- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00262821
Cisplatin og strålebehandling med eller uden tirapazamin til behandling af patienter med livmoderhalskræft
Et fase III, randomiseret forsøg med ugentlig cisplatin og stråling versus cisplatin og tirapazamin og stråling i trin IB2, IIA, IIIB og IVA Cervical Carcinoma begrænset til bækkenet
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
PRIMÆR MÅL:
I. Sammenlign den progressionsfrie overlevelse af patienter med stadium IB, IIA, IIB, IIIB eller IVA karcinom i livmoderhalsen behandlet med cisplatin og strålebehandling med vs uden tirapazamin.
SEKUNDÆRE MÅL:
I. Sammenlign den samlede overlevelse af patienter behandlet med disse regimer. II. Sammenlign toksiciteten af disse regimer hos disse patienter.
TERTIÆRE MÅL:
I. Korreler undersøgelsesbehandling med tumorekspression af kulsyreanhydrase IX (CA-IX) og recidivfri overlevelse, samlet overlevelse eller metastaser hos patienter behandlet med disse regimer.
II. Korreler ekspression af CA-IX, hypoxi-inducerbar faktor-1α, CD-31, thrombospondin-1, CD-105 eller vaskulær endotelvækstfaktor (VEGF) i primært tumorvæv med recidivfri overlevelse, samlet overlevelse eller metastase hos patienter behandlet med disse regimer.
III. Korrelér præ- og/eller post-behandlingserumkoncentrationer af angiogene markører inklusive angiogenin eller VEGF med recidivfri overlevelse, samlet overlevelse eller metastaser hos patienter behandlet med disse regimer.
IV. Korrelér forskellige kombinationer af biologiske markører for hypoxi og angiogenese med tilbagefaldsfri overlevelse, samlet overlevelse eller metastaser hos patienter behandlet med disse regimer.
V. Korrelér niveauer af individuelle biologiske markører for hypoxi eller angiogenese med klinisk-patologiske karakteristika, herunder tumorstørrelse, histologisk subtype, FIGO-stadie, invasionsdybde, bækkenknudestatus, tilbagefaldssted og hæmoglobinniveau samt patient, alder, race og præstation status hos patienter behandlet med disse regimer.
OVERSIGT: Dette er en randomiseret, kontrolleret, multicenter undersøgelse. Patienterne er stratificeret efter FIGO-stadiet af sygdom (IB2 vs IIA vs IIB vs IIIB vs IVA), brachyterapimetode (lavdosisrate vs højdosisrate), kirurgisk stadieinddeling af paraaorta-knuder (ja vs nej). Patienterne randomiseres til 1 ud af 2 behandlingsarme.
ARM I: Patienter får cisplatin IV over 30-60 minutter én gang om ugen på dag 1, 8, 15, 22, 29 og 36 (uge 1-6). Patienterne gennemgår også ekstern strålebehandling til bækkenet én gang dagligt på dag 1-5, 8-12, 15-19, 22-26 og 29-33 (uge 1-5). Patienterne modtager derefter enten 1 eller 2 applikationer med lavdosis-brachyterapi i uge 6-8 ELLER 5 applikationer med høj-dosis-rate (HDR)* brachyterapi en gang om ugen i uge 4-8 og 3-5 dage med parametrisk boost-strålebehandling** begyndende efter det første brachyterapiimplantat. Behandlingen fortsætter i fravær af sygdomsprogression eller uacceptabel toksicitet.
ARM II: Patienterne får tirapazamin IV over 2 timer på dag 1, 8, 10, 12, 15, 22, 24, 26 og 29 og cisplatin IV over 1 time på dag 1, 15 og 29. Patienter gennemgår også strålebehandling og brachyterapi som i arm I. Behandlingen fortsætter i fravær af sygdomsprogression eller uacceptabel toksicitet.
BEMÆRK: *Der gives ingen ekstern strålebehandling på dagen for HDR-brachyterapi. Hvis størstedelen af ekstern strålebehandling er blevet administreret, kan HDR-brachyterapi administreres i 2 applikationer om ugen (adskilt med mindst 72 timer) for at fuldføre al behandling inden for 8 uger.
BEMÆRK: ** Patienter kan få et parametrisk boost efter den behandlende stråleonkologs skøn.
Efter afsluttet undersøgelsesbehandling følges patienterne i mindst 5 år.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 3
Kontakter og lokationer
Studiesteder
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Alberta
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Calgary, Alberta, Canada, T2N 4N2
- Tom Baker Cancer Centre
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British Columbia
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Surrey, British Columbia, Canada, V3V 1Z2
- BCCA-Fraser Valley Cancer Centre
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Vancouver, British Columbia, Canada, V5Z 4E6
- BCCA-Vancouver Cancer Centre
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Ontario
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Sudbury, Ontario, Canada, P3E 5J1
- Health Sciences North
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Thunder Bay, Ontario, Canada, P7B 6V4
- Thunder Bay Regional Health Science Centre
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Toronto, Ontario, Canada, M4N 3M5
- Odette Cancer Centre- Sunnybrook Health Sciences Centre
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Quebec
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Montreal, Quebec, Canada, H2L 4M1
- CHUM - Hopital Notre-Dame
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Quebec City, Quebec, Canada, G1R 2J6
- CHUQ - Pavilion Hotel-Dieu de Quebec
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Saskatchewan
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Regina, Saskatchewan, Canada, S4T 7T1
- Allan Blair Cancer Centre
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Alabama
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Birmingham, Alabama, Forenede Stater, 35294
- University of Alabama at Birmingham
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Mobile, Alabama, Forenede Stater, 36607
- Mobile Infirmary Medical Center
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Alaska
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Anchorage, Alaska, Forenede Stater, 99508
- Providence Alaska Medical Center
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Arizona
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Phoenix, Arizona, Forenede Stater, 85006
- Banner Good Samaritan Medical Center
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Phoenix, Arizona, Forenede Stater, 85006
- Western Regional CCOP
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Arkansas
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Fayetteville, Arkansas, Forenede Stater, 72703
- Highlands Oncology Group PA - Fayetteville
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Fayetteville, Arkansas, Forenede Stater, 72703
- Washington Regional Medical Center - Fayetteville
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Little Rock, Arkansas, Forenede Stater, 72205
- University of Arkansas for Medical Sciences
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California
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Castro Valley, California, Forenede Stater, 94546
- East Bay Radiation Oncology Center
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Duarte, California, Forenede Stater, 91010
- City of Hope Medical Center
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Los Angeles, California, Forenede Stater, 90095
- Jonsson Comprehensive Cancer Center
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Oakland, California, Forenede Stater, 94609
- Bay Area Tumor Institute CCOP
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Orange, California, Forenede Stater, 92868
- University of California Medical Center At Irvine-Orange Campus
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Pomona, California, Forenede Stater, 91767
- Pomona Valley Hospital Medical Center
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Stanford, California, Forenede Stater, 94305
- Stanford University Hospitals and Clinics
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Sylmar, California, Forenede Stater, 91342
- Olive View-University of California Los Angeles Medical Center
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Colorado
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Aurora, Colorado, Forenede Stater, 80010
- Colorado Gynecologic Oncology Group
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Colorado Springs, Colorado, Forenede Stater, 80909
- Memorial Hospital Colorado Springs
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Greeley, Colorado, Forenede Stater, 80631
- North Colorado Medical Center
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Loveland, Colorado, Forenede Stater, 80539
- McKee Medical Center
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Connecticut
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Hartford, Connecticut, Forenede Stater, 06102
- Hartford Hospital
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New Britain, Connecticut, Forenede Stater, 06050
- The Hospital of Central Connecticut
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New Haven, Connecticut, Forenede Stater, 06520
- Yale University
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Delaware
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Lewes, Delaware, Forenede Stater, 19958
- Beebe Medical Center
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Newark, Delaware, Forenede Stater, 19718
- Christiana Care Health System-Christiana Hospital
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District of Columbia
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Washington, District of Columbia, Forenede Stater, 20010
- Washington Hospital Center
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Florida
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Fort Myers, Florida, Forenede Stater, 33905
- Florida Gynecologic Oncology
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Jacksonville, Florida, Forenede Stater, 32224-9980
- Mayo Clinic in Florida
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Orlando, Florida, Forenede Stater, 32806
- UF Cancer Center at Orlando Health
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Georgia
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Atlanta, Georgia, Forenede Stater, 30309
- Piedmont Hospital
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Atlanta, Georgia, Forenede Stater, 30342
- Northside Hospital
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Atlanta, Georgia, Forenede Stater, 30342
- Saint Joseph's Hospital of Atlanta
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Augusta, Georgia, Forenede Stater, 30912
- Georgia Regents University
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Columbus, Georgia, Forenede Stater, 31904
- John B Amos Cancer Center
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Decatur, Georgia, Forenede Stater, 30033
- Dekalb Medical Center
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Marietta, Georgia, Forenede Stater, 30060
- WellStar Kennestone Hospital
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Savannah, Georgia, Forenede Stater, 31403
- Memorial Health University Medical Center
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Hawaii
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'Aiea, Hawaii, Forenede Stater, 96701
- Pali Momi Medical Center
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Honolulu, Hawaii, Forenede Stater, 96813
- Queen's Medical Center
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Honolulu, Hawaii, Forenede Stater, 96817
- The Cancer Center of Hawaii-Liliha
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Honolulu, Hawaii, Forenede Stater, 96813
- Straub Clinic and Hospital
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Honolulu, Hawaii, Forenede Stater, 96859
- Tripler Army Medical Center
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Honolulu, Hawaii, Forenede Stater, 96813
- University of Hawaii
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Honolulu, Hawaii, Forenede Stater, 96813
- Hawaii Minority Based CCOP
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Wailuku, Hawaii, Forenede Stater, 96793
- Maui Memorial Medical Center
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Illinois
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Aurora, Illinois, Forenede Stater, 60504
- Rush - Copley Medical Center
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Bloomington, Illinois, Forenede Stater, 61701
- Saint Joseph Medical Center
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Canton, Illinois, Forenede Stater, 61520
- Graham Hospital Association
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Chicago, Illinois, Forenede Stater, 60612
- Rush University Medical Center
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Chicago, Illinois, Forenede Stater, 60637
- University of Chicago
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Chicago, Illinois, Forenede Stater, 60612
- University of Illinois
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Evanston, Illinois, Forenede Stater, 60202
- Saint Francis Hospital
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Galesburg, Illinois, Forenede Stater, 61401
- Western Illinois Cancer Treatment Center
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Joliet, Illinois, Forenede Stater, 60435
- Joliet Oncology-Hematology Associates Limited
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Normal, Illinois, Forenede Stater, 61761
- Community Cancer Center Foundation
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Normal, Illinois, Forenede Stater, 61761
- Bromenn Regional Medical Center
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Park Ridge, Illinois, Forenede Stater, 60068
- Advocate Lutheran General Hospital.
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Peoria, Illinois, Forenede Stater, 61637
- OSF Saint Francis Medical Center
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Peoria, Illinois, Forenede Stater, 61615
- Illinois CancerCare-Peoria
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Peru, Illinois, Forenede Stater, 61354
- Valley Radiation Oncology
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Spring Valley, Illinois, Forenede Stater, 61362
- Saint Margaret's Hospital
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Springfield, Illinois, Forenede Stater, 62781-0001
- Memorial Medical Center
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Urbana, Illinois, Forenede Stater, 61801
- Carle Cancer Center
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Urbana, Illinois, Forenede Stater, 61801
- Carle Clinic-Urbana Main
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Indiana
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Elkhart, Indiana, Forenede Stater, 46515
- Elkhart General Hospital
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Indianapolis, Indiana, Forenede Stater, 46202
- Indiana University Medical Center
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Indianapolis, Indiana, Forenede Stater, 46237
- Gynecologic Oncology of Indiana
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Kokomo, Indiana, Forenede Stater, 46904
- Community Howard Regional Health
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La Porte, Indiana, Forenede Stater, 46350
- IU Health La Porte Hospital
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Michigan City, Indiana, Forenede Stater, 46360
- Franciscan Saint Anthony Health-Michigan City
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Mishawaka, Indiana, Forenede Stater, 46545-1470
- Saint Joseph Regional Medical Center-Mishawaka
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South Bend, Indiana, Forenede Stater, 46601
- Memorial Hospital of South Bend
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South Bend, Indiana, Forenede Stater, 46628
- Northern Indiana Cancer Research Consortium
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Iowa
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Ames, Iowa, Forenede Stater, 50010
- McFarland Clinic PC-William R Bliss Cancer Center
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Clive, Iowa, Forenede Stater, 50325
- Medical Oncology and Hematology Associates-West Des Moines
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Des Moines, Iowa, Forenede Stater, 50309
- Iowa Methodist Medical Center
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Des Moines, Iowa, Forenede Stater, 50314
- Mercy Medical Center - Des Moines
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Des Moines, Iowa, Forenede Stater, 50309
- Medical Oncology and Hematology Associates-Des Moines
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Des Moines, Iowa, Forenede Stater, 50316
- Iowa Lutheran Hospital
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Des Moines, Iowa, Forenede Stater, 50314
- Medical Oncology and Hematology Associates-Laurel
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Des Moines, Iowa, Forenede Stater, 50307
- Mercy Capitol
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Des Moines, Iowa, Forenede Stater, 50309
- Iowa Oncology Research Association CCOP
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Iowa City, Iowa, Forenede Stater, 52242
- University of Iowa Hospitals and Clinics
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Sioux City, Iowa, Forenede Stater, 51101
- Siouxland Hematology Oncology Associates
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Kansas
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Anthony, Kansas, Forenede Stater, 67003
- Hospital District Sixth of Harper County
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Chanute, Kansas, Forenede Stater, 66720
- Cancer Center of Kansas - Chanute
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Dodge City, Kansas, Forenede Stater, 67801
- Cancer Center of Kansas - Dodge City
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El Dorado, Kansas, Forenede Stater, 67042
- Cancer Center of Kansas - El Dorado
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Fort Scott, Kansas, Forenede Stater, 66701
- Cancer Center of Kansas - Fort Scott
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Independence, Kansas, Forenede Stater, 67301
- Cancer Center of Kansas-Independence
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Kansas City, Kansas, Forenede Stater, 66160
- University of Kansas Medical Center
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Kansas City, Kansas, Forenede Stater, 66112
- Providence Medical Center
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Kingman, Kansas, Forenede Stater, 67068
- Cancer Center of Kansas-Kingman
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Lawrence, Kansas, Forenede Stater, 66044
- Lawrence Memorial Hospital
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Newton, Kansas, Forenede Stater, 67114
- Cancer Center of Kansas - Newton
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Overland Park, Kansas, Forenede Stater, 66210
- Radiation Oncology Practice Corporation Southwest
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Parsons, Kansas, Forenede Stater, 67357
- Cancer Center of Kansas - Parsons
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Pratt, Kansas, Forenede Stater, 67124
- Cancer Center of Kansas - Pratt
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Salina, Kansas, Forenede Stater, 67401
- Cancer Center of Kansas - Salina
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Wellington, Kansas, Forenede Stater, 67152
- Cancer Center of Kansas - Wellington
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Wichita, Kansas, Forenede Stater, 67208
- Cancer Center of Kansas-Wichita Medical Arts Tower
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Wichita, Kansas, Forenede Stater, 67208
- Associates In Womens Health
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Wichita, Kansas, Forenede Stater, 67214
- Cancer Center of Kansas - Main Office
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Wichita, Kansas, Forenede Stater, 67214
- Via Christi Regional Medical Center
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Wichita, Kansas, Forenede Stater, 67214
- Wesley Medical Center
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Wichita, Kansas, Forenede Stater, 67214
- Wichita CCOP
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Winfield, Kansas, Forenede Stater, 67156
- Cancer Center of Kansas - Winfield
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Kentucky
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Edgewood, Kentucky, Forenede Stater, 41017
- Saint Elizabeth Medical Center South
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Louisville, Kentucky, Forenede Stater, 40202
- The James Graham Brown Cancer Center at University of Louisville
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Louisiana
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New Orleans, Louisiana, Forenede Stater, 70112
- Tulane University Health Sciences Center
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Shreveport, Louisiana, Forenede Stater, 71130
- Louisiana State University Health Sciences Center Shreveport
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Maine
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Bangor, Maine, Forenede Stater, 04401
- Eastern Maine Medical Center
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Portland, Maine, Forenede Stater, 04102
- Maine Medical Center-Bramhall Campus
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Maryland
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Elkton, Maryland, Forenede Stater, 21921
- Union Hospital of Cecil County
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Massachusetts
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Worcester, Massachusetts, Forenede Stater, 01655
- University of Massachusetts Medical School
-
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Michigan
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Battle Creek, Michigan, Forenede Stater, 49017
- Bronson Battle Creek
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Big Rapids, Michigan, Forenede Stater, 49307
- Spectrum Health Big Rapids Hospital
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Detroit, Michigan, Forenede Stater, 48201
- Wayne State University/Karmanos Cancer Institute
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Escanaba, Michigan, Forenede Stater, 49431
- Green Bay Oncology - Escanaba
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Grand Rapids, Michigan, Forenede Stater, 49503
- Spectrum Health at Butterworth Campus
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Grand Rapids, Michigan, Forenede Stater, 49503
- Mercy Health Saint Mary's
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Grand Rapids, Michigan, Forenede Stater, 49503
- Grand Rapids Clinical Oncology Program
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Grand Rapids, Michigan, Forenede Stater, 49506
- Spectrum Health-Blodgett Campus
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Grand Rapids, Michigan, Forenede Stater, 49546
- Gynecologic Oncology of West Michigan PLLC
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Iron Mountain, Michigan, Forenede Stater, 49801
- Green Bay Oncology - Iron Mountain
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Muskegon, Michigan, Forenede Stater, 49444
- Mercy Health Mercy Campus
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Muskegon, Michigan, Forenede Stater, 49442
- Mercy Health Partners-Hackley Campus
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Royal Oak, Michigan, Forenede Stater, 48073
- William Beaumont Hospital-Royal Oak
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Saint Joseph, Michigan, Forenede Stater, 49085
- Lakeland Hospital
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Southfield, Michigan, Forenede Stater, 48075
- Providence Hospital
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Traverse City, Michigan, Forenede Stater, 49684
- Munson Medical Center
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Wyoming, Michigan, Forenede Stater, 49519
- Metro Health Hospital
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Minnesota
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Rochester, Minnesota, Forenede Stater, 55905
- Mayo Clinic
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Shakopee, Minnesota, Forenede Stater, 55379
- Saint Francis Regional Medical Center
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Mississippi
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Jackson, Mississippi, Forenede Stater, 39216
- University of Mississippi Medical Center
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Missouri
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Columbia, Missouri, Forenede Stater, 65212
- University of Missouri - Ellis Fischel
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Independence, Missouri, Forenede Stater, 64057
- Centerpoint Medical Center LLC
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Kansas City, Missouri, Forenede Stater, 64114
- Radiation Oncology Practice Corporation South
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Kansas City, Missouri, Forenede Stater, 64154
- Radiation Oncology Practice Corporation - North
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Saint Louis, Missouri, Forenede Stater, 63110
- Saint Louis University Hospital
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Saint Louis, Missouri, Forenede Stater, 63131
- Missouri Baptist Medical Center
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Saint Louis, Missouri, Forenede Stater, 63141
- Saint John's Mercy Medical Center
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Saint Louis, Missouri, Forenede Stater, 63141
- Center for Cancer Care and Research
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Springfield, Missouri, Forenede Stater, 65807
- CoxHealth South Hospital
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Springfield, Missouri, Forenede Stater, 65804
- Mercy Hospital Springfield
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Springfield, Missouri, Forenede Stater, 65804
- Ozark Health Ventures LLC-Cancer Research for The Ozarks Springfield
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Montana
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Billings, Montana, Forenede Stater, 59101
- Northern Rockies Radiation Oncology Center
-
Billings, Montana, Forenede Stater, 59101
- Montana Cancer Consortium CCOP
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Billings, Montana, Forenede Stater, 59102
- Hematology-Oncology Centers of the Northern Rockies PC
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Billings, Montana, Forenede Stater, 59107-7000
- Billings Clinic
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Great Falls, Montana, Forenede Stater, 59405
- Great Falls Clinic
-
Great Falls, Montana, Forenede Stater, 59405
- Berdeaux, Donald MD (UIA Investigator)
-
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Nebraska
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Kearney, Nebraska, Forenede Stater, 68847
- Good Samaritan Hospital
-
Omaha, Nebraska, Forenede Stater, 68114
- Nebraska Methodist Hospital
-
Omaha, Nebraska, Forenede Stater, 68198
- University Of Nebraska Medical Center
-
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Nevada
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Reno, Nevada, Forenede Stater, 89502
- Renown Regional Medical Center
-
Reno, Nevada, Forenede Stater, 89502
- Center of Hope at Renown Medical Center
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New Jersey
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Camden, New Jersey, Forenede Stater, 08103
- Cooper Hospital University Medical Center
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Montclair, New Jersey, Forenede Stater, 07042
- Mountainside Hospital
-
Mount Holly, New Jersey, Forenede Stater, 08060
- Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County
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Neptune, New Jersey, Forenede Stater, 07753
- Jersey Shore Medical Center
-
New Brunswick, New Jersey, Forenede Stater, 08903
- Rutgers Cancer Institute of New Jersey
-
Newark, New Jersey, Forenede Stater, 07103
- UMDNJ - New Jersey Medical School
-
Toms River, New Jersey, Forenede Stater, 08755
- Community Medical Center
-
Voorhees, New Jersey, Forenede Stater, 08043
- Virtua West Jersey Hospital Voorhees
-
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New Mexico
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Albuquerque, New Mexico, Forenede Stater, 87106
- University of New Mexico Cancer Center
-
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New York
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Albany, New York, Forenede Stater, 12208
- Women's Cancer Care Associates LLC
-
Brightwaters, New York, Forenede Stater, 11718
- Island Gynecologic Oncology
-
Bronx, New York, Forenede Stater, 10461
- Montefiore Medical Center-Weiler Division
-
Brooklyn, New York, Forenede Stater, 11203
- State University of New York Downstate Medical Center
-
Buffalo, New York, Forenede Stater, 14263
- Roswell Park Cancer Institute
-
Jamaica, New York, Forenede Stater, 11432
- Queens Hospital Center
-
Manhasset, New York, Forenede Stater, 11030
- North Shore University Hospital
-
Manhasset, New York, Forenede Stater, 11030
- North Shore-LIJ Health System CCOP
-
Middletown, New York, Forenede Stater, 10940
- Orange Regional Medical Center
-
New Hyde Park, New York, Forenede Stater, 11040
- Long Island Jewish Medical Center
-
New Hyde Park, New York, Forenede Stater, 11040
- North Shore-LIJ Health System/Center for Advanced Medicine
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New York, New York, Forenede Stater, 10065
- Memorial Sloan-Kettering Cancer Center
-
New York, New York, Forenede Stater, 10016
- New York University Langone Medical Center
-
Stony Brook, New York, Forenede Stater, 11794
- Stony Brook University Medical Center
-
Syracuse, New York, Forenede Stater, 13210
- State University of New York Upstate Medical University
-
West Islip, New York, Forenede Stater, 11795
- Good Samaritan Hospital Medical Center
-
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North Carolina
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Asheville, North Carolina, Forenede Stater, 28816
- Hope Women's Cancer Centers-Asheville
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Chapel Hill, North Carolina, Forenede Stater, 27599
- University of North Carolina
-
Durham, North Carolina, Forenede Stater, 27710
- Duke University Medical Center
-
Wilmington, North Carolina, Forenede Stater, 28401
- New Hanover Regional Medical Center
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Wilson, North Carolina, Forenede Stater, 27893
- Wilson Medical Center
-
Winston-Salem, North Carolina, Forenede Stater, 27157
- Wake Forest University Health Sciences
-
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North Dakota
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Bismarck, North Dakota, Forenede Stater, 58501
- Sanford Bismarck Medical Center
-
Bismarck, North Dakota, Forenede Stater, 58501
- Bismarck Cancer Center
-
Bismarck, North Dakota, Forenede Stater, 58501
- Mid Dakota Clinic
-
Bismarck, North Dakota, Forenede Stater, 58501
- Saint Alexius Medical Center
-
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Ohio
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Akron, Ohio, Forenede Stater, 44307
- Akron General Medical Center
-
Canton, Ohio, Forenede Stater, 44710
- Aultman Health Foundation
-
Cincinnati, Ohio, Forenede Stater, 45267
- University of Cincinnati
-
Cincinnati, Ohio, Forenede Stater, 45220
- Good Samaritan Hospital - Cincinnati
-
Cincinnati, Ohio, Forenede Stater, 45242
- Bethesda North Hospital
-
Cleveland, Ohio, Forenede Stater, 44106
- Case Western Reserve University
-
Cleveland, Ohio, Forenede Stater, 44109
- MetroHealth Medical Center
-
Cleveland, Ohio, Forenede Stater, 44195
- Cleveland Clinic Foundation
-
Cleveland, Ohio, Forenede Stater, 44111
- Cleveland Clinic Cancer Center/Fairview Hospital
-
Columbus, Ohio, Forenede Stater, 43214
- Riverside Methodist Hospital
-
Columbus, Ohio, Forenede Stater, 43210
- Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
-
Columbus, Ohio, Forenede Stater, 43222
- Mount Carmel Health Center West
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Dayton, Ohio, Forenede Stater, 45406
- Good Samaritan Hospital - Dayton
-
Dayton, Ohio, Forenede Stater, 45409
- Miami Valley Hospital
-
Dayton, Ohio, Forenede Stater, 45415
- Samaritan North Health Center
-
Mayfield Heights, Ohio, Forenede Stater, 44124
- Hillcrest Hospital Cancer Center
-
Mentor, Ohio, Forenede Stater, 44060
- Lake University Ireland Cancer Center
-
Wright-Patterson Air Force Base, Ohio, Forenede Stater, 45433-5529
- Wright-Patterson Medical Center
-
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Oklahoma
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Oklahoma City, Oklahoma, Forenede Stater, 73104
- University of Oklahoma Health Sciences Center
-
Tulsa, Oklahoma, Forenede Stater, 74146
- Tulsa Cancer Institute
-
Tulsa, Oklahoma, Forenede Stater, 74104
- Cancer Care Associates-Midtown
-
-
Oregon
-
Salem, Oregon, Forenede Stater, 97301
- Salem Hospital
-
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Pennsylvania
-
Abington, Pennsylvania, Forenede Stater, 19001
- Abington Memorial Hospital
-
Allentown, Pennsylvania, Forenede Stater, 18105
- LeHigh Valley Hospital
-
Bethlehem, Pennsylvania, Forenede Stater, 18015
- Saint Luke's University Hospital-Bethlehem Campus
-
Lancaster, Pennsylvania, Forenede Stater, 17604
- Lancaster General Hospital
-
Philadelphia, Pennsylvania, Forenede Stater, 19107
- Thomas Jefferson University Hospital
-
Pittsburgh, Pennsylvania, Forenede Stater, 15213
- Magee-Womens Hospital of UPMC
-
Pittsburgh, Pennsylvania, Forenede Stater, 15224-1791
- Western Pennsylvania Hospital
-
Scranton, Pennsylvania, Forenede Stater, 18510
- Scranton Hematology Oncology
-
Scranton, Pennsylvania, Forenede Stater, 18501
- Mercy Hospital
-
Scranton, Pennsylvania, Forenede Stater, 18508
- Hematology and Oncology Associates of North East Pennsylvania
-
West Reading, Pennsylvania, Forenede Stater, 19611
- Reading Hospital
-
-
Rhode Island
-
Providence, Rhode Island, Forenede Stater, 02905
- Women and Infants Hospital
-
-
South Carolina
-
Charleston, South Carolina, Forenede Stater, 29425
- Medical University of South Carolina
-
-
South Dakota
-
Rapid City, South Dakota, Forenede Stater, 57701
- Black Hills Obstetrics and Gynecology
-
-
Tennessee
-
Chattanooga, Tennessee, Forenede Stater, 37403
- Chattanooga's Program in Women's Oncology
-
Chattanooga, Tennessee, Forenede Stater, 37403
- Chattanooga Gynecological Oncology
-
Johnson City, Tennessee, Forenede Stater, 37614-0054
- East Tennessee State University
-
Nashville, Tennessee, Forenede Stater, 37232
- Vanderbilt-Ingram Cancer Center
-
Nashville, Tennessee, Forenede Stater, 37208-3599
- Meharry Medical College
-
-
Texas
-
Amarillo, Texas, Forenede Stater, 79106
- The Don and Sybil Harrington Cancer Center
-
Dallas, Texas, Forenede Stater, 75390
- University of Texas Southwestern Medical Center
-
Fort Sam Houston, Texas, Forenede Stater, 78234
- Brooke Army Medical Center
-
Galveston, Texas, Forenede Stater, 77555-0565
- University of Texas Medical Branch at Galveston
-
Houston, Texas, Forenede Stater, 77030
- M D Anderson Cancer Center
-
Laredo, Texas, Forenede Stater, 78041
- Doctor's Hospital of Laredo
-
Lubbock, Texas, Forenede Stater, 79430
- Texas Tech University Health Sciences Center
-
-
Utah
-
American Fork, Utah, Forenede Stater, 84003
- American Fork Hospital
-
Logan, Utah, Forenede Stater, 84321
- Logan Regional Hospital
-
Murray, Utah, Forenede Stater, 84107
- Cottonwood Hospital Medical Center
-
Ogden, Utah, Forenede Stater, 84403
- McKay-Dee Hospital Center
-
Provo, Utah, Forenede Stater, 84604-3337
- Utah Valley Regional Medical Center
-
Saint George, Utah, Forenede Stater, 84770
- Dixie Medical Center Regional Cancer Center
-
Salt Lake City, Utah, Forenede Stater, 84106
- Utah Cancer Specialists-Salt Lake City
-
Salt Lake City, Utah, Forenede Stater, 84143
- LDS Hospital
-
Salt Lake City, Utah, Forenede Stater, 84103
- Intermountain Health Care
-
-
Vermont
-
Burlington, Vermont, Forenede Stater, 05401
- Fletcher Allen Health Care-Medical Center
-
-
Virginia
-
Annandale, Virginia, Forenede Stater, 22003
- Northern Virginia Pelvic Surgery Associates
-
Charlottesville, Virginia, Forenede Stater, 22908
- University of Virginia
-
Newport News, Virginia, Forenede Stater, 23602
- Bon Secours Mary Immaculate Hospital
-
Norton, Virginia, Forenede Stater, 24273
- Southwest VA Regional Cancer Center
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Richmond, Virginia, Forenede Stater, 23298
- Virginia Commonwealth University
-
Roanoke, Virginia, Forenede Stater, 24016
- Carilion Clinic Gynecological Oncology
-
-
Washington
-
Puyallup, Washington, Forenede Stater, 98372
- Good Samaritan Community Hospital
-
Seattle, Washington, Forenede Stater, 98195
- University of Washington Medical Center
-
Tacoma, Washington, Forenede Stater, 98405
- Northwest Medical Specialties PLLC
-
Tacoma, Washington, Forenede Stater, 98405
- Saint Joseph Medical Center
-
Tacoma, Washington, Forenede Stater, 98415
- MultiCare Health System
-
Tacoma, Washington, Forenede Stater, 98405
- Tacoma General Hospital
-
Tacoma, Washington, Forenede Stater, 98405
- Northwest CCOP
-
-
West Virginia
-
Wheeling, West Virginia, Forenede Stater, 26003
- Wheeling Hospital
-
-
Wisconsin
-
Green Bay, Wisconsin, Forenede Stater, 54301
- Saint Vincent Hospital
-
Green Bay, Wisconsin, Forenede Stater, 54303
- Green Bay Oncology Limited at Saint Mary's Hospital
-
Green Bay, Wisconsin, Forenede Stater, 54303
- Saint Mary's Hospital
-
Green Bay, Wisconsin, Forenede Stater, 54301-3526
- Green Bay Oncology at Saint Vincent Hospital
-
Marinette, Wisconsin, Forenede Stater, 54143
- Bay Area Medical Center
-
Milwaukee, Wisconsin, Forenede Stater, 53226
- Froedtert and The Medical College of Wisconsin
-
Oconto Falls, Wisconsin, Forenede Stater, 54154
- Green Bay Oncology - Oconto Falls
-
Sturgeon Bay, Wisconsin, Forenede Stater, 54235
- Green Bay Oncology - Sturgeon Bay
-
West Allis, Wisconsin, Forenede Stater, 53227
- Aurora West Allis Medical Center
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inklusionskriterier:
Histologisk bekræftet invasivt planocellulært karcinom, adenocarcinom eller adenosquamøst cellekarcinom i livmoderhalsen
Stadie IB2, IIA, IIB, IIIB eller IVA sygdom
- Stadie IIA-tumorer skal være > 4 cm
- Primær, ubehandlet sygdom
- Negative, ikke-mistænkelige paraaorta-knuder ved lymfangiogram, CT-scanning, MR eller lymfadenektomi
- Skal have været tilstrækkeligt klinisk iscenesat
- Velegnet til behandling med radikale hensigter ved hjælp af samtidig kemoterapi og bækkenstrålebehandling
- Ingen sygdomsinvolvering af den nederste tredjedel af skeden uanset stadie (alle stadier IIIA, IIIB og IVA med lavere en tredjedel involvering)
- Intet karcinom i livmoderhalsstumpen
- Ydeevnestatus - GOG 0-3
- Absolut neutrofiltal ≥ 1.500/mm^3
- Blodpladeantal ≥ 100.000/mm^3
- Bilirubin ≤ 1,5 gange øvre normalgrænse (ULN)
- SGOT ≤ 3 gange ULN
- Alkalisk fosfatase ≤ 3 gange ULN
- Kreatinin ≤ ULN eller beregnet kreatininclearance ≥ 60 ml/min.
- Ingen New York Heart Association klasse III-IV hjertesvigt
- Ingen historie med myokardieinfarkt
- Ingen ustabil angina
- Ingen ukontrolleret hypertension
- Ingen gravid eller ammende
- Negativ graviditetstest
- Fertile patienter skal bruge effektiv prævention
- Ingen septikæmi eller alvorlig infektion
- Ingen anden invasiv malignitet inden for de seneste 5 år undtagen non-melanom hudkræft
- Ingen forudgående hysterektomi eller planlagt hysterektomi som en del af initial livmoderhalskræftbehandling
- Ingen tidligere koronar bypass-operation
- Ingen tidligere kræftbehandling, der ville udelukke undersøgelsesbehandling
- Ingen samtidig angina medicin
- Ingen samtidig intensitetsmoduleret strålebehandling
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: Arm I (cisplatin)
Patienter får cisplatin IV på dag 1, 8, 15, 22, 29 og 36 (uge 1-6).
|
Givet IV
Andre navne:
|
Eksperimentel: Arm II (cisplatin, tirapazamin)
Patienter får tirapazamin IV over 2 timer på dag 1, 8, 10, 12, 15, 22, 24, 26 og 29 og cisplatin IV over 1 time på dag 1, 15 og 29.
|
Givet IV
Andre navne:
Givet IV
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Progressionsfri overlevelse - Procentdel af patienter i live og progressionsfri
Tidsramme: Fra studiestart til første sygdomsprogression, død eller dato for sidste kontakt, op til 6 år
|
Patienternes progressionsstatus baseret på klinisk, radiologisk eller patologisk (histologisk) tegn på sygdom efter undersøgelsesterapi.
Progression omfatter enhver død uden tegn på sygdomsprogression.
Progressionsfri overlevelse (PFS) er defineret som tid i måned fra studieindskrivning til sygdomsprogression, død eller dato for sidste kontakt.
|
Fra studiestart til første sygdomsprogression, død eller dato for sidste kontakt, op til 6 år
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Samlet overlevelse
Tidsramme: Fra studiestart til død eller sidste kontakt, op til 6 år
|
Den observerede levetid fra indtræden i undersøgelsen til død eller dato for sidste kontakt.
|
Fra studiestart til død eller sidste kontakt, op til 6 år
|
Uønskede hændelser (grad 3 eller højere) under behandlingsperioden
Tidsramme: Alle bivirkninger, der opstår under behandlingen og op til 30 dage efter ophør af undersøgelsesbehandlingen, er rapporteret
|
Antal deltagere med en maksimal karakter på 3 eller højere i behandlingsperioden.
Bivirkninger er klassificeret og kategoriseret ved hjælp af CTCAE v3.0.
|
Alle bivirkninger, der opstår under behandlingen og op til 30 dage efter ophør af undersøgelsesbehandlingen, er rapporteret
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Paul DiSilvestro, Gynecologic Oncology Group
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Neoplasmer efter histologisk type
- Neoplasmer
- Urogenitale neoplasmer
- Neoplasmer efter sted
- Neoplasmer, kirtel og epitel
- Uterine neoplasmer
- Genitale neoplasmer, kvindelige
- Livmoderhalssygdomme
- Livmodersygdomme
- Neoplasmer, komplekse og blandede
- Uterine cervikale neoplasmer
- Karcinom
- Karcinom, Adenosquamous
- Antineoplastiske midler
- Tirapazamin
Andre undersøgelses-id-numre
- NCI-2009-00591 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- U10CA027469 (U.S. NIH-bevilling/kontrakt)
- CAN-NCIC-GOG-0219
- CDR0000455555
- GOG-0219 (Anden identifikator: CTEP)
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 .
Kliniske forsøg med Cervikal Adenocarcinom
-
Xin Jiang, MDUkendt
-
Gangnam Severance HospitalAfsluttetAnterior Cervical Discectomy and Fusion (ACDF) kirurgiKorea, Republikken
-
University of ArkansasAfsluttetAnterior Cervical Discectomy and Fusion (ACDF)Forenede Stater
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Cleveland Clinic Akron GeneralRekrutteringSmerte | Overfladisk Cervical Plexus BlockForenede Stater
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City of Hope Medical CenterNational Cancer Institute (NCI)Aktiv, ikke rekrutterendeEsophageal Adenocarcinom | Esophageal pladecellekarcinom | Klinisk trin III Gastroøsofageal Junction Adenocarcinoma AJCC v8 | Klinisk fase II Gastroøsofageal Junction Adenocarcinoma AJCC v8 | Klinisk fase IVA Gastroøsofageal Junction Adenocarcinoma AJCC v8 | Patologisk trin IIIA Gastroøsofageal... og andre forholdForenede Stater
-
AxioMed Spine CorporationUkendtSymptomatisk Cervical Degenerative Disc Disease (DDD) Fra C3-C7Tyskland, Schweiz
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)AfsluttetGastroøsofageal Junction Adenocarcinom | Stadie IB Esophageal Adenocarcinoma AJCC v7 | Stadie II Esophageal Adenocarcinoma AJCC v7 | Stadie IIA Esophageal Adenocarcinoma AJCC v7 | Stadie IIB Esophageal Adenocarcinoma AJCC v7 | Stadie IIIA Esophageal Adenocarcinoma AJCC v7 | Stadie IIIB Esophageal...Forenede Stater
-
M.D. Anderson Cancer CenterRekrutteringKlinisk fase III gastrisk cancer AJCC v8 | Klinisk trin III Gastroøsofageal Junction Adenocarcinoma AJCC v8 | Klinisk fase IV gastrisk cancer AJCC v8 | Klinisk trin IV Gastroøsofageal Junction Adenocarcinoma AJCC v8 | Metastatisk gastrisk adenocarcinom | Metastatisk Gastroøsofageal Junction Adenocarcinoma og andre forholdForenede Stater
-
Academic and Community Cancer Research UnitedNational Cancer Institute (NCI)RekrutteringKlinisk fase III gastrisk cancer AJCC v8 | Klinisk trin III Gastroøsofageal Junction Adenocarcinoma AJCC v8 | Klinisk fase IV gastrisk cancer AJCC v8 | Klinisk trin IV Gastroøsofageal Junction Adenocarcinoma AJCC v8 | Metastatisk gastrisk adenocarcinom | Metastatisk Gastroøsofageal Junction Adenocarcinoma og andre forholdForenede Stater
Kliniske forsøg med cisplatin
-
West China Second University HospitalRekrutteringNeoadjuverende kemoterapi | Epitelkarcinom, ovarieKina
-
Insmed IncorporatedAfsluttetOsteosarkom MetastatiskForenede Stater
-
Cedars-Sinai Medical CenterRekrutteringHPV-positivt orofaryngealt planocellulært karcinomForenede Stater
-
Privo TechnologiesNational Cancer Institute (NCI)AfsluttetOralt planocellulært karcinomForenede Stater
-
Lawson Health Research InstituteRekrutteringLokalt avanceret hoved- og halspladecellekarcinomCanada
-
Taiho Oncology, Inc.Quintiles, Inc.AfsluttetMavekræftForenede Stater, Canada
-
Sun Yat-sen UniversityAktiv, ikke rekrutterendeNasopharyngealt karcinomKina
-
Sun Yat-sen UniversityFirst Affiliated Hospital, Sun Yat-Sen University; Guangdong Provincial... og andre samarbejdspartnereAktiv, ikke rekrutterendeNasopharyngealt karcinom | Nasopharyngeale neoplasmer | Nasopharyngeale sygdomme | Neoplasma i hoved og halsKina
-
Fujian Cancer HospitalIkke rekrutterer endnuNasopharyngealt karcinomKina
-
University of VermontJohnson & JohnsonRekruttering