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Glutathion til forebyggelse af perifer neuropati forårsaget af paclitaxel og carboplatin hos patienter med ovariecancer, æggelederkræft og/eller primær peritoneal cancer

5. januar 2017 opdateret af: Alliance for Clinical Trials in Oncology

Brugen af ​​glutathion (GSH) til forebyggelse af paclitaxel/carboplatin (TAXOL/CBDCA) induceret perifer neuropati: en fase III randomiseret, dobbeltblind placebokontrolleret undersøgelse

Dette randomiserede fase III-forsøg studerer glutathion for at se, hvor godt det virker til at forebygge perifer neuropati forårsaget af paclitaxel og carboplatin hos patienter med ovariecancer, æggelederkræft og/eller primær peritoneal cancer. Lægemidler, der bruges i kemoterapi, virker på forskellige måder for at stoppe væksten af ​​kræftceller, enten ved at dræbe cellerne eller ved at forhindre dem i at dele sig. Kemobeskyttende lægemidler, såsom glutathion, kan hjælpe med at forhindre perifer neuropati forårsaget af paclitaxel og carboplatin. Det vides endnu ikke, om glutathion er mere effektivt end placebo til at forebygge perifer neuropati.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

PRIMÆRE MÅL:

I. At sammenligne TAXOL (paclitaxel)/carboplatin (CBDCA) induceret perifer neuropati som målt af European Organisation for Research and Treatment of Cancer (EORTC) - Quality of Life (QOL)-kemoterapi induceret perifer neuropati 20 (CIPN20) mellem glutathion (GSH) ) og placebo-arme.

SEKUNDÆRE MÅL:

I. At sammenligne forekomsten af ​​grad 2+ og grad 3+ TAXOL/CBDCA-induceret perifer neuropati målt ved Common Terminology Criteria for Adverse Events (CTCAE) neuropatiskala mellem GSH- og placeboarme.

II. For at sammenligne tiden til indtræden af ​​grad 2+ og grad 3+ TAXOL/CBDCA induceret perifer neuropati mellem GSH og placebo arme, målt ved CTCAE neuropati skala.

III. For at sammenligne andelen af ​​patienter, der har behov for kemoterapidosisreduktioner sekundært til TAXOL/CBDCA-induceret perifer neuropati mellem GSH- og placeboarme.

IV. At sammenligne andelen af ​​patienter, der stopper med TAXOL/CBDCA sekundært til perifer neuropati mellem GSH- og placeboarme.

V. At vurdere toksicitetsprofilen for GSH i denne situation. VI. For at evaluere om GSH påvirker antitumoraktiviteten af ​​TAXOL/CBDCA. VII. At evaluere patientens livskvalitet (QOL) målt ved Functional Assessment of Cancer Therapy-Ovarian (FACT-O) (kun ovarie-/æggeleder/primær peritoneal cancerpatienter) og patientens daglige symptomspørgeskemaer over tid mellem GSH- og placeboarme.

TERTIÆRE:

I. At udforske sammenhængen mellem genetiske variationer i gener involveret i taxan/platin metabolisme med forekomst af grad 2+ TAXOL/CBDCA induceret perifer neuropati.

II. Som en del af igangværende forskning til North Central Cancer Treatment Group (NCCTG) undersøgelser, er vi banker blodprodukter til fremtidige undersøgelser.

OMRIDS:

Patienterne er stratificeret efter baseline neuropati (ingen vs. grad 1), debulk status (ingen grov resterende sygdom [ingen klinisk tilsyneladende resterende læsioner ved afslutningen af ​​primær operation] vs optimal [største resterende læsion < 1 cm ved primær operation] vs sub- optimalt debulket [restlæsion > 1 cm] eller ikke opereret) og kræfttype (ovarie-/æggeleder/primær peritoneal cancer vs lungecancer vs anden). Patienterne randomiseres til 1 ud af 2 behandlingsarme. Patienterne er grupperet baseret på, planlagt paclitaxel dosis cyklus længde (ugentlig vs. hver 3. uge vs. hver 4. uge). De anførte stratificeringsfaktorer inkluderer demografiske, prognostiske faktorer og medicin, der potentielt kan påvirke de primære eller sekundære resultater, så de skal fordeles jævnt mellem de to arme. De 18 niveaukombinationer, der er involveret i disse fire stratificeringsfaktorer, er inden for det anbefalede maksimum på halvdelen af ​​gruppeprøvestørrelsen for undersøgelsen.

Ideelt set begynder patienter at få glutathion før deres første dosis kemoterapi, men skal begynde med glutathion før deres anden dosis kemoterapi.

ARM I: Patienter får glutathion intravenøst ​​(IV) over 15 minutter, paclitaxel* IV over 1 eller 3 timer afhængig af planlagt dosiscykluslængde og carboplatin IV over 30 minutter.

ARM II: Patienter får placebo IV over 15 minutter, paclitaxel* IV over 1 eller 3 timer afhængig af planlagt dosiscykluslængde og carboplatin IV over 30 minutter.

BEMÆRK: *Alternativt kan patienter få paclitaxel IV over 1 time og glutathion/placebo IV over 15 minutter ugentligt og carboplatin hver 21. dag i 12 uger.

Blodprøver indsamles periodisk til farmakogenomiske og andre biomarkøranalyser. Patienter udfylder spørgeskemaer med jævne mellemrum, herunder livskvalitetsvurderinger.

Efter afsluttet undersøgelsesbehandling følges patienterne op hver 3. måned i 1 år.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

195

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Alabama
      • Mobile, Alabama, Forenede Stater, 36608
        • Providence Hospital
    • Alaska
      • Fairbanks, Alaska, Forenede Stater, 99701
        • Fairbanks Memorial Hospital
    • Arizona
      • Scottsdale, Arizona, Forenede Stater, 85259
        • Mayo Clinic in Arizona
    • California
      • Fairfield, California, Forenede Stater, 94533
        • Northbay Cancer Center
      • Fresno, California, Forenede Stater, 93720
        • Cancer Care Associates of Fresno Medical Group Inc
      • Orange, California, Forenede Stater, 92868
        • UC Irvine Health/Chao Family Comprehensive Cancer Center
      • Orange, California, Forenede Stater, 92868
        • Saint Joseph Hospital - Orange
      • Paradise, California, Forenede Stater, 95969
        • Feather River Cancer Center
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        • Sutter Roseville Medical Center
      • Sacramento, California, Forenede Stater, 95816
        • Sutter General Hospital
    • Colorado
      • Aurora, Colorado, Forenede Stater, 80012
        • The Medical Center of Aurora
      • Boulder, Colorado, Forenede Stater, 80301
        • Boulder Community Hospital
      • Colorado Springs, Colorado, Forenede Stater, 80907
        • Penrose-Saint Francis Healthcare
      • Denver, Colorado, Forenede Stater, 80210
        • Porter Adventist Hospital
      • Denver, Colorado, Forenede Stater, 80218
        • Presbyterian - Saint Lukes Medical Center - Health One
      • Denver, Colorado, Forenede Stater, 80220
        • Rose Medical Center
      • Denver, Colorado, Forenede Stater, 80218
        • Exempla Saint Joseph Hospital
      • Denver, Colorado, Forenede Stater, 80224-2522
        • Colorado Cancer Research Program CCOP
      • Englewood, Colorado, Forenede Stater, 80113
        • Swedish Medical Center
      • Fort Collins, Colorado, Forenede Stater, 80524
        • Poudre Valley Hospital
      • Fort Collins, Colorado, Forenede Stater, 80528
        • Front Range Cancer Specialists
      • Grand Junction, Colorado, Forenede Stater, 81502
        • Saint Mary's Hospital and Regional Medical Center
      • Greeley, Colorado, Forenede Stater, 80631
        • North Colorado Medical Center
      • Lakewood, Colorado, Forenede Stater, 80228
        • Saint Anthony Hospital
      • Lone Tree, Colorado, Forenede Stater, 80124
        • Sky Ridge Medical Center
      • Longmont, Colorado, Forenede Stater, 80501
        • Longmont United Hospital
      • Loveland, Colorado, Forenede Stater, 80539
        • McKee Medical Center
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        • Saint Mary Corwin Medical Center
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        • North Suburban Medical Center
      • Wheat Ridge, Colorado, Forenede Stater, 80033
        • Exempla Lutheran Medical Center
    • Connecticut
      • Greenwich, Connecticut, Forenede Stater, 06830
        • Greenwich Hospital
      • Hartford, Connecticut, Forenede Stater, 06105
        • Saint Francis Hospital and Medical Center
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      • Daytona Beach, Florida, Forenede Stater, 32114
        • Halifax Health Medical Center-Centers for Oncology
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        • Mayo Clinic in Florida
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      • Albany, Georgia, Forenede Stater, 31701
        • Phoebe Putney Memorial Hospital
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        • Piedmont Hospital
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        • Northside Hospital
      • Atlanta, Georgia, Forenede Stater, 30342
        • Saint Joseph's Hospital of Atlanta
      • Atlanta, Georgia, Forenede Stater, 30342
        • Atlanta Regional CCOP
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        • Georgia Regents University Medical Center
      • Austell, Georgia, Forenede Stater, 30106
        • Well Star Cobb Hospital
      • Columbus, Georgia, Forenede Stater, 31904
        • John B Amos Cancer Center
      • Decatur, Georgia, Forenede Stater, 30033
        • Dekalb Medical Center
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        • Northeast Georgia Medical Center
      • Lawrenceville, Georgia, Forenede Stater, 30045
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      • Marietta, Georgia, Forenede Stater, 30060
        • WellStar Kennestone Hospital
      • Riverdale, Georgia, Forenede Stater, 30274
        • Southern Regional Medical Center
      • Rome, Georgia, Forenede Stater, 30165
        • Harbin Clinic Medical Oncology and Clinical Research
      • Savannah, Georgia, Forenede Stater, 31405
        • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
    • Hawaii
      • Aiea, Hawaii, Forenede Stater, 96701
        • Pali Momi Medical Center
      • 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, 96826
        • Kapiolani Medical Center for Women and Children
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        • Oncare Hawaii Inc-POB II
      • Honolulu, Hawaii, Forenede Stater, 96817
        • Oncare Hawaii Inc-Kuakini
      • Kailua, Hawaii, Forenede Stater, 96734
        • Castle Medical Center
      • Lihue, Hawaii, Forenede Stater, 96766
        • Wilcox Memorial Hospital and Kauai Medical Clinic
      • Wailuku, Hawaii, Forenede Stater, 96793
        • Maui Memorial Medical Center
      • Wailuku, Hawaii, Forenede Stater, 96793
        • Pacific Cancer Institute of Maui
    • Illinois
      • Bloomington, Illinois, Forenede Stater, 61704
        • Illinois CancerCare-Bloomington
      • Bloomington, Illinois, Forenede Stater, 61701
        • Saint Joseph Medical Center
      • Canton, Illinois, Forenede Stater, 61520
        • Illinois CancerCare-Canton
      • Canton, Illinois, Forenede Stater, 61520
        • Graham Hospital Association
      • Carthage, Illinois, Forenede Stater, 62321
        • Illinois CancerCare-Carthage
      • Carthage, Illinois, Forenede Stater, 62321
        • Memorial Hospital
      • Chicago, Illinois, Forenede Stater, 60631
        • Presence Resurrection Medical Center
      • Decatur, Illinois, Forenede Stater, 62526
        • Decatur Memorial Hospital
      • Eureka, Illinois, Forenede Stater, 61530
        • Illinois CancerCare-Eureka
      • Eureka, Illinois, Forenede Stater, 61530
        • Eureka Hospital
      • Galesburg, Illinois, Forenede Stater, 61401
        • Illinois CancerCare Galesburg
      • Harvey, Illinois, Forenede Stater, 60426
        • Ingalls Memorial Hospital
      • Havana, Illinois, Forenede Stater, 62644
        • Mason District Hospital
      • Havana, Illinois, Forenede Stater, 62644
        • Illinois CancerCare-Havana
      • Kewanee, Illinois, Forenede Stater, 61443
        • Illinois CancerCare-Kewanee Clinic
      • La Grange, Illinois, Forenede Stater, 60525
        • Adventist La Grange Memorial Hospital
      • Macomb, Illinois, Forenede Stater, 61455
        • Illinois CancerCare-Macomb
      • Macomb, Illinois, Forenede Stater, 61455
        • Mcdonough District Hospital
      • Maywood, Illinois, Forenede Stater, 60153
        • Loyola University Medical Center
      • Moline, Illinois, Forenede Stater, 61265
        • Garneau, Stewart C MD (UIA Investigator)
      • Moline, Illinois, Forenede Stater, 61265
        • Porubcin, Michael MD (UIA Investigator)
      • Moline, Illinois, Forenede Stater, 61265
        • Spector, David MD (UIA Investigator)
      • Moline, Illinois, Forenede Stater, 61265
        • Trinity Medical Center
      • Moline, Illinois, Forenede Stater, 61265
        • Sharis, Christine M MD (UIA Investigator)
      • Moline, Illinois, Forenede Stater, 61265
        • Stoffel, Thomas J MD (UIA Investigator)
      • Monmouth, Illinois, Forenede Stater, 61462
        • Illinois CancerCare-Monmouth
      • Monmouth, Illinois, Forenede Stater, 61462
        • Holy Family Medical Center
      • Normal, Illinois, Forenede Stater, 61761
        • Community Cancer Center Foundation
      • Normal, Illinois, Forenede Stater, 61761
        • Bromenn Regional Medical Center
      • Normal, Illinois, Forenede Stater, 61761
        • Illinois CancerCare-Community Cancer Center
      • Ottawa, Illinois, Forenede Stater, 61350
        • Illinois CancerCare-Ottawa Clinic
      • Ottawa, Illinois, Forenede Stater, 61350
        • Ottawa Regional Hospital and Healthcare Center
      • Pekin, Illinois, Forenede Stater, 61554
        • Illinois CancerCare-Pekin
      • Pekin, Illinois, Forenede Stater, 61554
        • Pekin Cancer Treatment Center
      • Pekin, Illinois, Forenede Stater, 61554
        • Pekin Hospital
      • Peoria, Illinois, Forenede Stater, 61637
        • OSF Saint Francis Medical Center
      • Peoria, Illinois, Forenede Stater, 61615
        • Illinois CancerCare-Peoria
      • Peoria, Illinois, Forenede Stater, 61614
        • Proctor Hospital
      • Peoria, Illinois, Forenede Stater, 61603
        • Methodist Medical Center of Illinois
      • Peoria, Illinois, Forenede Stater, 61615-7827
        • OSF Saint Francis Medical Center Radiation Oncology Service at the Central Illinois Comprehensive CC
      • Peoria, Illinois, Forenede Stater, 61615
        • Illinois Oncology Research Association CCOP
      • Peru, Illinois, Forenede Stater, 61354
        • Illinois CancerCare-Peru
      • Peru, Illinois, Forenede Stater, 61354
        • Valley Radiation Oncology
      • Peru, Illinois, Forenede Stater, 61354
        • Illinois Valley Hospital
      • Princeton, Illinois, Forenede Stater, 61356
        • Illinois CancerCare-Princeton
      • Princeton, Illinois, Forenede Stater, 61356
        • Perry Memorial Hospital
      • Spring Valley, Illinois, Forenede Stater, 61362
        • Saint Margaret's Hospital
      • Spring Valley, Illinois, Forenede Stater, 61362
        • Illinois CancerCare-Spring Valley
      • Springfield, Illinois, Forenede Stater, 62781
        • Memorial Medical Center
      • Urbana, Illinois, Forenede Stater, 61801
        • Carle Cancer Center
    • Indiana
      • Beech Grove, Indiana, Forenede Stater, 46107
        • Franciscan St. Francis Health-Beech Grove
      • 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
      • Lafayette, Indiana, Forenede Stater, 47904
        • IU Health Arnett Cancer Care
      • Michigan City, Indiana, Forenede Stater, 46360
        • Franciscan Saint Anthony Health-Michigan City
      • 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
      • Richmond, Indiana, Forenede Stater, 47374
        • Reid Hospital and Health Care Services
      • South Bend, Indiana, Forenede Stater, 46601
        • Memorial Hospital of South Bend
      • South Bend, Indiana, Forenede Stater, 46601
        • Michiana Hematology Oncology PC-South Bend
      • South Bend, Indiana, Forenede Stater, 46617
        • South Bend Clinic
      • South Bend, Indiana, Forenede Stater, 46628
        • Northern Indiana Cancer Research Consortium CCOP
      • Westville, Indiana, Forenede Stater, 46391
        • Michiana Hematology Oncology PC-Westville
    • Iowa
      • Ames, Iowa, Forenede Stater, 50010
        • McFarland Clinic PC-William R Bliss Cancer Center
      • Bettendorf, Iowa, Forenede Stater, 52722
        • Constantinou, Costas L MD (UIA Investigator)
      • Bettendorf, Iowa, Forenede Stater, 52722
        • Hematology Oncology Associates-Quad Cities
      • Cedar Rapids, Iowa, Forenede Stater, 52403
        • Mercy Hospital
      • Cedar Rapids, Iowa, Forenede Stater, 52403
        • Oncology Associates at Mercy Medical Center
      • Cedar Rapids, Iowa, Forenede Stater, 52403
        • Cedar Rapids Oncology Association
      • Clive, Iowa, Forenede Stater, 50325
        • Medical Oncology and Hematology Associates-West Des Moines
      • Des Moines, Iowa, Forenede Stater, 50309
        • Iowa Methodist Medical Center
      • Des Moines, Iowa, Forenede Stater, 50314
        • Mercy Medical Center - Des Moines
      • Des Moines, Iowa, Forenede Stater, 50309
        • Medical Oncology and Hematology Associates-Des Moines
      • Des Moines, Iowa, Forenede Stater, 50316
        • Iowa Lutheran Hospital
      • Des Moines, Iowa, Forenede Stater, 50314
        • Medical Oncology and Hematology Associates-Laurel
      • Des Moines, Iowa, Forenede Stater, 50309
        • Iowa Oncology Research Association CCOP
      • Ottumwa, Iowa, Forenede Stater, 52501
        • Ottumwa Regional Health Center
      • Sioux City, Iowa, Forenede Stater, 51101
        • Siouxland Regional Cancer Center
      • Sioux City, Iowa, Forenede Stater, 51104
        • Saint Luke's Regional Medical Center
      • Sioux City, Iowa, Forenede Stater, 51104
        • Mercy Medical Center-Sioux City
    • 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, 67901
        • Cancer Center of Kansas-Liberal
      • McPherson, Kansas, Forenede Stater, 67460
        • Cancer Center of Kansas - McPherson
      • Newton, Kansas, Forenede Stater, 67114
        • Cancer Center of Kansas - Newton
      • Overland Park, Kansas, Forenede Stater, 66209
        • Menorah Medical Center
      • Overland Park, Kansas, Forenede Stater, 66213
        • Saint Luke's South Hospital
      • Parsons, Kansas, Forenede Stater, 67357
        • Cancer Center of Kansas - Parsons
      • Prairie Village, Kansas, Forenede Stater, 66208
        • Kansas City CCOP
      • Pratt, Kansas, Forenede Stater, 67124
        • Cancer Center of Kansas - Pratt
      • Salina, Kansas, Forenede Stater, 67401
        • Cancer Center of Kansas - Salina
      • 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, 67208
        • Associates In Womens Health
      • Wichita, Kansas, Forenede Stater, 67214
        • Cancer Center of Kansas - Main Office
      • Wichita, Kansas, Forenede Stater, 67214
        • Via Christi Regional Medical Center
      • Wichita, Kansas, Forenede Stater, 67214
        • Wichita CCOP
      • Winfield, Kansas, Forenede Stater, 67156
        • Cancer Center of Kansas - Winfield
    • Kentucky
      • Louisville, Kentucky, Forenede Stater, 40215
        • Doctors Carrol, Sheth, Raghavan
    • Louisiana
      • Baton Rouge, Louisiana, Forenede Stater, 70809
        • Ochsner Health Center-Summa
      • Covington, Louisiana, Forenede Stater, 70433
        • Ochsner Health Center-Covington
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        • Louisiana State University Sciences Center- Monroe
      • New Orleans, Louisiana, Forenede Stater, 70121
        • Ochsner Medical Center Jefferson
      • Shreveport, Louisiana, Forenede Stater, 71103
        • Louisiana State University Health Sciences Center Shreveport
      • Shreveport, Louisiana, Forenede Stater, 71105
        • Highland Clinic
    • Maine
      • Augusta, Maine, Forenede Stater, 04330
        • Harold Alfond Center for Cancer Care
      • Bangor, Maine, Forenede Stater, 04401
        • Eastern Maine Medical Center
    • Maryland
      • Easton, Maryland, Forenede Stater, 21601
        • The Memorial Hospital at Easton
      • Rockville, Maryland, Forenede Stater, 20850-2062
        • Cancer Trials Support Unit
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48106-0995
        • Saint Joseph Mercy Hospital
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        • Michigan Cancer Research Consortium CCOP
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        • Oakwood Hospital and Medical Center
      • Detroit, Michigan, Forenede Stater, 48236
        • Saint John Hospital and Medical Center
      • Escanaba, Michigan, Forenede Stater, 49431
        • Green Bay Oncology - Escanaba
      • Flint, Michigan, Forenede Stater, 48502
        • Hurley Medical Center
      • Flint, Michigan, Forenede Stater, 48532
        • Genesys Regional Medical Center-West Flint Campus
      • Iron Mountain, Michigan, Forenede Stater, 49801
        • Green Bay Oncology - Iron Mountain
      • Jackson, Michigan, Forenede Stater, 49201
        • Allegiance Health
      • Kalamazoo, Michigan, Forenede Stater, 49007
        • West Michigan Cancer Center
      • Kalamazoo, Michigan, Forenede Stater, 49007
        • Bronson Methodist Hospital
      • Kalamazoo, Michigan, Forenede Stater, 49001
        • Borgess Medical Center
      • Lansing, Michigan, Forenede Stater, 48912
        • Sparrow Hospital
      • Livonia, Michigan, Forenede Stater, 48154
        • Saint Mary Mercy Hospital
      • Mount Clemens, Michigan, Forenede Stater, 48043
        • McLaren-Macomb
      • Niles, Michigan, Forenede Stater, 49120
        • Michiana Hematology Oncology PC-Niles
      • Pontiac, Michigan, Forenede Stater, 48341
        • Saint Joseph Mercy Oakland
      • Port Huron, Michigan, Forenede Stater, 48060
        • Saint Joseph Mercy Port Huron
      • Saginaw, Michigan, Forenede Stater, 48601
        • Saint Mary's of Michigan
      • Saint Joseph, Michigan, Forenede Stater, 49085
        • Marie Yeager Cancer Center
      • Southfield, Michigan, Forenede Stater, 48075
        • Providence Hospital-Southfield Cancer Center
      • St. Joseph, Michigan, Forenede Stater, 49085
        • Lakeland Hospital
      • Warren, Michigan, Forenede Stater, 48093
        • Saint John Macomb-Oakland Hospital
    • Minnesota
      • Alexandria, Minnesota, Forenede Stater, 56308
        • Medini, Eitan MD (UIA Investigator)
      • 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
      • Duluth, Minnesota, Forenede Stater, 55805
        • Essentia Health Saint Mary's Medical Center
      • Duluth, Minnesota, Forenede Stater, 55805
        • Miller-Dwan Hospital
      • Edina, Minnesota, Forenede Stater, 55435
        • Fairview-Southdale Hospital
      • Fridley, Minnesota, Forenede Stater, 55432
        • Unity Hospital
      • Hutchinson, Minnesota, Forenede Stater, 55350
        • Hutchinson Area Health Care
      • Mankato, Minnesota, Forenede Stater, 56001
        • Mayo Clinic Health Systems-Mankato
      • 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, 55417
        • Minneapolis Veterans Medical Center
      • Robbinsdale, Minnesota, Forenede Stater, 55422
        • North Memorial Medical Health Center
      • Rochester, Minnesota, Forenede Stater, 55905
        • Mayo Clinic
      • Saint Cloud, Minnesota, Forenede Stater, 56303
        • Coborn Cancer Center at Saint Cloud Hospital
      • Saint Cloud, Minnesota, Forenede Stater, 56303
        • Saint Cloud Hospital
      • Saint Louis Park, Minnesota, Forenede Stater, 55416
        • Park Nicollet Clinic - Saint Louis Park
      • Saint Louis Park, Minnesota, Forenede Stater, 55416
        • Metro-Minnesota NCI Community Oncology Research Program
      • Saint Paul, Minnesota, Forenede Stater, 55101
        • Regions Hospital
      • Saint Paul, Minnesota, Forenede Stater, 55102
        • United Hospital
      • Shakopee, Minnesota, Forenede Stater, 55379
        • Saint Francis Regional Medical Center
      • Stillwater, Minnesota, Forenede Stater, 55082
        • Lakeview Hospital
      • Waconia, Minnesota, Forenede Stater, 55387
        • Ridgeview Medical Center
      • Willmar, Minnesota, Forenede Stater, 56201
        • Rice Memorial Hospital
      • Woodbury, Minnesota, Forenede Stater, 55125
        • Minnesota Oncology and Hematology PA-Woodbury
    • Missouri
      • Kansas City, Missouri, Forenede Stater, 64116
        • North Kansas City Hospital
      • Kansas City, Missouri, Forenede Stater, 64111
        • Saint Luke's Hospital of Kansas City
      • Kansas City, Missouri, Forenede Stater, 64132
        • Research Medical Center
      • Kansas City, Missouri, Forenede Stater, 64118
        • Heartland Hematology and Oncology Associates Incorporated
      • Kansas City, Missouri, Forenede Stater, 64111
        • Saint Luke's Cancer Institute
      • Kansas City, Missouri, Forenede Stater, 64114
        • Saint Joseph Health Center
      • Lee's Summit, Missouri, Forenede Stater, 64086
        • Saint Luke's East - Lee's Summit
      • Liberty, Missouri, Forenede Stater, 64068
        • Liberty Radiation Oncology Center
      • Liberty, Missouri, Forenede Stater, 64068
        • Liberty Hospital
      • Saint Joseph, Missouri, Forenede Stater, 64506
        • Heartland Regional Medical Center
      • Saint Joseph, Missouri, Forenede Stater, 64507
        • Saint Joseph Oncology Inc
      • Springfield, Missouri, Forenede Stater, 65804
        • Cancer Research for the Ozarks NCORP
      • Springfield, Missouri, Forenede Stater, 65807
        • CoxHealth South Hospital
      • Springfield, Missouri, Forenede Stater, 65804
        • Mercy Hospital Springfield
    • Montana
      • Billings, Montana, Forenede Stater, 59101
        • Saint Vincent Healthcare
      • Billings, Montana, Forenede Stater, 59101
        • Northern Rockies Radiation Oncology Center
      • Billings, Montana, Forenede Stater, 59101
        • Montana Cancer Consortium CCOP
      • Billings, Montana, Forenede Stater, 59102
        • Frontier Cancer Center and Blood Institute-Billings
      • Billings, Montana, Forenede Stater, 59107
        • Billings Clinic Cancer Center
      • Bozeman, Montana, Forenede Stater, 59715
        • Bozeman Deaconess Hospital
      • Bozeman, Montana, Forenede Stater, 59715
        • Bozeman Deaconess Cancer Center
      • Butte, Montana, Forenede Stater, 59701
        • Saint James Community Hospital and Cancer Treatment Center
      • Great Falls, Montana, Forenede Stater, 59405
        • Great Falls Clinic
      • Great Falls, Montana, Forenede Stater, 59405
        • Benefis Healthcare- Sletten Cancer Institute
      • Great Falls, Montana, Forenede Stater, 59405
        • Berdeaux, Donald MD (UIA Investigator)
      • Great Falls, Montana, Forenede Stater, 59405
        • Big Sky Oncology
      • Havre, Montana, Forenede Stater, 59501
        • Northern Montana Hospital
      • Helena, Montana, Forenede Stater, 59601
        • Saint Peter's Community Hospital
      • Kalispell, Montana, Forenede Stater, 59901
        • Kalispell Regional Medical Center
      • Kalispell, Montana, Forenede Stater, 59901
        • Glacier Oncology PLLC
      • Kalispell, Montana, Forenede Stater, 59901
        • Kalispell Medical Oncology
      • Missoula, Montana, Forenede Stater, 59802
        • Saint Patrick Hospital - Community Hospital
      • Missoula, Montana, Forenede Stater, 59804
        • Guardian Oncology and Center for Wellness
      • Missoula, Montana, Forenede Stater, 59801
        • Community Medical Hospital
      • Missoula, Montana, Forenede Stater, 59802
        • Montana Cancer Specialists
    • Nebraska
      • Lincoln, Nebraska, Forenede Stater, 68510
        • Nebraska Cancer Research Center
      • Omaha, Nebraska, Forenede Stater, 68124
        • Alegent Health Bergan Mercy Medical Center
      • Omaha, Nebraska, Forenede Stater, 68122
        • Alegent Health Immanuel Medical Center
      • Omaha, Nebraska, Forenede Stater, 68131
        • Creighton University Medical Center
      • Omaha, Nebraska, Forenede Stater, 68106
        • Missouri Valley Cancer Consortium
    • Nevada
      • Las Vegas, Nevada, Forenede Stater, 89102
        • University Medical Center of Southern Nevada
      • Las Vegas, Nevada, Forenede Stater, 89106
        • Nevada Cancer Research Foundation CCOP
    • New Hampshire
      • Dover, New Hampshire, Forenede Stater, 03820
        • Wentworth-Douglass Hospital
      • Nashua, New Hampshire, Forenede Stater, 03060
        • Saint Joseph Hospital
    • New Jersey
      • Somerville, New Jersey, Forenede Stater, 08876
        • Robert Wood Johnson University Hospital Somerset
    • New York
      • Glens Falls, New York, Forenede Stater, 12801
        • Glens Falls Hospital
      • Staten Island, New York, Forenede Stater, 10305
        • Staten Island University Hospital
    • North Carolina
      • Asheboro, North Carolina, Forenede Stater, 27203
        • Randolph Hospital
      • Goldsboro, North Carolina, Forenede Stater, 27534
        • Wayne Memorial Hospital
      • Greensboro, North Carolina, Forenede Stater, 27403
        • Cone Health Cancer Center
      • Hendersonville, North Carolina, Forenede Stater, 28791
        • Margaret R Pardee Memorial Hospital
      • Kinston, North Carolina, Forenede Stater, 28501
        • Kinston Medical Specialists PA
      • Reidsville, North Carolina, Forenede Stater, 27320
        • Annie Penn Memorial Hospital
    • North Dakota
      • Bismarck, North Dakota, Forenede Stater, 58501
        • Sanford Bismarck Medical Center
      • Bismarck, North Dakota, Forenede Stater, 58501
        • Mid Dakota Clinic
      • Bismarck, North Dakota, Forenede Stater, 58501
        • Saint Alexius Medical Center
      • Grand Forks, North Dakota, Forenede Stater, 58201
        • Altru Cancer Center
      • Minot, North Dakota, Forenede Stater, 58701
        • Trinity Cancer Care Center
    • Ohio
      • Akron, Ohio, Forenede Stater, 44304
        • Summa Akron City Hospital/Cooper Cancer Center
      • Akron, Ohio, Forenede Stater, 44307
        • Akron General Medical Center
      • Barberton, Ohio, Forenede Stater, 44203
        • Summa Barberton Hospital
      • Bellefontaine, Ohio, Forenede Stater, 43311
        • Mary Rutan Hospital
      • Chillicothe, Ohio, Forenede Stater, 45601
        • Adena Regional Medical Center
      • Columbus, Ohio, Forenede Stater, 43214
        • Riverside Methodist Hospital
      • Columbus, Ohio, Forenede Stater, 43228
        • Doctors Hospital
      • Columbus, Ohio, Forenede Stater, 43215
        • Grant Medical Center
      • Columbus, Ohio, Forenede Stater, 43222
        • Mount Carmel Health Center West
      • Columbus, Ohio, Forenede Stater, 43215
        • Columbus CCOP
      • Dayton, Ohio, Forenede Stater, 45406
        • Good Samaritan Hospital - Dayton
      • Dayton, Ohio, Forenede Stater, 45409
        • Miami Valley Hospital
      • Dayton, Ohio, Forenede Stater, 45415
        • Samaritan North Health Center
      • Dayton, Ohio, Forenede Stater, 45405
        • Grandview Hospital
      • Dayton, Ohio, Forenede Stater, 45420
        • Dayton CCOP
      • Delaware, Ohio, Forenede Stater, 43015
        • Grady Memorial Hospital
      • Findlay, Ohio, Forenede Stater, 45840
        • Blanchard Valley Hospital
      • Franklin, Ohio, Forenede Stater, 45005-1066
        • Atrium Medical Center-Middletown Regional Hospital
      • Greenville, Ohio, Forenede Stater, 45331
        • Wayne Hospital
      • Kettering, Ohio, Forenede Stater, 45429
        • Kettering Medical Center
      • Lancaster, Ohio, Forenede Stater, 43130
        • Fairfield Medical Center
      • Lima, Ohio, Forenede Stater, 45801
        • Saint Rita's Medical Center
      • Marietta, Ohio, Forenede Stater, 45750
        • Marietta Memorial Hospital
      • Mount Vernon, Ohio, Forenede Stater, 43050
        • Knox Community Hospital
      • Newark, Ohio, Forenede Stater, 43055
        • Licking Memorial Hospital
      • Springfield, Ohio, Forenede Stater, 45505
        • Springfield Regional Medical Center
      • Troy, Ohio, Forenede Stater, 45373
        • Upper Valley Medical Center
      • Westerville, Ohio, Forenede Stater, 43081
        • Saint Ann's Hospital
      • Wilmington, Ohio, Forenede Stater, 45177
        • Clinton Memorial Hospital
      • Wright-Patterson Afb, Ohio, Forenede Stater, 45433-5529
        • Wright-Patterson Medical Center
      • Xenia, Ohio, Forenede Stater, 45385
        • Greene Memorial Hospital
      • Zanesville, Ohio, Forenede Stater, 43701
        • Genesis Healthcare System
    • Pennsylvania
      • Abington, Pennsylvania, Forenede Stater, 19001
        • Abington Memorial Hospital
      • Danville, Pennsylvania, Forenede Stater, 17822
        • Geisinger Medical Center
      • Hazleton, Pennsylvania, Forenede Stater, 18201
        • Geisinger Medical Center-Cancer Center Hazleton
      • Philadelphia, Pennsylvania, Forenede Stater, 19107
        • Pennsylvania Hospital
      • Phoenixville, Pennsylvania, Forenede Stater, 19460
        • Phoenixville Hospital
      • Sayre, Pennsylvania, Forenede Stater, 18840
        • Guthrie Medical Group PC-Robert Packer Hospital
      • State College, Pennsylvania, Forenede Stater, 16801
        • Geisinger Medical Group
      • West Chester, Pennsylvania, Forenede Stater, 19380
        • Chester County Hospital
      • Wilkes-Barre, Pennsylvania, Forenede Stater, 18711
        • Geisinger Wyoming Valley/Henry Cancer Center
    • South Carolina
      • Anderson, South Carolina, Forenede Stater, 29621
        • AnMed Health Cancer Center
      • Charleston, South Carolina, Forenede Stater, 29401
        • Roper Hospital
      • Easley, South Carolina, Forenede Stater, 29640
        • Greenville Health System Cancer Institute-Easley
      • Florence, South Carolina, Forenede Stater, 29506
        • McLeod Regional Medical Center
      • 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
      • Greenwood, South Carolina, Forenede Stater, 29646
        • Self Regional Healthcare
      • Greer, South Carolina, Forenede Stater, 29650
        • Cancer Centers of the Carolinas-Greer Medical Oncology
      • Seneca, South Carolina, Forenede Stater, 29672
        • Greenville Health System Cancer Institute-Seneca
      • Spartanburg, South Carolina, Forenede Stater, 29307
        • Greenville Health System Cancer Institute-Spartanburg
    • South Dakota
      • Sioux Falls, South Dakota, Forenede Stater, 57117-5134
        • Sanford USD Medical Center - Sioux Falls
      • Sioux Falls, South Dakota, Forenede Stater, 57104
        • Sanford Cancer Center-Oncology Clinic
      • Sioux Falls, South Dakota, Forenede Stater, 57105
        • Medical X-Ray Center
      • Sioux Falls, South Dakota, Forenede Stater, 57104
        • Sanford NCI Community Oncology Research Program of the North Central Plains
    • Tennessee
      • Kingsport, Tennessee, Forenede Stater, 37660
        • Wellmont Holston Valley Hospital and Medical Center
      • Knoxville, Tennessee, Forenede Stater, 37920
        • University of Tennessee - Knoxville
    • Virginia
      • Fredericksburg, Virginia, Forenede Stater, 22408
        • Hematology Oncology Associates of Fredericksburg Inc
      • Norton, Virginia, Forenede Stater, 24273
        • Southwest VA Regional Cancer Center
    • Washington
      • Bellingham, Washington, Forenede Stater, 98225
        • PeaceHealth Saint Joseph Medical Center
      • Centralia, Washington, Forenede Stater, 98531
        • Providence Regional Cancer System-Centralia
      • Federal Way, Washington, Forenede Stater, 98003
        • Saint Francis Hospital
      • Kirkland, Washington, Forenede Stater, 98033
        • EvergreenHealth Medical Center
      • Lakewood, Washington, Forenede Stater, 98499
        • Saint Clare Hospital
      • Olympia, Washington, Forenede Stater, 98506-5166
        • Providence - Saint Peter Hospital
      • Puyallup, Washington, Forenede Stater, 98372
        • MultiCare Good Samaritan Hospital
      • Renton, Washington, Forenede Stater, 98055
        • Valley Medical Center
      • Seattle, Washington, Forenede Stater, 98101
        • Virginia Mason Medical Center
      • Seattle, Washington, Forenede Stater, 98104
        • Pacific Medical Center-First Hill
      • Seattle, Washington, Forenede Stater, 98101
        • Virginia Mason CCOP
      • Tacoma, Washington, Forenede Stater, 98405
        • MultiCare Allenmore Hospital
      • Tacoma, Washington, Forenede Stater, 98405
        • Saint Joseph Medical Center
      • Tacoma, Washington, Forenede Stater, 98415
        • MultiCare Health System
      • Tacoma, Washington, Forenede Stater, 98405
        • Northwest CCOP
      • Yakima, Washington, Forenede Stater, 98902
        • North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
    • West Virginia
      • Huntington, West Virginia, Forenede Stater, 25701
        • Edwards Comprehensive Cancer Center
    • Wisconsin
      • Chippewa Falls, Wisconsin, Forenede Stater, 54729
        • Marshfield Clinic-Chippewa Center
      • Eau Claire, Wisconsin, Forenede Stater, 54701
        • Marshfield Clinic Cancer Center at Sacred Heart
      • Green Bay, Wisconsin, Forenede Stater, 54301
        • Saint Vincent Hospital
      • Green Bay, Wisconsin, Forenede Stater, 54303
        • Green Bay Oncology Limited at Saint Mary's Hospital
      • Green Bay, Wisconsin, Forenede Stater, 54303
        • 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, 53717
        • Dean Hematology and Oncology Clinic
      • Manitowoc, Wisconsin, Forenede Stater, 54221
        • Holy Family Memorial Hospital
      • Marinette, Wisconsin, Forenede Stater, 54143
        • Bay Area Medical Center
      • Marshfield, Wisconsin, Forenede Stater, 54449
        • Marshfield Clinic
      • Mequon, Wisconsin, Forenede Stater, 53097
        • Columbia Saint Mary's Hospital - Ozaukee
      • Milwaukee, Wisconsin, Forenede Stater, 53211
        • Columbia Saint Mary's Water Tower Medical Commons
      • Minocqua, Wisconsin, Forenede Stater, 54548
        • Marshfield Clinic-Minocqua Center
      • Oconto Falls, Wisconsin, Forenede Stater, 54154
        • Green Bay Oncology - Oconto Falls
      • Rhinelander, Wisconsin, Forenede Stater, 54501
        • Marshfield Clinic at James Beck Cancer Center
      • Rice Lake, Wisconsin, Forenede Stater, 54868
        • Marshfield Clinic-Rice Lake Center
      • Sheboygan, Wisconsin, Forenede Stater, 53081
        • Saint Nicholas Hospital
      • Stevens Point, Wisconsin, Forenede Stater, 54481
        • Marshfield Clinic Cancer Care at Saint Michael's Hospital
      • Sturgeon Bay, Wisconsin, Forenede Stater, 54235
        • Green Bay Oncology - Sturgeon Bay
      • Weston, Wisconsin, Forenede Stater, 54476
        • Marshfield Clinic - Weston Center
      • Wisconsin Rapids, Wisconsin, Forenede Stater, 54494
        • Marshfield Clinic - Wisconsin Rapids Center
    • Wyoming
      • Casper, Wyoming, Forenede Stater, 82609
        • Rocky Mountain Oncology
      • Sheridan, Wyoming, Forenede Stater, 82801
        • Welch Cancer Center

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

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inklusionskriterier:

  • Planlagt til at gennemgå behandling med TAXOL ved 150-200 mg/m2 og CBDCA ved area under the curve (AUC) = 5-7 hver 21. eller 28. dag i mindst 12 uger; alternativt kan paclitaxel ordineres ved 80 mg/m2 ugentligt i mindst 12 uger med den samme CBDCA-dosis på AUC = 5-7 hver 21. dag; yderligere kemoterapimidler er tilladt (bevacizumab, etoposid osv.) efter lægens skøn, så længe de ikke vides at være neurotoksiske; Bemærk: patienter vil ideelt set begynde GSH-terapi før deres første dosis af denne kemoterapi, men skal begynde GSH-terapi før deres anden dosis kemoterapi
  • Evne til at underskrive informeret samtykke og forstå karakteren af ​​et placebokontrolleret forsøg
  • Eastern Cooperative Oncology Group (ECOG) præstationsstatus 0-2
  • Evne til at udfylde engelsksprogede spørgeskema(r) alene eller med assistance
  • Forventet levetid >= 6 måneder
  • Negativ graviditetstest udført =< 7 dage før registrering, kun for kvinder i den fødedygtige alder, efter klinikerens skøn
  • Villighed til at levere blodprøver som krævet af protokollen
  • Hvide blodlegemer (WBC) >= 3400
  • Absolut neutrofiltal (ANC) >= 1500
  • Blodplader (PLT) >= 100.000
  • Hæmoglobin (HgB) > 10,0
  • Kreatinin =< 1,5 x øvre normalgrænse (ULN)

Ekskluderingskriterier:

  • Eksisterende historie med perifer neuropati > grad 1 (National Cancer Institute [NCI] CTCAE version [v] 4.0) på grund af enhver årsag (f.eks. kemoterapi, diabetes, alkohol, toksin eller arvelighed)
  • Andre medicinske tilstande, som efter den behandlende læges/allierede sundhedsprofessionelles mening ville gøre denne protokol urimelig farlig for patienten

  • Enhver af følgende:

    • Gravid kvinde
    • Sygeplejerske kvinder
    • Kvinder i den fødedygtige alder, som ikke er villige til at anvende passende prævention
  • Tidligere TAXOL- og/eller CBDCA-kemoterapibehandling (andre end det nuværende behandlingsregime)

  • Samtidig brug af ethvert middel, der anvendes specifikt til at forebygge eller behandle neuropati, herunder men ikke begrænset til følgende:

    • Gabapentin
    • Glutaminpulver eller glutamintabletter
    • Vitamin B6 eller E

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: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Arm I (glutathion, carboplatin)
Patienterne får glutathion intravenøst ​​(IV) over 15 minutter, paclitaxel* IV over 1 eller 3 timer afhængigt af planlagt dosiscykluslængde og carboplatin IV over 30 minutter.
Andet: Laboratoriebiomarkøranalyse
Korrelative undersøgelser
Andet: Livskvalitetsvurdering
Hjælpestudier
Andre navne:
  • Livskvalitetsvurdering
Medicin: Carboplatin
Givet IV, over 30 minutter pr. planlagt kemoterapiregime
Andre navne:
  • Blastocarb
  • Carboplat
  • Carboplatin Hexal
  • Carboplatino
  • Carbosin
  • Carbosol
  • Carbotec
  • CBDCA
  • Displata
  • Ercar
  • JM-8
  • Nealorin
  • Novoplatin
  • Paraplatin
  • Paraplatin AQ
  • Platinwas
  • Ribocarbo
  • Paraplat
Medicin: Glutathion
Gives IV, over 15 minutter, umiddelbart før kemoterapi administration
Andre navne:
  • GSH
  • Glutham
  • Reduceret glutathion
Medicin: Paclitaxel
Givet IV, over 1 eller 3 timer, pr. planlagt kemoterapiregime
Andre navne:
  • Taxol
  • Anzatax
  • Asotax
  • Bristaxol
  • Praxel
  • Taxol Konzentrat
Placebo komparator: Arm II (placebo, paclitaxel)
Patienter får placebo IV over 15 minutter, paclitaxel* IV over 1 eller 3 timer afhængig af planlagt dosiscykluslængde og carboplatin IV over 30 minutter.
Andet: Laboratoriebiomarkøranalyse
Korrelative undersøgelser
Andet: Livskvalitetsvurdering
Hjælpestudier
Andre navne:
  • Livskvalitetsvurdering
Andet: Placebo
Givet IV
Andre navne:
  • placebo terapi
  • PLCB
  • falsk terapi
Medicin: Carboplatin
Givet IV, over 30 minutter pr. planlagt kemoterapiregime
Andre navne:
  • Blastocarb
  • Carboplat
  • Carboplatin Hexal
  • Carboplatino
  • Carbosin
  • Carbosol
  • Carbotec
  • CBDCA
  • Displata
  • Ercar
  • JM-8
  • Nealorin
  • Novoplatin
  • Paraplatin
  • Paraplatin AQ
  • Platinwas
  • Ribocarbo
  • Paraplat
Medicin: Paclitaxel
Givet IV, over 1 eller 3 timer, pr. planlagt kemoterapiregime
Andre navne:
  • Taxol
  • Anzatax
  • Asotax
  • Bristaxol
  • Praxel
  • Taxol Konzentrat

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Paclitaxel/Carboplatin (PC)-induceret perifer neuropati som vurderet af EORTC QLQ-CIPN20 (European Organisation for Research and Treatment of Cancer (EORTC), Livskvalitet (QLQ), Kemoterapi-induceret perifer neuropati 20 (CIPN20)).
Tidsramme: Hver 28-dages cyklus, op til 6 cyklusser.
Den sensoriske CIPN-underskala vil blive beregnet ved hjælp af standardscoringsalgoritme og konverteret til 0-100 skala (højere score indikerer færre symptomer og bedre livskvalitet). Generaliserede lineære modeller (gentagne målinger af variansanalyse [ANOVA], hvis data er fuldstændige) vil blive brugt til at sammenligne CIPN mellem glutathion (GSH) og placebo-arme.
Hver 28-dages cyklus, op til 6 cyklusser.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Gentagelsesfri overlevelse (for patienter uden klinisk tegn på sygdom)
Tidsramme: Op til 1 år
En log-rank test og en Kaplan-Meier kurve vil blive brugt til at sammenligne den tilbagefaldsfrie overlevelse mellem GSH og placebo arme (kun for ovarie/æggeleder/primære peritoneale patienter).
Op til 1 år
Ændring i patientrapporteret livskvalitet som vurderet ved funktionel vurdering af kræftterapi-ovarie- (FACT-O) og patientens daglige symptom-spørgeskemaer over tid.
Tidsramme: Baseline til 1 år
Livskvalitet blev målt ved FACT-O (på en 0 til 100 skala, højere score repræsenterer bedre livskvalitet) fra baseline og ved slutningen af ​​TAXOL/CBDCA. Ændringen i livskvalitet blev beregnet som forskellen mellem baseline-mål og behandlingsslutmål (med et interval fra -100 til 100). En negativ ændring repræsenterer en forværring af QOL fra baseline til et år. Anvendte forkortelser: Ændring fra baseline (ændr fra bsl)
Baseline til 1 år
Paclitaxel Acute Pain Syndrome Incidens og sværhedsgrad mellem GSH og placeboarme
Tidsramme: Op til 1 år
Beskrivende statistik vil blive brugt til at beskrive TAXOL/CBDCA akut smertesyndrom forekomst/sværhedsgrad mellem GSH og placebo arme. Smerter blev scoret på en skala fra 0-10, hvor 0 = 'Ingen ømhed eller smerter' og 10 = 'Smerte eller smerter så slemt som muligt.'
Op til 1 år
Procentdel af patienter, der forsinker PC-kemoterapi sekundært til PN
Tidsramme: Op til 1 år
Patienter, der forsinker TAXOL/CBDCA sekundært til perifer neuropati mellem GSH- og placeboarme.
Op til 1 år
Procentdel af patienter, der gennemgår dosisreduktioner sekundært til PCI PN
Tidsramme: Op til 1 år
Andel af patienter, der har behov for kemoterapidosisreduktioner sekundært til TAXOL/CBDCA-induceret perifer neuropati mellem GSH- og placeboarme.
Op til 1 år
Procentdel af patienter med grad 2+ og grad 3+ paclitaxel/carboplatin-induceret (PCI) perifer neuropati (PN) ifølge fælles terminologikriterier for bivirkninger (CTCAE) neuropatiskala
Tidsramme: Op til 1 år
Andel grad 2+ og grad 3+ kemoterapi induceret perifer neuropati (CIPN) på et hvilket som helst tidspunkt under eller ved slutningen af ​​den TAXOL/CBDCA baserede kemoterapi mellem GSH og placebo arme. Neuropatiskalaen har grad 1 til 5 (1-mild, grad 2 moderat, grad 3 svær, grad 4 livstruende og grad 5 død relateret til AE).
Op til 1 år
Tider til indtræden af ​​CTCAE Grade 2+ PN
Tidsramme: Op til 1 år
Sammenlign tid til grad 2+ CIPN mellem GSH- og placeboarme.
Op til 1 år
Tider til indtræden af ​​CTCAE Grade 3+ PN
Tidsramme: Op til 5 år fra registrering
Tid til grad 3+ CIPN mellem GSH- og placeboarme.
Op til 5 år fra registrering

Samarbejdspartnere og efterforskere

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

Sponsor

Alliance for Clinical Trials in Oncology

Samarbejdspartnere

National Cancer Institute (NCI)

Efterforskere

  • Ledende efterforsker: Charles Loprinzi, Alliance for Clinical Trials in Oncology

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

1. december 2009

Primær færdiggørelse (Faktiske)

1. august 2012

Studieafslutning (Faktiske)

1. august 2012

Datoer for studieregistrering

Først indsendt

8. december 2014

Først indsendt, der opfyldte QC-kriterier

8. december 2014

Først opslået (Skøn)

9. december 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

23. februar 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. januar 2017

Sidst verificeret

1. januar 2017

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • N08CA
  • U10CA037404 (U.S. NIH-bevilling/kontrakt)
  • NCI-2011-01965 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • CDR0000654097

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 .

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