- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00002873
Stråleterapi til behandling af kvinder med trin I eller trin II brystkræft
ET FASE I/II FORSØG TIL EVALUERING AF BRACHYTERAPI SOM ENESTE METODE TIL STRÅLETERAPI FOR TRIN I OG II BRYSTERKARCINOMA
RATIONALE: Strålebehandling kan dræbe eventuelle resterende tumorceller efter operationen.
FORMÅL: Fase I/II-forsøg til undersøgelse af effektiviteten af brachyterapi til behandling af kvinder, der har stadium I eller stadium II brystkræft.
Studieoversigt
Detaljeret beskrivelse
MÅL: I. Evaluere den tekniske gennemførlighed og reproducerbarhed, kosmetiske resultater, komplikationsrater og erfaring med lokal kræftkontrolfrekvens med brachyterapi brugt som den eneste metode til strålebehandling hos kvinder med stadium I/II brystkræft behandlet med tylektomi, som har histologisk vurderet negativ kirurgisk behandling. marginer, mindre end 4 positive aksillære noder og ingen ekstrakapsulær nodal forlængelse eller omfattende intraduktal komponent. II. Reducer den samlede behandlingstid for brystbestråling fra 6 uger til 4-5 dage hos disse patienter.
OVERSIGT: Behandlingen begynder ikke tidligere end 4 dage og inden for 6 uger efter den endelige operation. Alle patienter modtager brachyterapi til målvolumenet (som defineret af udskæringskaviteten afgrænset af post-tylektomi kirurgiske clips plus 2 cm margin) ved hjælp af iridium-192 implantater til dosisfordeling til fem planer. Patienter kan efter institutionens skøn behandles med enten højdosis-rate eller lav-dosis-rate brachyterapi. Patienterne følges 2 og 6 uger efter behandling, derefter 3, 6, 9 og 12 måneder, derefter hver 4. måned i 1 år, hver 6. måned i 3 år og derefter årligt.
PROJEKTERET TILSLUTNING: Der vil maksimalt blive akkumuleret 46 patienter i hver gruppe (højdosisrate versus lavdosisrate) over 2 år.
Undersøgelsestype
Fase
- Fase 2
- Fase 1
Kontakter og lokationer
Studiesteder
-
-
Alberta
-
Calgary, Alberta, Canada, T2N 4N2
- Tom Baker Cancer Center - Calgary
-
Edmonton, Alberta, Canada, T6G 1Z2
- Cross Cancer Institute
-
-
British Columbia
-
Victoria, British Columbia, Canada, V8R 1J8
- British Columbia Cancer Agency - Vancouver Island Cancer Centre
-
-
New Brunswick
-
Moncton, New Brunswick, Canada, E1C 8X3
- Doctor Leon Richard Oncology Centre
-
Saint John, New Brunswick, Canada, E2L 4L2
- Saint John Regional Hospital
-
-
Nova Scotia
-
Halifax, Nova Scotia, Canada, B3H 1V7
- Nova Scotia Cancer Centre
-
-
Ontario
-
Hamilton, Ontario, Canada, L8V 5C2
- Cancer Care Ontario-Hamilton Regional Cancer Centre
-
Kingston, Ontario, Canada, K7L 5P9
- Kingston Regional Cancer Centre
-
London, Ontario, Canada, N6A 4L6
- Cancer Care Ontario-London Regional Cancer Centre
-
Ottawa, Ontario, Canada, K1Y 4K7
- Ottawa Regional Cancer Centre - Civic Campus
-
Sudbury, Ontario, Canada, P3E 5J1
- Northeastern Ontario Regional Cancer Centre, Sudbury
-
Thunder Bay, Ontario, Canada, P7A 7T1
- Northwestern Ontario Regional Cancer Centre, Thunder Bay
-
Toronto, Ontario, Canada, M5G 2M9
- Princess Margaret Hospital
-
-
Quebec
-
Montreal, Quebec, Canada, H2W 1S6
- McGill University Department of Oncology
-
Montreal, Quebec, Canada, H2W-W1T8
- Centre Hospitalier de l'Universite de Montreal
-
-
Saskatchewan
-
Saskatoon, Saskatchewan, Canada, S7N 4H4
- Saskatoon Cancer Centre
-
-
-
-
Alabama
-
Birmingham, Alabama, Forenede Stater, 35233
- Veterans Affairs Medical Center - Birmingham
-
Birmingham, Alabama, Forenede Stater, 35294
- University Of Alabama Comprehensive Cancer Center
-
Huntsville, Alabama, Forenede Stater, 35801
- Huntsville Hospital System
-
Mobile, Alabama, Forenede Stater, 36688
- MBCCOP - University of South Alabama
-
Mobile, Alabama, Forenede Stater, 36640
- Urology Associates - Mobile AL
-
Montgomery, Alabama, Forenede Stater, 36106-2801
- Alabama Oncology, LLC
-
Tuscallosa, Alabama, Forenede Stater, 35401
- Radiation Oncology Associates of West Alabama
-
-
Alaska
-
Anchorage, Alaska, Forenede Stater, 99508
- Providence Cancer Therapy Center
-
-
Arizona
-
Tucson, Arizona, Forenede Stater, 85724
- Arizona Cancer Center
-
-
California
-
Burbank, California, Forenede Stater, 91505
- Providence Saint Joseph Medical Center - Burbank
-
Concord, California, Forenede Stater, 94524-4110
- Mount Diablo Medical Center
-
Duarte, California, Forenede Stater, 91010
- Beckman Research Institute, City of Hope
-
Fresno, California, Forenede Stater, 93720
- California Cancer Center
-
Fresno, California, Forenede Stater, 93720
- Saint Agnes Cancer Center
-
Glendale, California, Forenede Stater, 91204
- Glendale Memorial Hospital and Health Center
-
Greenbrae, California, Forenede Stater, 94904
- Sutter Health Western Division Cancer Research Group
-
Loma Linda, California, Forenede Stater, 92354
- Loma Linda University Medical Center
-
Long Beach, California, Forenede Stater, 90822
- Veterans Affairs Medical Center - Long Beach
-
Los Angeles, California, Forenede Stater, 90033-0800
- USC/Norris Comprehensive Cancer Center
-
Los Angeles, California, Forenede Stater, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
-
Los Angeles, California, Forenede Stater, 90027
- Kaiser Permanente Medical Center - Los Angeles
-
Martinez, California, Forenede Stater, 94553
- Veterans Affairs Outpatient Clinic - Martinez
-
Oakland, California, Forenede Stater, 94609-3305
- CCOP - Bay Area Tumor Institute
-
Pomona, California, Forenede Stater, 91767
- Cancer Care Center
-
Redding, California, Forenede Stater, 96099-6009
- Mercy Medical Center - Redding
-
Sacramento, California, Forenede Stater, 95816
- Radiation Oncology Center - Sacramento
-
San Francisco, California, Forenede Stater, 94115-0128
- UCSF Cancer Center and Cancer Research Institute
-
Santa Cruz, California, Forenede Stater, 95065
- Santa Cruz Radiation Oncology Medical Group, Inc.
-
Santa Rosa, California, Forenede Stater, 95403
- CCOP - Santa Rosa Memorial Hospital
-
Stanford, California, Forenede Stater, 94305
- Stanford University
-
Travis Air Force Base, California, Forenede Stater, 94535
- David Grant Medical Center
-
Walnut Creek, California, Forenede Stater, 94598
- Radiation Oncology Center - Walnut Creek
-
-
Colorado
-
Colorado Springs, Colorado, Forenede Stater, 80909
- Memorial Hospital Cancer Center
-
Denver, Colorado, Forenede Stater, 80262
- University of Colorado Cancer Center
-
-
Connecticut
-
Bridgeport, Connecticut, Forenede Stater, 06610
- Bridgeport Hospital
-
Norwalk, Connecticut, Forenede Stater, 06856
- Whittingham Cancer Center
-
-
Delaware
-
Wilmington, Delaware, Forenede Stater, 19899
- CCOP - Christiana Care Health Services
-
-
District of Columbia
-
Washington, District of Columbia, Forenede Stater, 20307-5000
- Walter Reed Army Medical Center
-
-
Florida
-
Clearwater, Florida, Forenede Stater, 33757-0210
- Lykes Center for Radiation Therapy
-
Daytona Beach, Florida, Forenede Stater, 32114
- Halifax Medical Center
-
Fort Myers, Florida, Forenede Stater, 33901
- Radiation Therapy Associates - Fort Myers
-
Gainesville, Florida, Forenede Stater, 32610-0296
- University of Florida Health Science Center
-
Melbourne, Florida, Forenede Stater, 32901
- Health First Holmes Regional Medical Center
-
Miami, Florida, Forenede Stater, 33136
- Sylvester Cancer Center, University of Miami
-
Miami, Florida, Forenede Stater, 33176-2197
- Baptist Hospital of Miami
-
Miami Beach, Florida, Forenede Stater, 33140
- CCOP - Mount Sinai Medical Center
-
Orange Park, Florida, Forenede Stater, 32073
- Florida Radiation Oncology Group
-
Orlando, Florida, Forenede Stater, 32806
- MD Anderson Cancer Center Orlando
-
Panama City, Florida, Forenede Stater, 32405-4587
- Gulf Coast Cancer Treatment Center
-
Pensacola, Florida, Forenede Stater, 32514
- West Florida Cancer Institute - Pensacola
-
Saint Petersburg, Florida, Forenede Stater, 33701
- Bayfront Medical Center
-
Tampa, Florida, Forenede Stater, 33612
- H. Lee Moffitt Cancer Center and Research Institute
-
-
Georgia
-
Atlanta, Georgia, Forenede Stater, 30322
- Emory University Hospital - Atlanta
-
Atlanta, Georgia, Forenede Stater, 30342-1701
- CCOP - Atlanta Regional
-
Rome, Georgia, Forenede Stater, 30161
- InterCommunity Cancer Center at Rome
-
Valdosta, Georgia, Forenede Stater, 31603
- South Georgia Medical Center
-
-
Illinois
-
Chicago, Illinois, Forenede Stater, 60611
- Northwestern Memorial Hospital
-
Chicago, Illinois, Forenede Stater, 60637
- University of Chicago Cancer Research Center
-
Harvey, Illinois, Forenede Stater, 60426
- Ingalls Memorial Hospital
-
Maywood, Illinois, Forenede Stater, 60153
- Loyola University Medical Center
-
Park Ridge, Illinois, Forenede Stater, 60068
- Lutheran General Cancer Care Center
-
Peoria, Illinois, Forenede Stater, 61636
- Methodist Medical Center of Illinois
-
Springfield, Illinois, Forenede Stater, 62526
- CCOP - Central Illinois
-
Urbana, Illinois, Forenede Stater, 61801
- CCOP - Carle Cancer Center
-
-
Indiana
-
Anderson, Indiana, Forenede Stater, 46016
- St. John's Medical Center
-
Indianapolis, Indiana, Forenede Stater, 46206-1367
- Clarion Health Partners Inc.
-
Indianapolis, Indiana, Forenede Stater, 46219
- Community Hospitals of Indianapolis - Regional Cancer Center
-
Muncie, Indiana, Forenede Stater, 47303-3499
- Ball Memorial Hospital
-
South Bend, Indiana, Forenede Stater, 46601
- Memorial Hospital of South Bend
-
South Bend, Indiana, Forenede Stater, 46617
- St. Joseph's Radiation Oncology Center
-
-
Iowa
-
Dubuque, Iowa, Forenede Stater, 52001
- Wendt Regional Cancer Center of Finley Hospital
-
Iowa City, Iowa, Forenede Stater, 52242
- University of Iowa Hospitals and Clinics
-
-
Kentucky
-
Bowling Green, Kentucky, Forenede Stater, 42102
- Medical Center at Bowling Green
-
Lexington, Kentucky, Forenede Stater, 40511-1093
- Veterans Affairs Medical Center - Lexington
-
Lexington, Kentucky, Forenede Stater, 40536-0084
- Albert B. Chandler Medical Center, University of Kentucky
-
Louisville, Kentucky, Forenede Stater, 40202
- James Graham Brown Cancer Center
-
Louisville, Kentucky, Forenede Stater, 40215
- Louisville Radiation Oncology
-
Madisonville, Kentucky, Forenede Stater, 42431
- Merle M. Mahr Cancer Center
-
Paducah, Kentucky, Forenede Stater, 42001
- Western Baptist Hospital
-
-
Louisiana
-
Baton Rouge, Louisiana, Forenede Stater, 70809
- Mary Bird Perkins Cancer Center
-
Lafayette, Louisiana, Forenede Stater, 70501
- Romagosa Radiation Oncology Center
-
Metairie, Louisiana, Forenede Stater, 70011
- East Jefferson General Hospital
-
New Orleans, Louisiana, Forenede Stater, 70112
- MBCCOP - LSU Medical Center
-
New Orleans, Louisiana, Forenede Stater, 70121
- CCOP - Ochsner
-
-
Maine
-
Portland, Maine, Forenede Stater, 04102
- Maine Medical Center
-
-
Maryland
-
Annapolis, Maryland, Forenede Stater, 21401
- Anne Arundel Oncology Center
-
Baltimore, Maryland, Forenede Stater, 21201
- Marlene & Stewart Greenebaum Cancer Center, University of Maryland
-
Baltimore, Maryland, Forenede Stater, 21204
- Greater Baltimore Medical Center and Cancer Center
-
Baltimore, Maryland, Forenede Stater, 21225
- Harbor Hospital Center
-
Baltimore, Maryland, Forenede Stater, 21237
- Radiation Oncology Affiliates of Maryland, P.A.
-
Baltimore, Maryland, Forenede Stater, 21287
- Johns Hopkins Oncology Center
-
-
Massachusetts
-
Boston, Massachusetts, Forenede Stater, 02114
- Massachusetts General Hospital Cancer Center
-
Boston, Massachusetts, Forenede Stater, 02215
- Joint Center for Radiation Therapy
-
Hyannis, Massachusetts, Forenede Stater, 02601
- Cape Cod Hospital
-
-
Michigan
-
Ann Arbor, Michigan, Forenede Stater, 48109-0752
- University of Michigan Comprehensive Cancer Center
-
Ann Arbor, Michigan, Forenede Stater, 48105
- Veterans Affairs Medical Center - Ann Arbor
-
Ann Arbor, Michigan, Forenede Stater, 48106
- CCOP - Ann Arbor Regional
-
Detroit, Michigan, Forenede Stater, 48201
- Barbara Ann Karmanos Cancer Institute
-
Detroit, Michigan, Forenede Stater, 48202
- Henry Ford Hospital
-
Flint, Michigan, Forenede Stater, 48503
- Hurley Medical Center
-
Kalamazoo, Michigan, Forenede Stater, 49007-3731
- CCOP - Kalamazoo
-
Marquette, Michigan, Forenede Stater, 49855
- Marquette General Hospital
-
Saginaw, Michigan, Forenede Stater, 48601
- St. Mary's Medical Center
-
-
Minnesota
-
Rochester, Minnesota, Forenede Stater, 55905
- Mayo Clinic Cancer Center
-
Saint Louis Park, Minnesota, Forenede Stater, 55416
- CCOP - Metro-Minnesota
-
-
Missouri
-
Columbia, Missouri, Forenede Stater, 65203
- Ellis Fischel Cancer Center - Columbia
-
Kansas City, Missouri, Forenede Stater, 64131
- CCOP - Kansas City
-
Saint Louis, Missouri, Forenede Stater, 63110-0250
- St. Louis University Health Sciences Center
-
Saint Louis, Missouri, Forenede Stater, 63106
- Veterans Affairs Medical Center - Saint Louis
-
Saint Louis, Missouri, Forenede Stater, 63110
- Mallinckrodt Institute of Radiology
-
Springfield, Missouri, Forenede Stater, 65807
- Cancer Research for the Ozarks
-
Springfield, Missouri, Forenede Stater, 65807
- CCOP - Ozarks Regional
-
-
Montana
-
Billings, Montana, Forenede Stater, 59101
- CCOP - Montana Cancer Consortium
-
-
Nebraska
-
Omaha, Nebraska, Forenede Stater, 68114
- Methodist Cancer Center - Omaha
-
Omaha, Nebraska, Forenede Stater, 68131
- CCOP - Missouri Valley Cancer Consortium
-
-
Nevada
-
Las Vegas, Nevada, Forenede Stater, 89106
- CCOP - Southern Nevada Cancer Research Foundation
-
-
New Hampshire
-
Lebanon, New Hampshire, Forenede Stater, 03756
- Norris Cotton Cancer Center
-
Manchester, New Hampshire, Forenede Stater, 03103
- Elliot Regional Cancer Center
-
-
New Jersey
-
East Orange, New Jersey, Forenede Stater, 07018-1095
- Veterans Affairs Medical Center - East Orange
-
Edison, New Jersey, Forenede Stater, 08818
- John F. Kennedy Medical Center
-
Elizabeth, New Jersey, Forenede Stater, 07201
- Elizabeth General Medical Center - West
-
Millville, New Jersey, Forenede Stater, 08332
- South Jersey Hospital - Millville
-
Mount Holly, New Jersey, Forenede Stater, 08060
- Fox Chase Cancer Center at Virtua-Memorial Hospital Burlington County
-
Toms River, New Jersey, Forenede Stater, 08755
- Community Medical Center
-
Trenton, New Jersey, Forenede Stater, 08629
- St. Francis Medical Center
-
-
New Mexico
-
Albuquerque, New Mexico, Forenede Stater, 87102
- Saint Joseph Medical Center
-
-
New York
-
Albany, New York, Forenede Stater, 12208
- Cancer Center of Albany Medical Center
-
Albany, New York, Forenede Stater, 12208
- Veterans Affairs Medical Center - Albany
-
Bronx, New York, Forenede Stater, 10461
- Albert Einstein Comprehensive Cancer Center
-
Brooklyn, New York, Forenede Stater, 11203
- State University of New York Health Science Center at Brooklyn
-
Brooklyn, New York, Forenede Stater, 11215-3609
- New York Methodist Hospital
-
Buffalo, New York, Forenede Stater, 14263-0001
- Roswell Park Cancer Institute
-
Manhasset, New York, Forenede Stater, 11030
- CCOP - North Shore University Hospital
-
New York, New York, Forenede Stater, 10021
- Memorial Sloan-Kettering Cancer Center
-
New York, New York, Forenede Stater, 10016
- Kaplan Cancer Center
-
Plattsburgh, New York, Forenede Stater, 12901
- Champlain Valley Physicians Hospital Medical Center
-
Poughkeepsie, New York, Forenede Stater, 12601
- Vassar Brothers Hospital
-
Rochester, New York, Forenede Stater, 14607
- Genesee Hospital - Rochester
-
Rochester, New York, Forenede Stater, 14642
- University of Rochester Cancer Center
-
Valhalla, New York, Forenede Stater, 10595
- New York Medical College
-
-
North Carolina
-
Chapel Hill, North Carolina, Forenede Stater, 27599-7295
- Lineberger Comprehensive Cancer Center, UNC
-
Greenville, North Carolina, Forenede Stater, 27858-4354
- East Carolina University School of Medicine
-
Winston-Salem, North Carolina, Forenede Stater, 27104-4241
- CCOP - Southeast Cancer Control Consortium
-
Winston-Salem, North Carolina, Forenede Stater, 27157-1082
- Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
-
-
North Dakota
-
Fargo, North Dakota, Forenede Stater, 58122
- Meritcare Roger Maris Cancer Center
-
Minot, North Dakota, Forenede Stater, 58701
- UNI-MED Medical Center
-
-
Ohio
-
Akron, Ohio, Forenede Stater, 44302
- Akron General Medical Center
-
Akron, Ohio, Forenede Stater, 44309
- Akron City Hospital
-
Cincinnati, Ohio, Forenede Stater, 45219
- Christ Hospital
-
Cleveland, Ohio, Forenede Stater, 44106-5065
- Ireland Cancer Center
-
Columbus, Ohio, Forenede Stater, 43206
- CCOP - Columbus
-
Columbus, Ohio, Forenede Stater, 43210
- Arthur G. James Cancer Hospital - Ohio State University
-
Dayton, Ohio, Forenede Stater, 45428
- Veterans Affairs Medical Center - Dayton
-
Kettering, Ohio, Forenede Stater, 45429
- CCOP - Dayton
-
Toledo, Ohio, Forenede Stater, 43623-3456
- CCOP - Toledo Community Hospital Oncology Program
-
-
Oklahoma
-
Tulsa, Oklahoma, Forenede Stater, 74104
- St. John Medical Center
-
-
Oregon
-
Corvallis, Oregon, Forenede Stater, 97339
- Samaritan Regional Cancer Center
-
Portland, Oregon, Forenede Stater, 97213
- CCOP - Columbia River Program
-
-
Pennsylvania
-
Danville, Pennsylvania, Forenede Stater, 17822-2001
- Penn State Geisinger Medical Center
-
Darby, Pennsylvania, Forenede Stater, 19023
- Mercy Catholic Medical Center, Mercy Fitzgerald Divison
-
Drexel Hill, Pennsylvania, Forenede Stater, 19026
- Delaware County Memorial Hospital
-
Hershey, Pennsylvania, Forenede Stater, 17033
- Penn State Geisinger Cancer Center
-
Philadelphia, Pennsylvania, Forenede Stater, 19111
- Fox Chase Cancer Center
-
Philadelphia, Pennsylvania, Forenede Stater, 19102-1192
- Allegheny University Hospitals- Hahnemann
-
Philadelphia, Pennsylvania, Forenede Stater, 19104
- University of Pennsylvania Cancer Center
-
Philadelphia, Pennsylvania, Forenede Stater, 19104
- Veterans Affairs Medical Center - Philadelphia
-
Philadelphia, Pennsylvania, Forenede Stater, 19107
- Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
-
Philadelphia, Pennsylvania, Forenede Stater, 19141
- Albert Einstein Cancer Center
-
Pittsburgh, Pennsylvania, Forenede Stater, 15224
- Western Pennsylvania Hospital
-
Pittsburgh, Pennsylvania, Forenede Stater, 15213
- University of Pittsburgh Cancer Institute
-
Reading, Pennsylvania, Forenede Stater, 19612-6052
- Reading Hospital and Medical Center
-
Scranton, Pennsylvania, Forenede Stater, 18501
- Mercy Hospital Cancer Center - Scranton
-
Sellersville, Pennsylvania, Forenede Stater, 18960
- Grand View Hospital
-
Wilkes-Barre, Pennsylvania, Forenede Stater, 18764
- Wilkes Barre General Hospital
-
Wynnewood, Pennsylvania, Forenede Stater, 19096
- CCOP - MainLine Health
-
York, Pennsylvania, Forenede Stater, 17315
- York Hospital
-
-
South Carolina
-
Charleston, South Carolina, Forenede Stater, 29425-0721
- Medical University of South Carolina
-
Greenville, South Carolina, Forenede Stater, 29615
- CCOP - Greenville
-
Spartanburg, South Carolina, Forenede Stater, 29303
- CCOP - Upstate Carolina
-
-
Tennessee
-
Jackson, Tennessee, Forenede Stater, 38301
- Jackson-Madison County General Hospital
-
Knoxville, Tennessee, Forenede Stater, 37901
- Baptist Regional Cancer Center - Knoxville
-
Memphis, Tennessee, Forenede Stater, 38117
- CCOP - Baptist Cancer Institute
-
Memphis, Tennessee, Forenede Stater, 38163
- University of Tennessee, Memphis Cancer Center
-
Nashville, Tennessee, Forenede Stater, 37232-6838
- Vanderbilt Cancer Center
-
-
Texas
-
Beaumont, Texas, Forenede Stater, 77701
- Julie and Ben Rogers Cancer Institute
-
Galveston, Texas, Forenede Stater, 77555-1329
- University of Texas Medical Branch
-
Houston, Texas, Forenede Stater, 77030
- University of Texas - MD Anderson Cancer Center
-
Lackland Air Force Base, Texas, Forenede Stater, 78236-5300
- Wilford Hall - 59th Medical Wing
-
Pasadena, Texas, Forenede Stater, 77504
- Bayshore Medical Center
-
-
Utah
-
Saint George, Utah, Forenede Stater, 84770
- Dixie Regional Medical Center
-
Salt Lake City, Utah, Forenede Stater, 84143
- LDS Hospital
-
-
Vermont
-
Bennington, Vermont, Forenede Stater, 05201
- CCOP - Southwestern Vermont Regional Cancer Center
-
Rutland, Vermont, Forenede Stater, 05701
- Green Mountain Oncology Group
-
White River Junction, Vermont, Forenede Stater, 05009
- Veterans Affairs Medical Center - White River Junction
-
-
Virginia
-
Charlottesville, Virginia, Forenede Stater, 22901
- Martha Jefferson Hospital
-
Lynchburg, Virginia, Forenede Stater, 24503
- Virginia Baptist Hospital
-
Portsmouth, Virginia, Forenede Stater, 23708-2197
- Naval Medical Center, Portsmouth
-
Richmond, Virginia, Forenede Stater, 23298-0037
- Massey Cancer Center
-
-
Washington
-
Seattle, Washington, Forenede Stater, 98104
- Swedish Hospital Tumor Institute
-
Seattle, Washington, Forenede Stater, 98111
- Virginia Mason Medical Center
-
Spokane, Washington, Forenede Stater, 99210-0248
- Deaconess Medical Center
-
Yakima, Washington, Forenede Stater, 98902
- Yakima Valley Memorial Hospital
-
-
West Virginia
-
Wheeling, West Virginia, Forenede Stater, 26003
- Schiffler Oncology Center
-
-
Wisconsin
-
Green Bay, Wisconsin, Forenede Stater, 54307-3508
- St. Vincent Hospital
-
La Crosse, Wisconsin, Forenede Stater, 54601
- Gundersen Lutheran Medical Foundation
-
Madison, Wisconsin, Forenede Stater, 53705
- Veterans Affairs Medical Center - Madison
-
Madison, Wisconsin, Forenede Stater, 53792
- University of Wisconsin Comprehensive Cancer Center
-
Madison, Wisconsin, Forenede Stater, 53713
- Southern Wisconsin Radiotherapy Center
-
Marshfield, Wisconsin, Forenede Stater, 54449
- Marshfield Clinic
-
Menomonee Falls, Wisconsin, Forenede Stater, 53051
- Community Memorial Hospital
-
Milwaukee, Wisconsin, Forenede Stater, 53226
- Medical College of Wisconsin
-
Milwaukee, Wisconsin, Forenede Stater, 53210
- St. Joseph's Hospital
-
Milwaukee, Wisconsin, Forenede Stater, 53211
- Columbia Hospital
-
Milwaukee, Wisconsin, Forenede Stater, 53215
- St. Luke's Medical Center
-
Milwaukee, Wisconsin, Forenede Stater, 53295
- Veterans Affairs Medical Center - Milwaukee (Zablocki)
-
Racine, Wisconsin, Forenede Stater, 53405
- Southeastern Wisconsin Regional Cancer Center
-
-
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Køn, der er berettiget til at studere
Beskrivelse
SYGDOMSKARAKTERISTIKA: Histologisk bekræftet nonlobulær invasiv brystkræft af en af følgende histologier: Duktal papillær medullær kolloid (mucinøs) Tubulær stadium I/II (T1-2 N0-1 M0) tumor ikke større end 3 cm Tidligere tylektomi og aksillær lymfeknudedissektion påkrævet Ikke mere end 3 positive aksillære lymfeknuder og ingen ekstrakapsulær forlængelse. Der udtages mindst 6 lymfeknuder ELLER Negativ sentinal node Kirurgiske klip på plads, der afgrænser marginer af tylektomihulrum Negative eller tætte, men negative, indfarvede histologiske marginer af tylektomi eller re-ekscisionsprøve Negativ marginer defineret som ingen tumor mindst 2 mm væk fra de farvede kanter Tæt, men negative marginer defineret som tumor inden for 2 mm fra den farvede margin Positive marginer defineret som invasiv eller ikke-invasiv tumor ved sværtede resektionsmargener Negativ posttylektomi eller post-reexcision mammografi påkrævet, hvis sygdom præsenteret med malignitetsassocierede mikrokalcifikationer Ingen tilbageværende mistænkelige mikrokalcifikationer Hvis katetre placeres på tidspunktet for reexcision, er krieriane muligvis ikke gennemførlige, men et post brachyterapi mammografi bør indhentes så hurtigt som muligt. Intet omfattende intraduktalt karcinom ifølge Harvard-definitionen, dvs.: Mere end 25 % af tumoren er duktalt carcinom in situ (DCIS), og der er DCIS i tilstødende brystvæv ELLER Intraduktalt karcinom med mikroinvasion Intet påvist multicentrisk karcinom, dvs.: Tumor i forskellige kvadranter af brystet ELLER Tumor adskilt med mindst 4 cm Følgende udelukke: Hud- eller brystvægsinvasion Matt eller fikseret aksillær adenopati Metastatiske interne bryst- eller supraclavikulære knuder Pagets sygdom i brystvorten Tidligere behandlet kontralateralt brystcarcinom eller synkront bilateralt brystcarcinom Hormonreceptorstatus: Ikke specificeret
PATIENT KARAKTERISTIKA: Alder: Alle aldre Køn: Kvinde Menopausal status: Ikke specificeret Ydeevnestatus: Ikke specificeret Hæmatopoietisk: Ikke specificeret Lever: Ikke specificeret Nyre: Ikke specificeret Andet: Ingen kollagen vaskulær sygdom med et c-reaktivt protein niveau over det normale eller med en aktivt hududslæt (f.eks. systemisk lupus erythematosus, sklerodermi eller dermatomyositis) Ingen sameksisterende medicinsk tilstand, der reducerer forventet levetid til mindre end 2 år Ingen anden malignitet inden for 5 år undtagen ikke-melanomatøs hudkræft Ikke gravid eller ammende Negativ graviditetstest
TIDLIGERE SAMTYDENDE BEHANDLING: Biologisk behandling: Ikke specificeret Kemoterapi: Ingen forudgående kemoterapi mod brystkræft Planlagt kemoterapi kan begynde mindst 2 uger efter fjernelse af brachyterapikatetre Endokrin behandling: Samtidig tamoxifen tilladt Strålebehandling: Ingen forudgående strålebehandling mod brystkræft Kirurgi: Se Sygdomskarakteristisk
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: BEHANDLING
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Studiestol: Robert R. Kuske, MD, Ochsner Cancer Institute at Ochsner Clinic Foundation
Publikationer og nyttige links
Generelle publikationer
- Arthur DW, Winter K, Kuske RR, Bolton J, Rabinovitch R, White J, Hanson WF, Wilenzick RM, McCormick B. A Phase II trial of brachytherapy alone after lumpectomy for select breast cancer: tumor control and survival outcomes of RTOG 95-17. Int J Radiat Oncol Biol Phys. 2008 Oct 1;72(2):467-73. doi: 10.1016/j.ijrobp.2007.12.056. Epub 2008 Mar 4.
- Ibbott GS, Hanson WF, O'Meara E, Kuske RR, Arthur D, Rabinovitch R, White J, Wilenzick RM, Harris I, Tailor RC. Dose specification and quality assurance of radiation therapy oncology group protocol 95-17; a cooperative group study of iridium-192 breast implants as sole therapy. Int J Radiat Oncol Biol Phys. 2007 Dec 1;69(5):1572-8. doi: 10.1016/j.ijrobp.2007.08.011.
- Rabinovitch R, Winter K, Kuske R, Bolton J, Arthur D, Scroggins T, Vicini F, McCormick B, White J. RTOG 95-17, a Phase II trial to evaluate brachytherapy as the sole method of radiation therapy for Stage I and II breast carcinoma--year-5 toxicity and cosmesis. Brachytherapy. 2014 Jan-Feb;13(1):17-22. doi: 10.1016/j.brachy.2013.08.002. Epub 2013 Sep 14.
- Kuske RR, Winter K, Arthur DW, et al.: A phase II trial of brachytherapy alone following lumpectomy for stage I or II breast cancer: initial outcomes of RTOG 9517. [Abstract] J Clin Oncol 22 (Suppl 14): A-565, 18s, 2004.
- Kuske RR, Winter K, Arthur D, et al.: A phase I/II trial of brachytherapy alone following lumpectomy for select breast cancer: toxicity analysis of Radiation Therapy Oncology Group 95-17. [Abstract] Int J Radiat Oncol Biol Phys 54(2 suppl 1): A-151, 87, 2002.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (FAKTISKE)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (SKØN)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (SKØN)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- RTOG-9517
- CDR0000065157
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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Kliniske forsøg med brachyterapi
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