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Testing av kombinasjonen av Cediranib og Olaparib i sammenligning med hvert legemiddel alene eller annen kjemoterapi ved tilbakevendende platina-resistent eggstokkreft

En randomisert fase II/III -studie av kombinasjon av Cediranib og Olaparib sammenlignet med Cediranib eller Olaparib alene, eller standardbehandling for kjemoterapi hos kvinner med tilbakevendende platina -resistent eller -refraktær eggstokk, eggleder eller primær peritoneal kreft (COCOS)

Sponsorer

Hovedsponsor: National Cancer Institute (NCI)

Samarbeider: Canadian Cancer Trials Group
NRG Oncology

Kilde National Cancer Institute (NCI)
Kort oppsummering

Denne randomiserte fase II/III -studien studerer hvor godt cediranibmaleat og olaparib fungerer når gis sammen eller hver for seg, og sammenligner dem med standard kjemoterapi ved behandling av pasienter med eggstokk, eggleder eller primær peritoneal kreft som har kommet tilbake (tilbakevendende) etter å ha mottatt cellegift med legemidler som inneholder platina (platina-resistent) eller fortsatte å vokse mens de ble behandlet med platina-baserte kjemoterapimedisiner (platina-ildfast). Cediranib maleat og olaparib kan stoppe veksten av tumorceller ved blokkerende enzym som trengs for cellevekst. Kjemoterapimedisiner virker på forskjellige måter for å stoppe veksten av tumorceller, enten ved å drepe cellene, ved å stoppe dem fra å dele seg, eller ved stoppe dem fra å spre seg. Det er ikke kjent om cediranibmaleat og olaparib sammen kan forårsake mer skade på kreftceller sammenlignet med enten legemiddel alene eller standard cellegift.

Detaljert beskrivelse

Hovedmål: I.Å kontakte effekter og identifisere (in) active arm (er) av kombinasjonen av cediranib maleat (cediranib) og olaparib, cediranib alene, olaparib alene, og legens valg standard kjemoterapi, måltider ved progresjonsfri overlevelse (PFS) i innstillingen av tilbakevendende platina-resistent eller ildfast ovarie, primær peritoneal eller eggleder kreft. (fase II II. for å kontrollere effekten av kombinasjonen av cediranib og olaparib, og cediranib monoterapi, måltider ved total overlevelse (OS) og PFS, sammenlignet med leges valg standard kjemoterapi hos kvinner med tilbakevendende platina-resistente eller refraktær kreft i eggstokkene, primær peritoneal eller eggleder. (Fase III) SEKUNDÆRE MÅL: I.For å kontakte effekter av kombinasjonen av cediranib og olaparib, cediranib alene, olaparib alene, og leges valg standard kjemoterapi, måltider ved objektiv responsrate (ORR: delvis eller fullstendig respons) etter responsevalueringskriterier i solide svulster (RECIST) 1.1 kriterier, in setting of tilbakevendende platina-resistente eller refraktær ovarie-, primærbukhinne- eller egglederkreft.(Fase II) II.For å kontrollere sikkerhetsendepunkter, måltider etter hyppighet og alvorlighetsgrad av uønskede hendelser av Common Terminologikriterier for uønskede hendelser (CTCAE). (Fase II og Fase III) III.For å sjekke effekt av kombinasjonen av cediranib og olaparib, og cediranib monoterapi, måltider av ORR sammenlignet med legens valg standard for omsorg kjemoterapi i innstillingen av tilbakevendende platina-resistent eller ildfast ovarie, primær peritoneal eller eggleder kreft.(fase III) MÅL MED INTEGRERT BIOMARKØR: I.For å sjekke korrelasjon av status for homolog rekombinasjonsmangel (HRD), som vurderes via BROCA-HR-analyse med respons, måltider ved PFS og ORR.(Fase II) II.For å sjekke prognostisk og prediktiv rolle for sirkulerende endotelceller (CEC) på komparativ effektiviteten av målrettede terapier og referansekjemoterapi. (Fase II) III.For å sjekke overholdelse av livskvalitetsdata, måltider ved 9-elementers sykdomsrelaterte symptomer (DRS-9) underskala av National Comprehensive Cancer Network (NCCN) - funksjonell vurdering av kreft Terapi (FAKTA) Ovarial Symptom Index (NFOSI) for bruk og analyse i fase III studie.(Fase II) IV.For å sjekke korrelasjon av HRD-status, som rangert via BROCA-HR-analyse med respons, målt ved OS, PFS og ORR. (Fase III) V.For å sjekke prognose og prediktiv rolle sirkulerende endotelceller (CEC) på komparativ effektivitet av målrettede terapier og referansekjemoterapi.(Fase III) VI.For å kontrollere effekten på sykdomsrelaterte symptomer (DRS) måltider med 9-elementer DRS-P-underskalaen til NCCN-FACT Ovarial Symptom Index-18 (NFOSI-18), av enkeltmiddel cediranib og cediranib/olaparib kombinasjon, sammenlignet med standard kjemoterapi, i innstillingen av tilbakevendende platina-resistent eller ildfast eggstokkreft, primær peritoneal eller egglederkreft. (Fase III) UNDERØKENDE MÅL: I.Å kontakte utforskende biomarkører av potensielle HRD, inkludert gjennomisk arrangement, BRCA1 metylering, BRCA1-proteinekspresjon og mutasjoner i NHEJ, og andre generere som kan modifisere HRD.(Fase II og Fase III) II.For å sjekke prognostiske og prediktive ruller til angiogene biomarkører, som vurderer av Duke plasma-angiom. (Fase II og Fase III) III. For å kontrollere effekten på sekundære mål på livskvalitet, som rangert av behandling bivirkninger (TSE) og funksjon/velvære (F/WB) subskalaer av NFOSI-18, sensorisk nevropati måltider ved FACT/GOG-Ntx-4, og helseverktøy måltider ved EQ-5D, av enkeltmiddel cediranib og cediranib/olaparib kombinasjon, sammenlignet med standard kjemoterapi, ved tilbakevendende platina-resistente eller refraktære ovarie-, primære peritoneale eller egglederkreft. (Fase III) OVERSIKT: FASE II: Pasienter randomiseres til 1 av 4 behandlingsarmer. ARM I (REFERANSEREGIMEN): Pasienter gjennomgår legens valg av standardbehandling kjemoterapi, bestående av enten paklitaksel intravenøst ​​(IV) på dag 1, 8, 15 og 22 hver dag 28 dager (regime I); pegylert liposomalt doksorubicinhydroklorid IV på dag 1 hver 28.dag (Regime II); eller topotekanhydroklorid IV på dag 1, 8 og 15 hver 28.dag eller dag 1-5 hver 21.dag (regime III) .Behandlingen fortsetter i fravær av sykdomsprogresjon eller uakseptabel toksisitet.Ingen modifikasjon av de tildelte regimene, slik som tilleggsmedisiner (gemcitabin eller bevacizumab) er tillatt. (12.05.2016) ARM II (CEDIRANIB MALEAT OG OLAPARIB): Pasienter får cediranib maleat oralt (PO) én gang daglig (QD) og olaparib PO til ganger daglig (BID) .Sykluser gjentas hver 28.dag i fravær av sykdomsprogresjon eller uakseptabel toksisitet. ARM III (CEDIRANIB): Pasienter får cediranib maleat PO daglig daglig. hver 28.dag i fravær av sykdomsprogresjon eller uakseptabel toksisitet. ARM IV (OLAPARIB): Pasienter får olaparib PO BID på dag 1-28.Sykluser gjentas hver 28.dag i fravær av sykdomsprogresjon eller uakseptabel toksisitet. (I juli 2018 ble dataene Overvåkingskomiteen stemte for å ekskludere olaparib alene-regimet). FASE III: Pasientene er randomisert til 1 av 3 behandlingsarmer. ARM I (REFERANSE REGIMEN): Pasienter gjennomgår kjemoterapi etter leges valg. som i Fase II Arm I.Ingen modifikasjon av de tildelte regimene, slik som tilleggsmedisiner (gemcitabin eller bevacizumab) er tillatt. (12/05/2016) ARM II (CEDIRANIB OG OLAPARIB): Pasienter får cediranibmaleat PO og olaparib PO som i Fase II Arm II. ARM III (ENKELT AGENT): Pasienter får cediranib maleat PO som bestemt av fase II studie.Sykluser gjentas hver 28.dag i fravær av sykdomsprogresjon eller uakseptabelt toksisitet. Etter avsluttet studiebehandling følges pasientene opp hver 3.måned i 2 år og bruker hver sjette måned i utviklingen 3 år ...................

Samlet status Rekruttering
Startdato 2016-02-05
Fullføringsdato 2023-06-30
Primær sluttdato 2023-06-30
Fase Fase 2/fase 3
Studietype Intervensjonell
Primært utfall
Måle Tidsramme
Progression-free survival (PFS) (Phase II and Phase III) Time from study enrollment to the onset of progression as determined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST) criteria, or death due to any cause, whichever occurs first, assessed up to 5 years
Total overlevelse (OS) (fase III) Tid fra studiemelding til død på grunn av en hvilken som helst årsak, rangeres 5 år
Sekundært utfall
Måle Tidsramme
Objective response rate (partial or complete response) (Phase II and Phase III) Up to 5 years
Forekomst av bivirkninger (fase II og fase III) Opptil 5 år
Registrering 562
Tilstand
Innblanding

Intervensjonstype: Drug

Intervensjonsnavn: Cediranib

Beskrivelse: Given PO

Andre navn: AZD2171

Intervensjonstype: Legemiddel

Intervensjonsnavn: Cediranib maleat

Beskrivelse: Gitt PO

Intervensjonstype: Legemiddel

Intervensjonsnavn: Olaparib

Beskrivelse: Gitt PO

Intervensjonstype: Legemiddel

Intervensjonsnavn: Paclitaxel

Beskrivelse: Gitt IV

Intervensjonstype: Legemiddel

Intervensjonsnavn: Pegylert liposomalt doxorubicinhydroklorid

Beskrivelse: Gitt IV

Intervensjonstype: Annen

Intervensjonsnavn: Spørreskjemaadministrasjon

Beskrivelse: Hjelpestudier

Intervensjonstype: Legemiddel

Intervensjonsnavn: Topotecan

Beskrivelse: Gitt IV

Intervensjonstype: Legemiddel

Intervensjonsnavn: Topotecan hydroklorid

Beskrivelse: Gitt IV

Kvalifisering

Kriterier:

Inklusjonskriterier: - Pasienter må ha histologisk eller cytologisk bekreftet eggstokkreft, peritoneal kreft eller egglederkreft og må ha en histologisk diagnose på enten serøs eller endometrioid kreft basert på lokale histopatologiske funn; både endometrioid og serøs histologi bør være av høy kvalitet for kvalifisering av ikke-mutasjon bærere; pasienter med klarcelle, blandet epitel, udifferensiert karsinom, eller overgangscellekarsinomhistologier er også kvalifiserte, forutsatt at pasienten har en kjent skadelig kimlinje BRCA1 eller BRCA2 mutasjon identifisert gjennom testing ved et klinisk laboratorium - Merk: På grunn av den lange aksepteringen av BRCA -testing gjennom Myriad, Myriad testing vil bli akseptert; hvis testing for BRCA er utført av andre organisasjoner, dokumentasjon fra en kvalifisert lege (f.eks .eggstokkreft spesialist lege involvert i feltet, høy risiko genetikk lege, genetikk rådgiver) som viser mutasjonen og bekrefter at laboratorieresultatene viste en anerkjent kimlinje skadelig BRCA 1 eller BRCA 2 mutasjon eller BRCA omorganisering er nødvendig; en kopi av Myriad eller annen BRCA -mutasjonsanalyse (positiv eller varianter av ukjent betydning [VUS] eller negativ) rapporter vil være forespurt, men ikke påkrevd for studieregistrering - Pasienter bør ha tilbakevendende platina-resistent eller ildfast sykdom- definert som sykdom som har utviklet seg ved avbildning mens du mottok platina eller hadde tilbakefall innen 6 måneder etter siste mottak av platinabasert cellegift; bare stigende CA125 anses ikke som platina-resistent eller ildfast sykdom - Fase II -studie: målbar sykdom etter kriteriene RECIST 1.1; hvis arkivert svulstprøve er ikke tilgjengelig tumorprøve fra fersk biopsi er akseptabelt - Fase III studie: evaluerbar sykdom - definert som RECIST 1.1 målbar sykdom ELLER ikke-målbar sykdom (definert som solid og/eller cystiske abnormiteter ved radiografi bildebehandling som ikke oppfyller RECIST 1.1 -definisjonene for mållesjoner ELLER ascites og/eller pleural effusjon som er patologisk påvist å være sykdomsrelatert i innstillingen av et kreftantigen [CA] 125> = 2 x øvre grense for normal [ULN]) - Ikke mer enn 3 tidligere behandlingsregimer (inkludert primærterapi, ikke mer enn 1 tidligere ikke-platinabasert terapi i platina-resistente/-refraktoriske omgivelser); hormonelle terapier som brukes som enkeltmidler (dvs. tamoxifen, aromatasehemmere) vil ikke telle mot denne linjegrensen - Pasienter kan ikke ha hatt et tidligere antiangiogenisk middel i gjentagende omgivelser; Det er tillatt å bruke bevacizumab på forhånd eller vedlikehold - Pasienter har kanskje ikke tidligere fått en PARP-hemmer - Pasienten må ha gitt studiespesifikt informert samtykke før studiestart - Eastern Cooperative Oncology Group (ECOG) ytelsesstatus 0 eller 1 eller 2 - Absolutt nøytrofiltall> = 1500/mcL - Blodplater> = 100.000/mcL - Hemoglobin> = 10 g/dL - Totalt bilirubin inne =

Kjønn:

Hunn

Minimumsalder:

18 år

Maksimal alder:

Ikke tilgjengelig

Sunne frivillige:

Nei

Samlet offisiell
Etternavn Roll Tilhørighet
Jung-min Lee Principal Investigator NRG Oncology
plassering
Anlegget: Status:
University of Alabama at Birmingham Cancer Center | Birmingham, Alabama, 35233, United States Suspended
Alaska Women's Cancer Care | Anchorage, Alaska, 99508, United States Suspended
Providence Alaska Medical Center | Anchorage, Alaska, 99508, United States Suspended
University of Arkansas for Medical Sciences | Little Rock, Arkansas, 72205, United States Suspended
Sutter Auburn Faith Hospital | Auburn, California, 95602, United States Suspended
Alta Bates Summit Medical Center-Herrick Campus | Berkeley, California, 94704, United States Suspended
Mercy San Juan Medical Center | Carmichael, California, 95608, United States Suspended
Mercy Cancer Center - Elk Grove | Elk Grove, California, 95758, United States Suspended
Marin Cancer Care Inc | Greenbrae, California, 94904, United States Active, not recruiting
UC San Diego Moores Cancer Center | La Jolla, California, 92093, United States Suspended
Palo Alto Medical Foundation-Camino Division | Mountain View, California, 94040, United States Suspended
Palo Alto Medical Foundation-Gynecologic Oncology | Mountain View, California, 94040, United States Suspended
Kaiser Permanente-Oakland | Oakland, California, 94611, United States Suspended
Palo Alto Medical Foundation Health Care | Palo Alto, California, 94301, United States Suspended
Mercy Cancer Center - Rocklin | Rocklin, California, 95765, United States Suspended
Sutter Roseville Medical Center | Roseville, California, 95661, United States Suspended
Kaiser Permanente Downtown Commons | Sacramento, California, 95814, United States Suspended
Mercy Cancer Center - Sacramento | Sacramento, California, 95816, United States Suspended
Sutter Medical Center Sacramento | Sacramento, California, 95816, United States Suspended
University of California Davis Comprehensive Cancer Center | Sacramento, California, 95817, United States Suspended
Kaiser Permanente - Sacramento | Sacramento, California, 95825, United States Suspended
California Pacific Medical Center-Pacific Campus | San Francisco, California, 94115, United States Suspended
Kaiser Permanente-San Francisco | San Francisco, California, 94115, United States Suspended
UCSF Medical Center-Mission Bay | San Francisco, California, 94158, United States Suspended
Pacific Central Coast Health Center-San Luis Obispo | San Luis Obispo, California, 93401, United States Suspended
Kaiser Permanente Medical Center - Santa Clara | Santa Clara, California, 95051, United States Suspended
Palo Alto Medical Foundation-Santa Cruz | Santa Cruz, California, 95065, United States Suspended
Sutter Pacific Medical Foundation | Santa Rosa, California, 95403, United States Suspended
Palo Alto Medical Foundation-Sunnyvale | Sunnyvale, California, 94086, United States Suspended
Kaiser Permanente-Vallejo | Vallejo, California, 94589, United States Suspended
Kaiser Permanente-Walnut Creek | Walnut Creek, California, 94596, United States Suspended
Woodland Memorial Hospital | Woodland, California, 95695, United States Suspended
University of Colorado Hospital | Aurora, Colorado, 80045, United States Suspended
Penrose-Saint Francis Healthcare | Colorado Springs, Colorado, 80907, United States Suspended
UCHealth Memorial Hospital Central | Colorado Springs, Colorado, 80909, United States Suspended
Kaiser Permanente-Franklin | Denver, Colorado, 80205, United States Suspended
Rocky Mountain Cancer Centers-Rose | Denver, Colorado, 80220, United States Suspended
Poudre Valley Hospital | Fort Collins, Colorado, 80524, United States Suspended
UCHealth Highlands Ranch Hospital | Highlands Ranch, Colorado, 80129, United States Suspended
Kaiser Permanente-Rock Creek | Lafayette, Colorado, 80026, United States Suspended
Kaiser Permanente-Lone Tree | Lone Tree, Colorado, 80124, United States Suspended
Danbury Hospital | Danbury, Connecticut, 06810, United States Suspended
Smilow Cancer Hospital Care Center-Fairfield | Fairfield, Connecticut, 06824, United States Active, not recruiting
Hartford Hospital | Hartford, Connecticut, 06102, United States Suspended
Smilow Cancer Hospital Care Center at Saint Francis | Hartford, Connecticut, 06105, United States Active, not recruiting
Middlesex Hospital | Middletown, Connecticut, 06457, United States Suspended
The Hospital of Central Connecticut | New Britain, Connecticut, 06050, United States Suspended
Yale University | New Haven, Connecticut, 06520, United States Active, not recruiting
Norwalk Hospital | Norwalk, Connecticut, 06856, United States Suspended
Smilow Cancer Hospital Care Center-Trumbull | Trumbull, Connecticut, 06611, United States Active, not recruiting
Helen F Graham Cancer Center | Newark, Delaware, 19713, United States Suspended
Medical Oncology Hematology Consultants PA | Newark, Delaware, 19713, United States Suspended
Christiana Care Health System-Christiana Hospital | Newark, Delaware, 19718, United States Suspended
Sibley Memorial Hospital | Washington, District of Columbia, 20016, United States Suspended
University of Florida Health Science Center - Gainesville | Gainesville, Florida, 32610, United States Active, not recruiting
Mount Sinai Medical Center | Miami Beach, Florida, 33140, United States Suspended
Orlando Health Cancer Institute | Orlando, Florida, 32806, United States Active, not recruiting
Sarasota Memorial Hospital | Sarasota, Florida, 34239, United States Suspended
Emory University Hospital Midtown | Atlanta, Georgia, 30308, United States Suspended
Piedmont Hospital | Atlanta, Georgia, 30309, United States Suspended
Emory University Hospital/Winship Cancer Institute | Atlanta, Georgia, 30322, United States Suspended
Northside Hospital | Atlanta, Georgia, 30342, United States Suspended
Augusta University Medical Center | Augusta, Georgia, 30912, United States Suspended
WellStar Cobb Hospital | Austell, Georgia, 30106, United States Suspended
WellStar Health System Inc | Marietta, Georgia, 30060, United States Suspended
Wellstar Kennestone Hospital | Marietta, Georgia, 30060, United States Suspended
WellStar North Fulton Hospital | Roswell, Georgia, 30076, United States Suspended
Memorial Health University Medical Center | Savannah, Georgia, 31404, United States Active, not recruiting
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler | Savannah, Georgia, 31405, United States Suspended
WellStar Vinings Health Park | Smyrna, Georgia, 30080, United States Suspended
Queen's Medical Center | Honolulu, Hawaii, 96813, United States Active, not recruiting
Kapiolani Medical Center for Women and Children | Honolulu, Hawaii, 96826, United States Active, not recruiting
Saint Alphonsus Cancer Care Center-Boise | Boise, Idaho, 83706, United States Suspended
Saint Luke's Cancer Institute - Boise | Boise, Idaho, 83712, United States Suspended
Saint Luke's Cancer Institute - Fruitland | Fruitland, Idaho, 83619, United States Suspended
Saint Luke's Cancer Institute - Meridian | Meridian, Idaho, 83642, United States Suspended
Saint Luke's Cancer Institute - Nampa | Nampa, Idaho, 83686, United States Suspended
Rush - Copley Medical Center | Aurora, Illinois, 60504, United States Active, not recruiting
Illinois CancerCare-Bloomington | Bloomington, Illinois, 61704, United States Suspended
Illinois CancerCare-Canton | Canton, Illinois, 61520, United States Suspended
Illinois CancerCare-Carthage | Carthage, Illinois, 62321, United States Suspended
Centralia Oncology Clinic | Centralia, Illinois, 62801, United States Suspended
Northwestern University | Chicago, Illinois, 60611, United States Active, not recruiting
John H Stroger Jr Hospital of Cook County | Chicago, Illinois, 60612, United States Suspended
Rush University Medical Center | Chicago, Illinois, 60612, United States Suspended
Presence Saint Joseph Hospital-Chicago | Chicago, Illinois, 60657, United States Active, not recruiting
Cancer Care Specialists of Illinois - Decatur | Decatur, Illinois, 62526, United States Suspended
Decatur Memorial Hospital | Decatur, Illinois, 62526, United States Suspended
Crossroads Cancer Center | Effingham, Illinois, 62401, United States Suspended
Illinois CancerCare-Eureka | Eureka, Illinois, 61530, United States Suspended
NorthShore University HealthSystem-Evanston Hospital | Evanston, Illinois, 60201, United States Suspended
Illinois CancerCare-Galesburg | Galesburg, Illinois, 61401, United States Suspended
Northwestern Medicine Cancer Center Delnor | Geneva, Illinois, 60134, United States Active, not recruiting
NorthShore University HealthSystem-Glenbrook Hospital | Glenview, Illinois, 60026, United States Suspended
NorthShore University HealthSystem-Highland Park Hospital | Highland Park, Illinois, 60035, United States Suspended
Sudarshan K Sharma MD Limited-Gynecologic Oncology | Hinsdale, Illinois, 60521, United States Suspended
Illinois CancerCare-Kewanee Clinic | Kewanee, Illinois, 61443, United States Suspended
Illinois CancerCare-Macomb | Macomb, Illinois, 61455, United States Suspended
Cancer Care Center of O'Fallon | O'Fallon, Illinois, 62269, United States Suspended
Illinois CancerCare-Ottawa Clinic | Ottawa, Illinois, 61350, United States Suspended
Illinois CancerCare-Pekin | Pekin, Illinois, 61554, United States Suspended
Illinois CancerCare-Peoria | Peoria, Illinois, 61615, United States Suspended
Illinois CancerCare-Peru | Peru, Illinois, 61354, United States Suspended
Illinois CancerCare-Princeton | Princeton, Illinois, 61356, United States Suspended
Springfield Clinic | Springfield, Illinois, 62702, United States Suspended
Memorial Medical Center | Springfield, Illinois, 62781, United States Suspended
Northwestern Medicine Cancer Center Warrenville | Warrenville, Illinois, 60555, United States Active, not recruiting
Midwestern Regional Medical Center | Zion, Illinois, 60099, United States Active, not recruiting
Parkview Regional Medical Center | Fort Wayne, Indiana, 46845, United States Suspended
Indiana University/Melvin and Bren Simon Cancer Center | Indianapolis, Indiana, 46202, United States Suspended
Saint Vincent Hospital and Health Care Center | Indianapolis, Indiana, 46260, United States Suspended
Reid Health | Richmond, Indiana, 47374, United States Suspended
Memorial Hospital of South Bend | South Bend, Indiana, 46601, United States Active, not recruiting
Medical Oncology and Hematology Associates-West Des Moines | Clive, Iowa, 50325, United States Suspended
Mercy Cancer Center-West Lakes | Clive, Iowa, 50325, United States Suspended
Iowa Methodist Medical Center | Des Moines, Iowa, 50309, United States Suspended
Medical Oncology and Hematology Associates-Des Moines | Des Moines, Iowa, 50309, United States Suspended
Medical Oncology and Hematology Associates-Laurel | Des Moines, Iowa, 50314, United States Suspended
Mercy Medical Center - Des Moines | Des Moines, Iowa, 50314, United States Suspended
University of Iowa/Holden Comprehensive Cancer Center | Iowa City, Iowa, 52242, United States Suspended
Siouxland Regional Cancer Center | Sioux City, Iowa, 51101, United States Active, not recruiting
Mercy Medical Center-West Lakes | West Des Moines, Iowa, 50266, United States Suspended
Associates In Womens Health | Wichita, Kansas, 67208, United States Active, not recruiting
Ascension Via Christi Hospitals Wichita | Wichita, Kansas, 67214, United States Active, not recruiting
Saint Elizabeth Medical Center South | Edgewood, Kentucky, 41017, United States Suspended
University of Kentucky/Markey Cancer Center | Lexington, Kentucky, 40536, United States Suspended
Hematology/Oncology Clinic PLLC | Baton Rouge, Louisiana, 70809, United States Suspended
Mary Bird Perkins Cancer Center | Baton Rouge, Louisiana, 70809, United States Suspended
Woman's Hospital | Baton Rouge, Louisiana, 70817, United States Suspended
Women's Cancer Care-Covington | Covington, Louisiana, 70433, United States Suspended
Ochsner Medical Center Jefferson | New Orleans, Louisiana, 70121, United States Suspended
Eastern Maine Medical Center | Bangor, Maine, 04401, United States Suspended
Lafayette Family Cancer Center-EMMC | Brewer, Maine, 04412, United States Suspended
Maine Medical Center- Scarborough Campus | Scarborough, Maine, 04074, United States Suspended
Greater Baltimore Medical Center | Baltimore, Maryland, 21204, United States Active, not recruiting
MedStar Franklin Square Medical Center/Weinberg Cancer Institute | Baltimore, Maryland, 21237, United States Terminated
Johns Hopkins University/Sidney Kimmel Cancer Center | Baltimore, Maryland, 21287, United States Suspended
UM Upper Chesapeake Medical Center | Bel Air, Maryland, 21014, United States Active, not recruiting
National Institutes of Health Clinical Center | Bethesda, Maryland, 20892, United States Suspended
TidalHealth Richard A Henson Cancer Institute | Ocean Pines, Maryland, 21811, United States Active, not recruiting
TidalHealth Peninsula Regional | Salisbury, Maryland, 21801, United States Active, not recruiting
Brigham and Women's Hospital | Boston, Massachusetts, 02115, United States Suspended
Dana-Farber Cancer Institute | Boston, Massachusetts, 02215, United States Suspended
UMass Memorial Medical Center - Memorial Division | Worcester, Massachusetts, 01605, United States Active, not recruiting
Saint Joseph Mercy Hospital | Ann Arbor, Michigan, 48106, United States Suspended
University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan, 48109, United States Suspended
Henry Ford Cancer Institute-Downriver | Brownstown, Michigan, 48183, United States Active, not recruiting
Henry Ford Macomb Hospital-Clinton Township | Clinton Township, Michigan, 48038, United States Active, not recruiting
Wayne State University/Karmanos Cancer Institute | Detroit, Michigan, 48201, United States Active, not recruiting
Henry Ford Hospital | Detroit, Michigan, 48202, United States Active, not recruiting
Green Bay Oncology - Escanaba | Escanaba, Michigan, 49829, United States Active, not recruiting
Weisberg Cancer Treatment Center | Farmington Hills, Michigan, 48334, United States Active, not recruiting
Spectrum Health at Butterworth Campus | Grand Rapids, Michigan, 49503, United States Suspended
West Michigan Cancer Center | Kalamazoo, Michigan, 49007, United States Suspended
Sparrow Hospital | Lansing, Michigan, 48912, United States Suspended
Saint Joseph Mercy Oakland | Pontiac, Michigan, 48341, United States Suspended
Munson Medical Center | Traverse City, Michigan, 49684, United States Suspended
Henry Ford West Bloomfield Hospital | West Bloomfield, Michigan, 48322, United States Active, not recruiting
Sanford Joe Lueken Cancer Center | Bemidji, Minnesota, 56601, United States Suspended
Fairview Ridges Hospital | Burnsville, Minnesota, 55337, United States Suspended
Mercy Hospital | Coon Rapids, Minnesota, 55433, United States Suspended
Fairview Southdale Hospital | Edina, Minnesota, 55435, United States Suspended
Mayo Clinic Health Systems-Mankato | Mankato, Minnesota, 56001, United States Active, not recruiting
Fairview Clinics and Surgery Center Maple Grove | Maple Grove, Minnesota, 55369, United States Active, not recruiting
Saint John's Hospital - Healtheast | Maplewood, Minnesota, 55109, United States Suspended
Abbott-Northwestern Hospital | Minneapolis, Minnesota, 55407, United States Suspended
University of Minnesota/Masonic Cancer Center | Minneapolis, Minnesota, 55455, United States Suspended
Mayo Clinic in Rochester | Rochester, Minnesota, 55905, United States Active, not recruiting
Park Nicollet Clinic - Saint Louis Park | Saint Louis Park, Minnesota, 55416, United States Suspended
Regions Hospital | Saint Paul, Minnesota, 55101, United States Suspended
United Hospital | Saint Paul, Minnesota, 55102, United States Suspended
Saint Francis Regional Medical Center | Shakopee, Minnesota, 55379, United States Suspended
Minnesota Oncology Hematology PA-Woodbury | Woodbury, Minnesota, 55125, United States Suspended
University of Mississippi Medical Center | Jackson, Mississippi, 39216, United States Suspended
Saint Francis Medical Center | Cape Girardeau, Missouri, 63703, United States Suspended
University of Missouri - Ellis Fischel | Columbia, Missouri, 65212, United States Suspended
Mercy Hospital Joplin | Joplin, Missouri, 64804, United States Suspended
Barnes-Jewish Hospital | Saint Louis, Missouri, 63110, United States Active, not recruiting
Washington University School of Medicine | Saint Louis, Missouri, 63110, United States Suspended
Mercy Hospital Springfield | Springfield, Missouri, 65804, United States Suspended
CoxHealth South Hospital | Springfield, Missouri, 65807, United States Suspended
Billings Clinic Cancer Center | Billings, Montana, 59101, United States Suspended
Bozeman Deaconess Hospital | Bozeman, Montana, 59715, United States Suspended
Benefis Healthcare- Sletten Cancer Institute | Great Falls, Montana, 59405, United States Suspended
CHI Health Saint Francis | Grand Island, Nebraska, 68803, United States Suspended
CHI Health Good Samaritan | Kearney, Nebraska, 68847, United States Suspended
Nebraska Methodist Hospital | Omaha, Nebraska, 68114, United States Suspended
Alegent Health Bergan Mercy Medical Center | Omaha, Nebraska, 68124, United States Suspended
Alegent Health Lakeside Hospital | Omaha, Nebraska, 68130, United States Suspended
Women's Cancer Center of Nevada | Las Vegas, Nevada, 89169, United States Suspended
Dartmouth Hitchcock Medical Center | Lebanon, New Hampshire, 03756, United States Active, not recruiting
Norris Cotton Cancer Center-Nashua | Nashua, New Hampshire, 03063, United States Active, not recruiting
Cooper Hospital University Medical Center | Camden, New Jersey, 08103, United States Suspended
Hackensack University Medical Center | Hackensack, New Jersey, 07601, United States Withdrawn
The Cancer Institute of New Jersey Hamilton | Hamilton, New Jersey, 08690, United States Active, not recruiting
Morristown Medical Center | Morristown, New Jersey, 07960, United States Suspended
Jersey Shore Medical Center | Neptune, New Jersey, 07753, United States Active, not recruiting
Rutgers Cancer Institute of New Jersey | New Brunswick, New Jersey, 08903, United States Suspended
Robert Wood Johnson University Hospital Somerset | Somerville, New Jersey, 08876, United States Active, not recruiting
Overlook Hospital | Summit, New Jersey, 07902, United States Suspended
MD Anderson Cancer Center at Cooper-Voorhees | Voorhees, New Jersey, 08043, United States Suspended
University of New Mexico Cancer Center | Albuquerque, New Mexico, 87102, United States Suspended
Southwest Gynecologic Oncology Associates Inc | Albuquerque, New Mexico, 87106, United States Suspended
Memorial Medical Center - Las Cruces | Las Cruces, New Mexico, 88011, United States Suspended
Women's Cancer Care Associates LLC | Albany, New York, 12208, United States Suspended
Montefiore Medical Center-Einstein Campus | Bronx, New York, 10461, United States Active, not recruiting
State University of New York Downstate Medical Center | Brooklyn, New York, 11203, United States Active, not recruiting
Roswell Park Cancer Institute | Buffalo, New York, 14263, United States Active, not recruiting
Laura and Isaac Perlmutter Cancer Center at NYU Langone | New York, New York, 10016, United States Suspended
University of Rochester | Rochester, New York, 14642, United States Suspended
Stony Brook University Medical Center | Stony Brook, New York, 11794, United States Active, not recruiting
State University of New York Upstate Medical University | Syracuse, New York, 13210, United States Suspended
Dickstein Cancer Treatment Center | White Plains, New York, 10601, United States Active, not recruiting
AdventHealth Infusion Center Asheville | Asheville, North Carolina, 28803, United States Suspended
UNC Lineberger Comprehensive Cancer Center | Chapel Hill, North Carolina, 27599, United States Suspended
AdventHealth Infusion Center Haywood | Clyde, North Carolina, 28721, United States Suspended
Duke University Medical Center | Durham, North Carolina, 27710, United States Suspended
Southeastern Medical Oncology Center-Goldsboro | Goldsboro, North Carolina, 27534, United States Active, not recruiting
Margaret R Pardee Memorial Hospital | Hendersonville, North Carolina, 28791, United States Active, not recruiting
AdventHealth Hendersonville | Hendersonville, North Carolina, 28792, United States Active, not recruiting
Southeastern Medical Oncology Center-Jacksonville | Jacksonville, North Carolina, 28546, United States Active, not recruiting
FirstHealth of the Carolinas-Moore Regional Hospital | Pinehurst, North Carolina, 28374, United States Suspended
Duke Raleigh Hospital | Raleigh, North Carolina, 27609, United States Suspended
New Hanover Regional Medical Center/Zimmer Cancer Center | Wilmington, North Carolina, 28401, United States Active, not recruiting
Wake Forest University Health Sciences | Winston-Salem, North Carolina, 27157, United States Active, not recruiting
Sanford Bismarck Medical Center | Bismarck, North Dakota, 58501, United States Suspended
Sanford Broadway Medical Center | Fargo, North Dakota, 58122, United States Suspended
Sanford Roger Maris Cancer Center | Fargo, North Dakota, 58122, United States Suspended
Cleveland Clinic Akron General | Akron, Ohio, 44307, United States Active, not recruiting
Aultman Health Foundation | Canton, Ohio, 44710, United States Active, not recruiting
Miami Valley Hospital South | Centerville, Ohio, 45459, United States Suspended
University of Cincinnati Cancer Center-UC Medical Center | Cincinnati, Ohio, 45219, United States Suspended
Good Samaritan Hospital - Cincinnati | Cincinnati, Ohio, 45220, United States Suspended
TriHealth Cancer Institute-Westside | Cincinnati, Ohio, 45247, United States Suspended
MetroHealth Medical Center | Cleveland, Ohio, 44109, United States Suspended
Cleveland Clinic Cancer Center/Fairview Hospital | Cleveland, Ohio, 44111, United States Suspended
Cleveland Clinic Foundation | Cleveland, Ohio, 44195, United States Suspended
Ohio State University Comprehensive Cancer Center | Columbus, Ohio, 43210, United States Suspended
Riverside Methodist Hospital | Columbus, Ohio, 43214, United States Suspended
The Mark H Zangmeister Center | Columbus, Ohio, 43219, United States Suspended
Grandview Hospital | Dayton, Ohio, 45405, United States Active, not recruiting
Orion Cancer Care | Findlay, Ohio, 45840, United States Suspended
Hillcrest Hospital Cancer Center | Mayfield Heights, Ohio, 44124, United States Suspended
ProMedica Flower Hospital | Sylvania, Ohio, 43560, United States Suspended
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital | Toledo, Ohio, 43606, United States Suspended
University of Cincinnati Cancer Center-West Chester | West Chester, Ohio, 45069, United States Suspended
Wright-Patterson Medical Center | Wright-Patterson Air Force Base, Ohio, 45433, United States Active, not recruiting
University of Oklahoma Health Sciences Center | Oklahoma City, Oklahoma, 73104, United States Suspended
Cancer Treatment Centers of America | Tulsa, Oklahoma, 74133, United States Active, not recruiting
Oklahoma Cancer Specialists and Research Institute-Tulsa | Tulsa, Oklahoma, 74146, United States Suspended
Saint Charles Health System | Bend, Oregon, 97701, United States Suspended
Legacy Mount Hood Medical Center | Gresham, Oregon, 97030, United States Suspended
Legacy Good Samaritan Hospital and Medical Center | Portland, Oregon, 97210, United States Suspended
Legacy Meridian Park Hospital | Tualatin, Oregon, 97062, United States Suspended
Jefferson Abington Hospital | Abington, Pennsylvania, 19001, United States Suspended
Saint Luke's University Hospital-Bethlehem Campus | Bethlehem, Pennsylvania, 18015, United States Suspended
Bryn Mawr Hospital | Bryn Mawr, Pennsylvania, 19010, United States Suspended
Geisinger Medical Center | Danville, Pennsylvania, 17822, United States Active, not recruiting
Ephrata Cancer Center | Ephrata, Pennsylvania, 17522, United States Suspended
Ephrata Community Hospital | Ephrata, Pennsylvania, 17522, United States Suspended
Adams Cancer Center | Gettysburg, Pennsylvania, 17325, United States Suspended
Cherry Tree Cancer Center | Hanover, Pennsylvania, 17331, United States Suspended
UPMC Pinnacle Cancer Center/Community Osteopathic Campus | Harrisburg, Pennsylvania, 17109, United States Active, not recruiting
Sechler Family Cancer Center | Lebanon, Pennsylvania, 17042, United States Suspended
Geisinger Medical Oncology-Lewisburg | Lewisburg, Pennsylvania, 17837, United States Active, not recruiting
Paoli Memorial Hospital | Paoli, Pennsylvania, 19301, United States Suspended
University of Pennsylvania/Abramson Cancer Center | Philadelphia, Pennsylvania, 19104, United States Suspended
West Penn Hospital | Pittsburgh, Pennsylvania, 15224, United States Suspended
Guthrie Medical Group PC-Robert Packer Hospital | Sayre, Pennsylvania, 18840, United States Active, not recruiting
Reading Hospital | West Reading, Pennsylvania, 19611, United States Active, not recruiting
Wexford Health and Wellness Pavilion | Wexford, Pennsylvania, 15090, United States Suspended
UPMC Susquehanna | Williamsport, Pennsylvania, 17701, United States Active, not recruiting
Asplundh Cancer Pavilion | Willow Grove, Pennsylvania, 19090, United States Suspended
Lankenau Medical Center | Wynnewood, Pennsylvania, 19096, United States Suspended
WellSpan Health-York Hospital | York, Pennsylvania, 17403, United States Suspended
Women and Infants Hospital | Providence, Rhode Island, 02905, United States Suspended
AnMed Health Cancer Center | Anderson, South Carolina, 29621, United States Suspended
Gibbs Cancer Center-Gaffney | Gaffney, South Carolina, 29341, United States Active, not recruiting
Saint Francis Hospital | Greenville, South Carolina, 29601, United States Active, not recruiting
Saint Francis Cancer Center | Greenville, South Carolina, 29607, United States Active, not recruiting
Gibbs Cancer Center-Pelham | Greer, South Carolina, 29651, United States Active, not recruiting
South Carolina Cancer Specialists PC | Hilton Head Island, South Carolina, 29926-3827, United States Active, not recruiting
Spartanburg Medical Center | Spartanburg, South Carolina, 29303, United States Active, not recruiting
MGC Hematology Oncology-Union | Union, South Carolina, 29379, United States Active, not recruiting
Rapid City Regional Hospital | Rapid City, South Dakota, 57701, United States Recruiting Site Public Contact 605-716-3982 [email protected] Helen L. Frederickson Principal Investigator
Sanford Cancer Center Oncology Clinic | Sioux Falls, South Dakota, 57104, United States Suspended
Avera Cancer Institute | Sioux Falls, South Dakota, 57105, United States Suspended
Sanford USD Medical Center - Sioux Falls | Sioux Falls, South Dakota, 57117-5134, United States Suspended
Regional Cancer Center at Indian Path Community Hospital | Kingsport, Tennessee, 37660, United States Active, not recruiting
Wellmont Holston Valley Hospital and Medical Center | Kingsport, Tennessee, 37660, United States Active, not recruiting
Thompson Cancer Survival Center | Knoxville, Tennessee, 37916, United States Suspended
Thompson Cancer Survival Center - West | Knoxville, Tennessee, 37932, United States Suspended
Vanderbilt University/Ingram Cancer Center | Nashville, Tennessee, 37232, United States Suspended
Parkland Memorial Hospital | Dallas, Texas, 75235, United States Suspended
UT Southwestern/Simmons Cancer Center-Dallas | Dallas, Texas, 75390, United States Suspended
Houston Methodist Hospital | Houston, Texas, 77030, United States Active, not recruiting
Methodist Willowbrook Hospital | Houston, Texas, 77070, United States Active, not recruiting
Houston Methodist Sugar Land Hospital | Sugar Land, Texas, 77479, United States Active, not recruiting
Intermountain Medical Center | Murray, Utah, 84107, United States Suspended
Dixie Medical Center Regional Cancer Center | Saint George, Utah, 84770, United States Suspended
Utah Cancer Specialists-Salt Lake City | Salt Lake City, Utah, 84106, United States Suspended
Huntsman Cancer Institute/University of Utah | Salt Lake City, Utah, 84112, United States Suspended
South Jordan Health Center | South Jordan, Utah, 84009, United States Suspended
Central Vermont Medical Center/National Life Cancer Treatment | Berlin, Vermont, 05602, United States Suspended
University of Vermont Medical Center | Burlington, Vermont, 05401, United States Suspended
University of Vermont and State Agricultural College | Burlington, Vermont, 05405, United States Suspended
University of Virginia Cancer Center | Charlottesville, Virginia, 22908, United States Suspended
VCU Massey Cancer Center at Stony Point | Richmond, Virginia, 23235, United States Suspended
Virginia Commonwealth University/Massey Cancer Center | Richmond, Virginia, 23298, United States Suspended
PeaceHealth Saint Joseph Medical Center | Bellingham, Washington, 98225, United States Suspended
Swedish Cancer Institute-Edmonds | Edmonds, Washington, 98026, United States Suspended
Kadlec Clinic Hematology and Oncology | Kennewick, Washington, 99336, United States Suspended
Skagit Valley Hospital Regional Cancer Care Center | Mount Vernon, Washington, 98274, United States Active, not recruiting
Skagit Valley Hospital | Mount Vernon, Washington, 98274, United States Active, not recruiting
Pacific Gynecology Specialists | Seattle, Washington, 98104, United States Suspended
Fred Hutchinson Cancer Research Center | Seattle, Washington, 98109, United States Suspended
Seattle Cancer Care Alliance | Seattle, Washington, 98109, United States Suspended
Swedish Medical Center-First Hill | Seattle, Washington, 98122-4307, United States Suspended
University of Washington Medical Center - Northwest | Seattle, Washington, 98133, United States Active, not recruiting
Women's Cancer Center of Seattle | Seattle, Washington, 98133, United States Active, not recruiting
University of Washington Medical Center - Montlake | Seattle, Washington, 98195, United States Suspended
Legacy Salmon Creek Hospital | Vancouver, Washington, 98686, United States Suspended
Wenatchee Valley Hospital and Clinics | Wenatchee, Washington, 98801, United States Active, not recruiting
West Virginia University Charleston Division | Charleston, West Virginia, 25304, United States Suspended
Edwards Comprehensive Cancer Center | Huntington, West Virginia, 25701, United States Active, not recruiting
Monongalia Hospital | Morgantown, West Virginia, 26505, United States Active, not recruiting
West Virginia University Healthcare | Morgantown, West Virginia, 26506, United States Suspended
Ascension Saint Elizabeth Hospital | Appleton, Wisconsin, 54915, United States Suspended
Aurora Cancer Care-Southern Lakes VLCC | Burlington, Wisconsin, 53105, United States Suspended
Marshfield Clinic-Chippewa Center | Chippewa Falls, Wisconsin, 54729, United States Active, not recruiting
Marshfield Clinic Cancer Center at Sacred Heart | Eau Claire, Wisconsin, 54701, United States Suspended
Aurora Health Center-Fond du Lac | Fond Du Lac, Wisconsin, 54937, United States Suspended
Aurora Health Care Germantown Health Center | Germantown, Wisconsin, 53022, United States Suspended
Aurora Cancer Care-Grafton | Grafton, Wisconsin, 53024, United States Suspended
Saint Vincent Hospital Cancer Center Green Bay | Green Bay, Wisconsin, 54301, United States Suspended
Saint Vincent Hospital Cancer Center at Saint Mary's | Green Bay, Wisconsin, 54303, United States Suspended
Aurora BayCare Medical Center | Green Bay, Wisconsin, 54311, United States Suspended
Aurora Cancer Care-Kenosha South | Kenosha, Wisconsin, 53142, United States Suspended
Gundersen Lutheran Medical Center | La Crosse, Wisconsin, 54601, United States Active, not recruiting
Marshfield Clinic - Ladysmith Center | Ladysmith, Wisconsin, 54848, United States Active, not recruiting
University of Wisconsin Hospital and Clinics | Madison, Wisconsin, 53792, United States Suspended
Aurora Bay Area Medical Group-Marinette | Marinette, Wisconsin, 54143, United States Suspended
Saint Vincent Hospital Cancer Center at Marinette | Marinette, Wisconsin, 54143, United States Active, not recruiting
Marshfield Medical Center-Marshfield | Marshfield, Wisconsin, 54449, United States Active, not recruiting
Ascension Columbia Saint Mary's Hospital Ozaukee | Mequon, Wisconsin, 53097, United States Suspended
Aurora Cancer Care-Milwaukee | Milwaukee, Wisconsin, 53209, United States Suspended
Ascension Columbia Saint Mary's Hospital - Milwaukee | Milwaukee, Wisconsin, 53211, United States Suspended
Aurora Saint Luke's Medical Center | Milwaukee, Wisconsin, 53215, United States Suspended
Medical College of Wisconsin | Milwaukee, Wisconsin, 53226, United States Suspended
Aurora Sinai Medical Center | Milwaukee, Wisconsin, 53233, United States Suspended
Marshfield Clinic-Minocqua Center | Minocqua, Wisconsin, 54548, United States Active, not recruiting
ProHealth D N Greenwald Center | Mukwonago, Wisconsin, 53149, United States Active, not recruiting
ProHealth Oconomowoc Memorial Hospital | Oconomowoc, Wisconsin, 53066, United States Active, not recruiting
Saint Vincent Hospital Cancer Center at Oconto Falls | Oconto Falls, Wisconsin, 54154, United States Suspended
Ascension Mercy Hospital | Oshkosh, Wisconsin, 54904, United States Suspended
Vince Lombardi Cancer Clinic - Oshkosh | Oshkosh, Wisconsin, 54904, United States Suspended
Aurora Cancer Care-Racine | Racine, Wisconsin, 53406, United States Suspended
Marshfield Medical Center-Rice Lake | Rice Lake, Wisconsin, 54868, United States Active, not recruiting
Vince Lombardi Cancer Clinic-Sheboygan | Sheboygan, Wisconsin, 53081, United States Suspended
Ascension Saint Michael's Hospital | Stevens Point, Wisconsin, 54481, United States Suspended
Marshfield Clinic Stevens Point Center | Stevens Point, Wisconsin, 54482, United States Active, not recruiting
Saint Vincent Hospital Cancer Center at Sturgeon Bay | Sturgeon Bay, Wisconsin, 54235-1495, United States Suspended
Aurora Medical Center in Summit | Summit, Wisconsin, 53066, United States Suspended
Vince Lombardi Cancer Clinic-Two Rivers | Two Rivers, Wisconsin, 54241, United States Suspended
ProHealth Waukesha Memorial Hospital | Waukesha, Wisconsin, 53188, United States Active, not recruiting
UW Cancer Center at ProHealth Care | Waukesha, Wisconsin, 53188, United States Active, not recruiting
Marshfield Clinic-Wausau Center | Wausau, Wisconsin, 54401, United States Active, not recruiting
Aurora Cancer Care-Milwaukee West | Wauwatosa, Wisconsin, 53226, United States Suspended
Aurora West Allis Medical Center | West Allis, Wisconsin, 53227, United States Suspended
Marshfield Medical Center - Weston | Weston, Wisconsin, 54476, United States Active, not recruiting
Marshfield Clinic - Wisconsin Rapids Center | Wisconsin Rapids, Wisconsin, 54494, United States Active, not recruiting
Tom Baker Cancer Centre | Calgary, Alberta, T2N 4N2, Canada Suspended
Cross Cancer Institute | Edmonton, Alberta, T6G 1Z2, Canada Suspended
Royal Victoria Regional Health Centre | Barrie, Ontario, L4M 6M2, Canada Suspended
Juravinski Cancer Centre at Hamilton Health Sciences | Hamilton, Ontario, L8V 5C2, Canada Suspended
Kingston Health Sciences Centre | Kingston, Ontario, K7L 2V7, Canada Suspended
London Regional Cancer Program | London, Ontario, N6A 4L6, Canada Suspended
Algoma District Cancer Program Sault Area Hospital | Sault Ste Marie, Ontario, P6B 0A8, Canada Suspended
Odette Cancer Centre- Sunnybrook Health Sciences Centre | Toronto, Ontario, M4N 3M5, Canada Suspended
University Health Network-Princess Margaret Hospital | Toronto, Ontario, M5G 2M9, Canada Suspended
CIUSSSEMTL-Hopital Maisonneuve-Rosemont | Montreal, Quebec, H1T 2M4, Canada Suspended
CHUM - Hopital Notre-Dame | Montreal, Quebec, H2L 4M1, Canada Suspended
CHUM - Centre Hospitalier de l'Universite de Montreal | Montreal, Quebec, H2X 3E4, Canada Suspended
Jewish General Hospital | Montreal, Quebec, H3T 1E2, Canada Suspended
CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ) | Quebec City, Quebec, G1R 2J6, Canada Suspended
Ehime University Hospital | Toon, Ehime, 791-0295, Japan Suspended
Hokkaido University Hospital | Sapporo, Hokkaido, 060-8648, Japan Suspended
Kagoshima City Hospital | Kagoshima City, Kagoshima, 890-8760, Japan Suspended
The Cancer Institute Hospital Of JFCR | Koto-ku, Tokyo, 135-8550, Japan Suspended
Kindai University | Osaka, 589 8511, Japan Suspended
Saitama Medical University International Medical Center | Saitama, 350-1298, Japan Suspended
National Cancer Center Hospital | Tokyo, 104 0045, Japan Suspended
Keimyung University-Dongsan Medical Center | Dalseo-gu, Daegu, 42601, Korea, Republic of Suspended
Seoul National University Bundang Hospital | Seongnam City, Kyeonggi-do, 463-707, Korea, Republic of Suspended
Gachon University Gil Hospital | Incheon, 405-760, Korea, Republic of Suspended
Asan Medical Center | Seoul, 05505, Korea, Republic of Suspended
Gangnam Severance Hospital | Seoul, 06273, Korea, Republic of Suspended
Kyung Hee University Hospital at Gangdong | Seoul, 134-727, Korea, Republic of Suspended
Korea Cancer Center Hospital | Seoul, 139-706, Korea, Republic of Suspended
Centro Comprensivo de Cancer de UPR | San Juan, 00927, Puerto Rico Active, not recruiting
Sted Land

Canada

Japan

Korea, Republic of

Puerto Rico

United States

Bekreftelsesdato

2021-09-01

Ansvarlig fest

Type: Sponsor

Har utvidet tilgang Nei
Antall våpen 7
Arm Group

Merkelapp: Phase II Arm I (reference regimen)

Type: Active Comparator

Beskrivelse: Patients undergo physician's choice of standard of care chemotherapy, comprising either paclitaxel IV on days 1, 8, 15, and 22 every 28 days (Regimen I); pegylated liposomal doxorubicin hydrochloride IV on day 1 every 28 days (Regimen II); or topotecan hydrochloride IV on days 1, 8, and 15 every 28 days or days 1-5 every 21 days (Regimen III). Treatment continues in the absence of disease progression or unacceptable toxicity. No modification of the assigned regimens, such as additional drugs (gemcitabine, or bevacizumab) is allowed. (12/05/2016)

Merkelapp: Fase II Arm II (cediranibmaleat, olaparib)

Type: Intervenção do microrganismo intestinal no comprometimento cognitivo leve

Beskrivelse: Pasienter får cediranibmaleat PO QD og olaparib PO BID. Sykluser gjentas hver 28. dag i fravær av sykdomsprogresjon eller uakseptabel toksisitet.

Merkelapp: Fase II Arm III (cediranib maleat)

Type: Intervenção do microrganismo intestinal no comprometimento cognitivo leve

Beskrivelse: Pasienter får cediranib maleat PO daglig daglig. Sykluser gjentas hver 28. dag i fravær av sykdomsprogresjon eller uakseptabel toksisitet.

Merkelapp: Fase II arm IV (olaparib)

Type: Intervenção do microrganismo intestinal no comprometimento cognitivo leve

Beskrivelse: Pasienter får olaparib PO BID på dagene 1-28. Sykluser gjentas hver 28. dag i fravær av sykdomsprogresjon eller uakseptabel toksisitet. (I juli 2018 stemte dataovervåkingskomiteen for å ekskludere olaparib alene -regimet).

Merkelapp: Fase III Arm I (referansebehandling)

Type: Aktiv komparator

Beskrivelse: Pasienter gjennomgår legens valgstandard for behandlingskjemoterapi som i fase II arm I. Ingen endring av de tildelte regimene, for eksempel tilleggsmedisiner (gemcitabin eller bevacizumab) er tillatt. (12.05.2016)

Merkelapp: Fase III Arm II (cediranib maleat, olaparib)

Type: Intervenção do microrganismo intestinal no comprometimento cognitivo leve

Beskrivelse: Pasienter får cediranib maleat PO og olaparib PO som i fase II arm II.

Merkelapp: Fase III Arm III (enkeltmiddel cediranibmaleat)

Type: Intervenção do microrganismo intestinal no comprometimento cognitivo leve

Beskrivelse: Pasienter får cediranibmaleat PO som bestemt av fase II -studien. Sykluser gjentas hver 28. dag i fravær av sykdomsprogresjon eller uakseptabel toksisitet.

Informasjon om studiedesign

Tildeling: Tilfeldig

Intervensjonsmodell: Parallell oppgave

Hovedformål: Behandling

Maskering: Ingen (åpen etikett)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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