Adjuverende terapi ved POLE-muteret og p53-vildtype/NSMP endometriecancer i tidlig stadium RAINBO BLUE & TAPER
13. oktober 2026 opdateret af: Canadian Cancer Trials Group
Et fase II-studie af skræddersyet adjuverende terapi i POLE-muteret og p53-vildtype/NSMP endormetrisk cancer i tidligt stadium (RAINBO BLUE & TAPER)
This protocol tests de-escalated adjuvant treatment in patients with POLE-mutated or p53wt/NSMP (p53 wildtype/no specific molecular profile) early-stage endometrial cancer (EC). Patients may be enrolled in one of two sub-studies
- EN10.A/RAINBO BLUE: POLE-mutated EC
- EN10.B/TAPER: p53 wildtype / NSMP EC
Studieoversigt
Status
Status
Rekruttering
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Detaljeret beskrivelse
This study is being done in order to find out if this new approach is better or worse than the usual approach for early-stage endometrial cancer. The usual approach is defined as the care most people get for early-stage endometrial cancer.
The usual approach for patients who are not in a study is treatment with surgery. Tissue that is removed as part of this procedure is analyzed in the pathology laboratory to guide the doctor to decide whether or not additional treatment such as radiation and or chemotherapy should be recommended.
Undersøgelsestype
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
Tilmelding
393
Fase
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
Studiekontakt
- Navn: Wendy Parulekar
- Telefonnummer: 613-533-6430
- E-mail: wparulekar@ctg.queensu.ca
Studiesteder
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Garran, Australien, ACT 2605
- Rekruttering
- Canberra Hospital
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Kontakt:
- Andrew Douglas Lee
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Herston, Australien, 4029
- Rekruttering
- Royal Brisbane and Womens Hospital
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Kontakt:
- Andrea Garrett
- Telefonnummer: 73 646-8111
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New South Wales
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Liverpool, New South Wales, Australien, 2170
- Rekruttering
- South Western Sydney Local Health District
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Kontakt:
- Viet Do
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St Leonards, New South Wales, Australien, 2065
- Rekruttering
- Royal North Shore Hospital
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Kontakt:
- Marita Morgia
- Telefonnummer: 2 946-3130
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Waratah, New South Wales, Australien, 2298
- Rekruttering
- Calvary Mater Newcastle Hospital
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Kontakt:
- Geetha Govindarajulu
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Westmead, New South Wales, Australien, 2145
- Rekruttering
- Westmead Hospital
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Kontakt:
- Alison Brand
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Queensland
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South Brisbane, Queensland, Australien, 4101
- Rekruttering
- Mater Research Institute South Brisbane
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Kontakt:
- Nimithri Cabraal
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Tiwi
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Darwin, Tiwi, Australien, 0810
- Rekruttering
- Royal Darwin Hospital
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Kontakt:
- Michelle Harris
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Victoria
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Clayton, Victoria, Australien, 3168
- Rekruttering
- Monash Medical Centre
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Kontakt:
- Shih-Ern Yao
- Telefonnummer: 39 594-6666
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Frankston, Victoria, Australien, 3199
- Rekruttering
- Frankston Hospital
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Kontakt:
- Yoland Antill
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Parkville, Victoria, Australien, 3053
- Rekruttering
- The Royal Women's Hospital
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Kontakt:
- Orla McNally
- Telefonnummer: 2 613 834-5356
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Alberta
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Calgary, Alberta, Canada, T2N 5G2
- Rekruttering
- Arthur J.E. Child Comprehensive Cancer Centre
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Kontakt:
- Ruth Fullerton
- Telefonnummer: 403 521-3095
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Edmonton, Alberta, Canada, T6G 1Z2
- Rekruttering
- Cross Cancer Institute
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Kontakt:
- Fleur Huang
- Telefonnummer: 780 432-8516
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British Columbia
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Kelowna, British Columbia, Canada, V1Y 5L3
- Rekruttering
- BCCA - Kelowna
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Kontakt:
- Hamid Raziee
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Prince George, British Columbia, Canada, V2M 7E9
- Rekruttering
- BCCA - Prince George
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Kontakt:
- Allison Ye
- Telefonnummer: 250 645-7300
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Vancouver, British Columbia, Canada, V5Z 4E6
- Rekruttering
- BCCA - Vancouver
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Kontakt:
- Jessica McAlpine
- Telefonnummer: 2395 604 877-6000
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Victoria, British Columbia, Canada, V8R 6V5
- Rekruttering
- BCCA - Victoria
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Kontakt:
- Caroline Holloway
- Telefonnummer: 250 519-5609
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Ontario
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Barrie, Ontario, Canada, L4M 6M2
- Rekruttering
- Royal Victoria Regional Health Centre
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Kontakt:
- Jessica Conway
- Telefonnummer: 705 728-9090
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Hamilton, Ontario, Canada, L8V 5C2
- Rekruttering
- Juravinski Cancer Centre at Hamilton Health Sciences
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Kontakt:
- Clare Reade
- Telefonnummer: 905 389-5688
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London, Ontario, Canada, N6A 5W9
- Rekruttering
- London Health Sciences Centre Research Inc.
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Kontakt:
- Lucas Mendez
- Telefonnummer: 53169 519 685-8600
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Mississauga, Ontario, Canada, L5M 2N1
- Rekruttering
- Trillium Health Partners - Credit Valley Hospital
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Kontakt:
- Katherine Pulman
- Telefonnummer: 1841 905 813-1100
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Toronto, Ontario, Canada, M5G 2M9
- Rekruttering
- University Health Network
-
Kontakt:
- Kathy Han
- Telefonnummer: 2919 416 946-4501
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Toronto, Ontario, Canada, M4N 3M5
- Rekruttering
- Odette Cancer Centre
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Kontakt:
- Helen MacKay
- Telefonnummer: 416 480-5145
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Quebec
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Montreal, Quebec, Canada, H3T 1E2
- Rekruttering
- The Jewish General Hospital
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Kontakt:
- Susie K.S. Lau
- Telefonnummer: 3114 514 340-8222
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Montreal, Quebec, Canada, H2X 3E4
- Rekruttering
- CHUM-Centre Hospitalier de l'Universite de Montreal
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Kontakt:
- Maroie Barkati
- Telefonnummer: 514 890-8254
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Sherbrooke, Quebec, Canada, J1H 5N4
- Rekruttering
- CIUSSS de l'Estrie - Centre hospitalier
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Kontakt:
- Mathieu Viau
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-
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Alaska
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Anchorage, Alaska, Forenede Stater, 99508
- Rekruttering
- Alaska Womens Cancer Care
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Kontakt:
- Melissa Hardesty
- Telefonnummer: 907-212-6871
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Arizona
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Tucson, Arizona, Forenede Stater, 85719
- Rekruttering
- University of Arizona Cancer Center
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Kontakt:
- Marina Miller
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California
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Los Angeles, California, Forenede Stater, 90048
- Rekruttering
- Cedars-Sinai Medical Center
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Kontakt:
- Emily Prendergast
- Telefonnummer: 310-423-5246
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Pasadena, California, Forenede Stater, 91105
- Rekruttering
- Huntington Memorial Hospital
-
Kontakt:
- Emily Prendergast
- Telefonnummer: 310-423-5246
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Sacramento, California, Forenede Stater, 95816
- Rekruttering
- Sutter Medical Center Sacramento
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Kontakt:
- Anna Likhacheva
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Colorado
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Aurora, Colorado, Forenede Stater, 80045
- Rekruttering
- UCHealth University of Colorado Hospital
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Kontakt:
- Bradley Corr
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Denver, Colorado, Forenede Stater, 80210
- Rekruttering
- AdventHealth Porter
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Kontakt:
- Neil Phippen
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Florida
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Deerfield Beach, Florida, Forenede Stater, 33442
- Rekruttering
- UM Sylvester Comprehensive Cancer Center at
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Kontakt:
- Joseph Pearson
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Doral, Florida, Forenede Stater, 33166
- Rekruttering
- UM Sylvester Comprehensive Cancer Center at Doral
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Kontakt:
- Joseph Pearson
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Gainesville, Florida, Forenede Stater, 32610-0277
- Rekruttering
- University of Florida
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Kontakt:
- Danielle Cerbon
- Telefonnummer: 352-265-0287
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Miami, Florida, Forenede Stater, 33136
- Rekruttering
- University of Miami School of Medicine
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Kontakt:
- Joseph Pearson
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N. Venice, Florida, Forenede Stater, 34275
- Rekruttering
- Sarasota Memorial Hospital - Venice
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Kontakt:
- Beverly Long
- Telefonnummer: 941-917-2225
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North Miami, Florida, Forenede Stater, 33181
- Rekruttering
- University of Miami Sylvester
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Kontakt:
- Joseph Pearson
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Plantation, Florida, Forenede Stater, 33324
- Rekruttering
- UM Sylvester Comprehensive Cancer Center
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Kontakt:
- Joseph Pearson
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Sarasota, Florida, Forenede Stater, 34236
- Rekruttering
- Florida Cancer Specialists - Sarasota Downtown
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Kontakt:
- Beverly Long
- Telefonnummer: 941-917-2225
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Sarasota, Florida, Forenede Stater, 34239
- Rekruttering
- Sarasota Memorial Hospital
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Kontakt:
- Beverly Long
- Telefonnummer: 941-917-2225
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Sarasota, Florida, Forenede Stater, 34239
- Rekruttering
- First Physicians Group-Sarasota
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Kontakt:
- Beverly Long
- Telefonnummer: 941-917-2225
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Sarasota, Florida, Forenede Stater, 34243
- Rekruttering
- Sarasota Memorial Health Care Centre
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Kontakt:
- Beverly Long
- Telefonnummer: 941-917-2225
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Venice, Florida, Forenede Stater, 34275
- Rekruttering
- Florida Cancer Specialists - Venice Pinebrook
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Kontakt:
- Beverly Long
- Telefonnummer: 941-917-2225
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Georgia
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Atlanta, Georgia, Forenede Stater, 30303
- Rekruttering
- Grady Health System
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Kontakt:
- Jill Remick
- Telefonnummer: 404-778-1900
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Atlanta, Georgia, Forenede Stater, 30308
- Rekruttering
- Emory University Hospital Midtown
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Kontakt:
- Jill Remick
- Telefonnummer: 404-778-1900
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Atlanta, Georgia, Forenede Stater, 30309
- Rekruttering
- Piedmont Hospital
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Kontakt:
- Leda Gattoc
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Atlanta, Georgia, Forenede Stater, 30322
- Rekruttering
- Emory University Hospital Winship Cancer Institute
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Kontakt:
- Jill Remick
- Telefonnummer: 404-778-1900
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Atlanta, Georgia, Forenede Stater, 30342
- Rekruttering
- Emory Saint Josephs Hospital
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Kontakt:
- Jill Remick
- Telefonnummer: 404-778-1900
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Decatur, Georgia, Forenede Stater, 30033
- Rekruttering
- Emory Decatur Hospital
-
Kontakt:
- Jill Remick
- Telefonnummer: 404-778-1900
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Illinois
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Chicago, Illinois, Forenede Stater, 60611
- Rekruttering
- Northwestern University
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Kontakt:
- Dario Roque
- Telefonnummer: 312-695-0990
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Orland Park, Illinois, Forenede Stater, 60462
- Rekruttering
- Northwestern Medicine Orland Park
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Kontakt:
- Dario Roque
- Telefonnummer: 312-695-0990
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Warrenville, Illinois, Forenede Stater, 60555
- Rekruttering
- Northwestern Medicine Cancer Center Warrenville
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Kontakt:
- Dario Roque
- Telefonnummer: 312-695-0990
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Indiana
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Indianapolis, Indiana, Forenede Stater, 46260
- Rekruttering
- Ascension Saint Vincent Indianapolis Hospital
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Kontakt:
- Megan Buechel
- Telefonnummer: 317-415-6740
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Kentucky
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Louisville, Kentucky, Forenede Stater, 40202
- Rekruttering
- Norton Hospital Pavilion and Medical Campus
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Kontakt:
- Monica Vetter
- Telefonnummer: 502-899-3366
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Louisville, Kentucky, Forenede Stater, 40207
- Rekruttering
- Norton Suburban Hospital and Medical Campus
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Kontakt:
- Monica Vetter
- Telefonnummer: 502-899-3366
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Louisiana
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New Orleans, Louisiana, Forenede Stater, 70112
- Rekruttering
- University Medical Center New Orleans
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Kontakt:
- Tara Castellano
- Telefonnummer: 504-210-3539
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02114
- Rekruttering
- Massachusetts General Hospital Cancer Center
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Kontakt:
- Andrea Russo
- Telefonnummer: 617-726-7941
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Springfield, Massachusetts, Forenede Stater, 01199
- Rekruttering
- Baystate Medical Center
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Kontakt:
- Tashanna Myers
- Telefonnummer: 413-974-3565
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Worcester, Massachusetts, Forenede Stater, 01605
- Rekruttering
- UMass Memorial Medical Centre
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Kontakt:
- Susan Zweizig
- Telefonnummer: 508-856-6265
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Minnesota
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Coon Rapids, Minnesota, Forenede Stater, 55433
- Rekruttering
- Mercy Hospital
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Kontakt:
- Annie Tan
- Telefonnummer: 952-993-1517
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Missouri
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St Louis, Missouri, Forenede Stater, 63110
- Rekruttering
- Washington University School of Medicine
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Kontakt:
- Premal Thaker
- Telefonnummer: 314-747-3604
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Nebraska
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Omaha, Nebraska, Forenede Stater, 68114
- Rekruttering
- Nebraska Methodist Hospital
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Kontakt:
- Brent Tierney
- Telefonnummer: 402-354-5144
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Nevada
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Las Vegas, Nevada, Forenede Stater, 89106
- Rekruttering
- Womens Cancer Center of Nevada
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Kontakt:
- Nicola Spirtos
- Telefonnummer: 702-851-4672
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New Jersey
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Sewell, New Jersey, Forenede Stater, 08080
- Rekruttering
- Sidney Kimmel Cancer Center Washington Township
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Kontakt:
- Mitchell Edelson
- Telefonnummer: 215-481-4000
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New York
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Buffalo, New York, Forenede Stater, 14263
- Rekruttering
- Roswell Park Cancer Institute
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Kontakt:
- Emese Zsiros
- Telefonnummer: 716-845-8337
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New York, New York, Forenede Stater, 10011
- Rekruttering
- Mount Sinai Chelsea
-
Kontakt:
- Caitlin Carr
- Telefonnummer: 212-824-7309
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New York, New York, Forenede Stater, 10029
- Rekruttering
- Mount Sinai Hospital
-
Kontakt:
- Caitlin Carr
- Telefonnummer: 212-824-7309
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Oswego, New York, Forenede Stater, 13126
- Rekruttering
- Upstate Cancer Center Radiation Oncology at Oswego
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Kontakt:
- Mary Cunningham
- Telefonnummer: 315-634-4112
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Syracuse, New York, Forenede Stater, 13210
- Rekruttering
- Upstate Cancer Center at Hill Radiation Oncology
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Kontakt:
- Mary Cunningham
- Telefonnummer: 315-634-4112
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Syracuse, New York, Forenede Stater, 13210
- Rekruttering
- State University of New York
-
Kontakt:
- Mary Cunningham
- Telefonnummer: 315-634-4112
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Verona, New York, Forenede Stater, 13478
- Rekruttering
- Upstate Cancer Center at Verona
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Kontakt:
- Mary Cunningham
- Telefonnummer: 315-634-4112
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North Carolina
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Chapel Hill, North Carolina, Forenede Stater, 27599
- Rekruttering
- UNC Lineberger Comprehensive Cancer Center
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Kontakt:
- Olivia Lara
- Telefonnummer: 877-668-0683
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Durham, North Carolina, Forenede Stater, 27710
- Rekruttering
- Duke University Medical Center
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Kontakt:
- Angeles Secord
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Raleigh, North Carolina, Forenede Stater, 27607
- Rekruttering
- Duke Womens Cancer Care Raleigh
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Kontakt:
- Angeles Secord
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Ohio
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Beachwood, Ohio, Forenede Stater, 44122
- Rekruttering
- UHHS-Chagrin Highlands Medical Center
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Kontakt:
- Sarah Lynam
- Telefonnummer: 216-844-3954
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Chardon, Ohio, Forenede Stater, 44024
- Rekruttering
- Geauga Hospital
-
Kontakt:
- Sarah Lynam
- Telefonnummer: 216-844-3954
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Cleveland, Ohio, Forenede Stater, 44106
- Rekruttering
- Case Western Reserve University
-
Kontakt:
- Sarah Lynam
- Telefonnummer: 216-844-3954
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Columbus, Ohio, Forenede Stater, 43210
- Rekruttering
- Ohio State University Comprehensive
-
Kontakt:
- Casey Cosgrove
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Mentor, Ohio, Forenede Stater, 44060
- Rekruttering
- UH Seidman Cancer Center
-
Kontakt:
- Sarah Lynam
- Telefonnummer: 216-844-3954
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Parma, Ohio, Forenede Stater, 44129
- Rekruttering
- University Hospitals Parma Medical Center
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Kontakt:
- Sarah Lynam
- Telefonnummer: 216-844-3954
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Westlake, Ohio, Forenede Stater, 44145
- Rekruttering
- UH Seidman Cancer Center
-
Kontakt:
- Sarah Lynam
- Telefonnummer: 216-844-3954
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Oklahoma
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Oklahoma City, Oklahoma, Forenede Stater, 73104
- Rekruttering
- University of Oklahoma Health Sciences Center
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Kontakt:
- Christina Washington
- Telefonnummer: 405-271-8777
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Oregon
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Portland, Oregon, Forenede Stater, 97225
- Rekruttering
- Providence Saint Vincent Medical Center
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Kontakt:
- Alison Conlin
- Telefonnummer: 503-215-6259
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Portland, Oregon, Forenede Stater, 97213
- Rekruttering
- Providence Portland Medical Centre
-
Kontakt:
- Alison Conlin
- Telefonnummer: 503-215-6259
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Pennsylvania
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Hershey, Pennsylvania, Forenede Stater, 17033
- Rekruttering
- Penn State Milton S Hershey Medical Center
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Kontakt:
- Shaina Bruce
- Telefonnummer: 717-531-3779
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Paoli, Pennsylvania, Forenede Stater, 19301
- Rekruttering
- Paoli Memorial Hospital
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Kontakt:
- Paul Gilman
- Telefonnummer: 484-476-2649
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Philadelphia, Pennsylvania, Forenede Stater, 19107
- Rekruttering
- Thomas Jefferson University
-
Kontakt:
- Mitchell Edelson
- Telefonnummer: 215-481-4000
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Willow Grove, Pennsylvania, Forenede Stater, 19090
- Rekruttering
- Asplundh Cancer Pavilion
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Kontakt:
- Mitchell Edelson
- Telefonnummer: 215-481-4000
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Wynnewood, Pennsylvania, Forenede Stater, 19096
- Rekruttering
- Lankenau Medical Center
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Kontakt:
- Paul Gilman
- Telefonnummer: 484-476-2649
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Rhode Island
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Providence, Rhode Island, Forenede Stater, 02905
- Rekruttering
- Women and Infants Hospital
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Kontakt:
- Matthew Oliver
- Telefonnummer: 48181 401-274-1122
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Texas
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Houston, Texas, Forenede Stater, 77030
- Rekruttering
- M.D. Anderson Cancer Center
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Kontakt:
- Ann Klopp
- Telefonnummer: 713-563-2444
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Utah
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Farmington, Utah, Forenede Stater, 84025
- Rekruttering
- Farmington Health Centre
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Kontakt:
- Cristina DeCesaris
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Salt Lake City, Utah, Forenede Stater, 84112
- Rekruttering
- Huntsman Cancer Institute University of Utah
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Kontakt:
- Cristina DeCesaris
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Salt Lake City, Utah, Forenede Stater, 84106
- Rekruttering
- University of Utah Sugarhouse Health Centre
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Kontakt:
- Cristina DeCesaris
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Vermont
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Burlington, Vermont, Forenede Stater, 05401
- Rekruttering
- University of Vermont Medical Center
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Kontakt:
- Puyao Li
- Telefonnummer: 802-656-8990
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Burlington, Vermont, Forenede Stater, 05405
- Rekruttering
- University of Vermont and State Agricultural College
-
Kontakt:
- Puyao Li
- Telefonnummer: 802-656-8990
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Virginia
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Charlottesville, Virginia, Forenede Stater, 22908
- Rekruttering
- University of Virginia Cancer Center
-
Kontakt:
- Kara Romano
- Telefonnummer: 434-924-5191
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Richmond, Virginia, Forenede Stater, 23298
- Rekruttering
- Virginia Commonwealth University
-
Kontakt:
- Emma Fields
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Washington
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Seattle, Washington, Forenede Stater, 98122
- Rekruttering
- Swedish Medical Center First Hill
-
Kontakt:
- Charles Drescher
- Telefonnummer: 206-991-2000
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Wisconsin
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Green Bay, Wisconsin, Forenede Stater, 54301
- Rekruttering
- Saint Vincent Hospital Cancer Center Green Bay
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Kontakt:
- Matthew Ryan
- Telefonnummer: 920-884-3135
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Milwaukee, Wisconsin, Forenede Stater, 53226
- Rekruttering
- Medical College of Wisconsin
-
Kontakt:
- William Bradley
- Telefonnummer: 414-805-6600
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-
-
-
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Paris, Frankrig, 75012
- Rekruttering
- Groupe Hospitalier Diaconesses Croix Saint-Simon
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Kontakt:
- Frederic Selle
- Telefonnummer: 33 144-6437
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Auvergne-Rhône-Alpes
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Lyon, Auvergne-Rhône-Alpes, Frankrig, 69008
- Rekruttering
- Centre Leon Berard
-
Kontakt:
- Olivia Le Saux
- Telefonnummer: 47 878-2828
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FR
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Villejuif, FR, Frankrig, 94805
- Rekruttering
- Institut Gustave-Roussy
-
Kontakt:
- Alexandra Leary
- Telefonnummer: 11 33 142-1142
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Nord
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Lille, Nord, Frankrig, 59000
- Rekruttering
- Centre Oscar Lambret
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Kontakt:
- Abel Cardoba Largo
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Occitanie
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Toulouse, Occitanie, Frankrig, 31100
- Rekruttering
- Institut Universitaire du Cancer de Toulouse - IUCT
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Kontakt:
- Laurence Gladieff
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-
-
-
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Leiden, Holland, 2333ZA
- Rekruttering
- Leiden University Medical Center (LUMC)
-
Kontakt:
- Stephanie De Boer
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Rotterdam, Holland
- Rekruttering
- Erasmus Medical Center (EMC)
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Kontakt:
- Henrieke Westerveld
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Gelderland
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Arnhem, Gelderland, Holland, 6815AD
- Rekruttering
- Radiotherapiegroep
-
Kontakt:
- Dorien Haverkort
- Telefonnummer: 318 877-9000
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Limburg
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Maastricht, Limburg, Holland, 6229ET
- Rekruttering
- Maastro clinic (Maastricht UMC)
-
Kontakt:
- Nienke Kuijsters
- Telefonnummer: 31 088-4456
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North Brabant
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Eindhoven, North Brabant, Holland, 5623 EJ
- Rekruttering
- Catharina ziekenhuis
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Kontakt:
- Bastiaan Wortman
- Telefonnummer: 40 239-9111
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South Holland
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The Hague, South Holland, Holland, 432
- Rekruttering
- MC Haaglanden
-
Kontakt:
- Mandy Kiderlen
- Telefonnummer: 3 889-7979
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-
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-
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Brescia, Italien, 25123
- Rekruttering
- ASST Spedali Civili Brescia
-
Kontakt:
- Germana Tognon
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Lecco, Italien, 23900
- Rekruttering
- ASST Lecco
-
Kontakt:
- Romerai D'Amico
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Milan, Italien, 20141
- Rekruttering
- European Institute of Oncology
-
Kontakt:
- Ilaria Betella
- Telefonnummer: 39 025-7489
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Rome, Italien, 00161
- Rekruttering
- Policlinico Umberto I, Universita Sapienza
-
Kontakt:
- Federica Tomao
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Florence
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Florence, Florence, Italien, 50134
- Rekruttering
- Policliico Careggi
-
Kontakt:
- Maria Cristina Petrella
-
-
-
-
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Auckland, New Zealand, 1023
- Rekruttering
- Auckland City Hospital
-
Kontakt:
- Ruth Angell
-
Christchurch, New Zealand, 8140
- Rekruttering
- Christchurch Hospital
-
Kontakt:
- Bryony Simcock
-
-
-
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Ullernchausseen 70
-
Oslo, Ullernchausseen 70, Norge, 0379
- Rekruttering
- Oslo University Hospital
-
Kontakt:
- Kristina Lindemann
- Telefonnummer: 2 293-4983
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-
-
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Baden-Wurttemberg
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Schwäbisch Hall, Baden-Wurttemberg, Tyskland, 74523
- Rekruttering
- Diak Klinikum Landkreis Schwaebisch Hall
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Kontakt:
- Stefan Kommoss
-
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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
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
Inclusion Criteria:
- Patients must have had surgery consisting of hysterectomy and bilateral salpingo-oophorectomy. Lymph node dissection can be performed as per institutional standards. There must be no macroscopic residual disease after surgery.
- Patients must have histologically confirmed Stage I to III endometrial carcinoma which can be endometrioid, serous, clear cell, un/dedifferentiated, carcinosarcoma or mixed.
- Patients' Eastern Cooperative Group (ECOG) performance status must be 0, 1, or 2.
- HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
- Patients' age must be ≥ 18 years.
- Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements.
- Patient is able (i.e. sufficiently fluent) and willing to complete the patient-reported outcomes (PRO) questionnaires in either English, French or a validated language
- Patients must be accessible for treatment and follow-up. Patients enrolled on this trial must be treated and followed at the participating centre
- Protocol treatment is to begin within 10 weeks of hysterectomy/bilateral salpingo-oophorectomy
Exclusion Criteria:
- Prior Neoadjuvant chemotherapy for current endometrial cancer diagnosis.
- Prior pelvic radiation.
- Patients with a history of other malignancies, except: carcinoma in-situ without evidence of invasive disease when resected, adequately treated non-melanoma skin cancer, or other tumours curatively treated with no evidence of disease for ≥ 5 years.
- Clinical evidence of distant metastasis as determined by pre-surgical or post-surgical imaging (CT scan of chest, abdomen and pelvis or whole-body PET-CT scan)
- Patients with a documented positive surgical margin.
- Patients with a documented positive peritoneal washings, if performed.
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: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Antal våben
3
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
|
Eksperimentel: Sub-study A: RAINBO BLUE Cohort A1
Observation |
Observation |
|
Eksperimentel: Sub-Study A: RAINBO BLUE Cohort A2
Observation or Adjuvant Radiotherapy |
Observation Treatment is to be delivered using 4-18 MV photons. MV, kV or CBCT imaging capabilities are required. Planning systems with capability for DICOM data transfer must be used. |
|
Eksperimentel: Sub-Study B: TAPER
Observation or Vaginal Brachytherapy |
Observation Vaginal brachytherapy should be delivered using a vaginal cylinder, or alternatively ovoids |
Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Estimer frekvensen af tilbagefald af bækken efter 3 år hos patienter, der behandles med deeskaleret adjuverende behandling styret af tumormolekylær status
Tidsramme: 3 år
|
3 år
|
Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Estimer antallet af isoleret vaginalt tilbagefald efter 3 år
Tidsramme: 3 år
|
3 år
|
|
Estimer frekvensen af para-aorta-tilbagefald til 3 år
Tidsramme: 3 år
|
3 år
|
|
Estimer frekvensen af fjernmetastaser ved 3 år
Tidsramme: 3 år
|
3 år
|
|
Estimer gentagelsesfri overlevelse
Tidsramme: 9 år
|
9 år
|
|
Estimer endometriecancer-specifik overlevelse
Tidsramme: 9 år
|
9 år
|
|
Estimer den samlede overlevelse
Tidsramme: 9 år
|
9 år
|
|
Beskriv indvirkningen af molekylær klassificering på frygt for gentagelse ved Fear of Recidiv Inventory
Tidsramme: 9 år
|
9 år
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Sponsor
Samarbejdspartnere
Samarbejdspartnere
Efterforskere
Efterforskere
- Studiestol: Kathy Han, University Health Network, Princess Margaret Hospital, Toronto ON Canada
- Studiestol: Jessica McAlpine, BCCA-Vancouver Cancer Centre, Vancouver BC Canada
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
Studiestart
19. december 2022
Primær færdiggørelse (Anslået)
Primær færdiggørelse
31. december 2028
Studieafslutning (Anslået)
Studieafslutning
30. juni 2029
Datoer for studieregistrering
Først indsendt
Først indsendt
29. november 2022
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
29. november 2022
Først opslået (Faktiske)
Først opslået
7. december 2022
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
14. oktober 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
13. oktober 2026
Sidst verificeret
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Urogenitale sygdomme
- Genitale sygdomme
- Urogenitale neoplasmer
- Neoplasmer efter sted
- Neoplasmer
- Urogenitale sygdomme hos kvinder
- Kvinders urogenitale sygdomme og graviditetskomplikationer
- Livmodersygdomme
- Kønssygdomme, kvindelige
- Genitale neoplasmer, kvindelige
- Uterine neoplasmer
- Endometriale neoplasmer
- Undersøgelsesteknikker
- Metoder
- Terapeutik
- Strålebehandling
- Kombineret modalitetsterapi
- Observation
- Strålebehandling, adjuvans
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- EN10
- NRG-GY032 (Anden identifikator: NRG)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ja
produkt fremstillet i og eksporteret fra U.S.A.
Ingen
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 .