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Stråleterapi med eller uten valgfri tamoksifen ved behandling av kvinner med duktalt karsinom in situ

23. mai 2022 oppdatert av: Radiation Therapy Oncology Group

Fase III-studie av Tamoxifen alene vs. Tamoxifen Plus strålebehandling for god risiko kanalkarsinom in-situ (DCIS) av kvinnelige bryster

BAKGRUNN: Strålebehandling bruker høyenergirøntgenstråler for å skade tumorceller. Østrogen kan stimulere veksten av brystkreftceller. Hormonbehandling med tamoxifen kan bekjempe brystkreft ved å blokkere opptaket av østrogen i svulstcellene. Det er ennå ikke kjent om strålebehandling er mer effektiv enn observasjon, med eller uten tamoxifen, ved behandling av duktalt karsinom in situ.

FORMÅL: Randomisert fase III-studie for å sammenligne effektiviteten av strålebehandling med effekten av observasjon, med eller uten tamoxifen, ved behandling av kvinner som har duktalt karsinom in situ.

Studieoversikt

Detaljert beskrivelse

MÅL:

  • Sammenlign effekten av helbryststrålebehandling vs observasjon med eller uten valgfritt tamoxifen for å redusere eller forsinke forekomsten av lokal svikt (både invasiv og in situ) og forhindre behovet for mastektomi hos kvinner med god-risiko ductal carcinoma in situ (DCIS) av brystet.
  • Sammenlign fjern sykdomsfri overlevelse av pasienter behandlet med disse regimene.

OVERSIKT: Dette er en randomisert, multisenterstudie. Pasientene er stratifisert i henhold til alder (under 50 vs 50 og over), endelige banemarginer (negative vs 3-9 mm vs minst 10 mm), mammografisk størrelse på primær (ikke større enn 1 cm vs. større enn 1 cm til 2,5 cm ), kjernekvalitet (lav vs middels) og tamoksifenbruk (ja vs nei). Pasientene er randomisert til 1 av 2 behandlingsarmer.

  • Arm I: Pasienter gjennomgår observasjon og kan få valgfri oral tamoxifen én gang daglig (etter legens skjønn) i 5 år.
  • Arm II: Fra og med 12 uker etter siste operasjon får pasienter strålebehandling av hele brystet en gang daglig, 5 dager i uken, i 3,5-5,5 uker. Pasienter kan få valgfri tamoxifen som i arm I.

Pasientene følges hver 3. måned i 1 år, hver 6. måned i 2 år, og deretter årlig.

PROSJEKTERT PASSING: Totalt 1790 pasienter vil bli påløpt for denne studien innen 6 år.

Studietype

Intervensjonell

Registrering (Faktiske)

636

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

      • Quebec, Canada, G1S 4L8
        • Centre Hospitalier Regional De Rimouski
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute at University of Alberta
      • Lethbridge, Alberta, Canada, T1J 1W5
        • Lethbridge Cancer Centre
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 5L3
        • British Columbia Cancer Agency - Centre for the Southern Interior
      • Nanaimo, British Columbia, Canada, V9S 2B7
        • Nanaimo Cancer Clinic at Nanaimo Regional General Hospital
      • North Vancouver, British Columbia, Canada, V7L 2P9
        • Lions Gate Hospital
      • Surrey, British Columbia, Canada, V3V 1Z2
        • BCCA - Fraser Valley Cancer Centre
      • Vancouver, British Columbia, Canada, V5Z 3J5
        • Prostate Centre at Vancouver General Hospital
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • British Columbia Cancer Agency - Vancouver Cancer Centre
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • Providence Health Care - Vancouver
      • Victoria, British Columbia, Canada, V8V 3N1
        • G. Steinhoff Clinical Research
      • Victoria, British Columbia, Canada, V8R 6V5
        • British Columbia Cancer Agency - Vancouver Island Cancer Centre
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
        • CancerCare Manitoba
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1C 6ZB
        • Moncton Hospital
      • Saint John, New Brunswick, Canada, E2L 4L2
        • Saint John Regional Hospital
    • Newfoundland and Labrador
      • St. Johns, Newfoundland and Labrador, Canada, A1B 3V6
        • Newfoundland Cancer Treatment and Research Foundation
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • Nova Scotia Cancer Centre
      • Sydney, Nova Scotia, Canada, B1P 1P3
        • Cape Breton Cancer Centre
    • Ontario
      • Barrie, Ontario, Canada, L4M 6M2
        • Royal Victoria Hospital of Barrie
      • Brampton, Ontario, Canada, L6W 2Z8
        • William Osler Health Centre
      • Hamilton, Ontario, Canada, L8V 5C2
        • Margaret and Charles Juravinski Cancer Centre
      • Hamilton, Ontario, Canada, L8N 4A6
        • St. Joseph's Hospital
      • Kingston, Ontario, Canada, K7L 5P9
        • Cancer Centre of Southeastern Ontario at Kingston General Hospital
      • Kitchner, Ontario, Canada, N2G 1G3
        • Grand River Regional Cancer Centre at Grand River Hospital
      • London, Ontario, Canada, N6A 4L6
        • London Regional Cancer Program at London Health Sciences Centre
      • Markham, Ontario, Canada, L6B IAI
        • Markham Stouffville Hospital
      • Mississauga, Ontario, Canada, L5B 1B8
        • Trillium Health Centre - Mississauga Site
      • Newmarket, Ontario, Canada, L3Y 2P9
        • Southlake Regional Health Centre
      • North York, Ontario, Canada, M2K 1E1
        • North York General Hospital - Ontario
      • Oakville, Ontario, Canada, L6H 3PI
        • Male Health Centre - Oakville
      • Oshawa, Ontario, Canada, L1G 2B9
        • R. S. McLaughlin Durham Regional Cancer Centre at Lakeridge Health Oshawa
      • Ottawa, Ontario, Canada, K1H 8L6
        • Ottawa Hospital Regional Cancer Centre - General Campus
      • Peterborough, Ontario, Canada, K9H 7B6
        • Peterborough Oncology Clinic
      • Sault Sainte Marie, Ontario, Canada, P6A 2C4
        • Algoma Regional Cancer Program at Sault Area Hospital
      • Scarborough, Ontario, Canada, M1P 2V5
        • Scarborough Hospital - General Campus
      • St. Catharines, Ontario, Canada, L2R 5K3
        • St. Catharines General Hospital at Niagara Health System
      • Sudbury, Ontario, Canada, P3E 5J1
        • Northeastern Ontario Regional Cancer Centre
      • Thunder Bay, Ontario, Canada, P7B 6V4
        • Northwestern Ontario Regional Cancer Care at Thunder Bay Regional Health Sciences Centre
      • Toronto, Ontario, Canada, M4C 3E7
        • Toronto East General Hospital
      • Toronto, Ontario, Canada, M5B 1W8
        • St. Michael's Hospital - Toronto
      • Toronto, Ontario, Canada, M5G 1X5
        • Mount Sinai Hospital - Toronto
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Hospital
      • Toronto, Ontario, Canada, M6R 1B5
        • St. Joseph's Health Centre - Toronto
      • Toronto, Ontario, Canada, M6A 3B5
        • Male Health Centre - North York
      • Toronto, Ontario, Canada, M4N 3M5
        • Toronto Sunnybrook Regional Cancer Centre at Sunnybrook Health Sciences Centre
      • Weston, Ontario, Canada, M9N 1N8
        • Humber River Regional Hospital - Weston
      • Windsor, Ontario, Canada, N8W 2X3
        • Windsor Regional Cancer Centre at Windsor Regional Hospital
    • Prince Edward Island
      • Charlottetown, Prince Edward Island, Canada, C1A 8T5
        • Prince Edward Island Cancer Centre at Queen Elizabeth Hospital
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 5H6
        • Centre De Sante Et De Services Sociaux De Chicoutimi
      • Fleurimont, Quebec, Canada, J1H 5N4
        • CHUS-Hopital Fleurimont
      • Greenfield Park, Quebec, Canada, J4V 2H1
        • Hôpital Charles LeMoyne
      • Greenfield Park, Quebec, Canada, J4V 2H1
        • Doctor Leon Richard Oncology Centre
      • Joliette, Quebec, Canada, J6E 6J2
        • Centre hospitalier régional de Lanaudière
      • Levis, Quebec, Canada, G6V 3Z1
        • Hotel-Dieu de Levis
      • Montreal, Quebec, Canada, H1T 2M4
        • Maisonneuve-Rosemont Hospital
      • Montreal, Quebec, Canada, H2W 1T8
        • Hotel Dieu de Montreal
      • Montreal, Quebec, Canada, H4J 1C5
        • Hôpital du Sacré-Cœur de Montréal
      • Montreal, Quebec, Canada, H3T 1C5
        • Hôpital Sainte Justine
      • Montreal, Quebec, Canada, (P.Q.) H2X 3J4
        • Centre Hospitalier de l'Université de Montréal
      • Quebec City, Quebec, Canada, G1R 2J6
        • Centre Hospitalier Universitaire de Quebec
      • Quebec City, Quebec, Canada, G1S 4L8
        • Hopital du Saint-Sacrement - Quebec
      • Ste-Foy, Quebec, Canada, G1V 4G5
        • L'Hopital Laval
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4T 7T1
        • Allan Blair Cancer Centre at Pasqua Hospital
      • Saskatoon, Saskatchewan, Canada, S7N 4H4
        • Saskatoon Cancer Centre at the University of Saskatchewan
    • Alabama
      • Mobile, Alabama, Forente stater, 36652-2144
        • Mobile Infirmary Medical Center
    • Alaska
      • Fairbanks, Alaska, Forente stater, 99701
        • Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital
    • Arizona
      • Phoenix, Arizona, Forente stater, 85013
        • Arizona Oncology Services Foundation
    • Arkansas
      • Hot Springs, Arkansas, Forente stater, 71913
        • Saint Joseph's Mercy Cancer Center
    • California
      • Burbank, California, Forente stater, 91505
        • Providence Saint Joseph Medical Center - Burbank
      • Chico, California, Forente stater, 95926
        • Enloe Cancer Center at Enloe Medical Center
      • Concord, California, Forente stater, 94524-4110
        • Mount Diablo Regional Cancer Center
      • Fairfield, California, Forente stater, 94533
        • North Bay Cancer Center
      • Fremont, California, Forente stater, 94538
        • Washington Township Hospital
      • Fresno, California, Forente stater, 93720-3397
        • Saint Agnes Medical Center
      • Inglewood, California, Forente stater, 90301
        • Cancer Care Consultants Medical Associates at Daniel Freeman Memorial Hospital
      • Los Angeles, California, Forente stater, 90089-9181
        • USC/Norris Comprehensive Cancer Center and Hospital
      • Mission Hills, California, Forente stater, 91346-9600
        • Providence Holy Cross Cancer Center
      • Modesto, California, Forente stater, 95355
        • Memorial Medical Center Cancer Services
      • Oakland, California, Forente stater, 94609
        • CCOP - Bay Area Tumor Institute
      • Pomona, California, Forente stater, 91767
        • Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center
      • Sacramento, California, Forente stater, 95815
        • Radiological Associates of Sacramento Medical Group, Incorporated
      • Sacramento, California, Forente stater, 95817
        • University of California Davis Cancer Center
      • Santa Rosa, California, Forente stater, 95405
        • CCOP - Santa Rosa Memorial Hospital
      • Torrance, California, Forente stater, 90509
        • Torrance Memorial Medical Center
      • Walnut Creek, California, Forente stater, 94598
        • John Muir/Mt. Diablo Comprehensive Cancer Center
      • Whittier, California, Forente stater, 90602
        • Ruby L. Golleher Cancer Program at Presbyterian Intercommunity Hospital
    • Connecticut
      • Bridgeport, Connecticut, Forente stater, 06606
        • St. Vincent's Medical Center
      • New Haven, Connecticut, Forente stater, 06511
        • Hospital of Saint Raphael
      • Norwich, Connecticut, Forente stater, 06360
        • Eastern Connecticut Hematology and Oncology Associates
    • Delaware
      • Newark, Delaware, Forente stater, 19713
        • CCOP - Christiana Care Health Services
    • District of Columbia
      • Washington, District of Columbia, Forente stater, 20007
        • Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
    • Florida
      • Gainesville, Florida, Forente stater, 32610-0232
        • University of Florida Shands Cancer Center
      • Jacksonville, Florida, Forente stater, 32224
        • Mayo Clinic - Jacksonville
      • Lakeland, Florida, Forente stater, 33805
        • Lakeland Regional Cancer Center at Lakeland Regional Medical Center
      • Miami, Florida, Forente stater, 33136
        • University of Miami Sylvester Comprehensive Cancer Center
      • Miami, Florida, Forente stater, 33176
        • Baptist-South Miami Regional Cancer Program
    • Georgia
      • Gainesville, Georgia, Forente stater, 30501
        • Northeast Georgia Medical Center
      • Savannah, Georgia, Forente stater, 31405
        • Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
    • Hawaii
      • 'Ewa Beach, Hawaii, Forente stater, 96706
        • Leeward Radiation Oncology Center
      • Honolulu, Hawaii, Forente stater, 96813
        • Cancer Research Center of Hawaii
      • Honolulu, Hawaii, Forente stater, 96813
        • Queen's Cancer Institute at Queen's Medical Center
      • Honolulu, Hawaii, Forente stater, 96859
        • Tripler Army Medical Center
      • Honolulu, Hawaii, Forente stater, 96817
        • St. Francis Medical Center
    • Idaho
      • Boise, Idaho, Forente stater, 83712
        • St. Luke's Mountain States Tumor Institute - Boise
      • Idaho Falls, Idaho, Forente stater, 83404
        • Hematology Oncology Associates of Eastern Idaho
    • Illinois
      • Arlington Heights, Illinois, Forente stater, 60005
        • Northwest Community Hospital
      • Aurora, Illinois, Forente stater, 60507
        • Rush-Copley Cancer Care Center
      • Barrington, Illinois, Forente stater, 60010
        • Good Shepherd Hospital
      • Bloomington, Illinois, Forente stater, 61701
        • St. Joseph Medical Center
      • Chicago, Illinois, Forente stater, 60611-3013
        • Robert H. Lurie Comprehensive Cancer Center at Northwestern University
      • Chicago, Illinois, Forente stater, 60657
        • Creticos Cancer Center at Advocate Illinois Masonic Medical Center
      • Chicago, Illinois, Forente stater, 60612-3785
        • John H. Stroger, Jr. Hospital of Cook County
      • Downers Grove, Illinois, Forente stater, 60515
        • Advocate Good Samaritan Hospital
      • Galesburg, Illinois, Forente stater, 61401
        • InterCommunity Cancer Center of Western Illinois
      • Joliet, Illinois, Forente stater, 60435
        • Joliet Oncology-Hematology Associates, Limited - West
      • Maywood, Illinois, Forente stater, 60153
        • Cardinal Bernardin Cancer Center at Loyola University Medical Center
      • Normal, Illinois, Forente stater, 61761
        • Bromenn Regional Medical Center
      • Normal, Illinois, Forente stater, 61761
        • Community Cancer Center
      • Park Ridge, Illinois, Forente stater, 60068
        • Lutheran General Cancer Care Center
      • Pekin, Illinois, Forente stater, 61554
        • Cancer Treatment Center at Pekin Hospital
      • Peoria, Illinois, Forente stater, 61636
        • Methodist Medical Center of Illinois
      • Peoria, Illinois, Forente stater, 61637
        • OSF St. Francis Medical Center
      • Peoria, Illinois, Forente stater, 61615
        • CCOP - Illinois Oncology Research Association
      • Peoria, Illinois, Forente stater, 61615
        • Oncology Hematology Associates of Central Illinois, PC - Peoria
      • Spring Valley, Illinois, Forente stater, 61362
        • Valley Cancer Center
      • Urbana, Illinois, Forente stater, 61801
        • Carle Cancer Center at Carle Foundation Hospital
      • Urbana, Illinois, Forente stater, 61801
        • CCOP - Carle Cancer Center
    • Indiana
      • Anderson, Indiana, Forente stater, 46016
        • St. John's Cancer Center at St. John's Medical Center
      • Bloomington, Indiana, Forente stater, 47403
        • Regional Cancer Institute at Bloomington Hospital
      • Elkhart, Indiana, Forente stater, 46515
        • Elkhart General Hospital
      • Fort Wayne, Indiana, Forente stater, 46805
        • Parkview Regional Cancer Center at Parkview Health
      • Indianapolis, Indiana, Forente stater, 46202-5289
        • Indiana University Cancer Center
      • Kokomo, Indiana, Forente stater, 46904
        • Howard Community Hospital at Howard Regional Health System
      • La Porte, Indiana, Forente stater, 46350
        • Center for Cancer Therapy at LaPorte Hospital and Health Services
      • Michigan City, Indiana, Forente stater, 46360
        • Saint Anthony Memorial Health Centers
      • South Bend, Indiana, Forente stater, 46601
        • Memorial Hospital of South Bend
      • South Bend, Indiana, Forente stater, 46601
        • CCOP - Northern Indiana CR Consortium
    • Iowa
      • Cedar Rapids, Iowa, Forente stater, 52402
        • St. Luke's Hospital
      • Cedar Rapids, Iowa, Forente stater, 52403
        • Cedar Rapids Oncology Associates
      • Cedar Rapids, Iowa, Forente stater, 52403
        • Mercy Regional Cancer Center at Mercy Medical Center
    • Kansas
      • Topeka, Kansas, Forente stater, 66606
        • St. Francis Comprehensive Cancer Center
      • Topeka, Kansas, Forente stater, 66604
        • Stormont-Vail Cancer Center
    • Kentucky
      • Bowling Green, Kentucky, Forente stater, 42101
        • Cancer Treatment Center for Southern Kentucky
      • Lexington, Kentucky, Forente stater, 40503-9985
        • Central Baptist Hospital
      • Madisonville, Kentucky, Forente stater, 42431
        • Merle M. Mahr Cancer Center at Regional Medical Center of Hopkins County
    • Maine
      • Lewiston, Maine, Forente stater, 04240
        • Central Maine Medical Center
      • Portland, Maine, Forente stater, 04102
        • Maine Medical Center - Bramhall Campus
    • Maryland
      • Annapolis, Maryland, Forente stater, 21401
        • DeCesaris Cancer Institute at Anne Arundel Medical Center
      • Baltimore, Maryland, Forente stater, 21204
        • Greater Baltimore Medical Center
      • Bethesda, Maryland, Forente stater, 20814
        • Suburban Hospital
      • Salisbury, Maryland, Forente stater, 21801
        • Peninsula Regional Medical Center
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02115
        • Brigham and Women's Hospital
      • Boston, Massachusetts, Forente stater, 02115
        • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
      • Boston, Massachusetts, Forente stater, 02114
        • Massachusetts General Hospital Cancer Center
      • Boston, Massachusetts, Forente stater, 02118
        • Cancer Research Center at Boston Medical Center
      • Burlington, Massachusetts, Forente stater, 01805
        • Lahey Clinic Medical Center - Burlington
      • Concord, Massachusetts, Forente stater, 01742
        • Bethke Cancer Center at Emerson Hospital
      • Fall River, Massachusetts, Forente stater, 02721
        • Hudner Oncology Center at Saint Anne's Hospital
      • Framingham, Massachusetts, Forente stater, 01702
        • Metrowest Medical Center - Framingham Union Hospital
      • Hyannis, Massachusetts, Forente stater, 02601
        • Cape Cod Hospital
      • Lowell, Massachusetts, Forente stater, 01854
        • Lowell General Hospital
      • Milford, Massachusetts, Forente stater, 01757
        • Community Cancer Care at Milford Regional Medical Center
      • Norwood, Massachusetts, Forente stater, 02062
        • Caritas Norwood Hospital
      • Springfield, Massachusetts, Forente stater, 01199
        • Baystate Regional Cancer Program at D'Amour Center for Cancer Care
    • Michigan
      • Adrian, Michigan, Forente stater, 49221
        • Hickman Cancer Center at Bixby Medical Center
      • Ann Arbor, Michigan, Forente stater, 48109-0942
        • University Of Michigan Comprehensive Cancer Center
      • Ann Arbor, Michigan, Forente stater, 48106
        • CCOP - Michigan Cancer Research Consortium
      • Ann Arbor, Michigan, Forente stater, 48106-0995
        • St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital
      • Detroit, Michigan, Forente stater, 48202
        • Josephine Ford Cancer Center at Henry Ford Hospital
      • Detroit, Michigan, Forente stater, 48201-1379
        • Barbara Ann Karmanos Cancer Institute
      • Escanaba, Michigan, Forente stater, 49431
        • Green Bay Oncology, Limited - Escanaba
      • Flint, Michigan, Forente stater, 48503
        • Genesys Hurley Cancer Institute
      • Flint, Michigan, Forente stater, 48532
        • Great Lakes Cancer Institute at McLaren Regional Medical Center
      • Grand Rapids, Michigan, Forente stater, 49503
        • CCOP - Grand Rapids
      • Grand Rapids, Michigan, Forente stater, 49503
        • Lacks Cancer Center at Saint Mary's Mercy Medical Center
      • Grand Rapids, Michigan, Forente stater, 49503
        • Spectrum Health Cancer Care - Butterworth Campus
      • Grosse Pointe Woods, Michigan, Forente stater, 48236
        • Van Elslander Cancer Center at St. John Hospital and Medical Center
      • Iron Mountain, Michigan, Forente stater, 49801
        • Green Bay Oncology, Limited - Iron Mountain
      • Jackson, Michigan, Forente stater, 49201
        • Foote Hospital
      • Kalamazoo, Michigan, Forente stater, 49007
        • Bronson Methodist Hospital
      • Kalamazoo, Michigan, Forente stater, 49001
        • Borgess Medical Center
      • Kalamazoo, Michigan, Forente stater, 49007-3731
        • West Michigan Cancer Center
      • Lansing, Michigan, Forente stater, 48910
        • Breslin Cancer Center at Ingham Regional Medical Center
      • Marquette, Michigan, Forente stater, 49855
        • Upper Michigan Cancer Center at Marquette General Hospital
      • Midland, Michigan, Forente stater, 48670
        • MidMichigan Medical Center - Midland
      • Petoskey, Michigan, Forente stater, 49770
        • Northern Michigan Hospital
      • Royal Oak, Michigan, Forente stater, 48073
        • William Beaumont Hospital - Royal Oak Campus
      • Saginaw, Michigan, Forente stater, 48601
        • Seton Cancer Institute - Saginaw
      • Saint Joseph, Michigan, Forente stater, 49085
        • Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
      • Traverse City, Michigan, Forente stater, 49684
        • Munson Medical Center
      • Warren, Michigan, Forente stater, 48093
        • St. John Macomb Hospital
    • Minnesota
      • Burnsville, Minnesota, Forente stater, 55337
        • Fairview Ridges Hospital
      • Coon Rapids, Minnesota, Forente stater, 55433
        • Mercy and Unity Cancer Center at Mercy Hospital
      • Duluth, Minnesota, Forente stater, 55805
        • St. Mary's - Duluth Clinic Cancer Center
      • Edina, Minnesota, Forente stater, 55435
        • Fairview Southdale Hospital
      • Fridley, Minnesota, Forente stater, 55432
        • Mercy and Unity Cancer Center at Unity Hospital
      • Mankato, Minnesota, Forente stater, 56002
        • Immanuel St. Joseph's Clinic
      • Minneapolis, Minnesota, Forente stater, 55407
        • Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
      • Robbinsdale, Minnesota, Forente stater, 55422-2900
        • Hubert H. Humphrey Cancer Center at North Memorial Medical Center
      • Rochester, Minnesota, Forente stater, 55905
        • Mayo Clinic Cancer Center
      • Saint Cloud, Minnesota, Forente stater, 56303
        • CentraCare Clinic - River Campus
      • Saint Cloud, Minnesota, Forente stater, 56303
        • Coborn Cancer Center
      • Saint Louis Park, Minnesota, Forente stater, 55416
        • CCOP - Metro-Minnesota
      • Saint Louis Park, Minnesota, Forente stater, 55416
        • Park Nicollet Health Services
      • Saint Paul, Minnesota, Forente stater, 55102
        • United Hospital
      • Saint Paul, Minnesota, Forente stater, 55101
        • Regions Hospital Cancer Care Center
      • Waconia, Minnesota, Forente stater, 55387
        • Ridgeview Medical Center
    • Mississippi
      • Jackson, Mississippi, Forente stater, 39216
        • University of Mississippi Medical Center
    • Missouri
      • Columbia, Missouri, Forente stater, 65203
        • Ellis Fischel Cancer Center at University of Missouri - Columbia
      • Kansas City, Missouri, Forente stater, 64131
        • CCOP - Kansas City
    • Montana
      • Billings, Montana, Forente stater, 59101
        • CCOP - Montana Cancer Consortium
      • Billings, Montana, Forente stater, 59101
        • Northern Rockies Radiation Oncology Center
      • Billings, Montana, Forente stater, 59107-7000
        • Deaconess Billings Clinic - Downtown
      • Great Falls, Montana, Forente stater, 59405
        • Great Falls Clinic
    • Nebraska
      • Kearney, Nebraska, Forente stater, 68848-1990
        • Good Samaritan Cancer Center at Good Samaritan Hospital
      • Omaha, Nebraska, Forente stater, 68114
        • Methodist Cancer Center at Methodist Hospital - Omaha
    • Nevada
      • Las Vegas, Nevada, Forente stater, 89106
        • CCOP - Nevada Cancer Research Foundation
    • New Hampshire
      • Concord, New Hampshire, Forente stater, 03301
        • Dartmouth - Hitchcock Concord
      • Dover, New Hampshire, Forente stater, 03820
        • Seacoast Cancer Center at Wentworth-Douglass Hospital
      • Lebanon, New Hampshire, Forente stater, 03756-0002
        • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
      • Manchester, New Hampshire, Forente stater, 03103
        • Elliot Regional Cancer Center at Elliot Hospital
    • New Jersey
      • East Orange, New Jersey, Forente stater, 07018-1095
        • Veterans Affairs Medical Center - East Orange
      • Edison, New Jersey, Forente stater, 08818
        • John F. Kennedy Medical Center
      • Englewood, New Jersey, Forente stater, 07631
        • Dizzy Gillespie Cancer Institute at Englewood Hospital and Medical Center
      • Long Branch, New Jersey, Forente stater, 07740-6395
        • Monmouth Medical Center
      • Marlton, New Jersey, Forente stater, 08053
        • Fox Chase Virtua Health Cancer Program - Marlton
      • New Brunswick, New Jersey, Forente stater, 08903
        • Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
      • New Brunswick, New Jersey, Forente stater, 08903
        • Saint Peter's University Hospital
      • Newark, New Jersey, Forente stater, 07112
        • Newark Beth Israel Medical Center
      • Pomona, New Jersey, Forente stater, 08240
        • AtlantiCare Regional Medical Center
      • Red Bank, New Jersey, Forente stater, 07701
        • Booker Cancer Center at Riverview Medical Center
      • Trenton, New Jersey, Forente stater, 08629
        • Fox Chase Cancer Center at St. Francis Medical Center
      • Voorhees, New Jersey, Forente stater, 08043
        • Cancer Institute of New Jersey at Cooper - Voorhees
    • New Mexico
      • Albuquerque, New Mexico, Forente stater, 87131-5636
        • University of New Mexico Cancer Research and Treatment Center
      • Albuquerque, New Mexico, Forente stater, 87102
        • Albuquerque Regional Medical Center at Lovelace Sandia Health System
    • New York
      • Brooklyn, New York, Forente stater, 11201
        • Long Island College Hospital
      • Buffalo, New York, Forente stater, 14263-0001
        • Roswell Park Cancer Institute
      • Manhasset, New York, Forente stater, 11030
        • CCOP - North Shore University Hospital
      • Manhasset, New York, Forente stater, 11030
        • North Shore University Hospital
      • Middletown, New York, Forente stater, 10940-4199
        • Tucker Center for Cancer Care at Orange Regional Medical Center
      • New Hyde Park, New York, Forente stater, 11042
        • Long Island Jewish Medical Center
      • New York, New York, Forente stater, 10021
        • Memorial Sloan-Kettering Cancer Center
      • Syracuse, New York, Forente stater, 13057
        • CCOP - Hematology-Oncology Associates of Central New York
    • North Carolina
      • Chapel Hill, North Carolina, Forente stater, 27599-7295
        • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
      • Charlotte, North Carolina, Forente stater, 28232-2861
        • Blumenthal Cancer Center at Carolinas Medical Center
      • Concord, North Carolina, Forente stater, 28025
        • Batte Cancer Center at Northeast Medical Center
      • Durham, North Carolina, Forente stater, 27710
        • Duke Comprehensive Cancer Center
      • Goldsboro, North Carolina, Forente stater, 27534
        • Wayne Radiation Oncology
      • Goldsboro, North Carolina, Forente stater, 27534
        • Wayne Memorial Hospital, Incorporated
      • Greenville, North Carolina, Forente stater, 27835-6028
        • Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital
      • Hendersonville, North Carolina, Forente stater, 28791
        • Pardee Memorial Hospital
      • Kinston, North Carolina, Forente stater, 28501
        • Lenoir Memorial Cancer Center
      • Pinehurst, North Carolina, Forente stater, 28374
        • Moore Regional Community Hospital Comprehensive Cancer Center
      • Raleigh, North Carolina, Forente stater, 27607
        • Rex Cancer Center at Rex Hospital
      • Rutherfordton, North Carolina, Forente stater, 28139
        • Rutherford Hospital
      • Wilmington, North Carolina, Forente stater, 28401
        • Zimmer Cancer Center at New Hanover Regional Medical Center
      • Wilson, North Carolina, Forente stater, 27893
        • Wilmed Radiation Oncology Services
    • North Dakota
      • Minot, North Dakota, Forente stater, 58701
        • Trinity Cancer Care Center
    • Ohio
      • Akron, Ohio, Forente stater, 44307
        • McDowell Cancer Center at Akron General Medical Center
      • Canton, Ohio, Forente stater, 44708
        • Mercy Cancer Center at Mercy Medical Center
      • Chillicothe, Ohio, Forente stater, 45601
        • Adena Regional Medical Center
      • Cincinnati, Ohio, Forente stater, 45242
        • Bethesda North Hospital
      • Cincinnati, Ohio, Forente stater, 45220
        • Cancer Treatment Center at Good Samaritan Hospital
      • Cleveland, Ohio, Forente stater, 44195
        • Cleveland Clinic Taussig Cancer Center
      • Cleveland, Ohio, Forente stater, 44109
        • MetroHealth's Cancer Care Center at MetroHealth Medical Center
      • Cleveland, Ohio, Forente stater, 44106
        • Case Comprehensive Cancer Center
      • Columbus, Ohio, Forente stater, 43210-1240
        • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
      • Columbus, Ohio, Forente stater, 43214-3998
        • Riverside Methodist Hospital Cancer Care
      • Columbus, Ohio, Forente stater, 43222
        • Mount Carmel Health - West Hospital
      • Columbus, Ohio, Forente stater, 43215
        • CCOP - Columbus
      • Delaware, Ohio, Forente stater, 43015
        • Grady Memorial Hospital
      • Findlay, Ohio, Forente stater, 45840
        • Blanchard Valley Medical Associates
      • Lima, Ohio, Forente stater, 45804
        • Lima Memorial Hospital
      • Lima, Ohio, Forente stater, 45801
        • St. Rita's Medical Center
      • Marietta, Ohio, Forente stater, 45750
        • Strecker Cancer Center at Marietta Memorial Hospital
      • Maumee, Ohio, Forente stater, 43623
        • Northwest Ohio Oncology Center
      • Mayfield Heights, Ohio, Forente stater, 44124
        • Hillcrest Cancer Center at Hillcrest Hospital
      • Newark, Ohio, Forente stater, 43055
        • Licking Memorial Cancer Care Program at Licking Memorial Hospital
      • Oregon, Ohio, Forente stater, 43616
        • St. Charles Mercy Hospital
      • Sandusky, Ohio, Forente stater, 44870
        • Firelands Regional Medical Center
      • Springfield, Ohio, Forente stater, 45504
        • Mercy Medical Center
      • Sylvania, Ohio, Forente stater, 43560
        • Promedica Cancer Center at Flower Hospital
      • Toledo, Ohio, Forente stater, 43608
        • St. Vincent Mercy Medical Center
      • Toledo, Ohio, Forente stater, 43614
        • Medical University of Ohio Cancer Center
      • Toledo, Ohio, Forente stater, 43623
        • Toledo Clinic, Incorporated - Main Clinic
      • Toledo, Ohio, Forente stater, 43623
        • CCOP - Toledo Community Hospital
      • Warren, Ohio, Forente stater, 44484
        • St. Joseph Cancer Center at St. Joseph Health Center
      • Westerville, Ohio, Forente stater, 43081
        • Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital
    • Oklahoma
      • Tulsa, Oklahoma, Forente stater, 74136
        • Natalie Warren Bryant Cancer Center at St. Francis Hospital
    • Oregon
      • Grants Pass, Oregon, Forente stater, 97527
        • Three Rivers Community Hospital
      • Gresham, Oregon, Forente stater, 97030
        • Legacy Mount Hood Medical Center
      • Medford, Oregon, Forente stater, 97504
        • Providence Medford Medical Center
      • Medford, Oregon, Forente stater, 97504
        • Dubs Cancer Center at Rogue Valley Medical Center
      • Milwaukie, Oregon, Forente stater, 97222
        • Providence Milwaukie Hospital
      • Portland, Oregon, Forente stater, 97213-2967
        • Providence Cancer Center at Providence Portland Medical Center
      • Portland, Oregon, Forente stater, 97225
        • CCOP - Columbia River Oncology Program
      • Portland, Oregon, Forente stater, 97225
        • Providence St. Vincent Medical Center
      • Portland, Oregon, Forente stater, 97210
        • Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center
      • Portland, Oregon, Forente stater, 97227
        • Legacy Emanuel Hospital and Health Center & Children's Hospital
      • Portland, Oregon, Forente stater, 97239-3098
        • Cancer Institute at Oregon Health and Science University
      • Tualatin, Oregon, Forente stater, 97062
        • Legacy Meridian Park Hospital
    • Pennsylvania
      • Abington, Pennsylvania, Forente stater, 19001
        • Rosenfeld Cancer Center at Abington Memorial Hospital
      • Bethlehem, Pennsylvania, Forente stater, 18015
        • St. Luke's Hospital Cancer Center
      • Bryn Mawr, Pennsylvania, Forente stater, 19010
        • Bryn Mawr Hospital
      • Danville, Pennsylvania, Forente stater, 17822-0001
        • Geisinger Medical Center
      • Darby, Pennsylvania, Forente stater, 19023
        • Mercy Fitzgerald Hospital
      • Easton, Pennsylvania, Forente stater, 18042
        • Easton Regional Cancer Center at Easton Hospital
      • Langhorne, Pennsylvania, Forente stater, 19047
        • St. Mary Regional Cancer Center
      • Paoli, Pennsylvania, Forente stater, 19301-1792
        • Paoli Memorial Hospital
      • Philadelphia, Pennsylvania, Forente stater, 19107-5541
        • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
      • Philadelphia, Pennsylvania, Forente stater, 19140
        • Fox Chase-Temple Cancer Center CCOP Research Base
      • Pittsburgh, Pennsylvania, Forente stater, 15232
        • Hillman Cancer Center at University of Pittsburgh Cancer Institute
      • Pittsburgh, Pennsylvania, Forente stater, 15219
        • Mercy Cancer Institute at Mercy Hospital
      • Reading, Pennsylvania, Forente stater, 19612-6052
        • Reading Hospital and Medical Center
      • Scranton, Pennsylvania, Forente stater, 18501
        • Mercy Hospital Cancer Center - Scranton
      • State College, Pennsylvania, Forente stater, 16803
        • Mount Nittany Medical Center
      • Wilkes-Barre, Pennsylvania, Forente stater, 18711
        • Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
      • Wynnewood, Pennsylvania, Forente stater, 19096
        • CCOP - MainLine Health
      • Wynnewood, Pennsylvania, Forente stater, 19096
        • Lankenau Cancer Center at Lankenau Hospital
      • York, Pennsylvania, Forente stater, 17403
        • York Cancer Center at Wellspan Health
    • South Carolina
      • Anderson, South Carolina, Forente stater, 29621
        • AnMed Health Cancer Center
      • Columbia, South Carolina, Forente stater, 29203
        • Palmetto Health South Carolina Cancer Center
      • Greenville, South Carolina, Forente stater, 29615
        • CCOP - Greenville
      • Greenville, South Carolina, Forente stater, 29601
        • Bon Secours St. Francis Health System
      • Spartanburg, South Carolina, Forente stater, 29303
        • CCOP - Upstate Carolina
      • Spartanburg, South Carolina, Forente stater, 29303
        • Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
    • South Dakota
      • Rapid City, South Dakota, Forente stater, 57701
        • Rapid City Regional Hospital
      • Sioux Falls, South Dakota, Forente stater, 57117-5039
        • Sioux Valley Hospital and University of South Dakota Medical Center
      • Sioux Falls, South Dakota, Forente stater, 57105
        • Medical X-Ray Center, PC
    • Texas
      • Galveston, Texas, Forente stater, 77555-0209
        • University of Texas Medical Branch
      • Houston, Texas, Forente stater, 77030-4009
        • M.D. Anderson Cancer Center at University of Texas
      • Laredo, Texas, Forente stater, 78041
        • Doctor's Hospital of Laredo
      • Lubbock, Texas, Forente stater, 79410-1894
        • Joe Arrington Cancer Research and Treatment Center
    • Utah
      • Murray, Utah, Forente stater, 84107
        • Cottonwood Hospital Medical Center
      • Ogden, Utah, Forente stater, 84403
        • McKay-Dee Hospital Center
      • Provo, Utah, Forente stater, 84604
        • Utah Valley Regional Medical Center - Provo
      • Saint George, Utah, Forente stater, 84770
        • Dixie Regional Medical Center - East Campus
      • Salt Lake City, Utah, Forente stater, 84143
        • LDS Hospital
      • Salt Lake City, Utah, Forente stater, 84106
        • Utah Cancer Specialists at UCS Cancer Center
    • Vermont
      • Burlington, Vermont, Forente stater, 05401
        • Fletcher Allen Health Care - University Health Center Campus
      • Rutland, Vermont, Forente stater, 05701
        • Community Cancer Center at Rutland Regional Medical Center
    • Virginia
      • Charlottesville, Virginia, Forente stater, 22901
        • Martha Jefferson Hospital Cancer Care Center
      • Portsmouth, Virginia, Forente stater, 23708-2197
        • Naval Medical Center - Portsmouth
    • Washington
      • Federal Way, Washington, Forente stater, 98003
        • St. Francis Hospital
      • Kirkland, Washington, Forente stater, 98033
        • Cascade Cancer Center at Evergreen Hospital Medical Center
      • Seattle, Washington, Forente stater, 98101
        • CCOP - Virginia Mason Research Center
      • Seattle, Washington, Forente stater, 98112
        • Group Health Central Hospital
      • Seattle, Washington, Forente stater, 98122-4307
        • Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
      • Seattle, Washington, Forente stater, 98195-6043
        • University Cancer Center at University of Washington Medical Center
      • Spokane, Washington, Forente stater, 99202
        • Cancer Care Northwest - Spokane South
      • Tacoma, Washington, Forente stater, 98431
        • Madigan Army Medical Center - Tacoma
      • Vancouver, Washington, Forente stater, 98668
        • Southwest Washington Medical Center Cancer Center
    • Wisconsin
      • Appleton, Wisconsin, Forente stater, 54911
        • Theda Care Cancer Institute
      • Green Bay, Wisconsin, Forente stater, 54307-3508
        • St. Vincent Hospital Regional Cancer Center
      • Green Bay, Wisconsin, Forente stater, 54303
        • Green Bay Oncology, Limited at St. Mary's Hospital
      • Green Bay, Wisconsin, Forente stater, 54303
        • St. Mary's Hospital Medical Center - Green Bay
      • Green Bay, Wisconsin, Forente stater, 54301-3526
        • Green Bay Oncology, Limited at St. Vincent Hospital
      • Green Bay, Wisconsin, Forente stater, 54311
        • Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center
      • La Crosse, Wisconsin, Forente stater, 54601
        • Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
      • Madison, Wisconsin, Forente stater, 53792-6164
        • University of Wisconsin Comprehensive Cancer Center
      • Marinette, Wisconsin, Forente stater, 54143
        • Bay Area Cancer Care Center at Bay Area Medical Center
      • Menomonee Falls, Wisconsin, Forente stater, 53051
        • Community Memorial Hospital Cancer Care Center
      • Milwaukee, Wisconsin, Forente stater, 53215
        • Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center
      • Milwaukee, Wisconsin, Forente stater, 53211
        • Columbia St. Mary's Cancer Care Center
      • Oconomowoc, Wisconsin, Forente stater, 53066
        • Regional Cancer Center at Oconomowoc Memorial Hospital
      • Oconto Falls, Wisconsin, Forente stater, 54154
        • Green Bay Oncology, Limited - Oconto Falls
      • Sturgeon Bay, Wisconsin, Forente stater, 54235
        • Green Bay Oncology, Limited - Sturgeon Bay
      • Waukesha, Wisconsin, Forente stater, 53188
        • Waukesha Memorial Hospital Regional Cancer Center
      • West Milwaukee, Wisconsin, Forente stater, 53227
        • West Allis Memorial Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

22 år til 116 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

SYKDOMENS KARAKTERISTIKA:

  • Duktalt karsinom in situ (DCIS) i brystet oppdaget ved mammografi ved diagnosetidspunktet

    • Unisentrisk
    • Lesjoner ≤ 2,5 cm
    • Lav nuclei grade (NG1) eller middels nuclei grade (NG2) med nekrose i < en tredjedel av de involverte kanalene
    • Fargede marger ≥ 3 mm
    • Klinisk node negativ
    • Ikke-følbar
  • Ingen mistenkelige områder på postoperativ mammografi tatt innen 12 uker etter siste operasjon
  • Ingen blodig utflod fra brystvorten
  • Ikke mer enn 12 uker siden forrige siste operasjon (kun arm II)
  • Hormonreseptorstatus:

    • Ikke spesifisert

PASIENT KARAKTERISTIKA:

Alder:

  • 26 og over

Kjønn:

  • Hunn

Menopausal status:

  • Ikke spesifisert

Ytelsesstatus:

  • Ikke spesifisert

Forventet levealder:

  • Ikke spesifisert

Hematopoetisk:

  • Ikke spesifisert

Hepatisk:

  • Ikke spesifisert

Nyre:

  • Ikke spesifisert

Annen:

  • Ikke gravid eller ammende
  • Ingen aktive bindevevssykdommer (f.eks. lupus eller sklerodermi)
  • Ingen tidligere malignitet innen de siste 5 årene bortsett fra tilstrekkelig behandlet basalcelle- eller plateepitelkreft eller karsinom in situ i livmorhalsen

FØR SAMTIDIG TERAPI:

Biologisk terapi:

  • Ikke spesifisert

Kjemoterapi:

  • Ingen tidligere kjemoterapi

Endokrin terapi:

  • Ingen annen samtidig hormonbehandling (f.eks. raloksifen, hormonbehandling eller p-piller)

Strålebehandling:

  • Ingen tidligere strålebehandling

Kirurgi:

  • Se Sykdomskarakteristikker

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Observasjon +/- tamoxifen i 5 år
Observasjon +/- tamoxifen 20 mg per dag i 5 år
Eksperimentell: Strålebehandling +/- tamoxifen i 5 år
Strålebehandling til hele brystet +/- tamoxifen 20 mg per dag i 5 år

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Lokalt tilbakefall (f.eks. invasivt eller ikke-invasivt tilbakefall)
Tidsramme: Fra randomisering til dato for lokal svikt i det behandlede brystet eller siste oppfølging. Analyse skjer etter at alle pasienter potensielt har blitt fulgt i 5 år.
Fra randomisering til dato for lokal svikt i det behandlede brystet eller siste oppfølging. Analyse skjer etter at alle pasienter potensielt har blitt fulgt i 5 år.

Sekundære resultatmål

Resultatmål
Tidsramme
Total overlevelse
Tidsramme: Fra randomisering til dødsdato eller siste oppfølging. Analyse skjer etter at alle pasienter potensielt har blitt fulgt i 5 år.
Fra randomisering til dødsdato eller siste oppfølging. Analyse skjer etter at alle pasienter potensielt har blitt fulgt i 5 år.
Tid for fjernmetastasering
Tidsramme: Fra randomisering til dato for fjernmetastase eller siste oppfølging. Analyse skjer etter at alle pasienter potensielt har blitt fulgt i 5 år.
Fra randomisering til dato for fjernmetastase eller siste oppfølging. Analyse skjer etter at alle pasienter potensielt har blitt fulgt i 5 år.
Invasiv lokalt tilbakefall
Tidsramme: Fra randomisering til dato for invasiv lokal svikt i det behandlede brystet eller siste oppfølging. Analyse skjer etter at alle pasienter potensielt har blitt fulgt i 5 år.
Fra randomisering til dato for invasiv lokal svikt i det behandlede brystet eller siste oppfølging. Analyse skjer etter at alle pasienter potensielt har blitt fulgt i 5 år.
Salvage mastektomi rate
Tidsramme: Analyse skjer etter at alle pasienter potensielt har blitt fulgt i 5 år.
Analyse skjer etter at alle pasienter potensielt har blitt fulgt i 5 år.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Studiestol: Barbara L. Smith, MD, PhD, Massachusetts General Hospital
  • Studiestol: Beryl McCormick, MD, Memorial Sloan Kettering Cancer Center
  • Clifford A. Hudis, MD, Memorial Sloan Kettering Cancer Center
  • Studiestol: Timothy J. Whelan, MD, Margaret and Charles Juravinski Cancer Centre
  • Eileen Rakovitch, MD, Toronto Sunnybrook Regional Cancer Centre

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. desember 1999

Primær fullføring (Faktiske)

1. februar 2004

Studiet fullført (Faktiske)

20. mai 2022

Datoer for studieregistrering

Først innsendt

1. november 1999

Først innsendt som oppfylte QC-kriteriene

26. januar 2003

Først lagt ut (Anslag)

27. januar 2003

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

25. mai 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

23. mai 2022

Sist bekreftet

1. mai 2022

Mer informasjon

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere