Hospital
      • Lebanon, New Hampshire, Forenede Stater, 03756
        • Dartmouth Hitchcock Medical Center
    • New Jersey
      • Somerville, New Jersey, Forenede Stater, 08876
        • Robert Wood Johnson University Hospital Somerset
    • New York
      • Bronx, New York, Forenede Stater, 10461
        • Montefiore Medical Center-Einstein Campus
      • Bronx, New York, Forenede Stater, 10467
        • Montefiore Medical Center - Moses Campus
      • East Syracuse, New York, Forenede Stater, 13057
        • Hematology Oncology Associates of Central New York-East Syracuse
      • New York, New York, Forenede Stater, 10065
        • Memorial Sloan Kettering Cancer Center
      • New York, New York, Forenede Stater, 10032
        • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
      • Rochester, New York, Forenede Stater, 14642
        • University of Rochester
      • Rochester, New York, Forenede Stater, 14620
        • Highland Hospital
      • Rochester, New York, Forenede Stater, 14626
        • University Radiation Oncology
    • North Carolina
      • Asheville, North Carolina, Forenede Stater, 28801
        • Mission Hospital Inc-Memorial Campus
      • Charlotte, North Carolina, Forenede Stater, 28203
        • Carolinas Medical Center/Levine Cancer Institute
      • Charlotte, North Carolina, Forenede Stater, 28204
        • Novant Health Presbyterian Medical Center
      • Clinton, North Carolina, Forenede Stater, 28328
        • Southeastern Medical Oncology Center-Clinton
      • Goldsboro, North Carolina, Forenede Stater, 27534
        • Southeastern Medical Oncology Center-Goldsboro
      • Goldsboro, North Carolina, Forenede Stater, 27534
        • Wayne Memorial Hospital
      • Hendersonville, North Carolina, Forenede Stater, 28792
        • AdventHealth Hendersonville
      • Jacksonville, North Carolina, Forenede Stater, 28546
        • Southeastern Medical Oncology Center-Jacksonville
      • Kernersville, North Carolina, Forenede Stater, 27284
        • Novant Health Oncology Specialists-Kernersville
      • Kinston, North Carolina, Forenede Stater, 28501
        • Vidant Oncology-Kinston
      • Mount Airy, North Carolina, Forenede Stater, 27030
        • Novant Health Oncology Specialists-Mount Airy
      • Statesville, North Carolina, Forenede Stater, 28625
        • Novant Health Oncology Specialists-Statesville
      • Thomasville, North Carolina, Forenede Stater, 27360
        • Novant Health Oncology Specialists-Davidson County
      • Wilkesboro, North Carolina, Forenede Stater, 28659
        • Novant Health Oncology Specialists-Wilkesboro
      • Wilson, North Carolina, Forenede Stater, 27893
        • Southeastern Medical Oncology Center-Wilson
      • Winston-Salem, North Carolina, Forenede Stater, 27103
        • Novant Health Forsyth Medical Center
      • Winston-Salem, North Carolina, Forenede Stater, 27103
        • Novant Health Oncology Specialists
    • North Dakota
      • Grand Forks, North Dakota, Forenede Stater, 58201
        • Altru Cancer Center
    • Ohio
      • Akron, Ohio, Forenede Stater, 44307
        • Cleveland Clinic Akron General
      • Columbus, Ohio, Forenede Stater, 43214
        • Riverside Methodist Hospital
      • Elyria, Ohio, Forenede Stater, 44035
        • Mercy Cancer Center-Elyria
      • Maumee, Ohio, Forenede Stater, 43537
        • Toledo Clinic Cancer Centers-Maumee
      • Oregon, Ohio, Forenede Stater, 43616
        • Saint Charles Hospital
      • Perrysburg, Ohio, Forenede Stater, 43551
        • Mercy Health Perrysburg Cancer Center
      • Sylvania, Ohio, Forenede Stater, 43560
        • ProMedica Flower Hospital
      • Toledo, Ohio, Forenede Stater, 43623
        • Toledo Clinic Cancer Centers-Toledo
      • Toledo, Ohio, Forenede Stater, 43614
        • University of Toledo
      • Toledo, Ohio, Forenede Stater, 43623
        • Mercy Saint Anne Hospital
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73104
        • University of Oklahoma Health Sciences Center
      • Tulsa, Oklahoma, Forenede Stater, 74104
        • Saint John Medical Center
    • Oregon
      • Bend, Oregon, Forenede Stater, 97701
        • Saint Charles Health System
      • Clackamas, Oregon, Forenede Stater, 97015
        • Clackamas Radiation Oncology Center
      • Gresham, Oregon, Forenede Stater, 97030
        • Legacy Mount Hood Medical Center
      • Newberg, Oregon, Forenede Stater, 97132
        • Providence Newberg Medical Center
      • Oregon City, Oregon, Forenede Stater, 97045
        • Providence Willamette Falls Medical Center
      • Portland, Oregon, Forenede Stater, 97210
        • Legacy Good Samaritan Hospital and Medical Center
      • Portland, Oregon, Forenede Stater, 97213
        • Providence Portland Medical Center
      • Portland, Oregon, Forenede Stater, 97225
        • Providence Saint Vincent Medical Center
      • Portland, Oregon, Forenede Stater, 97227
        • Kaiser Permanente Northwest
      • Tualatin, Oregon, Forenede Stater, 97062
        • Legacy Meridian Park Hospital
    • Pennsylvania
      • Allentown, Pennsylvania, Forenede Stater, 18103
        • Lehigh Valley Hospital-Cedar Crest
      • Bethlehem, Pennsylvania, Forenede Stater, 18017
        • Lehigh Valley Hospital - Muhlenberg
      • Danville, Pennsylvania, Forenede Stater, 17822
        • Geisinger Medical Center
      • Gettysburg, Pennsylvania, Forenede Stater, 17325
        • Adams Cancer Center
      • Hanover, Pennsylvania, Forenede Stater, 17331
        • Cherry Tree Cancer Center
      • Wilkes-Barre, Pennsylvania, Forenede Stater, 18711
        • Geisinger Wyoming Valley/Henry Cancer Center
      • York, Pennsylvania, Forenede Stater, 17403
        • WellSpan Health-York Hospital
    • South Carolina
      • Anderson, South Carolina, Forenede Stater, 29621
        • AnMed Health Cancer Center
      • Easley, South Carolina, Forenede Stater, 29640
        • Greenville Health System Cancer Institute-Easley
      • Gaffney, South Carolina, Forenede Stater, 29341
        • Gibbs Cancer Center-Gaffney
      • Greenville, South Carolina, Forenede Stater, 29601
        • Greenville Health System Cancer Institute-Andrews
      • Greenville, South Carolina, Forenede Stater, 29605
        • Greenville Health System Cancer Institute-Faris
      • Greenville, South Carolina, Forenede Stater, 29605
        • Greenville Memorial Hospital
      • Greenville, South Carolina, Forenede Stater, 29615
        • Greenville Health System Cancer Institute-Eastside
      • Greenville, South Carolina, Forenede Stater, 29605
        • Greenville Health System Cancer Institute-Butternut
      • Greer, South Carolina, Forenede Stater, 29651
        • Gibbs Cancer Center-Pelham
      • Greer, South Carolina, Forenede Stater, 29650
        • Greenville Health System Cancer Institute-Greer
      • Seneca, South Carolina, Forenede Stater, 29672
        • Greenville Health System Cancer Institute-Seneca
      • Spartanburg, South Carolina, Forenede Stater, 29303
        • Spartanburg Medical Center
      • Spartanburg, South Carolina, Forenede Stater, 29307
        • Greenville Health System Cancer Institute-Spartanburg
    • South Dakota
      • Aberdeen, South Dakota, Forenede Stater, 57401
        • Avera Cancer Institute-Aberdeen
      • Rapid City, South Dakota, Forenede Stater, 57701
        • Rapid City Regional Hospital
      • Sioux Falls, South Dakota, Forenede Stater, 57105
        • Avera Cancer Institute
    • Tennessee
      • Kingsport, Tennessee, Forenede Stater, 37660
        • Regional Cancer Center at Indian Path Community Hospital
      • Knoxville, Tennessee, Forenede Stater, 37916
        • Thompson Cancer Survival Center
      • Knoxville, Tennessee, Forenede Stater, 37932
        • Thompson Cancer Survival Center - West
      • Lenoir City, Tennessee, Forenede Stater, 37772
        • Thompson Oncology Group-Lenoir City
      • Oak Ridge, Tennessee, Forenede Stater, 37830
        • Thompson Oncology Group-Oak Ridge
    • Texas
      • Austin, Texas, Forenede Stater, 78701
        • Dell Seton Medical Center at The University of Texas
      • Austin, Texas, Forenede Stater, 78702
        • Austin Cancer Centers-Central Austin
      • Austin, Texas, Forenede Stater, 78758
        • Austin Cancer Centers-North
      • Dallas, Texas, Forenede Stater, 75390
        • UT Southwestern/Simmons Cancer Center-Dallas
      • San Antonio, Texas, Forenede Stater, 78229
        • University of Texas Health Science Center at San Antonio
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84112
        • Huntsman Cancer Institute/University of Utah
    • Virginia
      • McLean, Virginia, Forenede Stater, 22102
        • Kaiser Permanente Tysons Corner Medical Center
      • Norton, Virginia, Forenede Stater, 24273
        • Southwest VA Regional Cancer Center
    • Washington
      • Aberdeen, Washington, Forenede Stater, 98520
        • Providence Regional Cancer System-Aberdeen
      • Auburn, Washington, Forenede Stater, 98001
        • MultiCare Auburn Medical Center
      • Bellingham, Washington, Forenede Stater, 98225
        • PeaceHealth Saint Joseph Medical Center
      • Bremerton, Washington, Forenede Stater, 98310
        • Harrison HealthPartners Hematology and Oncology-Bremerton
      • Burien, Washington, Forenede Stater, 98166
        • Highline Medical Center-Main Campus
      • Centralia, Washington, Forenede Stater, 98531
        • Providence Regional Cancer System-Centralia
      • Gig Harbor, Washington, Forenede Stater, 98335
        • MultiCare Gig Harbor Medical Park
      • Lacey, Washington, Forenede Stater, 98503
        • Providence Regional Cancer System-Lacey
      • Longview, Washington, Forenede Stater, 98632
        • PeaceHealth Saint John Medical Center
      • Port Townsend, Washington, Forenede Stater, 98368
        • Jefferson Healthcare
      • Puyallup, Washington, Forenede Stater, 98372
        • MultiCare Good Samaritan Hospital
      • Seattle, Washington, Forenede Stater, 98122-5711
        • Swedish Medical Center-Cherry Hill
      • Shelton, Washington, Forenede Stater, 98584
        • Providence Regional Cancer System-Shelton
      • Tacoma, Washington, Forenede Stater, 98405
        • MultiCare Tacoma General Hospital
      • Tacoma, Washington, Forenede Stater, 98405
        • Northwest NCI Community Oncology Research Program
      • Vancouver, Washington, Forenede Stater, 98686
        • Legacy Salmon Creek Hospital
      • Vancouver, Washington, Forenede Stater, 98664
        • PeaceHealth Southwest Medical Center
      • Yakima, Washington, Forenede Stater, 98902
        • North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
      • Yelm, Washington, Forenede Stater, 98597
        • Providence Regional Cancer System-Yelm
    • West Virginia
      • Morgantown, West Virginia, Forenede Stater, 26506
        • West Virginia University Healthcare
    • Wisconsin
      • Fond Du Lac, Wisconsin, Forenede Stater, 54937
        • Aurora Health Center-Fond du Lac
      • Green Bay, Wisconsin, Forenede Stater, 54311
        • Aurora BayCare Medical Center
      • Green Bay, Wisconsin, Forenede Stater, 54301
        • Saint Vincent Hospital Cancer Center Green Bay
      • Green Bay, Wisconsin, Forenede Stater, 54303
        • Saint Vincent Hospital Cancer Center at Saint Mary's
      • Green Bay, Wisconsin, Forenede Stater, 54303
        • Green Bay Oncology Limited at Saint Mary's Hospital
      • Green Bay, Wisconsin, Forenede Stater, 54301-3526
        • Green Bay Oncology at Saint Vincent Hospital
      • La Crosse, Wisconsin, Forenede Stater, 54601
        • Gundersen Lutheran Medical Center
      • Madison, Wisconsin, Forenede Stater, 53792
        • University of Wisconsin Hospital and Clinics
      • Manitowoc, Wisconsin, Forenede Stater, 54221
        • Holy Family Memorial Hospital
      • Marshfield, Wisconsin, Forenede Stater, 54449
        • Marshfield Medical Center-Marshfield
      • Milwaukee, Wisconsin, Forenede Stater, 53226
        • Froedtert and The Medical College of Wisconsin
      • Milwaukee, Wisconsin, Forenede Stater, 53215
        • Aurora Saint Luke's Medical Center
      • Minocqua, Wisconsin, Forenede Stater, 54548
        • Marshfield Clinic-Minocqua Center
      • Mukwonago, Wisconsin, Forenede Stater, 53149
        • ProHealth D N Greenwald Center
      • Oconomowoc, Wisconsin, Forenede Stater, 53066
        • ProHealth Oconomowoc Memorial Hospital
      • Oshkosh, Wisconsin, Forenede Stater, 54904
        • Vince Lombardi Cancer Clinic - Oshkosh
      • Rice Lake, Wisconsin, Forenede Stater, 54868
        • Marshfield Medical Center-Rice Lake
      • Sheboygan, Wisconsin, Forenede Stater, 53081
        • HSHS Saint Nicholas Hospital
      • Stevens Point, Wisconsin, Forenede Stater, 54482
        • Marshfield Clinic Stevens Point Center
      • Waukesha, Wisconsin, Forenede Stater, 53188
        • UW Cancer Center at ProHealth Care
      • Waukesha, Wisconsin, Forenede Stater, 53188
        • ProHealth Waukesha Memorial Hospital
      • Weston, Wisconsin, Forenede Stater, 54476
        • Marshfield Clinic - Weston Center
    • Wyoming
      • Cody, Wyoming, Forenede Stater, 82414
        • Billings Clinic-Cody

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  • Diagnosticeret med glioblastom, gliosarkom, småcellet eller storcellet glioblastom, glioblastom med oligotræk, glioblastom med primitive neuroektodermale tumorlignende komponenter (GBM-PNET), anaplastisk astrocytom, anaplastisk oligodendrogliom eller anaplastisk oligoastrocytom, som er fuldstændigt klinisk stotologiske terapi (eksklusive stereotaktisk strålekirurgi) > 21 dage og =< 24 måneder før indskrivning; BEMÆRK: klinisk stabilitet vil blive defineret som en stabil eller forbedret Karnofsky præstationsstatus (KPS) sammenlignet med den foregående måned
  • >= 6 score på det værste træthedsspørgsmål af BFI (Brief Fatigue Inventory, spørgsmål 3); det er ikke nødvendigt for patienten at udfylde hele BFI for at opfylde dette kriterium
  • Gennemgået kirurgi (total eller subtotal resektion) eller biopsi og vil være blevet behandlet med samtidig strålebehandling og kemoterapi som standardbehandling for glioblastom, gliosarkom, småcellet eller storcellet glioblastom, glioblastom med oligotræk, glioblastom med primitiv neuroektodermal tumorlignende komponenter (GBM-PNET) funktioner, anaplastisk astrocytom, anaplastisk oligodendrogliom eller anaplastisk oligoastrocytom patienter; Bemærk: stråling skal afsluttes, men kemoterapi er tilladt; patienter, der i øjeblikket bruger Optune-enheden, vil være berettiget til at deltage i dette forsøg
  • Negativ serumgraviditetstest udført =< 7 dage før registrering kun for kvinder, som er fastslået at være i den fødedygtige alder af deres behandlende læge
  • Evne til at udfylde spørgeskema(r) selv eller med assistance
  • Eastern Cooperative Oncology Group (ECOG) præstationsstatus (PS) på 0, 1, 2 eller 3
  • Giv informeret skriftligt samtykke
  • Villig til at vende tilbage til den indskrivende institution for opfølgning (under den aktive overvågningsfase af undersøgelsen)
  • Stabil dosis af kortikosteroid >= 14 dage før registrering

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Arm I
Patienterne får 150 mg armodafinil oralt hver dag om morgenen i 8 uger.
givet mundtligt
Placebo komparator: Arm II
Patienterne får placebo oralt hver dag om morgenen i 8 uger.
givet mundtligt
Eksperimentel: Arm III
Patienterne får 250 mg armodafinil oralt hver dag om morgenen i 8 uger.
givet mundtligt

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Antallet af deltagere med et svar i form af en klinisk meningsfuld forbedring i patientrapporteret træthed efter 8 uger.
Tidsramme: Ved 8 uger

En respons er defineret som en forbedring på 2 point på 0-10-skalaen af ​​den sædvanlige træthed på Brief Fatigue Inventory (BFI). Antallet af deltagere med respons i form af en klinisk meningsfuld forbedring af patientrapporteret træthed efter 8 uger.

Skala: 0 (Ingen træthed) - 10 (Så slemt som du kan forestille dig) Fortolkning: højere score betyder et dårligere resultat

Ved 8 uger

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Fatigue: Brief Fatigue Inventory (BFI): Antallet af deltagere med et svar i form af en klinisk meningsfuld forbedring i patientrapporteret træthed efter 4 uger.
Tidsramme: Op til 4 uger
En respons er defineret som en forbedring på 2 point på 0-10-skalaen af ​​den sædvanlige træthed på Brief Fatigue Inventory (BFI). Antallet af deltagere med respons i form af en klinisk meningsfuld forbedring af patientrapporteret træthed efter 4 uger Skala: 0 (Ingen træthed) - 10 (Så slemt som du kan forestille dig) Fortolkning: højere score betyder et dårligere resultat
Op til 4 uger
Kognitiv funktion: Vurderet ved ændringen i Z-score for Symbol Digit Modalities Test (SDMT) fra baseline til slutningen af ​​uge 8
Tidsramme: Op til 8 uger
Deltageren bliver præsenteret for en side med en nøgle i spidsen, der parrer enkeltcifrene 1-9 med ni symboler. Rækker nedenfor indeholder kun symboler, emnets opgave er mundtligt at indberette det korrekte antal i felterne nedenfor. Efter at have afsluttet de første 10 punkter med vejledning, tidsindstilles emnet til at bestemme, hvor mange svar der kan foretages på 90 sekunder. Range score: ikke relevant. Højere score betyder et bedre resultat. Udforsket domæne: Vedvarende opmærksomhed og informationsbehandlingshastighed. Hvert neuropsykologisk mål blev konverteret til en aldersnormativ z-score ved hjælp af publicerede normative data. Nedsat SDMT-ydeevne blev defineret som faldende en standardafvigelse eller mere under det normative gennemsnit.
Op til 8 uger
Ændring i livskvalitet målt ved lineær analog selvvurdering (LASA) fra baseline til slutningen af ​​uge 4 og 8
Tidsramme: Op til 8 uger
Livskvalitet: Linear Analog Self Assessment (LASA) vil blive analyseret ved at sammenligne den samlede score for hver behandlingstest for ændring fra baseline til fire og otte uger. Linear Analogue Self Assessment (LASA) er et 12 globalt QOL-værktøj, som måler 10 underskalaer: overordnet QOL, fysisk velvære, træthed, hyppighed og sværhedsgrad af smerte, samt social funktion og åndelig, følelsesmæssig og mental velvære. Alle underskalaer blev konverteret til en skala fra 0-100, hvor højere score indikerer bedre QOL. Samlet score er gennemsnittet af alle 10 underskalaer.
Op til 8 uger
Antal deltagere, der oplevede mindst én grad 3 eller højere uønskede hændelser, der anses for at være mindst muligvis relateret til behandling via CTCAE version 4.0
Tidsramme: Op til 8 uger
Antallet af deltagere, der oplevede mindst én grad 3 eller højere bivirkninger, der som minimum anses for at være relateret til behandling via CTCAE version 4.0
Op til 8 uger

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Samarbejdspartnere

Efterforskere

  • Studiestol: Alyx B. Porter Umphrey, MD, Mayo Clinic

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

21. juni 2013

Primær færdiggørelse (Faktiske)

1. maj 2019

Studieafslutning (Faktiske)

15. december 2019

Datoer for studieregistrering

Først indsendt

29. januar 2013

Først indsendt, der opfyldte QC-kriterier

31. januar 2013

Først opslået (Anslået)

1. februar 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

25. marts 2025

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. januar 2025

Sidst verificeret

1. januar 2025

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • A221101
  • UG1CA189823 (U.S. NIH-bevilling/kontrakt)
  • U10CA037447 (U.S. NIH-bevilling/kontrakt)
  • U10CA037404 (U.S. NIH-bevilling/kontrakt)
  • N10C3
  • NCI-2012-02020 (Registry Identifier: Clinical Trial Reporting Program)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

IPD, der ligger til grund, resulterer i publikationen PubMed ID 34882169.

IPD-delingstidsramme

Dataene, der ligger til grund for publikationen, er tilgængelige fra 20/10/2023 og vil være tilgængelige i NCTN/NCORP-dataarkivets varighed. .

IPD-delingsadgangskriterier

Instruktioner

  1. Klik for at åbne protokolsektionen.
  2. Klik på Rediger ved siden af ​​IPD-delingserklæringen, og vælg muligheder for "Planlæg at dele IPD".
  3. Klik på Rediger ud for afsnittet Referencer.
  4. Rediger følgende felter under afsnittet Referencer:

    1. Links: https://nctn-data-archive.nci.nih.gov/
    2. Tilgængelig IPD/information: Tilgængelige data: Vælg individuelle data på patientniveau fra dette forsøg kan rekvireres fra NCTN/NCORP Data Archive

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner