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Postoperativ kemoterapi med eller uden bevacizumab til patienter med stadium II eller III rektal cancer

20. juni 2023 opdateret af: ECOG-ACRIN Cancer Research Group

Intergroup randomiseret fase III-undersøgelse af postoperativ Oxaliplatin, 5-Fluorouracil og Leucovorin vs. Oxaliplatin, 5-Fluorouracil, Leucovorin og Bevacizumab til patienter med fase II eller III rektal cancer, der modtager præoperativ kemoradiation

Lægemidler, der bruges i kemoterapi, såsom oxaliplatin, leucovorin og fluorouracil, virker på forskellige måder for at stoppe væksten af ​​tumorceller, enten ved at dræbe cellerne eller ved at forhindre dem i at dele sig. Monoklonale antistoffer, såsom bevacizumab, kan blokere tumorvækst på forskellige måder. Nogle blokerer tumorcellernes evne til at vokse og sprede sig. Andre finder tumorceller og hjælper med at dræbe dem eller bære tumor-dræbende stoffer til dem. Bevacizumab kan også stoppe væksten af ​​tumorceller ved at blokere blodtilførslen til tumoren. At give mere end ét lægemiddel (kombinationskemoterapi) sammen med bevacizumab efter operationen kan dræbe eventuelle tumorceller, der er tilbage efter operationen. Det vides endnu ikke, om oxaliplatin, leucovorin og fluorouracil er mere effektive med eller uden bevacizumab til behandling af endetarmskræft. Dette randomiserede fase III-forsøg studerer kombinationskemoterapi for at se, hvor godt det virker med eller uden bevacizumab til behandling af patienter, der er blevet opereret for stadium II eller stadium III endetarmskræft.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

PRIMÆRE MÅL:

I. Sammenlign den samlede overlevelse af patienter, der har gennemgået tidligere operation og neoadjuverende kemoradioterapi for klinisk stadium II eller III rektal cancer behandlet med adjuverende oxaliplatin, leucovorin calcium, fluorouracil med vs uden bevacizumab.

SEKUNDÆRE MÅL:

I. Evaluer tolerance over for behandling, mønstre for svigt og sygdomsfri overlevelse hos patienter behandlet med disse regimer

UNDERSØGENDE MÅL:

I. Vurder langvarig rektalfunktion ved hjælp af patientens tarmfunktion/Uniscale-spørgeskema og underskalaen Functional Assessment of Cancer (FACT)-Diarré hos patienter behandlet med disse regimer.

II. Valider FACT-Diarrhea subskalaen. III. Vurder langsigtede symptomer på oxaliplatin-relateret neurotoksicitet ved hjælp af FACT/Gynecologic Oncology Group (GOG)-neurotoksicitetssubskalaen hos patienter behandlet med disse regimer.

IV. Korreler TS-, DPD- og TP-ekspression (nøglemål for fluorouracil); tilbageholdelse af kromosom 18q-alleler og mikrosatellitinstabilitet (MSI) med TGFβ1RII-mutation (markører for fluorouracil-effektivitet); ERCC1-, ERCC2- og XPF-ekspression (deltagere i reparation af addukter fra oxaliplatin); og p53-genmutation og muligvis andre molekylære markører, der er relevante for vaskulær endotelvækstfaktor i tumorvævsprøver med behandlingseffektivitet hos disse patienter.

V. Korreler tumormolekylære prognostiske markører (kromosom 18q alleltab og MSI) med overlevelse hos patienter behandlet med dette regime.

OMRIDS:

Dette er en randomiseret undersøgelse. Patienterne er stratificeret efter Eastern Cooperative Oncology Group (ECOG) præstationsstatus (0 vs 1), klinisk stadieinddeling (høj risiko [T3, N+, M0 eller T4, enhver N, M0] vs lav risiko [T1-2, N+, M0 eller T3, N0, M0]), forudgående præoperativ oxaliplatin (ja vs nej) og forudgående strålebehandlingsdosis (40-50 Gy vs > 50-55,8 Gy). Patienterne randomiseres til 1 ud af 2 behandlingsarme i forholdet 1:1.

ARM I: Patienterne får oxaliplatin intravenøst ​​(IV) over 2 timer, leucovorin calcium IV over 2 timer og fluorouracil IV på dag 1 efterfulgt af fluorouracil IV kontinuerligt over 46 timer på dag 1 og 2. Behandlingen gentages hver 2. uge i op til 12. forløb* i fravær af sygdomsprogression eller uacceptabel toksicitet.

ARM II: Patienterne får bevacizumab** IV over 30-90 minutter på dag 1. Patienterne får også oxaliplatin, leucovorin calcium og fluorouracil som i arm I*.

[Bemærk: *Patienter, der tidligere har modtaget neoadjuverende oxaliplatin, inklusive patienter på protokol NSABP-R-04, modtager op til 9 behandlingsforløb efterfulgt af leucovorin calcium IV og fluorouracil IV med (arm II) eller uden (arm I) bevacizumab i op til 3 kurser.]

[Bemærk: **Patienter modtager ikke længere bevacizumab pr. 29.4.2009, da optjening blev afsluttet på grund af langsom optjening for undersøgelsen)]

Patienterne udfylder 10-15 minutters spørgeskemaer om tarmfunktion ved randomisering, afslutning af behandlingen, 12 måneder efter behandling og derefter årligt til 5 år efter behandling.

Efter afslutning af undersøgelsesbehandlingen følges patienterne periodisk i ca. 10 år.

PROJEKTERET OPSLAG: 2100 patienter

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

355

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute
    • New Brunswick
      • Saint John, New Brunswick, Canada, E2L 4L2
        • Atlantic Health Sciences Corporation-Saint John Regional Hospital
    • Ontario
      • Kitchener, Ontario, Canada, N2G 1G3
        • Grand River Regional Cancer Centre at Grand River Hospital
      • London, Ontario, Canada, N6A 4L6
        • London Regional Cancer Program
      • Mississauga, Ontario, Canada, L5M 2N1
        • Credit Valley Hospital
      • Oshawa, Ontario, Canada, L1G 2B9
        • Lakeridge Health Oshawa
      • Ottawa, Ontario, Canada, K1H 1C4
        • Ottawa Health Research Institute-General Division
      • Thunder Bay, Ontario, Canada, P7B 6V4
        • Thunder Bay Regional Health Science Centre
      • Toronto, Ontario, Canada, M5G 2M9
        • University Health Network-Princess Margaret Hospital
      • Toronto, Ontario, Canada, M5B 1W8
        • Saint Michael's Hospital
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2H1
        • CSSS Champlain-Charles Le Moyne
      • Quebec City, Quebec, Canada, G1R 2J6
        • CHUQ - Pavilion Hotel-Dieu de Quebec
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4T 7T1
        • Allan Blair Cancer Centre
      • Saskatoon, Saskatchewan, Canada, S7N 4H4
        • Saskatoon Cancer Centre
  • Forenede Stater
    • Alabama
      • Mobile, Alabama, Forenede Stater, 36608
        • Providence Hospital
    • Alaska
      • Anchorage, Alaska, Forenede Stater, 99508
        • Providence Alaska Medical Center
    • Arizona
      • Scottsdale, Arizona, Forenede Stater, 85259
        • Mayo Clinic in Arizona
    • Arkansas
      • Jonesboro, Arkansas, Forenede Stater, 72401
        • Saint Bernards Regional Medical Center
    • California
      • Berkeley, California, Forenede Stater, 94704
        • Alta Bates Summit Medical Center-Herrick Campus
      • Burlingame, California, Forenede Stater, 94010
        • Mills - Peninsula Hospitals
      • Castro Valley, California, Forenede Stater, 94546
        • Eden Hospital Medical Center
      • Castro Valley, California, Forenede Stater, 94546
        • East Bay Radiation Oncology Center
      • Castro Valley, California, Forenede Stater, 94546
        • Valley Medical Oncology Consultants-Castro Valley
      • Fremont, California, Forenede Stater, 94538
        • Valley Medical Oncology Consultants-Fremont
      • Fremont, California, Forenede Stater, 94538
        • Kaiser Permanente, Fremont
      • Fresno, California, Forenede Stater, 93720
        • Cancer Care Associates of Fresno Medical Group Inc
      • Fullerton, California, Forenede Stater, 92835
        • Saint Jude Medical Center
      • Glendale, California, Forenede Stater, 91204
        • Glendale Memorial Hospital and Health Center
      • Greenbrae, California, Forenede Stater, 94904
        • Marin General Hospital
      • Hayward, California, Forenede Stater, 94545
        • Saint Rose Hospital
      • Hayward, California, Forenede Stater, 94545
        • Kaiser Permanente, Hayward
      • Los Angeles, California, Forenede Stater, 90033
        • University of Southern California/Norris Cancer Center
      • Martinez, California, Forenede Stater, 94553-3156
        • Contra Costa Regional Medical Center
      • Marysville, California, Forenede Stater, 95901
        • Fremont - Rideout Cancer Center
      • Monterey, California, Forenede Stater, 93940
        • Community Hospital of Monterey Peninsula
      • Mountain View, California, Forenede Stater, 94040
        • El Camino Hospital
      • Mountain View, California, Forenede Stater, 94040
        • Palo Alto Medical Foundation-Camino Division
      • Novato, California, Forenede Stater, 94945
        • Sutter Cancer Research Consortium
      • Oakland, California, Forenede Stater, 94611
        • Kaiser Permanente-Oakland
      • Oakland, California, Forenede Stater, 94609
        • Alta Bates Summit Medical Center - Summit Campus
      • Oakland, California, Forenede Stater, 94609
        • Bay Area Tumor Institute CCOP
      • Oakland, California, Forenede Stater, 94602
        • Highland General Hospital
      • Oakland, California, Forenede Stater, 94609
        • Bay Area Breast Surgeons Inc
      • Oakland, California, Forenede Stater, 94609
        • Larry G Strieff MD Medical Corporation
      • Oakland, California, Forenede Stater, 94609
        • Tom K Lee Inc
      • Palm Springs, California, Forenede Stater, 92262
        • Desert Regional Medical Center
      • Palo Alto, California, Forenede Stater, 94301
        • Palo Alto Medical Foundation Heath Care
      • Pleasanton, California, Forenede Stater, 94588
        • Valley Care Health System - Pleasanton
      • Pleasanton, California, Forenede Stater, 94588
        • Valley Medical Oncology Consultants
      • Redwood City, California, Forenede Stater, 94063
        • Kaiser Permanente-Redwood City
      • Richmond, California, Forenede Stater, 94801
        • Kaiser Permanente-Richmond
      • Roseville, California, Forenede Stater, 95661
        • Kaiser Permanente-Roseville
      • Sacramento, California, Forenede Stater, 95823
        • Kaiser Permanente-South Sacramento
      • Sacramento, California, Forenede Stater, 95825
        • Kaiser Permanente - Sacramento
      • Sacramento, California, Forenede Stater, 95817
        • University of California at Davis Cancer Center
      • Salinas, California, Forenede Stater, 93901
        • Salinas Valley Memorial
      • San Diego, California, Forenede Stater, 92103
        • University of California at San Diego
      • San Diego, California, Forenede Stater, 92120
        • Kaiser Permanente
      • San Francisco, California, Forenede Stater, 94115
        • Kaiser Permanente-San Francisco
      • San Francisco, California, Forenede Stater, 94118
        • California Pacific Medical Center
      • San Jose, California, Forenede Stater, 95119
        • Kaiser Permanente-Santa Teresa-San Jose
      • San Pablo, California, Forenede Stater, 94806
        • Doctors Medical Center- JC Robinson Regional Cancer Center
      • San Rafael, California, Forenede Stater, 94903
        • Kaiser Permanente-San Rafael
      • Santa Clara, California, Forenede Stater, 95051
        • Kaiser Permanente Medical Center - Santa Clara
      • Santa Rosa, California, Forenede Stater, 95403
        • Kaiser Permanente-Santa Rosa
      • South San Francisco, California, Forenede Stater, 94080
        • Kaiser Permanente-South San Francisco
      • Stockton, California, Forenede Stater, 95210
        • Kaiser Permanente-Stockton
      • Truckee, California, Forenede Stater, 96161
        • Tahoe Forest Cancer Center
      • Vallejo, California, Forenede Stater, 94589
        • Kaiser Permanente-Vallejo
      • Vallejo, California, Forenede Stater, 94589
        • Sutter Solano Medical Center
      • Walnut Creek, California, Forenede Stater, 94596
        • Kaiser Permanente-Walnut Creek
    • 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
      • Colorado Springs, Colorado, Forenede Stater, 80909
        • Memorial Hospital Colorado Springs
      • 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, 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
      • Pueblo, Colorado, Forenede Stater, 81004
        • Saint Mary Corwin Medical Center
      • Thornton, Colorado, Forenede Stater, 80229
        • North Suburban Medical Center
      • Wheat Ridge, Colorado, Forenede Stater, 80033
        • Exempla Lutheran Medical Center
    • Connecticut
      • Norwich, Connecticut, Forenede Stater, 06360
        • Eastern Connecticut Hematology and Oncology Associates
    • Delaware
      • Lewes, Delaware, Forenede Stater, 19958
        • Beebe Medical Center
      • Newark, Delaware, Forenede Stater, 19718
        • Christiana Care Health System-Christiana Hospital
    • District of Columbia
      • Washington, District of Columbia, Forenede Stater, 20010
        • Washington Hospital Center
      • Washington, District of Columbia, Forenede Stater, 20057
        • Lombardi Comprehensive Cancer Center at Georgetown University
    • Florida
      • Fort Lauderdale, Florida, Forenede Stater, 33308
        • Holy Cross Hospital
      • Jacksonville, Florida, Forenede Stater, 32224-9980
        • Mayo Clinic in Florida
      • Jupiter, Florida, Forenede Stater, 33458
        • Jupiter Medical Center
      • Lakeland, Florida, Forenede Stater, 33805
        • The Watson Clinic
      • Miami, Florida, Forenede Stater, 33136
        • University of Miami Miller School of Medicine-Sylvester Cancer Center
      • Miami Beach, Florida, Forenede Stater, 33140
        • Mount Sinai Medical Center CCOP
      • Orange Park, Florida, Forenede Stater, 32073
        • Cancer Specialists of North Florida-Orange Park
    • Georgia
      • Athens, Georgia, Forenede Stater, 30607
        • University Cancer and Blood Center LLC
      • Atlanta, Georgia, Forenede Stater, 30309
        • Piedmont Hospital
      • Atlanta, Georgia, Forenede Stater, 30342
        • Northside Hospital
      • Atlanta, Georgia, Forenede Stater, 30342
        • Saint Joseph's Hospital of Atlanta
      • Atlanta, Georgia, Forenede Stater, 30342
        • Atlanta Regional CCOP
      • Augusta, Georgia, Forenede Stater, 30912
        • Georgia Regents University
      • Austell, Georgia, Forenede Stater, 30106
        • Well Star Cobb Hospital
      • Decatur, Georgia, Forenede Stater, 30033
        • Dekalb Medical Center
      • Decatur, Georgia, Forenede Stater, 30033
        • Atlanta VA Medical Center
      • Lawrenceville, Georgia, Forenede Stater, 30045
        • Gwinnett Medical Center
      • Macon, Georgia, Forenede Stater, 31208
        • Medical Center of Central Georgia
      • 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, 31403
        • Memorial Health University Medical Center
    • 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, 96826
        • Kapiolani Medical Center for Women and Children
      • Honolulu, Hawaii, Forenede Stater, 96859
        • Tripler Army Medical Center
      • Honolulu, Hawaii, Forenede Stater, 96813
        • University of Hawaii
      • Honolulu, Hawaii, Forenede Stater, 96813
        • Oncare Hawaii Inc-POB II
      • Honolulu, Hawaii, Forenede Stater, 96817
        • Oncare Hawaii Inc-Kuakini
      • Wailuku, Hawaii, Forenede Stater, 96793
        • Maui Memorial Medical Center
      • Wailuku, Hawaii, Forenede Stater, 96793
        • Pacific Cancer Institute of Maui
    • Idaho
      • Boise, Idaho, Forenede Stater, 83712
        • Saint Luke's Mountain States Tumor Institute
      • Boise, Idaho, Forenede Stater, 83706
        • Saint Alphonsus Regional Medical Center
      • Idaho Falls, Idaho, Forenede Stater, 83404
        • Hematology Oncology Associates of Eastern Idaho
      • Pocatello, Idaho, Forenede Stater, 83201
        • Portneuf Medical Center
    • Illinois
      • Alton, Illinois, Forenede Stater, 62002
        • Saint Anthony's Health
      • Aurora, Illinois, Forenede Stater, 60504
        • Rush - Copley Medical Center
      • Bloomington, Illinois, Forenede Stater, 61701
        • Saint Joseph Medical Center
      • Canton, Illinois, Forenede Stater, 61520
        • Graham Hospital Association
      • Carthage, Illinois, Forenede Stater, 62321
        • Memorial Hospital
      • Chicago, Illinois, Forenede Stater, 60611
        • Northwestern University
      • Chicago, Illinois, Forenede Stater, 60612
        • Rush University Medical Center
      • Chicago, Illinois, Forenede Stater, 60637
        • University of Chicago
      • Chicago, Illinois, Forenede Stater, 60608
        • Mount Sinai Hospital Medical Center
      • Chicago, Illinois, Forenede Stater, 60625
        • Swedish Covenant Hospital
      • Chicago, Illinois, Forenede Stater, 60611
        • Hematology and Oncology Associates
      • Chicago, Illinois, Forenede Stater, 60631
        • Resurrection Healthcare
      • Chicago, Illinois, Forenede Stater, 60612
        • Jesse Brown Veterans Affairs Medical Center
      • Chicago, Illinois, Forenede Stater, 60612-3785
        • John H Stroger Jr Hospital of Cook County
      • Chicago, Illinois, Forenede Stater, 60616
        • Mercy Hospital and Medical Center
      • Decatur, Illinois, Forenede Stater, 62526
        • Decatur Memorial Hospital
      • Downers Grove, Illinois, Forenede Stater, 60515
        • Good Samaritan Hospital
      • Elmhurst, Illinois, Forenede Stater, 60126
        • Elmhurst Memorial Hospital
      • Eureka, Illinois, Forenede Stater, 61530
        • Eureka Hospital
      • Evanston, Illinois, Forenede Stater, 60201
        • NorthShore University HealthSystem-Evanston Hospital
      • Evanston, Illinois, Forenede Stater, 60202
        • Saint Francis Hospital
      • Galesburg, Illinois, Forenede Stater, 61401
        • Western Illinois Cancer Treatment Center
      • Galesburg, Illinois, Forenede Stater, 61401
        • Galesburg Cottage Hospital
      • Galesburg, Illinois, Forenede Stater, 61401
        • Illinois CancerCare Galesburg
      • Havana, Illinois, Forenede Stater, 62644
        • Mason District Hospital
      • Hinsdale, Illinois, Forenede Stater, 60521
        • Hinsdale Hematology Oncology Associates Incorporated
      • Hopedale, Illinois, Forenede Stater, 61747
        • Hopedale Medical Complex - Hospital
      • Joliet, Illinois, Forenede Stater, 60435
        • Joliet Oncology-Hematology Associates Limited
      • Joliet, Illinois, Forenede Stater, 60432
        • Midwest Center for Hematology Oncology
      • Kewanee, Illinois, Forenede Stater, 61443
        • Kewanee Hospital
      • Libertyville, Illinois, Forenede Stater, 60048
        • North Shore Hematology Oncology
      • 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
        • Sharis, Christine M MD (UIA Investigator)
      • Moline, Illinois, Forenede Stater, 61265
        • Stoffel, Thomas J MD (UIA Investigator)
      • Moline, Illinois, Forenede Stater, 61265
        • Vigliotti, Antonio, P.G. M.D. (UIA Investigator)
      • Mount Vernon, Illinois, Forenede Stater, 62864
        • Good Samaritan Regional Health Center
      • Naperville, Illinois, Forenede Stater, 60540
        • Edward Hospital/Cancer Center
      • Niles, Illinois, Forenede Stater, 60714
        • Illinois Cancer Specialists-Niles
      • Normal, Illinois, Forenede Stater, 61761
        • Community Cancer Center Foundation
      • Normal, Illinois, Forenede Stater, 61761
        • Bromenn Regional Medical 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
        • 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
        • Valley Radiation Oncology
      • Peru, Illinois, Forenede Stater, 61354
        • Illinois Valley Hospital
      • Princeton, Illinois, Forenede Stater, 61356
        • Perry Memorial Hospital
      • Rockford, Illinois, Forenede Stater, 61104
        • Swedish American Hospital
      • Skokie, Illinois, Forenede Stater, 60076
        • Hematology Oncology Associates of Illinois - Skokie
      • Skokie, Illinois, Forenede Stater, 60076
        • Edward H Kaplan MD and Associates
      • Skokie, Illinois, Forenede Stater, 60077
        • Midwest Cancer Research Group Incorporated
      • Spring Valley, Illinois, Forenede Stater, 61362
        • Saint Margaret's Hospital
      • Springfield, Illinois, Forenede Stater, 62781-0001
        • Memorial Medical Center
      • Urbana, Illinois, Forenede Stater, 61801
        • Carle Cancer Center
      • Urbana, Illinois, Forenede Stater, 61801
        • Carle Clinic-Urbana Main
    • Indiana
      • Beech Grove, Indiana, Forenede Stater, 46107
        • Saint Francis Hospital and Health Centers
      • Elkhart, Indiana, Forenede Stater, 46515
        • Elkhart General Hospital
      • Fort Wayne, Indiana, Forenede Stater, 46845
        • Fort Wayne Medical Oncology and Hematology Inc-Parkview
      • Indianapolis, Indiana, Forenede Stater, 46260
        • Saint Vincent Hospital and Health Services
      • Kokomo, Indiana, Forenede Stater, 46904
        • Community Howard Regional Health
      • La Porte, Indiana, Forenede Stater, 46350
        • IU Health La Porte Hospital
      • Michigan City, Indiana, Forenede Stater, 46360
        • Franciscan Saint Anthony Health-Michigan City
      • Mishawaka, Indiana, Forenede Stater, 46545-1470
        • Saint Joseph Regional Medical Center-Mishawaka
      • Muncie, Indiana, Forenede Stater, 47303
        • IU Health Ball Memorial Hospital
      • Newburgh, Indiana, Forenede Stater, 47630
        • Oncology Hematology Associates of Southwest Indiana
      • 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, 46628
        • Northern Indiana Cancer Research Consortium
    • 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)
      • 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
      • Davenport, Iowa, Forenede Stater, 52803
        • Genesis Medical Center - East Campus
      • Davenport, Iowa, Forenede Stater, 52804
        • Genesis Medical Center - West Campus
      • 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, 50307
        • Mercy Capitol
      • Des Moines, Iowa, Forenede Stater, 50309
        • Iowa Oncology Research Association CCOP
      • Iowa City, Iowa, Forenede Stater, 52242
        • University of Iowa Hospitals and Clinics
      • Mason City, Iowa, Forenede Stater, 50401
        • Mercy Medical Center - North Iowa
      • Sioux City, Iowa, Forenede Stater, 51104
        • Saint Luke's Regional Medical Center
      • Sioux City, Iowa, Forenede Stater, 51101-1733
        • Siouxland Regional Cancer Center
      • Sioux City, Iowa, Forenede Stater, 51101
        • Siouxland Hematology Oncology Associates
      • Sioux City, Iowa, Forenede Stater, 51104
        • Mercy Medical Center-Sioux City
      • Waterloo, Iowa, Forenede Stater, 50702
        • Covenant Medical Center
      • Waterloo, Iowa, Forenede Stater, 50701
        • Cedar Valley Medical Specialists
    • Kansas
      • Anthony, Kansas, Forenede Stater, 67003
        • Hospital District Sixth of Harper County
      • 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
      • Kansas City, Kansas, Forenede Stater, 66160
        • University of Kansas Medical Center
      • Kingman, Kansas, Forenede Stater, 67068
        • Cancer Center of Kansas-Kingman
      • Lawrence, Kansas, Forenede Stater, 66044
        • Lawrence Memorial Hospital
      • Newton, Kansas, Forenede Stater, 67114
        • Cancer Center of Kansas - Newton
      • Olathe, Kansas, Forenede Stater, 66061
        • Olathe Cancer Center
      • Parsons, Kansas, Forenede Stater, 67357
        • Cancer Center of Kansas - Parsons
      • Pratt, Kansas, Forenede Stater, 67124
        • Cancer Center of Kansas - Pratt
      • Salina, Kansas, Forenede Stater, 67401
        • Cancer Center of Kansas - Salina
      • Topeka, Kansas, Forenede Stater, 66604
        • Stormont-Vail Regional Health Center
      • 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, 40202
        • The James Graham Brown Cancer Center at University of Louisville
    • Maine
      • Bangor, Maine, Forenede Stater, 04401
        • Eastern Maine Medical Center
      • Lewiston, Maine, Forenede Stater, 04240
        • Saint Mary's Regional Medical Center
      • Scarborough, Maine, Forenede Stater, 04074
        • Maine Medical Center- Scarborough Campus
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21237
        • Franklin Square Hospital Center
      • Easton, Maryland, Forenede Stater, 21601
        • Memorial Hospital at Easton - Shore Regional Cancer Center
      • Elkton, Maryland, Forenede Stater, 21921
        • Union Hospital of Cecil County
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02215
        • Eastern Cooperative Oncology Group
      • Brighton, Massachusetts, Forenede Stater, 02135-2997
        • Caritas Saint Elizabeth's Medical Center
      • Burlington, Massachusetts, Forenede Stater, 01805
        • Lahey Hospital and Medical Center
      • Fitchburg, Massachusetts, Forenede Stater, 01420
        • Simonds-Sinon Regional Cancer Center
      • Pittsfield, Massachusetts, Forenede Stater, 01201
        • Berkshire Hematology Oncology PC
      • Worcester, Massachusetts, Forenede Stater, 01655
        • University of Massachusetts Medical School
    • Michigan
      • Adrian, Michigan, Forenede Stater, 49221
        • Bixby Medical Center
      • Adrian, Michigan, Forenede Stater, 49221
        • Hickman Cancer Center
      • Ann Arbor, Michigan, Forenede Stater, 48106-0995
        • Saint Joseph Mercy Hospital
      • Ann Arbor, Michigan, Forenede Stater, 48106
        • Michigan Cancer Research Consortium Community Clinical Oncology Program
      • Battle Creek, Michigan, Forenede Stater, 49017
        • Bronson Battle Creek
      • Big Rapids, Michigan, Forenede Stater, 49307
        • Spectrum Health Big Rapids Hospital
      • Dearborn, Michigan, Forenede Stater, 48124
        • Oakwood Hospital
      • Detroit, Michigan, Forenede Stater, 48236
        • Saint John Hospital and Medical Center
      • Detroit, Michigan, Forenede Stater, 48201
        • Wayne State University/Karmanos Cancer Institute
      • 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
      • Grand Rapids, Michigan, Forenede Stater, 49503
        • Spectrum Health at Butterworth Campus
      • Grand Rapids, Michigan, Forenede Stater, 49503
        • Mercy Health Saint Mary's
      • Grand Rapids, Michigan, Forenede Stater, 49503
        • Grand Rapids Clinical Oncology Program
      • Holland, Michigan, Forenede Stater, 49423
        • Holland Community Hospital
      • Iron Mountain, Michigan, Forenede Stater, 49801
        • Green Bay Oncology - Iron Mountain
      • Jackson, Michigan, Forenede Stater, 49201
        • Allegiance Health
      • Lansing, Michigan, Forenede Stater, 48912
        • Sparrow Hospital
      • Livonia, Michigan, Forenede Stater, 48154
        • Saint Mary Mercy Hospital
      • Marquette, Michigan, Forenede Stater, 49855
        • Marquette General Hospital
      • Monroe, Michigan, Forenede Stater, 48162
        • Mercy Memorial Hospital
      • Monroe, Michigan, Forenede Stater, 48162
        • Community Cancer Center of Monroe
      • Muskegon, Michigan, Forenede Stater, 49444
        • Mercy Health Mercy Campus
      • Muskegon, Michigan, Forenede Stater, 49442
        • Mercy Health Partners-Hackley Campus
      • Pontiac, Michigan, Forenede Stater, 48341-2985
        • Saint Joseph Mercy Oakland
      • Port Huron, Michigan, Forenede Stater, 48060
        • Saint Joseph Mercy Port Huron
      • Royal Oak, Michigan, Forenede Stater, 48073
        • William Beaumont Hospital-Royal Oak
      • Saginaw, Michigan, Forenede Stater, 48601
        • Saint Mary's of Michigan
      • Saint Joseph, Michigan, Forenede Stater, 49085
        • Lakeland Hospital
      • Traverse City, Michigan, Forenede Stater, 49684
        • Munson Medical Center
      • Warren, Michigan, Forenede Stater, 48093
        • Saint John Macomb-Oakland Hospital
      • Wyoming, Michigan, Forenede Stater, 49519
        • Metro Health Hospital
    • Minnesota
      • Bemidji, Minnesota, Forenede Stater, 56601
        • Sanford Clinic North-Bemidgi
      • Burnsville, Minnesota, Forenede Stater, 55337
        • Fairview Ridges Hospital
      • Coon Rapids, Minnesota, Forenede Stater, 55433
        • Mercy Hospital
      • Duluth, Minnesota, Forenede Stater, 55805
        • Essentia Health Saint Mary's Medical Center
      • Duluth, Minnesota, Forenede Stater, 55805
        • Miller-Dwan Hospital
      • Duluth, Minnesota, Forenede Stater, 55805
        • Essentia Health Duluth Clinic CCOP
      • Edina, Minnesota, Forenede Stater, 55435
        • Fairview-Southdale Hospital
      • Fridley, Minnesota, Forenede Stater, 55432
        • Unity Hospital
      • Hutchinson, Minnesota, Forenede Stater, 55350
        • Hutchinson Area Health Care
      • Litchfield, Minnesota, Forenede Stater, 55355
        • Meeker County Memorial Hospital
      • 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, 55407
        • Virginia Piper Cancer Institute
      • 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 Louis Park, Minnesota, Forenede Stater, 55416
        • Park Nicollet Clinic - Saint Louis Park
      • Saint Louis Park, Minnesota, Forenede Stater, 55416
        • Metro-Minnesota CCOP
      • Saint Paul, Minnesota, Forenede Stater, 55101
        • Regions Hospital
      • Saint Paul, Minnesota, Forenede Stater, 55102
        • United Hospital
      • Saint Paul, Minnesota, Forenede Stater, 55102
        • Saint Joseph's Hospital - Healtheast
      • Shakopee, Minnesota, Forenede Stater, 55379
        • Saint Francis Regional Medical Center
      • Waconia, Minnesota, Forenede Stater, 55387
        • Ridgeview Medical Center
      • Willmar, Minnesota, Forenede Stater, 56201
        • Rice Memorial Hospital
      • Woodbury, Minnesota, Forenede Stater, 55125
        • Woodwinds Health Campus
      • Woodbury, Minnesota, Forenede Stater, 55125
        • Minnesota Oncology and Hematology PA-Woodbury
    • Missouri
      • Cape Girardeau, Missouri, Forenede Stater, 63703
        • Saint Francis Medical Center
      • Cape Girardeau, Missouri, Forenede Stater, 63701
        • Southeast Missouri Hospital
      • Joplin, Missouri, Forenede Stater, 64804
        • Freeman Health System
      • Joplin, Missouri, Forenede Stater, 64804
        • Mercy Hospital-Joplin
      • Saint Louis, Missouri, Forenede Stater, 63110
        • Washington University School of Medicine
      • Saint Louis, Missouri, Forenede Stater, 63110
        • Saint Louis University Hospital
      • Saint Louis, Missouri, Forenede Stater, 63131
        • Missouri Baptist Medical Center
      • Saint Louis, Missouri, Forenede Stater, 63109
        • Saint Louis Cancer and Breast Institute-South City
      • Saint Louis, Missouri, Forenede Stater, 63141
        • Saint John's Mercy Medical Center
      • Saint Louis, Missouri, Forenede Stater, 63141
        • Saint Louis-Cape Girardeau CCOP
      • Saint Louis, Missouri, Forenede Stater, 63141
        • Center for Cancer Care and Research
      • 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
        • Hematology-Oncology Centers of the Northern Rockies PC
      • Billings, Montana, Forenede Stater, 59107-7000
        • Billings Clinic
      • Billings, Montana, Forenede Stater, 59107
        • Deaconess Medical 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)
      • 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, 68114
        • Nebraska Methodist Hospital
      • Omaha, Nebraska, Forenede Stater, 68198
        • University of Nebraska Medical 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 CCOP
    • 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
      • Exeter, New Hampshire, Forenede Stater, 03833
        • Exeter Hospital
      • Keene, New Hampshire, Forenede Stater, 03431
        • Cheshire Medical Center-Dartmouth-Hitchcock Keene
      • Manchester, New Hampshire, Forenede Stater, 03103
        • Elliot Hospital
    • New Jersey
      • Brick, New Jersey, Forenede Stater, 08724
        • Ocean Medical Center
      • Camden, New Jersey, Forenede Stater, 08103
        • Cooper Hospital University Medical Center
      • Hamilton, New Jersey, Forenede Stater, 08690
        • Cancer Institute of New Jersey At Hamilton
      • Long Branch, New Jersey, Forenede Stater, 07740
        • Monmouth Medical Center
      • Montclair, New Jersey, Forenede Stater, 07042
        • Mountainside Hospital
      • Morristown, New Jersey, Forenede Stater, 07962
        • Morristown Memorial Hospital
      • Mount Holly, New Jersey, Forenede Stater, 08060
        • Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County
      • New Brunswick, New Jersey, Forenede Stater, 08903
        • Rutgers Cancer Institute of New Jersey
      • Newark, New Jersey, Forenede Stater, 07112
        • Newark Beth Israel Medical Center
      • Ridgewood, New Jersey, Forenede Stater, 07450
        • Valley Hospital
      • Sparta, New Jersey, Forenede Stater, 07871
        • Sparta Cancer Treatment Center
      • Summit, New Jersey, Forenede Stater, 07902
        • Overlook Hospital
      • Voorhees, New Jersey, Forenede Stater, 08043
        • Virtua West Jersey Hospital Voorhees
    • New Mexico
      • Albuquerque, New Mexico, Forenede Stater, 87106
        • University of New Mexico Cancer Center
      • Albuquerque, New Mexico, Forenede Stater, 87106
        • Hematology Oncology Associates
      • Albuquerque, New Mexico, Forenede Stater, 87110
        • Presbyterian Kaseman Hospital
      • Santa Fe, New Mexico, Forenede Stater, 87505
        • New Mexico Cancer Care Associates
    • New York
      • Bronx, New York, Forenede Stater, 10461
        • Albert Einstein College of Medicine
      • Bronx, New York, Forenede Stater, 10467-2490
        • Montefiore Medical Center
      • Brooklyn, New York, Forenede Stater, 11203
        • Kings County Hospital
      • Brooklyn, New York, Forenede Stater, 11203
        • University Hospital of Brooklyn
      • Brooklyn, New York, Forenede Stater, 11203
        • State University of New York Downstate Medical Center
      • Buffalo, New York, Forenede Stater, 14263
        • Roswell Park Cancer Institute
      • Buffalo, New York, Forenede Stater, 14215
        • Veterans Affairs Western New York Health Care System-Buffalo
      • East Syracuse, New York, Forenede Stater, 13057
        • Hematology Oncology Associates of Central New York PC-East Syracuse
      • Glens Falls, New York, Forenede Stater, 12801
        • Glens Falls Hospital
      • Middletown, New York, Forenede Stater, 10940
        • Orange Regional Medical Center
      • New York, New York, Forenede Stater, 10032
        • Columbia University Medical Center
      • New York, New York, Forenede Stater, 10065
        • Weill Medical College of Cornell University
      • New York, New York, Forenede Stater, 10016
        • New York University Langone Medical Center
      • Rochester, New York, Forenede Stater, 14642
        • University of Rochester
      • Rochester, New York, Forenede Stater, 14620
        • Highland Hospital
      • Rochester, New York, Forenede Stater, 14623
        • Interlakes Foundation Inc-Rochester
      • Syracuse, New York, Forenede Stater, 13210
        • State University of New York Upstate Medical University
      • Syracuse, New York, Forenede Stater, 13215
        • Community General Hospital
    • North Carolina
      • Asheville, North Carolina, Forenede Stater, 28801
        • Mission Hospital-Memorial Campus
      • Burlington, North Carolina, Forenede Stater, 27216
        • Cone Health Alamance Regional Medical Center
      • Charlotte, North Carolina, Forenede Stater, 28203
        • Carolinas Medical Center
      • Concord, North Carolina, Forenede Stater, 28025
        • Carolinas Medical Center - Northeast
      • Goldsboro, North Carolina, Forenede Stater, 27534
        • Wayne Memorial Hospital
      • Goldsboro, North Carolina, Forenede Stater, 27534
        • Wayne Radiation Oncology
      • Rutherfordton, North Carolina, Forenede Stater, 28139
        • Rutherford Hospital
      • Wilson, North Carolina, Forenede Stater, 27893
        • Wilson Medical Center
    • North Dakota
      • Bismarck, North Dakota, Forenede Stater, 58501
        • Sanford Bismarck Medical Center
      • Bismarck, North Dakota, Forenede Stater, 58501
        • Bismarck Cancer Center
      • Bismarck, North Dakota, Forenede Stater, 58501
        • Mid Dakota Clinic
      • Bismarck, North Dakota, Forenede Stater, 58501
        • Saint Alexius Medical Center
      • Fargo, North Dakota, Forenede Stater, 58122
        • Sanford Clinic North-Fargo
      • Fargo, North Dakota, Forenede Stater, 58122
        • Sanford Medical Center-Fargo
      • Grand Forks, North Dakota, Forenede Stater, 58201
        • Altru Cancer Center
    • Ohio
      • Bellefontaine, Ohio, Forenede Stater, 43311
        • Mary Rutan Hospital
      • Bowling Green, Ohio, Forenede Stater, 43402
        • Toledo Clinic Cancer Centers-Bowling Green
      • Canton, Ohio, Forenede Stater, 44710
        • Aultman Health Foundation
      • Canton, Ohio, Forenede Stater, 44708
        • Mercy Medical Center
      • Chillicothe, Ohio, Forenede Stater, 45601
        • Adena Regional Medical Center
      • Cincinnati, Ohio, Forenede Stater, 45219
        • The Christ Hospital
      • Cincinnati, Ohio, Forenede Stater, 45267
        • University of Cincinnati
      • Cleveland, Ohio, Forenede Stater, 44106
        • Case Western Reserve University
      • Cleveland, Ohio, Forenede Stater, 44109
        • MetroHealth Medical Center
      • Cleveland, Ohio, Forenede Stater, 44195
        • Cleveland Clinic Foundation
      • Clyde, Ohio, Forenede Stater, 43410
        • North Coast Cancer Care-Clyde
      • Columbus, Ohio, Forenede Stater, 43214
        • Riverside Methodist Hospital
      • Columbus, Ohio, Forenede Stater, 43210
        • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
      • 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
      • Dayton, Ohio, Forenede Stater, 45428
        • Veteran Affairs Medical Center
      • Delaware, Ohio, Forenede Stater, 43015
        • Grady Memorial Hospital
      • Elyria, Ohio, Forenede Stater, 44035
        • Hematology Oncology Center Incorporated
      • Findlay, Ohio, Forenede Stater, 45840
        • Blanchard Valley Hospital
      • Franklin, Ohio, Forenede Stater, 45005-1066
        • Atrium Medical Center-Middletown Regional Hospital
      • Fremont, Ohio, Forenede Stater, 43420
        • Fremont Memorial Hospital
      • Greenville, Ohio, Forenede Stater, 45331
        • Wayne Hospital
      • Independence, Ohio, Forenede Stater, 44131
        • Cleveland Clinic Cancer Center Independence
      • Kenton, Ohio, Forenede Stater, 43326
        • Cole, Sharon, K. M.D. (UIA Investigator)
      • Kettering, Ohio, Forenede Stater, 45429
        • Kettering Medical Center
      • Lancaster, Ohio, Forenede Stater, 43130
        • Fairfield Medical Center
      • Lima, Ohio, Forenede Stater, 45804
        • Lima Memorial Hospital
      • Marietta, Ohio, Forenede Stater, 45750
        • Marietta Memorial Hospital
      • Maumee, Ohio, Forenede Stater, 43537
        • Toledo Clinic Cancer Centers-Maumee
      • Maumee, Ohio, Forenede Stater, 43537
        • Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
      • Maumee, Ohio, Forenede Stater, 43537
        • Saint Luke's Hospital
      • Newark, Ohio, Forenede Stater, 43055
        • Licking Memorial Hospital
      • Oregon, Ohio, Forenede Stater, 43616
        • Saint Charles Hospital
      • Oregon, Ohio, Forenede Stater, 43616
        • Toledo Clinic Cancer Centers-Oregon
      • Sandusky, Ohio, Forenede Stater, 44870
        • North Coast Cancer Care
      • Sandusky, Ohio, Forenede Stater, 44870
        • Firelands Regional Medical Center
      • Springfield, Ohio, Forenede Stater, 45505
        • Springfield Regional Medical Center
      • Sylvania, Ohio, Forenede Stater, 43560
        • Flower Hospital
      • Tiffin, Ohio, Forenede Stater, 44883
        • Mercy Hospital of Tiffin
      • Toledo, Ohio, Forenede Stater, 43608
        • Saint Vincent Mercy Medical Center
      • Toledo, Ohio, Forenede Stater, 43623
        • Toledo Clinic Cancer Centers-Toledo
      • Toledo, Ohio, Forenede Stater, 43614
        • University of Toledo
      • Toledo, Ohio, Forenede Stater, 43617
        • Toledo Community Hospital Oncology Program CCOP
      • Toledo, Ohio, Forenede Stater, 43606
        • The Toledo Hospital/Toledo Children's Hospital
      • Toledo, Ohio, Forenede Stater, 43623
        • Mercy Saint Anne Hospital
      • Toledo, Ohio, Forenede Stater, 43623
        • Stark, Michael, Edward. M.D. (UIA Investigator)
      • Troy, Ohio, Forenede Stater, 45373
        • Upper Valley Medical Center
      • Wauseon, Ohio, Forenede Stater, 43567
        • Fulton County Health Center
      • Westerville, Ohio, Forenede Stater, 43081
        • Saint Ann's Hospital
      • Wilmington, Ohio, Forenede Stater, 45177
        • Clinton Memorial Hospital
      • Wooster, Ohio, Forenede Stater, 44691
        • Cleveland Clinic Wooster Specialty Center
      • Xenia, Ohio, Forenede Stater, 45385
        • Greene Memorial Hospital
      • Zanesville, Ohio, Forenede Stater, 43701
        • Genesis HealthCare System
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73104
        • University of Oklahoma Health Sciences Center
      • Oklahoma City, Oklahoma, Forenede Stater, 73120
        • Cancer Care Associates
      • Tulsa, Oklahoma, Forenede Stater, 74136
        • Natalie Warren Bryant Cancer Center at Saint Francis
    • Oregon
      • Bend, Oregon, Forenede Stater, 97701
        • Saint Charles Medical Center-Bend
      • Milwaukie, Oregon, Forenede Stater, 97222
        • Providence Milwaukie Hospital
      • Portland, Oregon, Forenede Stater, 97213
        • Providence Portland Medical Center
      • Portland, Oregon, Forenede Stater, 97225
        • Providence Saint Vincent Medical Center
      • Portland, Oregon, Forenede Stater, 97227
        • Kaiser Permanente
      • Portland, Oregon, Forenede Stater, 97213
        • Western Oncology Research Consortium
      • Portland, Oregon, Forenede Stater, 97216
        • Adventist Medical Center
    • Pennsylvania
      • Abington, Pennsylvania, Forenede Stater, 19001
        • Abington Memorial Hospital
      • Allentown, Pennsylvania, Forenede Stater, 18105
        • LeHigh Valley Hospital
      • Bethlehem, Pennsylvania, Forenede Stater, 18015
        • Saint Luke's University Hospital-Bethlehem Campus
      • Bryn Mawr, Pennsylvania, Forenede Stater, 19010
        • Bryn Mawr Hospital
      • Danville, Pennsylvania, Forenede Stater, 17822-2001
        • Geisinger Medical Center
      • Kittanning, Pennsylvania, Forenede Stater, 16201
        • Armstrong Center for Medicine and Health
      • Media, Pennsylvania, Forenede Stater, 19063
        • Riddle Hospital
      • Paoli, Pennsylvania, Forenede Stater, 19301
        • Paoli Memorial Hospital
      • Philadelphia, Pennsylvania, Forenede Stater, 19111
        • Fox Chase Cancer Center
      • Philadelphia, Pennsylvania, Forenede Stater, 19141
        • Albert Einstein Medical Center
      • Philadelphia, Pennsylvania, Forenede Stater, 19107
        • Thomas Jefferson University Hospital
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • University of Pennsylvania/Abramson Cancer Center
      • Philadelphia, Pennsylvania, Forenede Stater, 19107
        • Pennsylvania Hospital
      • Pittsburgh, Pennsylvania, Forenede Stater, 15232
        • University of Pittsburgh
      • Pittsburgh, Pennsylvania, Forenede Stater, 15212
        • Allegheny Cancer Center at Allegheny General Hospital
      • Pottstown, Pennsylvania, Forenede Stater, 19464
        • Pottstown Memorial Medical Center
      • Scranton, Pennsylvania, Forenede Stater, 18510
        • Scranton Hematology Oncology
      • Scranton, Pennsylvania, Forenede Stater, 18501
        • Mercy Hospital
      • Scranton, Pennsylvania, Forenede Stater, 18508
        • Hematology and Oncology Associates of North East Pennsylvania
      • State College, Pennsylvania, Forenede Stater, 16801
        • Geisinger Medical Group
      • West Reading, Pennsylvania, Forenede Stater, 19611
        • Reading Hospital
      • Wilkes-Barre, Pennsylvania, Forenede Stater, 18711
        • Geisinger Wyoming Valley
      • Wynnewood, Pennsylvania, Forenede Stater, 19096
        • Lankenau Hospital
      • Wynnewood, Pennsylvania, Forenede Stater, 19096
        • Mainline Health CCOP
      • York, Pennsylvania, Forenede Stater, 17405
        • WellSpan Health-York Hospital
    • Rhode Island
      • Cranston, Rhode Island, Forenede Stater, 02920
        • Hematology and Oncology Associates of Rhode Island Inc
      • Warwick, Rhode Island, Forenede Stater, 02886
        • Kent County Hospital
    • South Carolina
      • Anderson, South Carolina, Forenede Stater, 29621
        • AnMed Health Hospital
      • Charleston, South Carolina, Forenede Stater, 29401
        • Roper Hospital
      • Florence, South Carolina, Forenede Stater, 29506
        • McLeod Regional Medical Center
      • Greenville, South Carolina, Forenede Stater, 29615
        • Greenville Health System Cancer Institute/Greenville CCOP
      • Spartanburg, South Carolina, Forenede Stater, 29303
        • Spartanburg Regional Medical Center
      • Spartanburg, South Carolina, Forenede Stater, 29303
        • Upstate Carolina CCOP
    • 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
    • Tennessee
      • Kingsport, Tennessee, Forenede Stater, 37660
        • Wellmont Holston Valley Hospital and Medical Center
      • Knoxville, Tennessee, Forenede Stater, 37916
        • Thompson Cancer Survival Center
      • Memphis, Tennessee, Forenede Stater, 38163
        • University of Tennessee - Memphis
      • Nashville, Tennessee, Forenede Stater, 37232
        • Vanderbilt-Ingram Cancer Center
      • Nashville, Tennessee, Forenede Stater, 37203
        • Nashville Oncology Associates PC
      • Nashville, Tennessee, Forenede Stater, 37203
        • Tennessee Oncology PLLC- Centennial Medical Center
      • Nashville, Tennessee, Forenede Stater, 37208-3599
        • Meharry Medical College
    • Texas
      • Dallas, Texas, Forenede Stater, 75390
        • University of Texas Southwestern Medical Center
      • Dallas, Texas, Forenede Stater, 75235
        • Parkland Memorial Hospital
      • Dallas, Texas, Forenede Stater, 75235
        • Zale Lipshy University Hospital
      • Dallas, Texas, Forenede Stater, 75390
        • Saint Paul Hospital
      • Lubbock, Texas, Forenede Stater, 79430
        • Texas Tech University Health Sciences Center
      • Temple, Texas, Forenede Stater, 76508
        • Scott and White Memorial Hospital
    • Utah
      • American Fork, Utah, Forenede Stater, 84003
        • American Fork Hospital
      • Cedar City, Utah, Forenede Stater, 84720
        • Sandra L Maxwell Cancer Center
      • Logan, Utah, Forenede Stater, 84321
        • Logan Regional Hospital
      • Murray, Utah, Forenede Stater, 84107
        • Cottonwood Hospital Medical Center
      • Murray, Utah, Forenede Stater, 84157
        • Intermountain Medical Center
      • Ogden, Utah, Forenede Stater, 84403
        • McKay-Dee Hospital Center
      • Provo, Utah, Forenede Stater, 84604-3337
        • Utah Valley Regional Medical Center
      • Saint George, Utah, Forenede Stater, 84770
        • Dixie Medical Center Regional Cancer Center
      • Salt Lake City, Utah, Forenede Stater, 84112
        • Huntsman Cancer Institute/University of Utah
      • Salt Lake City, Utah, Forenede Stater, 84106
        • Utah Cancer Specialists-Salt Lake City
      • Salt Lake City, Utah, Forenede Stater, 84143
        • LDS Hospital
      • Salt Lake City, Utah, Forenede Stater, 84103
        • Intermountain Health Care
    • Vermont
      • Burlington, Vermont, Forenede Stater, 05401
        • University of Vermont
    • Virginia
      • Charlottesville, Virginia, Forenede Stater, 22908
        • University of Virginia
      • Charlottesville, Virginia, Forenede Stater, 22901
        • Martha Jefferson Hospital
      • Fredericksburg, Virginia, Forenede Stater, 22401
        • Fredericksburg Oncology Inc
      • Hampton, Virginia, Forenede Stater, 23666
        • Virginia Oncology Associates-Hampton
      • Harrisonburg, Virginia, Forenede Stater, 22801
        • Rockingham Memorial Hospital Hahn Cancer Center
      • Lynchburg, Virginia, Forenede Stater, 24501
        • Lynchburg Hematology-Oncology Clinic
      • Norton, Virginia, Forenede Stater, 24273
        • Southwest VA Regional Cancer Center
    • Washington
      • Auburn, Washington, Forenede Stater, 98001
        • Auburn Regional Medical Center
      • Bellingham, Washington, Forenede Stater, 98225
        • PeaceHealth Saint Joseph Medical Center
      • Bremerton, Washington, Forenede Stater, 98310
        • Harrison HealthPartners Hematology and Oncology-Bremerton
      • Centralia, Washington, Forenede Stater, 98531
        • Providence Centralia Hospital
      • Federal Way, Washington, Forenede Stater, 98003
        • Saint Francis Hospital
      • Kennewick, Washington, Forenede Stater, 99336
        • Columbia Basin Hematology and Oncology PLLC
      • Olympia, Washington, Forenede Stater, 98506-5166
        • Providence - Saint Peter Hospital
      • Puyallup, Washington, Forenede Stater, 98372
        • Good Samaritan Community Hospital
      • Seattle, Washington, Forenede Stater, 98195
        • University of Washington Medical Center
      • Seattle, Washington, Forenede Stater, 98104
        • Minor and James Medical PLLC
      • Seattle, Washington, Forenede Stater, 98112
        • Group Health Cooperative-Seattle
      • Seattle, Washington, Forenede Stater, 98122-4307
        • Swedish Medical Center-First Hill
      • Seattle, Washington, Forenede Stater, 98122
        • The Polyclinic
      • Spokane, Washington, Forenede Stater, 99202
        • Cancer Care Northwest - Spokane South
      • Spokane, Washington, Forenede Stater, 99220
        • Rockwood Clinic
      • Tacoma, Washington, Forenede Stater, 98431
        • Madigan Army Medical Center
      • Tacoma, Washington, Forenede Stater, 98405
        • Saint Joseph Medical Center
      • Tacoma, Washington, Forenede Stater, 98405
        • Allenmore Hospital
      • Tacoma, Washington, Forenede Stater, 98415
        • MultiCare Health System
      • Tacoma, Washington, Forenede Stater, 98405
        • Northwest CCOP
      • Tacoma, Washington, Forenede Stater, 98499
        • Saint Clare Hospital
      • Vancouver, Washington, Forenede Stater, 98664
        • PeaceHealth Southwest Medical Center
      • Vancouver, Washington, Forenede Stater, 98684
        • Compass Oncology Vancouver
    • West Virginia
      • Parkersburg, West Virginia, Forenede Stater, 26101
        • Camden-Clark Memorial Hospital
    • Wisconsin
      • Eau Claire, Wisconsin, Forenede Stater, 54701
        • Marshfield Clinic Cancer Center at Sacred Heart
      • Eau Claire, Wisconsin, Forenede Stater, 54701
        • Sacred Heart Hospital
      • Elkhorn, Wisconsin, Forenede Stater, 53121
        • Aurora Cancer Care-Southern Lakes
      • Fond Du Lac, Wisconsin, Forenede Stater, 54935
        • Agnesian Cancer Center
      • Glendale, Wisconsin, Forenede Stater, 53212
        • Aurora Cancer Care-Glendale
      • 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
      • Janesville, Wisconsin, Forenede Stater, 53547
        • Mercy Health System
      • La Crosse, Wisconsin, Forenede Stater, 54601
        • Mayo Clinic Health System-Franciscan Healthcare
      • Marinette, Wisconsin, Forenede Stater, 54143
        • Bay Area Medical Center
      • Marshfield, Wisconsin, Forenede Stater, 54449
        • Marshfield Clinic
      • Marshfield, Wisconsin, Forenede Stater, 54449
        • Saint Joseph's Hospital
      • Milwaukee, Wisconsin, Forenede Stater, 53215
        • Medical Consultants Limited
      • 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
        • Vince Lombardi Cancer Clinic-Sheboygan
      • Stevens Point, Wisconsin, Forenede Stater, 54481
        • Saint Michael's Hospital
      • Sturgeon Bay, Wisconsin, Forenede Stater, 54235
        • Green Bay Oncology - Sturgeon Bay
      • Wausau, Wisconsin, Forenede Stater, 54401
        • Marshfield Clinic-Wausau Center
      • Weston, Wisconsin, Forenede Stater, 54476
        • Marshfield Clinic - Weston Center
      • Wisconsin Rapids, Wisconsin, Forenede Stater, 54494
        • Marshfield Clinic - Wisconsin Rapids Center
    • Wyoming
      • Sheridan, Wyoming, Forenede Stater, 82801
        • Welch Cancer Center
  • Peru
      • Lima, Peru, Lima 34
        • Instituto Nacional de Enfermedades Neoplasicas
  • Puerto Rico
      • San Juan, Puerto Rico, 00936
        • San Juan City Hospital
      • San Juan, Puerto Rico, 00919
        • I Gonzales Martinez-Oncologic Hospital

Deltagelseskriterier

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

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  • Histologisk bekræftet adenocarcinom i endetarmen, der opfylder 1 af følgende kliniske (f.eks. før neoadjuverende terapi) eller patologiske stadiekriterier:

    • T3, N+, M0
    • T3, N0, M0
    • T4, N0, M0
    • Enhver T, N1-2, M0

  • T4, N0-2, M0 sygdom skal opfylde 1 af følgende kriterier:

    • Klinisk fikseret tumor ved rektal undersøgelse med tumor adhærent til bækkensidevæggen eller korsbenet
    • Hydronefrose på computertomografi (CT) scanning eller intravenøst ​​pyelogram (IVP)
    • Ureterisk eller blæreinvasion som dokumenteret ved cystoskopi og cytologi eller biopsi
    • Invasion i prostata
    • Vaginal eller livmoderpåvirkning
  • Skal have gennemgået en fuldstændig tumorresektion for >= 28 dage siden og kunne påbegynde behandlingen på dag 56

  • Skal have gennemgået samtidig neoadjuverende kemoradioterapi*

    • BEMÆRK: *Neoadjuverende kemoradioterapi modtaget efter protokol NSABP-R-04 tilladt, forudsat at den opfyldte disse kriterier

  • Skal have gennemgået tidligere strålebehandling ved 40-55,8 Gy** OG modtaget 1 af følgende kemoterapiregimer:

    • Kontinuerlig infusion af fluorouracil med eller uden oxaliplatin; fluorouracil og leucovorin calcium
    • Capecitabin med eller uden oxaliplatin; capecitabin med eller uden oxaliplatin ELLER en kontinuerlig infusion af fluorouracil med eller uden oxaliplatin modtaget efter protokol NSABP-R-04
    • BEMÆRK: **Intensitetsmoduleret strålebehandling tilladt
  • ECOG ydeevne status 0-1
  • Blodpladetal >= 100.000/mm^3
  • Absolut granulocyttal >= 1.500/mm^3
  • Bilirubin normalt (medmindre kronisk grad 1 bilirubinforhøjelse på grund af Gilberts sygdom eller lignende syndrom på grund af langsom konjugering af bilirubin)
  • Alkalisk fosfatase (AP) < 2,5 gange øvre normalgrænse (ULN) og aspartataminotransferase (AST) < 1,5 gange ULN
  • Hepatitis B og C negativ (for patienter med AP > normal), medmindre de tidligere er vaccineret
  • Serumkreatinin =< 1,5 gange ULN
  • Urinprotein:kreatinin (UPC)-forhold < 1,0 ELLER urinprotein < 1 g ved 24-timers urinopsamling
  • International Normalized Ratio (INR) =< 1,5

  • INR > 1,5 tilladt, forudsat at patienten er på fuld dosis antikoagulantia OG opfylder alle følgende kriterier:

    • INR inden for området (dvs. mellem 2 og 3) på en stabil dosis warfarin eller lavmolekylært heparin
    • Ingen aktiv blødning eller patologisk tilstand, der er forbundet med høj risiko for blødning
  • Negativ graviditetstest
  • Fertile patienter skal anvende effektiv prævention under og i mindst 3 måneder efter undersøgelsesbehandlingen
  • Ingen anden tidligere eller samtidig malignitet undtagen non-melanom hudkræft, brystkræft in situ, carcinom in situ i livmoderhalsen eller tidligere behandlet ikke-bækkenkræft, som har været sygdomsfri i > 5 år
  • Patienter med brystkræft i anamnesen (uden tegn på sygdom), som forbliver på hormonbehandling i > 5 år, er berettigede
  • Patienter med hypertension i anamnesen skal have blodtryk < 150/90 mm Hg OG have et stabilt regime med antihypertensiv behandling
  • Ingen anden forudgående kemoterapi eller bækkenstrålebehandling undtagen som neoadjuverende behandling for aktuel diagnose af endetarmskræft
  • Samtidig deltagelse på protokol NSABP-R-04 tilladt

Ekskluderingskriterier:

  • Gravid eller ammende
  • Bevis for metastatisk sygdom ved den kirurgiske/intraoperative undersøgelse
  • Bevis på metastatisk sygdom bekræftet ved CT-scanning, magnetisk resonansbilleddannelse (MRI) eller ultralyd af leveren eller CT-scanning af brystet eller røntgen af ​​thorax inden for de seneste 6 måneder
  • Tegn på tumor uden for bækkenet, inklusive levermetastaser, peritoneal seeding eller metastatisk inguinal lymfadenopati
  • Samtidig større operation
  • Aktiv blødning, der ikke er relateret til den primære rektaltumor inden for de seneste 6 måneder
  • Aktiv inflammatorisk tarmsygdom eller anden alvorlig medicinsk sygdom, som kan begrænse patientens evne til at modtage protokolterapi
  • Aktiv gastroduodenal ulcus bestemmes ved endoskopi
  • Alvorligt eller ikke-helende sår, hudsår eller knoglebrud
  • Klinisk signifikant perifer sensorisk eller motorisk neuropati >= grad 2

  • Ikke-malign systemisk sygdom (f.eks. kardiovaskulær, nyre eller lever), der ville udelukke undersøgelsesbehandling, herunder, men ikke begrænset til, et af følgende:

    • New York Heart Association klasse III eller IV kongestiv hjertesvigt
    • Samtidig symptomatisk arytmi
  • Forbigående iskæmisk anfald eller cerebrovaskulær ulykke
  • Arteriel tromboembolisk hændelse, ustabil angina eller myokardieinfarkt inden for de seneste 12 måneder
  • Betydelig perifer vaskulær sygdom
  • Psykiatriske eller vanedannende lidelser eller andre tilstande, der efter investigatorens mening vil udelukke studiekrav
  • Betydelig traumatisk skade inden for de seneste 28 dage
  • Kendt allergi over for platinforbindelser

  • Tidligere invasiv procedure, herunder et af følgende:

    • Større kirurgisk indgreb eller åben biopsi inden for de seneste 28 dage
    • Kernebiopsi eller anden mindre procedure, undtagen placering af en vaskulær adgangsenhed, inden for de seneste 7 dage

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Arm I
Patienterne får oxaliplatin IV over 2 timer, leucovorin calcium IV over 2 timer og fluorouracil IV på dag 1 efterfulgt af fluorouracil IV kontinuerligt over 46 timer på dag 1 og 2. Behandlingen gentages hver 2. uge i op til 12 kure.
Medicin: oxaliplatin
Givet IV
Andre navne:
  • 1-OHP
  • Dakotin
  • Dacplat
  • Eloxatin
  • L-OHP
Medicin: leucovorin calcium
Givet IV
Andre navne:
  • CF
  • CFR
  • LV
Medicin: fluorouracil
Givet IV
Andre navne:
  • 5-FU
  • 5-fluoruracil
  • 5-Fluracil
Eksperimentel: Arm II
Patienterne får bevacizumab IV over 30-90 minutter på dag 1. Patienterne får også oxaliplatin, leucovorin calcium og fluorouracil som i arm I.
Medicin: oxaliplatin
Givet IV
Andre navne:
  • 1-OHP
  • Dakotin
  • Dacplat
  • Eloxatin
  • L-OHP
Medicin: leucovorin calcium
Givet IV
Andre navne:
  • CF
  • CFR
  • LV
Medicin: fluorouracil
Givet IV
Andre navne:
  • 5-FU
  • 5-fluoruracil
  • 5-Fluracil
Medicin: bevacizumab
Givet IV
Andre navne:
  • Avastin
  • anti-VEGF humaniseret monoklonalt antistof
  • anti-VEGF monoklonalt antistof
  • rhuMAb VEGF

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
5-års samlet overlevelsesrate
Tidsramme: Opfølgningsvurderinger udført hver 3. måned for patienter < 2 år fra randomisering, hver 6. måned for patienter 2-5 år fra randomisering og hver 12. måned for patienter 5-10 år fra randomisering
Samlet overlevelse (OS) blev defineret som tiden fra randomisering til dato for død uanset årsag. Patienter, der stadig var i live, blev censureret på sidste dato for kendt i live. Kaplan-Meier-metoden blev brugt til at estimere den 5-årige OS-rate.
Opfølgningsvurderinger udført hver 3. måned for patienter < 2 år fra randomisering, hver 6. måned for patienter 2-5 år fra randomisering og hver 12. måned for patienter 5-10 år fra randomisering

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
5-års sygdomsfri overlevelsesrate
Tidsramme: Opfølgningsvurderinger udført hver 3. måned for patienter < 2 år fra randomisering, hver 6. måned for patienter 2-5 år fra randomisering og hver 12. måned for patienter 5-10 år fra randomisering
Sygdomsfri overlevelse (DFS) blev defineret som tid fra randomisering til recidiv, anden invasiv primær cancer eller død, alt efter hvad der indtrådte først. Patienter, der stadig var i live og ikke havde nogen DFS-hændelser, blev censureret på den sidste sygdomsvurderingsdato, der vides at være fri for DFS-hændelser. Kaplan-Meier metode blev brugt til at estimere 5-års DFS rate.
Opfølgningsvurderinger udført hver 3. måned for patienter < 2 år fra randomisering, hver 6. måned for patienter 2-5 år fra randomisering og hver 12. måned for patienter 5-10 år fra randomisering
Mønstre af fiasko
Tidsramme: Opfølgningsvurderinger udført hver 3. måned for patienter < 2 år fra randomisering, hver 6. måned for patienter 2-5 år fra randomisering og hver 12. måned for patienter 5-10 år fra randomisering
Fejl inkluderede recidiv, anden primær cancer og død uden recidiv.
Opfølgningsvurderinger udført hver 3. måned for patienter < 2 år fra randomisering, hver 6. måned for patienter 2-5 år fra randomisering og hver 12. måned for patienter 5-10 år fra randomisering
Andel af patienter, der gennemførte 12 behandlingscyklusser
Tidsramme: vurderes ved behandlingens afslutning
I undersøgelsen blev behandlingen gentaget hver 2. uge i i alt 12 cyklusser på begge arme. Det samlede antal behandlingscyklusser, som patienten modtog, indtil behandlingen af ​​en eller anden grund blev afsluttet, blev registreret. Det var et mål for terapiens tolerance.
vurderes ved behandlingens afslutning

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Ændring i rektal funktion mellem baseline og 12 måneder
Tidsramme: vurderet ved baseline og 12 måneder efter randomisering
Ændring i rektalfunktion mellem baseline og 12 måneder målte den langsigtede rektalfunktion blandt patienterne. Rektalfunktion blev målt ved hjælp af tarmfunktionsspørgeskemaet ved baseline og 12 måneder efter randomisering. Spørgeskemaets samlede score blev beregnet som antallet af problemer med tarmfunktionen (scoreområde 0-11). Ændring i rektalfunktion mellem baseline og 12 måneder = total score ved 12 måneder - total score ved baseline. En negativ værdi indikerede forbedret rektal funktion. Denne ændring i score blev beregnet for hver enkelt patient, der havde dataene.
vurderet ved baseline og 12 måneder efter randomisering
Ændring i Oxaliplatin-relateret neurotoksicitet mellem baseline og 12 måneder
Tidsramme: vurderet ved baseline og 12 måneder efter randomisering
Ændring i oxaliplatin-relateret neurotoksicitet mellem baseline og 12 måneder målte det langsigtede symptom på oxaliplatin-relateret neurotoksicitet blandt patienterne. Oxaliplatin-relateret neurotoksicitet blev målt ved hjælp af FACT/GOG-Ntx-subskalaen ved baseline og 12 måneder efter randomisering. Området for den samlede score på skalaen var mellem 0 og 44, og lavere værdier indikerer højere neurotoksicitet. Ændring i oxaliplatin-relateret neurotoksicitet mellem baseline og 12 måneder = total score efter 12 måneder - total score ved baseline. En negativ værdi indikerede forværret symptom. Denne ændring i score blev beregnet for hver enkelt patient, der havde dataene.
vurderet ved baseline og 12 måneder efter randomisering

Samarbejdspartnere og efterforskere

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

Sponsor

ECOG-ACRIN Cancer Research Group

Samarbejdspartnere

National Cancer Institute (NCI)

Efterforskere

  • Ledende efterforsker: Al Benson, Eastern Cooperative Oncology Group

Datoer for undersøgelser

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

Studer store datoer

Studiestart (Faktiske)

11. maj 2006

Primær færdiggørelse (Faktiske)

1. april 2015

Studieafslutning (Faktiske)

11. februar 2019

Datoer for studieregistrering

Først indsendt

15. marts 2006

Først indsendt, der opfyldte QC-kriterier

15. marts 2006

Først opslået (Anslået)

17. marts 2006

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. juli 2023

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. juni 2023

Sidst verificeret

1. juni 2023

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • E5204 (Anden identifikator: ECOG-ACRIN Cancer Research Group)
  • U10CA021115 (U.S. NIH-bevilling/kontrakt)
  • NCI-2009-00563 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • CDR0000467561 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Individuelle deltagerdata kan stilles til rådighed efter anmodning i henhold til ECOG-ACRINs datadelingspolitik.

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

Abonner