Strålebehandling (WBI versus PBI) til behandling af kvinder, der har gennemgået kirurgi for duktalt karcinom in situ eller stadium I eller stadium II brystkræft
13. april 2022 opdateret af: NSABP Foundation Inc
En randomiseret fase III-undersøgelse af konventionel helbrystbestråling (WBI) versus delvis brystbestråling (PBI) for kvinder med trin 0, I eller II brystkræft
RATIONALE: Strålebehandling bruger højenergi røntgenstråler til at dræbe tumorceller. At give strålebehandling på forskellige måder kan dræbe eventuelle tumorceller, der er tilbage efter operationen. Det vides endnu ikke, om strålebehandling af hele bryster er mere effektiv end delvis bryststrålebehandling til behandling af brystkræft.
FORMÅL: Dette randomiserede fase III-forsøg studerer strålebehandling af hele bryster for at se, hvor godt det virker sammenlignet med delvis bryststrålebehandling ved behandling af kvinder, der har gennemgået operation for duktalt carcinom in situ eller stadium I eller stadium II brystkræft.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
MÅL:
Primær
- Sammenlign lokal tumorkontrol hos kvinder med duktalt carcinom in situ eller stadium I eller II brystkræft behandlet med adjuverende helbryst versus delvis brystbestråling efter lumpektomi.
Sekundær
- Sammenlign samlet overlevelse, tilbagefaldsfri overlevelse og fjern sygdomsfri overlevelse hos patienter behandlet med disse regimer.
- Sammenlign det kosmetiske resultat hos patienter behandlet med disse regimer.
- Sammenlign træthed og behandlingsrelaterede symptomer hos patienter behandlet med disse regimer.
- Sammenlign opfattet bekvemmelighed ved pleje hos patienter behandlet med disse regimer.
- Sammenlign akutte og sene toksiske virkninger af disse regimer hos disse patienter.
OVERSIGT: Dette er en randomiseret, multicenter undersøgelse. Patienterne er stratificeret efter sygdomsstadie (kun duktalt carcinom in situ [DCIS] vs invasiv og node negative vs invasive med 1-3 positive knuder), overgangsalderen status (præmenopausal vs postmenopausal), hormonreceptorstatus (østrogenreceptor [ER]-positiv og/eller progesteronreceptor [PR]-positiv vs ER-negativ og PR-negativ), intention om at modtage kemoterapi (ja vs nej). Patienterne randomiseres til 1 ud af 2 behandlingsarme. (Patienter, der er 50 år og derover med DCIS uanset hormonreceptorstatus OG patienter med invasiv brystkræft, der opfylder alle følgende kriterier: ≥ 50 år, node-negativ og hormonreceptor-positiv status vil ikke blive tilmeldt i studiet efter 30/12/2006.)
- Gruppe 1: Patienter gennemgår helbrystbestråling (WBI) én gang dagligt, 5 dage om ugen, i 5-7 uger.
- Gruppe 2: Patienter gennemgår delvis brystbestråling (PBI) to gange dagligt på 5 dage over en periode på 5-10 dage. Dette kan leveres ved multikateter brachyterapi, enkeltindgangs intrakavitær brachyterapi eller 3-D konform strålebehandling.
Patienter i begge arme kan modtage adjuverende kemoterapi mindst 2 uger før påbegyndelse af WBI ELLER mindst 2 uger efter afslutning af PBI efter den behandlende læges skøn. Patienter med ER-positive eller PR-positive tumorer kan også modtage hormonbehandling, begyndende 3-12 uger efter afslutning af adjuverende kemoterapi (eller før, under eller efter afslutning af WBI eller PBI for patienter, der ikke modtager adjuverende kemoterapi) og fortsætter til kl. mindst 5 år.
Efter afsluttet undersøgelsesbehandling følges patienterne efter 1 og 6 måneder, hver 6. måned i 4,5 år og derefter årligt.
PROJEKTERET TILSLUTNING: I alt 4.300 patienter (2.150 pr. behandlingsarm) vil blive akkumuleret til denne undersøgelse inden for 4,6 år. Bemærk: Periodiseringen lukkede den 16. april 2013 efter godkendelse af dataovervågningsudvalget for at reducere stikprøvestørrelsen fra 4.300 til 4.214 patienter.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
4216
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Alberta
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Edmonton, Alberta, Canada, T6G 1Z2
- Cross Cancer Institute at University of Alberta
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British Columbia
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Victoria, British Columbia, Canada, V8R 6V5
- British Columbia Cancer Agency - Vancouver Island Centre
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Manitoba
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Winnipeg, Manitoba, Canada, R3E 0V9
- CancerCare Manitoba
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Ontario
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London, Ontario, Canada, N6A 4L6
- London Regional Cancer Program at London Health Sciences Centre
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Toronto, Ontario, Canada, M4N 3M5
- Odette Cancer Centre at Sunnybrook
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Quebec
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Montreal, Quebec, Canada, H3G 1A4
- Montreal General Hospital
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Montreal, Quebec, Canada, H3A 1A1
- Royal Victoria Hospital - Montreal
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Montreal, Quebec, Canada, H3T 1E2
- Jewish General Hospital - Montreal
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Montreal, Quebec, Canada, H2L 4M1
- Hopital Notre-Dame du CHUM
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Quebec City, Quebec, Canada, G1S 4L8
- Hopital du Saint-Sacrement - Quebec
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Saskatchewan
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Saskatoon, Saskatchewan, Canada, S7N 4H4
- Saskatoon Cancer Centre at the University of Saskatchewan
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Alabama
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Birmingham, Alabama, Forenede Stater, 35294
- UAB Comprehensive Cancer Center
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Arizona
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Peoria, Arizona, Forenede Stater, 85381
- Arizona Center for Cancer Care - Peoria
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Phoenix, Arizona, Forenede Stater, 85013
- Arizona Oncology Services Foundation
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Scottsdale, Arizona, Forenede Stater, 85259-5499
- Mayo Clinic Scottsdale
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Scottsdale, Arizona, Forenede Stater, 85258
- Arizona Breast Cancer Specialists
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Arkansas
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Little Rock, Arkansas, Forenede Stater, 72205
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
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California
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Auburn, California, Forenede Stater, 95603
- Auburn Radiation Oncology
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Berkeley, California, Forenede Stater, 94704
- Alta Bates Summit Comprehensive Cancer Center
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Burlingame, California, Forenede Stater, 94010
- Peninsula Medical Center
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Cameron Park, California, Forenede Stater, 95682
- Radiation Oncology Centers - Cameron Park
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Carmichael, California, Forenede Stater, 95608
- Mercy Cancer Center at Mercy San Juan Medical Center
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Chico, California, Forenede Stater, 95926
- Enloe Cancer Center at Enloe Medical Center
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Concord, California, Forenede Stater, 94524-4110
- Cancer Care Center at John Muir Health - Concord Campus
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Duarte, California, Forenede Stater, 91010-3000
- City of Hope Comprehensive Cancer Center
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Fairfield, California, Forenede Stater, 94533
- North Bay Cancer Center
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Fresno, California, Forenede Stater, 93720
- California Cancer Center - Woodward Park Office
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Hayward, California, Forenede Stater, 94545
- Kaiser Permanente Medical Center - Hayward
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La Jolla, California, Forenede Stater, 92093-0658
- Rebecca and John Moores UCSD Cancer Center
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Los Angeles, California, Forenede Stater, 90095-1781
- Jonsson Comprehensive Cancer Center at UCLA
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Monterey, California, Forenede Stater, 93940
- Community Hospital of the Monterey Peninsula Comprehensive Cancer Center
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Novato, California, Forenede Stater, 94945
- Sutter Health - Western Division Cancer Research Group
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Oakland, California, Forenede Stater, 94609
- CCOP - Bay Area Tumor Institute
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Orange, California, Forenede Stater, 92868
- St. Joseph Hospital Regional Cancer Center - Orange
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Palm Springs, California, Forenede Stater, 92262
- Desert Regional Medical Center Comprehensive Cancer Center
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Paradise, California, Forenede Stater, 95969
- Feather River Hospital Cancer Center
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Pomona, California, Forenede Stater, 91767
- Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center
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Redding, California, Forenede Stater, 96049
- Mercy Regional Cancer Center at Mercy Medical Center
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Roseville, California, Forenede Stater, 95661
- Radiation Oncology Center - Roseville
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Sacramento, California, Forenede Stater, 95815
- Radiological Associates of Sacramento Medical Group, Incorporated
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Sacramento, California, Forenede Stater, 95819
- Mercy General Hospital
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Sacramento, California, Forenede Stater, 95817
- University of California Davis Cancer Center
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San Diego, California, Forenede Stater, 92123
- Sharp Memorial Hospital Cancer Center
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San Diego, California, Forenede Stater, 92108
- Kaiser Permanente Medical Office -Vandever Medical Office
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San Francisco, California, Forenede Stater, 94118
- California Pacific Medical Center - California Campus
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San Pablo, California, Forenede Stater, 94806
- Doctors Medical Center - San Pablo Campus
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Stanford, California, Forenede Stater, 94305-5824
- Stanford Cancer Center
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Vacaville, California, Forenede Stater, 95687
- Solano Radiation Oncology Center
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Vallejo, California, Forenede Stater, 94589
- Sutter Solano Medical Center
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Vallejo, California, Forenede Stater, 94589
- Kaiser Permanente Medical Center - Vallejo
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Walnut Creek, California, Forenede Stater, 94598
- John Muir/Mt. Diablo Comprehensive Cancer Center
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Whittier, California, Forenede Stater, 90602
- Ruby L. Golleher Cancer Program at Presbyterian Intercommunity Hospital
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Colorado
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Aurora, Colorado, Forenede Stater, 80045
- University of Colorado Cancer Center at UC Health Sciences Center
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Aurora, Colorado, Forenede Stater, 80012
- Aurora Presbyterian Hospital
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Boulder, Colorado, Forenede Stater, 80301-9019
- Boulder Community Hospital
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Colorado Springs, Colorado, Forenede Stater, 80933
- Penrose Cancer Center at Penrose Hospital
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Colorado Springs, Colorado, Forenede Stater, 80909
- Memorial Hospital Cancer Center - Colorado Springs
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Denver, Colorado, Forenede Stater, 80210
- Porter Adventist Hospital
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Englewood, Colorado, Forenede Stater, 80110
- Swedish Medical Center
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Fort Collins, Colorado, Forenede Stater, 80528
- Poudre Valley Radiation Oncology
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Greeley, Colorado, Forenede Stater, 80631
- North Colorado Medical Center
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Lone Tree, Colorado, Forenede Stater, 80124
- Sky Ridge Medical Center
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Longmont, Colorado, Forenede Stater, 80501
- Hope Cancer Care Center at Longmont United Hospital
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Loveland, Colorado, Forenede Stater, 80539
- McKee Medical Center
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Pueblo, Colorado, Forenede Stater, 81004
- St. Mary - Corwin Regional Medical Center
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Thornton, Colorado, Forenede Stater, 80229
- North Suburban Medical Center
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Connecticut
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Bridgeport, Connecticut, Forenede Stater, 06610
- Bridgeport Hospital
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Hartford, Connecticut, Forenede Stater, 06102-5037
- Helen and Harry Gray Cancer Center at Hartford Hospital
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New Haven, Connecticut, Forenede Stater, 06511
- Hospital of Saint Raphael
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New Haven, Connecticut, Forenede Stater, 06520-8028
- Yale Cancer Center
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Norwalk, Connecticut, Forenede Stater, 06856
- Norwalk Hospital
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Torrington, Connecticut, Forenede Stater, 06790
- Connecticut Oncology & Hematology - Torrington
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Delaware
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Newark, Delaware, Forenede Stater, 19713
- CCOP - Christiana Care Health Services
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District of Columbia
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Washington, District of Columbia, Forenede Stater, 20010
- Washington Cancer Institute at Washington Hospital Center
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Florida
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Boca Raton, Florida, Forenede Stater, 33486
- Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - Main Campus
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Gainesville, Florida, Forenede Stater, 32610-0232
- University of Florida Shands Cancer Center
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Jacksonville, Florida, Forenede Stater, 32224
- Mayo Clinic - Jacksonville
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Jacksonville, Florida, Forenede Stater, 32207
- Baptist Cancer Institute - Jacksonville
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Jacksonville, Florida, Forenede Stater, 32207
- Integrated Community Oncology Network at Southside Cancer Center
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Jacksonville, Florida, Forenede Stater, 32258
- Baptist Medical Center South
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Jacksonville Beach, Florida, Forenede Stater, 32250
- Integrated Community Oncology Network
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Jupiter, Florida, Forenede Stater, 33458
- Ella Milbank Foshay Cancer Center at Jupiter Medical Center
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Lakeland, Florida, Forenede Stater, 33805
- Lakeland Regional Cancer Center at Lakeland Regional Medical Center
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Miami Beach, Florida, Forenede Stater, 33140
- CCOP - Mount Sinai Medical Center
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Orange Park, Florida, Forenede Stater, 32073
- Integrated Community Oncology Network - Orange Park
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Palatka, Florida, Forenede Stater, 32177
- Florida Cancer Center - Palatka
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Saint Augustine, Florida, Forenede Stater, 32086
- Flagler Cancer Center
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Georgia
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Atlanta, Georgia, Forenede Stater, 30342-1611
- Northside Hospital Cancer Center
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Atlanta, Georgia, Forenede Stater, 30342
- CCOP - Atlanta Regional
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Decatur, Georgia, Forenede Stater, 30033
- Charles B. Eberhart Cancer Center at DeKalb Medical Center
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Marietta, Georgia, Forenede Stater, 30060
- Kennestone Cancer Center at Wellstar Kennestone Hospital
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Hawaii
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Honolulu, Hawaii, Forenede Stater, 96813
- Cancer Research Center of Hawaii
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Honolulu, Hawaii, Forenede Stater, 96813
- Queen's Cancer Institute at Queen's Medical Center
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Honolulu, Hawaii, Forenede Stater, 96813
- Straub Clinic and Hospital, Incorporated
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Idaho
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Boise, Idaho, Forenede Stater, 83712
- Mountain States Tumor Institute at St. Luke's Regional Medical Center
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Coeur d'Alene, Idaho, Forenede Stater, 83814
- Kootenai Cancer Center - Coeur d'Alene
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Illinois
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Aurora, Illinois, Forenede Stater, 60504
- Rush-Copley Cancer Care Center
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Barrington, Illinois, Forenede Stater, 60010
- Good Shepherd Hospital
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Bloomington, Illinois, Forenede Stater, 61701
- Illinois CancerCare - Bloomington
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Canton, Illinois, Forenede Stater, 61520
- Illinois CancerCare - Canton
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Carthage, Illinois, Forenede Stater, 62321
- Illinois CancerCare - Carthage
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Chicago, Illinois, Forenede Stater, 60657
- Creticos Cancer Center at Advocate Illinois Masonic Medical Center
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Downers Grove, Illinois, Forenede Stater, 60515-1500
- Good Samaritan Cancer Care Center at Advocate Good Samaritan Hospital
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Elk Grove Village, Illinois, Forenede Stater, 60007
- Alexian Brothers Radiation Oncology
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Eureka, Illinois, Forenede Stater, 61530
- Illinois CancerCare - Eureka
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Galesburg, Illinois, Forenede Stater, 61401
- Illinois CancerCare - Galesburg
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Galesburg, Illinois, Forenede Stater, 61401
- Illinois CancerCare - Cottage
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Havana, Illinois, Forenede Stater, 62644
- Illinois CancerCare - Havana
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Kewanee, Illinois, Forenede Stater, 61443
- Illinois CancerCare - Kewanee Clinic
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Macomb, Illinois, Forenede Stater, 61455
- Illinois CancerCare - Macomb
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Maywood, Illinois, Forenede Stater, 60153
- Cardinal Bernardin Cancer Center at Loyola University Medical Center
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Moline, Illinois, Forenede Stater, 61265
- Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
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Monmouth, Illinois, Forenede Stater, 61462
- Illinois CancerCare - Monmouth
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Monmouth, Illinois, Forenede Stater, 61462
- OSF Holy Family Medical Center
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Naperville, Illinois, Forenede Stater, 60540
- Edward Hospital Cancer Center
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Normal, Illinois, Forenede Stater, 61761
- Community Cancer Center
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Normal, Illinois, Forenede Stater, 61761
- Illinois CancerCare - Community Cancer Center
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Ottawa, Illinois, Forenede Stater, 61350
- Oncology Hematology Associates of Central Illinois, PC - Ottawa
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Park Ridge, Illinois, Forenede Stater, 60068-1174
- Advocate Lutheran General Cancer Care Center
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Pekin, Illinois, Forenede Stater, 61554
- Cancer Treatment Center at Pekin Hospital
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Pekin, Illinois, Forenede Stater, 61603
- Illinois CancerCare - Pekin
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Peoria, Illinois, Forenede Stater, 61636
- Methodist Medical Center of Illinois
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Peoria, Illinois, Forenede Stater, 61615
- CCOP - Illinois Oncology Research Association
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Peoria, Illinois, Forenede Stater, 61615
- Oncology Hematology Associates of Central Illinois, PC - Peoria
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Peoria, Illinois, Forenede Stater, 61615-7827
- OSF St. Francis Medical Center
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Peru, Illinois, Forenede Stater, 61354
- Illinois CancerCare - Peru
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Princeton, Illinois, Forenede Stater, 61356
- Illinois CancerCare - Princeton
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Spring Valley, Illinois, Forenede Stater, 61362
- Illinois CancerCare - Spring Valley
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Springfield, Illinois, Forenede Stater, 62702
- Cancer Institute at St. John's Hospital
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Urbana, Illinois, Forenede Stater, 61801
- CCOP - Carle Cancer Center
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Warrenville, Illinois, Forenede Stater, 60555
- Central Dupage Cancer Center
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Indiana
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Anderson, Indiana, Forenede Stater, 46016
- Saint John's Cancer Center at Saint John's Medical Center
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Elkhart, Indiana, Forenede Stater, 46515
- Elkhart General Hospital
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Fort Wayne, Indiana, Forenede Stater, 46805
- Parkview Regional Cancer Center at Parkview Health
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Fort Wayne, Indiana, Forenede Stater, 46804
- Radiation Oncology Associates Southwest
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Goshen, Indiana, Forenede Stater, 46526
- Center for Cancer Care at Goshen General Hospital
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Indianapolis, Indiana, Forenede Stater, 46260
- St. Vincent Indianapolis Hospital
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Indianapolis, Indiana, Forenede Stater, 46202
- Methodist Cancer Center at Methodist Hospital
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Indianapolis, Indiana, Forenede Stater, 46219
- Central Indiana Cancer Centers - East
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South Bend, Indiana, Forenede Stater, 46601
- Memorial Hospital of South Bend
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Iowa
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Davenport, Iowa, Forenede Stater, 52803
- Genesis Regional Cancer Center at Genesis Medical Center
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Des Moines, Iowa, Forenede Stater, 50309
- John Stoddard Cancer Center at Iowa Methodist Medical Center
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Iowa City, Iowa, Forenede Stater, 52242-1002
- Holden Comprehensive Cancer Center at University of Iowa
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Kansas
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Prairie Village, Kansas, Forenede Stater, 66208
- CCOP - Kansas City
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Kentucky
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Lexington, Kentucky, Forenede Stater, 40536-0093
- Lucille P. Markey Cancer Center at University of Kentucky
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Lexington, Kentucky, Forenede Stater, 40503-9985
- Central Baptist Hospital
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Louisville, Kentucky, Forenede Stater, 40202
- Louisville Oncology at Norton Cancer Institute - Louisville
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Louisville, Kentucky, Forenede Stater, 40202
- James Graham Brown Cancer Center at University of Louisville
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Louisiana
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Baton Rouge, Louisiana, Forenede Stater, 70809
- Mary Bird Perkins Cancer Center - Baton Rouge
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Baton Rouge, Louisiana, Forenede Stater, 70809
- Ochsner Health Center - Bluebonnet
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New Orleans, Louisiana, Forenede Stater, 70121
- CCOP - Ochsner
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Maine
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Bangor, Maine, Forenede Stater, 04401
- CancerCare of Maine at Eastern Maine Medical Center
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Lewiston, Maine, Forenede Stater, 04240
- Central Maine Comprehensive Cancer Center at Central Maine Medical Center
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Maryland
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Annapolis, Maryland, Forenede Stater, 21401
- DeCesaris Cancer Institute at Anne Arundel Medical Center
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Baltimore, Maryland, Forenede Stater, 21231-2410
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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Baltimore, Maryland, Forenede Stater, 21229
- St. Agnes Hospital Cancer Center
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Baltimore, Maryland, Forenede Stater, 21201
- Greenebaum Cancer Center at University of Maryland Medical Center
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Baltimore, Maryland, Forenede Stater, 21237
- Harry and Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center
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Columbia, Maryland, Forenede Stater, 21044
- Central Maryland Oncology Center
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Easton, Maryland, Forenede Stater, 21601
- Shore Regional Cancer Center at Memorial Hospital - Easton
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Elkton, Maryland, Forenede Stater, 21921
- Union Hospital of Cecil County
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Salisbury, Maryland, Forenede Stater, 21801
- Peninsula Regional Medical Center
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Silver Spring, Maryland, Forenede Stater, 20910
- Holy Cross Hospital
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02114
- Massachusetts General Hospital
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Boston, Massachusetts, Forenede Stater, 02118
- Boston University Cancer Research Center
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Burlington, Massachusetts, Forenede Stater, 01805
- Lahey Clinic Medical Center - Burlington
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Danvers, Massachusetts, Forenede Stater, 01923
- NSMC Cancer Center - Peabody
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Framingham, Massachusetts, Forenede Stater, 01702
- Metrowest Medical Center - Framingham Union Hospital
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Hyannis, Massachusetts, Forenede Stater, 02601
- Cape Cod Hospital
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Michigan
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Ann Arbor, Michigan, Forenede Stater, 48106-0995
- Saint Joseph Mercy Cancer Center
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Battle Creek, Michigan, Forenede Stater, 49017
- Battle Creek Health System Cancer Care Center
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Clinton Township, Michigan, Forenede Stater, 48038
- Henry Ford Macomb Hospital
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Dearborn, Michigan, Forenede Stater, 48123-2500
- Oakwood Cancer Center at Oakwood Hospital and Medical Center
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Detroit, Michigan, Forenede Stater, 48202
- Josephine Ford Cancer Center at Henry Ford Hospital
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Detroit, Michigan, Forenede Stater, 48201-1379
- Barbara Ann Karmanos Cancer Institute
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Flint, Michigan, Forenede Stater, 48503
- Genesys Hurley Cancer Institute
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Flint, Michigan, Forenede Stater, 48532
- McLaren Cancer Institute
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Grand Rapids, Michigan, Forenede Stater, 49503
- Butterworth Hospital at Spectrum Health
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Grand Rapids, Michigan, Forenede Stater, 49503
- CCOP - Grand Rapids
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Grosse Pointe Woods, Michigan, Forenede Stater, 48236
- Van Elslander Cancer Center at St. John Hospital and Medical Center
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Kalamazoo, Michigan, Forenede Stater, 49007
- Bronson Methodist Hospital
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Kalamazoo, Michigan, Forenede Stater, 49001
- Borgess Medical Center
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Kalamazoo, Michigan, Forenede Stater, 49007-3731
- West Michigan Cancer Center
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Lansing, Michigan, Forenede Stater, 48910
- Breslin Cancer Center at Ingham Regional Medical Center
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Pontiac, Michigan, Forenede Stater, 48341-2985
- St. Joseph Mercy Oakland
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Royal Oak, Michigan, Forenede Stater, 48073
- William Beaumont Hospital - Royal Oak Campus
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Saginaw, Michigan, Forenede Stater, 48601
- Seton Cancer Institute at Saint Mary's - Saginaw
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Warren, Michigan, Forenede Stater, 48093
- St. John Macomb Hospital
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Minnesota
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Bemidji, Minnesota, Forenede Stater, 56601
- MeritCare Bemidji
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Burnsville, Minnesota, Forenede Stater, 55337
- Fairview Ridges Hospital
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Coon Rapids, Minnesota, Forenede Stater, 55433
- Mercy and Unity Cancer Center at Mercy Hospital
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Duluth, Minnesota, Forenede Stater, 55805
- St. Luke's Hospital Cancer Care Center
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Edina, Minnesota, Forenede Stater, 55435
- Fairview Southdale Hospital
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Fridley, Minnesota, Forenede Stater, 55432
- Mercy and Unity Cancer Center at Unity Hospital
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Mankato, Minnesota, Forenede Stater, 56002
- Immanuel St. Joseph's
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Maplewood, Minnesota, Forenede Stater, 55109
- Minnesota Oncology - Maplewood
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Minneapolis, Minnesota, Forenede Stater, 55407
- Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
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Robbinsdale, Minnesota, Forenede Stater, 55422-2900
- Humphrey Cancer Center at North Memorial Outpatient Center
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Rochester, Minnesota, Forenede Stater, 55905
- Mayo Clinic Cancer Center
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Saint Cloud, Minnesota, Forenede Stater, 56303
- CentraCare Clinic - River Campus
-
Saint Louis Park, Minnesota, Forenede Stater, 55416
- CCOP - Metro-Minnesota
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Saint Louis Park, Minnesota, Forenede Stater, 55416
- Park Nicollet Cancer Center
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Saint Paul, Minnesota, Forenede Stater, 55102
- United Hospital
-
Saint Paul, Minnesota, Forenede Stater, 55101
- Regions Hospital Cancer Care Center
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Waconia, Minnesota, Forenede Stater, 55387
- Ridgeview Medical Center
-
Woodbury, Minnesota, Forenede Stater, 55125
- Minnesota Oncology - Woodbury
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Mississippi
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Jackson, Mississippi, Forenede Stater, 39216
- University of Mississippi Cancer Clinic
-
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Missouri
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Kansas City, Missouri, Forenede Stater, 64154
- Kansas City Cancer Centers - North
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Montana
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Billings, Montana, Forenede Stater, 59107-7000
- Billings Clinic - Downtown
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Great Falls, Montana, Forenede Stater, 59405
- Great Falls Clinic - Main Facility
-
Great Falls, Montana, Forenede Stater, 59405
- Sletten Cancer Institute at Benefis Healthcare
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Missoula, Montana, Forenede Stater, 59807
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
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Nebraska
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Kearney, Nebraska, Forenede Stater, 68848-1990
- Good Samaritan Cancer Center at Good Samaritan Hospital
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Omaha, Nebraska, Forenede Stater, 68122
- Immanuel Medical Center
-
Omaha, Nebraska, Forenede Stater, 68124
- Alegant Health Cancer Center at Bergan Mercy Medical Center
-
Omaha, Nebraska, Forenede Stater, 68131-2197
- Creighton University Medical Center
-
Omaha, Nebraska, Forenede Stater, 68114
- Methodist Estabrook Cancer Center
-
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Nevada
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Las Vegas, Nevada, Forenede Stater, 89106
- CCOP - Nevada Cancer Research Foundation
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Reno, Nevada, Forenede Stater, 89503
- Saint Mary's Regional Medical Center
-
Reno, Nevada, Forenede Stater, 89502
- Renown Institute for Cancer at Renown Regional Medical Center
-
-
New Hampshire
-
Concord, New Hampshire, Forenede Stater, 03301
- Payson Center for Cancer Care at Concord Hospital
-
Dover, New Hampshire, Forenede Stater, 03820
- Seacoast Cancer Center at Wentworth - Douglass Hospital
-
Exeter, New Hampshire, Forenede Stater, 03833
- Center for Cancer Care at Exeter Hospital
-
Lebanon, New Hampshire, Forenede Stater, 03756-0002
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
-
Manchester, New Hampshire, Forenede Stater, 03103
- Elliot Regional Cancer Center at Elliot Hospital
-
-
New Jersey
-
Basking Ridge, New Jersey, Forenede Stater, 07920
- Memorial Sloan-Kettering Cancer Center - Basking Ridge
-
Elizabeth, New Jersey, Forenede Stater, 07207
- Trinitas Comprehensive Cancer Center at Trinitas Hospital
-
Englewood, New Jersey, Forenede Stater, 07631
- Dizzy Gillespie Cancer Institute at Englewood Hospital and Medical Center
-
Livingston, New Jersey, Forenede Stater, 07039
- St. Barnabas Medical Center Cancer Center
-
Marlton, New Jersey, Forenede Stater, 08053
- Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
-
New Brunswick, New Jersey, Forenede Stater, 08901
- Saint Peter's University Hospital
-
Newark, New Jersey, Forenede Stater, 07112
- Newark Beth Israel Medical Center
-
Sparta, New Jersey, Forenede Stater, 07871
- Frederick R. and Betty M. Smith Cancer Treatment Center
-
Toms River, New Jersey, Forenede Stater, 08755
- J. Phillip Citta Regional Cancer Center at Community Medical Center
-
Trenton, New Jersey, Forenede Stater, 08629
- St. Francis Regional Cancer Center
-
Voorhees, New Jersey, Forenede Stater, 08043
- Cancer Institute of New Jersey at Cooper - Voorhees
-
-
New Mexico
-
Albuquerque, New Mexico, Forenede Stater, 87131-5636
- University of New Mexico Cancer Center
-
-
New York
-
Albany, New York, Forenede Stater, 12206
- New York Oncology Hematology, PC at Albany Regional Cancer Care
-
Buffalo, New York, Forenede Stater, 14263-0001
- Roswell Park Cancer Institute
-
Canandaigua, New York, Forenede Stater, 14424
- Sands Cancer Center
-
Commack, New York, Forenede Stater, 11725
- Memorial Sloan-Kettering Cancer Center
-
Cooperstown, New York, Forenede Stater, 13326
- Bassett Healthcare Regional Cancer Program at Mary Imogene Bassett Hospital
-
East Syracuse, New York, Forenede Stater, 13057
- CCOP - Hematology-Oncology Associates of Central New York
-
Ithaca, New York, Forenede Stater, 14850
- Cayuga Medical Center of Ithaca
-
Jamaica, New York, Forenede Stater, 11432
- Queens Cancer Center of Queens Hospital
-
Manhasset, New York, Forenede Stater, 11030
- CCOP - North Shore University Hospital
-
New Hyde Park, New York, Forenede Stater, 11040
- Long Island Jewish Medical Center
-
Poughkeepsie, New York, Forenede Stater, 12601
- Saint Francis Hospital Cancer Center
-
Poughkeepsie, New York, Forenede Stater, 12601
- Hudson Valley Oncology Associates
-
Rochester, New York, Forenede Stater, 14642
- James P. Wilmot Cancer Center at University of Rochester Medical Center
-
Rochester, New York, Forenede Stater, 14620
- Highland Hospital of Rochester
-
Rochester, New York, Forenede Stater, 14621
- Lipson Cancer and Blood Center at Rochester General Hospital
-
Rochester, New York, Forenede Stater, 14626
- University Radiation Oncology at Parkridge Hospital
-
Sleepy Hollow, New York, Forenede Stater, 10591
- Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center
-
Syracuse, New York, Forenede Stater, 13210
- SUNY Upstate Medical University Hospital
-
-
North Carolina
-
Asheville, North Carolina, Forenede Stater, 28801
- Mission Hospitals - Memorial Campus
-
Asheville, North Carolina, Forenede Stater, 28816
- Hope A Women's Cancer Center
-
Charlotte, North Carolina, Forenede Stater, 28232-2861
- Blumenthal Cancer Center at Carolinas Medical Center
-
Charlotte, North Carolina, Forenede Stater, 28233-3549
- Presbyterian Cancer Center at Presbyterian Hospital
-
Durham, North Carolina, Forenede Stater, 27710
- Duke Cancer Institute
-
Hendersonville, North Carolina, Forenede Stater, 28791
- Pardee Memorial Hospital
-
High Point, North Carolina, Forenede Stater, 27261
- High Point Regional Hospital
-
Raleigh, North Carolina, Forenede Stater, 27607
- Cancer Centers of North Carolina - Raleigh
-
Wilmington, North Carolina, Forenede Stater, 28401
- Coastal Carolina Radiation Oncology Center
-
Winston-Salem, North Carolina, Forenede Stater, 27103
- Forsyth Regional Cancer Center at Forsyth Medical Center
-
-
North Dakota
-
Fargo, North Dakota, Forenede Stater, 58102
- MeritCare Broadway
-
Grand Forks, North Dakota, Forenede Stater, 58201
- Altru Cancer Center at Altru Hospital
-
-
Ohio
-
Akron, Ohio, Forenede Stater, 44307
- McDowell Cancer Center at Akron General Medical Center
-
Akron, Ohio, Forenede Stater, 44309-2090
- Summa Center for Cancer Care at Akron City Hospital
-
Barberton, Ohio, Forenede Stater, 44203
- Barberton Citizens Hospital
-
Canton, Ohio, Forenede Stater, 44710-1799
- Aultman Cancer Center at Aultman Hospital
-
Cleveland, Ohio, Forenede Stater, 44195
- Cleveland Clinic Taussig Cancer Center
-
Cleveland, Ohio, Forenede Stater, 44106-5065
- Case Comprehensive Cancer Center
-
Cleveland, Ohio, Forenede Stater, 44111
- Cleveland Clinic Cancer Center at Fairview Hospital
-
Columbus, Ohio, Forenede Stater, 43215
- CCOP - Columbus
-
Columbus, Ohio, Forenede Stater, 43210-1240
- Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
-
Independence, Ohio, Forenede Stater, 44131
- Cleveland Clinic Cancer Center
-
Lima, Ohio, Forenede Stater, 45804
- Lima Memorial Hospital
-
Lima, Ohio, Forenede Stater, 45801
- St. Rita's Medical Center
-
Mansfield, Ohio, Forenede Stater, 44903
- MedCentral - Mansfield Hospital
-
Mayfield Heights, Ohio, Forenede Stater, 44124
- Hillcrest Cancer Center at Hillcrest Hospital
-
Springfield, Ohio, Forenede Stater, 45505
- Community Hospital of Springfield and Clark County
-
Sylvania, Ohio, Forenede Stater, 43560
- Flower Hospital Cancer Center
-
Toledo, Ohio, Forenede Stater, 43614
- Medical University of Ohio Cancer Center
-
Toledo, Ohio, Forenede Stater, 43623
- St. Anne Mercy Hospital
-
Wooster, Ohio, Forenede Stater, 44691
- Cleveland Clinic - Wooster
-
-
Oklahoma
-
Tulsa, Oklahoma, Forenede Stater, 74136
- Natalie Warren Bryant Cancer Center at St. Francis Hospital
-
-
Oregon
-
Clackamas, Oregon, Forenede Stater, 97015
- Clackamas Radiation Oncology Center
-
Eugene, Oregon, Forenede Stater, 97401
- Willamette Valley Cancer Center - Eugene
-
Grants Pass, Oregon, Forenede Stater, 97527
- Three Rivers Community Hospital
-
Gresham, Oregon, Forenede Stater, 97030
- Legacy Mount Hood Medical Center
-
Medford, Oregon, Forenede Stater, 97504
- Dubs Cancer Center at Rogue Valley Medical Center
-
Medford, Oregon, Forenede Stater, 97504
- Providence Cancer Center at PMCC
-
Milwaukie, Oregon, Forenede Stater, 97222
- Providence Milwaukie Hospital
-
Portland, Oregon, Forenede Stater, 97239-3098
- Knight Cancer Institute at Oregon Health and Science University
-
Portland, Oregon, Forenede Stater, 97210
- Legacy Good Samaritan Hospital & Comprehensive Cancer Center
-
Portland, Oregon, Forenede Stater, 97213-2967
- Providence Cancer Center at Providence Portland Medical Center
-
Portland, Oregon, Forenede Stater, 97225
- CCOP - Columbia River Oncology Program
-
Portland, Oregon, Forenede Stater, 97225
- Providence St. Vincent Medical Center
-
Portland, Oregon, Forenede Stater, 97227
- Legacy Emanuel Hospital and Health Center and Children's Hospital
-
Salem, Oregon, Forenede Stater, 97309-5014
- Salem Hospital Regional Cancer Care Services
-
Tualatin, Oregon, Forenede Stater, 97062
- Legacy Meridian Park Hospital
-
-
Pennsylvania
-
Beaver, Pennsylvania, Forenede Stater, 15009
- UPMC Cancer Center at Beaver Medical Center
-
Bethlehem, Pennsylvania, Forenede Stater, 18015
- St. Luke's Cancer Network at St. Luke's Hospital
-
Danville, Pennsylvania, Forenede Stater, 17822-0001
- Geisinger Cancer Institute at Geisinger Health
-
Drexel Hill, Pennsylvania, Forenede Stater, 19026
- Delaware County Regional Cancer Center at Delaware County Memorial Hospital
-
Dunmore, Pennsylvania, Forenede Stater, 18512
- Northeast Radiation Oncology Center
-
Erie, Pennsylvania, Forenede Stater, 16505
- Regional Cancer Center - Erie
-
Harrisburg, Pennsylvania, Forenede Stater, 17110-2098
- PinnacleHealth Regional Cancer Center at Polyclinic Hospital
-
Monroeville, Pennsylvania, Forenede Stater, 15146
- Intercommunity Cancer Center
-
Norristown, Pennsylvania, Forenede Stater, 19401
- Norristown Regional Cancer Center
-
Philadelphia, Pennsylvania, Forenede Stater, 19111-2497
- Fox Chase Cancer Center - Philadelphia
-
Philadelphia, Pennsylvania, Forenede Stater, 19102
- Drexel University College of Medicine - Center City Hahnemann Campus
-
Philadelphia, Pennsylvania, Forenede Stater, 19107-5541
- Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
-
Philadelphia, Pennsylvania, Forenede Stater, 19114
- Frankford Hospital Cancer Center - Torresdale Campus
-
Pittsburgh, Pennsylvania, Forenede Stater, 15212
- Allegheny Cancer Center at Allegheny General Hospital
-
Pittsburgh, Pennsylvania, Forenede Stater, 15224-1791
- Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
-
Pittsburgh, Pennsylvania, Forenede Stater, 15213-2582
- UPMC - Shadyside
-
Reading, Pennsylvania, Forenede Stater, 19612-6052
- McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
-
State College, Pennsylvania, Forenede Stater, 16803
- Mount Nittany Medical Center
-
Upland, Pennsylvania, Forenede Stater, 19013
- Crozer-Chester Medical Center
-
Wilkes-Barre, Pennsylvania, Forenede Stater, 18711
- Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
-
York, Pennsylvania, Forenede Stater, 17405
- York Cancer Center at Apple Hill Medical Center
-
-
Rhode Island
-
Providence, Rhode Island, Forenede Stater, 02903
- Rhode Island Hospital Comprehensive Cancer Center
-
Providence, Rhode Island, Forenede Stater, 02904
- Northmain Radiation Oncology
-
-
South Carolina
-
Charleston, South Carolina, Forenede Stater, 29425
- Hollings Cancer Center at Medical University of South Carolina
-
Charleston, South Carolina, Forenede Stater, 29401
- Roper St. Francis Cancer Center at Roper Hospital
-
Georgetown, South Carolina, Forenede Stater, 29440
- Georgetown Memorial Hospital
-
-
South Dakota
-
Rapid City, South Dakota, Forenede Stater, 57701
- Rapid City Regional Hospital
-
Sioux Falls, South Dakota, Forenede Stater, 57117-5039
- Sanford Cancer Center at Sanford USD Medical Center
-
-
Tennessee
-
Knoxville, Tennessee, Forenede Stater, 37916
- Thompson Cancer Survival Center
-
Nashville, Tennessee, Forenede Stater, 37232-6838
- Vanderbilt-Ingram Cancer Center
-
-
Texas
-
Bedford, Texas, Forenede Stater, 76022
- Texas Oncology, PA at Harris Center HEB
-
Dallas, Texas, Forenede Stater, 75390
- Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
-
Denton, Texas, Forenede Stater, 76210
- Texas Oncology, PA at Texas Cancer Center - Denton South
-
Fort Worth, Texas, Forenede Stater, 76104
- Klabzuba Cancer Center at Harris Methodist Fort Worth Hospital
-
Houston, Texas, Forenede Stater, 77030-4009
- M. D. Anderson Cancer Center at University of Texas
-
Irving, Texas, Forenede Stater, 75061
- Baylor Medical Center at Irving
-
Lewisville, Texas, Forenede Stater, 75067
- Texas Oncology, PA at Lake Vista Cancer Center
-
Lubbock, Texas, Forenede Stater, 79410-1894
- Joe Arrington Cancer Research and Treatment Center
-
Round Rock, Texas, Forenede Stater, 78681
- Texas Oncology, PA at Texas Cancer Center Round Rock
-
San Antonio, Texas, Forenede Stater, 78229-3900
- University of Texas Health Science Center at San Antonio
-
San Antonio, Texas, Forenede Stater, 78217
- Cancer Care Centers of South Texas - Northeast
-
Sherman, Texas, Forenede Stater, 75090
- Texas Oncology, PA at Texas Cancer Center - Sherman
-
Sugar Land, Texas, Forenede Stater, 77479
- Texas Oncology, PA at Texas Oncology Cancer Center Sugar Land
-
-
Utah
-
Cedar City, Utah, Forenede Stater, 84720
- Sandra L. Maxwell Cancer Center
-
Ogden, Utah, Forenede Stater, 84403
- Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
-
Provo, Utah, Forenede Stater, 84604
- Utah Valley Regional Medical Center - Provo
-
Saint George, Utah, Forenede Stater, 84770
- Dixie Regional Medical Center - East Campus
-
Salt Lake City, Utah, Forenede Stater, 84143
- LDS Hospital
-
Salt Lake City, Utah, Forenede Stater, 84112
- Huntsman Cancer Institute at University of Utah
-
Salt Lake City, Utah, Forenede Stater, 84106
- Utah Cancer Specialists at UCS Cancer Center
-
-
Vermont
-
Burlington, Vermont, Forenede Stater, 05401
- Fletcher Allen Health Care - University Health Center Campus
-
-
Virginia
-
Charlottesville, Virginia, Forenede Stater, 22908
- University of Virginia Cancer Center
-
Portsmouth, Virginia, Forenede Stater, 23708-2197
- Naval Medical Center - Portsmouth
-
Richmond, Virginia, Forenede Stater, 23298-0037
- Virginia Commonwealth University Massey Cancer Center
-
-
Washington
-
Bellingham, Washington, Forenede Stater, 98225
- St. Joseph Cancer Center
-
Seattle, Washington, Forenede Stater, 98109-1023
- Seattle Cancer Care Alliance
-
Seattle, Washington, Forenede Stater, 98195
- University Cancer Center at University of Washington Medical Center
-
Spokane, Washington, Forenede Stater, 99204
- Providence Cancer Center at Sacred Heart Medical Center
-
Vancouver, Washington, Forenede Stater, 98664
- Southwest Washington Medical Center Cancer Center
-
-
West Virginia
-
Charleston, West Virginia, Forenede Stater, 25304
- West Virginia University Health Sciences Center - Charleston
-
Huntington, West Virginia, Forenede Stater, 25702
- St. Mary's Regional Cancer Center at St. Mary's Medical Center
-
Wheeling, West Virginia, Forenede Stater, 26003
- Schiffler Cancer Center at Wheeling Hospital
-
-
Wisconsin
-
Eau Claire, Wisconsin, Forenede Stater, 54701
- Center for Cancer Treatment & Prevention at Sacred Heart Hospital
-
Green Bay, Wisconsin, Forenede Stater, 54307-3508
- St. Vincent Hospital Regional Cancer Center
-
Green Bay, Wisconsin, Forenede Stater, 54311
- Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center
-
La Crosse, Wisconsin, Forenede Stater, 54601
- Franciscan Skemp Healthcare - La Crosse Campus
-
Madison, Wisconsin, Forenede Stater, 53792-6164
- University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
-
Madison, Wisconsin, Forenede Stater, 53717
- Dean Medical Center - Madison
-
Marshfield, Wisconsin, Forenede Stater, 54449
- Marshfield Clinic - Marshfield Center
-
Menomonee Falls, Wisconsin, Forenede Stater, 53051
- Community Memorial Hospital Cancer Care Center
-
Mequon, Wisconsin, Forenede Stater, 53097
- Columbia Saint Mary's Hospital - Ozaukee
-
Milwaukee, Wisconsin, Forenede Stater, 53226
- Medical College of Wisconsin Cancer Center
-
Milwaukee, Wisconsin, Forenede Stater, 53211
- Columbia-Saint Mary's Cancer Care Center
-
Milwaukee, Wisconsin, Forenede Stater, 53215
- Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center
-
Oconomowoc, Wisconsin, Forenede Stater, 53066
- Regional Cancer Center at Oconomowoc Memorial Hospital
-
Oshkosh, Wisconsin, Forenede Stater, 54904
- Vince Lombardi Cancer Clinic - Oshkosh
-
Racine, Wisconsin, Forenede Stater, 53405
- All Saints Cancer Center at Wheaton Franciscan Healthcare
-
Stevens Point, Wisconsin, Forenede Stater, 54481
- Saint Michael's Hospital Cancer Center
-
Summit, Wisconsin, Forenede Stater, 53066
- Aurora Medical Center
-
Waukesha, Wisconsin, Forenede Stater, 53188
- Waukesha Memorial Hospital Regional Cancer Center
-
Wausau, Wisconsin, Forenede Stater, 54401
- University of Wisconcin Cancer Center at Aspirus Wausau Hospital
-
West Allis, Wisconsin, Forenede Stater, 53227
- West Allis Memorial Hospital
-
Weston, Wisconsin, Forenede Stater, 54476
- Diagnostic and Treatment Center
-
-
-
-
-
Galway, Irland
- University College Hospital
-
-
-
-
-
Tel Aviv, Israel, 64239
- Tel-Aviv Sourasky Medical Center
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
SYGDOMS KARAKTERISTIKA:
Histologisk bekræftet duktalt karcinom in situ (DCIS*) eller invasivt* adenokarcinom i brystet
Stadie 0, I eller II sygdom
- Stadie II tumorer skal være ≤ 3 cm
Grov sygdom skal være unifokal
- Mikroskopisk multifokalitet tilladt, forudsat at den totale patologiske tumorstørrelse er ≤ 3 cm
- Intet påvist multicentrisk karcinom i mere end 1 kvadrant eller adskilt med ≥ 4 cm
- Ingen ikke-epiteliale brystmaligniteter (f.eks. sarkom eller lymfom) BEMÆRK: *Patienter, der er 50 år og derover med DCIS uanset hormonreceptorstatus OG patienter med invasiv brystkræft, der opfylder alle følgende kriterier: ≥ 50 år , node-negativ og hormon-receptor positiv status vil ikke blive optaget i undersøgelsen efter 30/12/2006
Forudgående aksillær stadieinddeling påkrævet for patienter med invasiv brystkræft, herunder 1 af følgende:
- Sentinel node biopsi alene (hvis sentinel node er negativ)
- Sentinel node biopsi efterfulgt af aksillær dissektion eller prøveudtagning med ≥ 6 aksillære noder (hvis sentinel node er positiv)
- Akseldissektion alene med ≥ 6 aksillære knuder
Ikke mere end 3 positive aksillære knuder
- Ingen aksillære knuder med tydelige tegn på mikroskopisk eller makroskopisk ekstrakapsulær forlængelse
- Ingen positive ikke-aksillære sentinel noder (intramammary noder er iscenesat som aksillære noder)
- Ingen håndgribelige eller radiografisk mistænkelige ipsilaterale eller kontralaterale aksillære, supraclavikulære, infraclavikulære eller interne brystknuder, medmindre der er histologisk bekræftelse på, at disse knuder er negative for tumor
Skal have gennemgået lumpektomi
- Resekerede kanter histologisk fri for tumor
- Genudskæring af kirurgiske marginer tilladt
- Mål lumpektomi hulrum tydeligt afgrænset OG mål lumpektomi/helbryst referencevolumen ≤ 30 % baseret på postoperativ præ-randomisering CT-scanning
- Afsluttende operation (dvs. lumpektomi, re-excision af marginer eller aksillær stadieindgreb) inden for de seneste 42 dage
- Ingen mistænkelige mikroforkalkninger, tætheder eller palpable abnormiteter i det ipsilaterale eller kontralaterale bryst, medmindre der er biopsiet og fundet godartet
- Ingen Pagets sygdom i brystvorten
Ingen historie med invasiv brystkræft eller DCIS
- Tidligere lobulært karcinom in situ behandlet ved kirurgi alene tilladt
- Ingen synkron bilateral invasiv eller ikke-invasiv brystkræft
- Delvis brystbestråling vurderes at være teknisk mulig af strålingsonkolog på en godkendt facilitet
- Skal have gennemgået en historie og fysisk undersøgelse inden for de seneste 4 måneder OG en bilateral mammografi inden for de seneste 6 måneder
Hormonreceptorstatus:
- Østrogenreceptor (ER) status kendt
- Progesteronstatus kendt, hvis ER-analyse er negativ
- Marginale eller grænseoverskridende resultater betragtes som positive
PATIENT KARAKTERISTIKA:
Alder
- 18 og derover
Køn
- Kvinde
Menopausal status
- Præmenopausal eller postmenopausal
Præstationsstatus
- Ikke specificeret
Forventede levealder
- Mindst 10 år, eksklusive diagnosticering af brystkræft
Hæmatopoietisk
- Ikke specificeret
Hepatisk
- Ikke specificeret
Renal
- Ikke specificeret
Andet
- Ikke gravid eller ammende
- Negativ graviditetstest
- Fertile patienter skal bruge effektiv ikke-hormonel prævention
Ingen anden malignitet inden for de seneste 5 år undtagen tidligere behandlet carcinom in situ i livmoderhalsen eller tyktarmen, melanom in situ eller basalcelle- eller pladecellehudkræft
- Anses for at have lav risiko for gentagelse
- Ingen kollagen vaskulær sygdom (f.eks. systemisk lupus erythematosus eller sklerodermi), specifikt dermatomyositis med et kreatin phosphokinase (CPK) niveau over normalt, eller aktivt hududslæt
- Ingen psykiatrisk eller vanedannende lidelse, der ville udelukke studieterapi
FORUDSÆTNING SAMTYDLIG TERAPI:
Biologisk terapi
- Ingen tidligere biologisk behandling for denne malignitet
Kemoterapi
- Ingen forudgående kemoterapi for denne malignitet
- Ingen samtidig kemoterapi under undersøgelsesstrålebehandling
Endokrin terapi
- Ingen tidligere hormonbehandling for denne malignitet, medmindre den samlede varighed af hormonbehandling ikke var mere end 28 dage før randomisering
- Samtidig hormonbehandling tilladt, forudsat at den ikke administreres under kemoterapi
- Ingen samtidig raloxifen, tamoxifen eller andre selektive østrogenreceptormodulerende lægemidler
- Ingen samtidig hormonbehandling
- Ingen samtidig Femring^®
Strålebehandling
- Ingen forudgående strålebehandling for denne malignitet
- Ingen forudgående bryst- eller thoraxstrålebehandling
- Ingen samtidige brachyterapi-boosts
- Ingen samtidig intensitetsmoduleret strålebehandling
- Ingen samtidig regional nodal bestråling
Kirurgi
- Se Sygdomskarakteristika
Ingen tidligere brystimplantater
- Patienter, der har fået fjernet implantater, er berettigede
Andet
- Ingen anden samtidig anticancerterapi
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: Gruppe 1: WBI
Patienter gennemgår helbrystbestråling (WBI) en gang dagligt 5 dage om ugen i 5-7 uger.
|
Patienterne får strålebehandling én gang dagligt (dag 1-5) i op til 7 uger
|
|
Eksperimentel: Gruppe 2: PBI
Patienter gennemgår delvis brystbestråling (PBI) to gange dagligt på 5 dage over en periode på 5-10 dage.
Dette kan leveres ved intrakavitær brachyterapi, MammoSite eller anden intrakavitær enhed med enkelt indgang eller 3-dimensionel konform accelereret delvis brystbestråling.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
In-breast tumor recidiv (IBTR)
Tidsramme: hver 6. måned i 5 år; årligt derefter i op til 10 år
|
hver 6. måned i 5 år; årligt derefter i op til 10 år
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Samlet overlevelse
Tidsramme: tid fra randomisering til død på grund af enhver årsag vurderet op til 15 år
|
tid fra randomisering til død på grund af enhver årsag vurderet op til 15 år
|
|
Overlevelse uden gentagelse
Tidsramme: tid fra randomisering til gentagelse vurderet hver 6. måned i 5 år og årligt derefter i op til 10 år
|
tid fra randomisering til gentagelse vurderet hver 6. måned i 5 år og årligt derefter i op til 10 år
|
|
Fjern sygdomsfri overlevelse
Tidsramme: tid fra randomisering til hændelse vurderet hver 6. måned i 5 år og årligt derefter i op til 10 år
|
tid fra randomisering til hændelse vurderet hver 6. måned i 5 år og årligt derefter i op til 10 år
|
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Livskvalitet og patientrapporteret kosmese efter Breast Cancer Treatment Outcome Scale, MOS SF-36 Vitality, Convenience of Care-skala og symptomer
Tidsramme: målt ved baseline og 1 og 6 måneder og 1, 2 og 3 år efter afsluttet undersøgelsesbehandling
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målt ved baseline og 1 og 6 måneder og 1, 2 og 3 år efter afsluttet undersøgelsesbehandling
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Toksicitet vurderet ved uønskede hændelser under behandlingen
Tidsramme: ved slutningen af RT og 4 uger, 6 måneder, 12 måneder; hver 6. måned i år 2 til 5; og derefter årligt i op til 10 år
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ved slutningen af RT og 4 uger, 6 måneder, 12 måneder; hver 6. måned i år 2 til 5; og derefter årligt i op til 10 år
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Hepel JT, Tokita M, MacAusland SG, Evans SB, Hiatt JR, Price LL, DiPetrillo T, Wazer DE. Toxicity of three-dimensional conformal radiotherapy for accelerated partial breast irradiation. Int J Radiat Oncol Biol Phys. 2009 Dec 1;75(5):1290-6. doi: 10.1016/j.ijrobp.2009.01.009. Epub 2009 Apr 22.
- Croshaw R, Kim Y, Lappinen E, Julian T, Trombetta M. Avoiding mastectomy: accelerated partial breast irradiation for breast cancer patients with pacemakers or defibrillators. Ann Surg Oncol. 2011 Nov;18(12):3500-5. doi: 10.1245/s10434-011-1784-2. Epub 2011 May 24.
- Hasan Y, Kim L, Wloch J, Chi Y, Liang J, Martinez A, Yan D, Vicini F. Comparison of planned versus actual dose delivered for external beam accelerated partial breast irradiation using cone-beam CT and deformable registration. Int J Radiat Oncol Biol Phys. 2011 Aug 1;80(5):1473-6. doi: 10.1016/j.ijrobp.2010.04.013. Epub 2010 Jul 23.
- Kainz K, White J, Herman J, Li XA. Investigation of helical tomotherapy for partial-breast irradiation of prone-positioned patients. Int J Radiat Oncol Biol Phys. 2009 May 1;74(1):275-82. doi: 10.1016/j.ijrobp.2008.11.028.
- Langen KM, Buchholz DJ, Burch DR, Burkavage R, Limaye AU, Meeks SL, Kupelian PA, Ruchala KJ, Haimerl J, Henderson D, Olivera GH. Investigation of accelerated partial breast patient alignment and treatment with helical tomotherapy unit. Int J Radiat Oncol Biol Phys. 2008 Mar 15;70(4):1272-80. doi: 10.1016/j.ijrobp.2007.11.019. Epub 2008 Jan 22.
- Wojcicka JB, Lasher DE, Malcom R, Fortier G. Clinical and dosimetric experience with MammoSite-based brachytherapy under the RTOG 0413 protocol. J Appl Clin Med Phys. 2007 Oct 24;8(4):176-184. doi: 10.1120/jacmp.v8i4.2654.
- Akbari M, Russo SA, Jacobson JS, et al.: Association of women's local treatment decisions with local recurrence risk and life expectancy. [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-2035, S228-9, 2006.
- Burch D, Langen KM, Buchholz D, et al.: Partial breast irradiation with helical tomotherapy using RTOG 0413 planning constraints. [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-2047, S235-6, 2006.
- Hiatt JR, Evans SB, Price LL, Cardarelli GA, Dipetrillo TA, Wazer DE. Dose-modeling study to compare external beam techniques from protocol NSABP B-39/RTOG 0413 for patients with highly unfavorable cardiac anatomy. Int J Radiat Oncol Biol Phys. 2006 Aug 1;65(5):1368-74. doi: 10.1016/j.ijrobp.2006.03.060.
- Bovi J, Qi XS, White J, Li XA. Comparison of three accelerated partial breast irradiation techniques: treatment effectiveness based upon biological models. Radiother Oncol. 2007 Sep;84(3):226-32. doi: 10.1016/j.radonc.2007.07.004. Epub 2007 Aug 10.
- Dickler A. The MammoSite breast brachytherapy device: targeted delivery of breast brachytherapy. Future Oncol. 2005 Dec;1(6):799-804. doi: 10.2217/14796694.1.6.799.
- Sanghani M, Wazer DE. Patient selection for NSABP B-39/RTOG 0413: have we posed the right questions in the right way? Brachytherapy. 2007 Apr-Jun;6(2):119-22. doi: 10.1016/j.brachy.2007.01.002. No abstract available.
- Julian TB, Costantino JP, Vicini FA, et al.: Early toxicity results with 3D conformal external beam therapy (CEBT) from the NSABP B-39/RTOG 0413 accelerated partial breast irradiation (APBI) trial. [Abstract] J Clin Oncol 29 (Suppl 15): A-1011, 2011.
- Jain AK, Vallow LA, Gale AA, Buskirk SJ. Does three-dimensional external beam partial breast irradiation spare lung tissue compared with standard whole breast irradiation? Int J Radiat Oncol Biol Phys. 2009 Sep 1;75(1):82-8. doi: 10.1016/j.ijrobp.2008.10.041. Epub 2009 Feb 21.
- Tendulkar RD, Chellman-Jeffers M, Rybicki LA, Rim A, Kotwal A, Macklis R, Obi BB. Preoperative breast magnetic resonance imaging in early breast cancer: implications for partial breast irradiation. Cancer. 2009 Apr 15;115(8):1621-30. doi: 10.1002/cncr.24172.
- Patel RR, Christensen ME, Hodge CW, Adkison JB, Das RK. Clinical outcome analysis in "high-risk" versus "low-risk" patients eligible for national surgical adjuvant breast and bowel B-39/radiation therapy oncology group 0413 trial: five-year results. Int J Radiat Oncol Biol Phys. 2008 Mar 15;70(4):970-3. doi: 10.1016/j.ijrobp.2007.12.005.
- Al-Hallaq H, Mell L, Advani S, et al.: Magnetic resonance imaging (MRI) identifies multifocal and multicentric disease in breast cancer patients eligible for the NSABP B-39/RTOG 0413 partial breast irradiation (PBI) trial. [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-1086, S179-S180, 2006.
- Vicini FA, Cecchini RS, White JR, Arthur DW, Julian TB, Rabinovitch RA, Kuske RR, Ganz PA, Parda DS, Scheier MF, Winter KA, Paik S, Kuerer HM, Vallow LA, Pierce LJ, Mamounas EP, McCormick B, Costantino JP, Bear HD, Germain I, Gustafson G, Grossheim L, Petersen IA, Hudes RS, Curran WJ Jr, Bryant JL, Wolmark N. Long-term primary results of accelerated partial breast irradiation after breast-conserving surgery for early-stage breast cancer: a randomised, phase 3, equivalence trial. Lancet. 2019 Dec 14;394(10215):2155-2164. doi: 10.1016/S0140-6736(19)32514-0. Epub 2019 Dec 5.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. marts 2005
Primær færdiggørelse (Faktiske)
1. august 2018
Studieafslutning (Faktiske)
1. august 2018
Datoer for studieregistrering
Først indsendt
7. februar 2005
Først indsendt, der opfyldte QC-kriterier
7. februar 2005
Først opslået (Skøn)
8. februar 2005
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
14. april 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
13. april 2022
Sidst verificeret
1. april 2022
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- NSABP B-39/RTOG 0413
- NSABP-B-39
- RTOG-0413
- SWOG-NSABP-B-39
- NCI-2009-00698 (Registry Identifier: CTRP (Clinical Trials Reporting Program))
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 .