Radiation Therapy in Treating Patients With Stage II Cancer of the Vocal Cord
30 dicembre 2016 aggiornato da: Radiation Therapy Oncology Group
A RANDOMIZED STUDY OF HYPERFRACTIONATION VERSUS CONVENTIONAL FRACTIONATION IN T2 SQUAMOUS CELL CARCINOMA OF THE VOCAL CORD
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which radiation therapy regimen is more effective in treating patients with stage II cancer of the vocal cord.
PURPOSE: Randomized phase III trial to compare two regimens of radiation therapy in treating patients who have stage II cancer of the vocal cord.
Panoramica dello studio
Descrizione dettagliata
OBJECTIVES:
- Compare the local response rate in patients with stage II invasive squamous cell carcinoma of the true vocal cord treated with hyperfractionation vs conventional fractionation radiotherapy.
- Compare the acute and late toxic effects of these regimens in this patient population.
- Compare the overall and disease-free survival patterns in this patient population treated with these regimens.
OUTLINE: This is a randomized study. Patients are stratified according to substage (T2a vs T2b). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo conventional radiotherapy 5 days a week for 5 weeks followed by boost radiotherapy 5 days a week for 2 weeks.
- Arm II: Patients undergo hyperfractionation radiotherapy 5 days a week for 5 weeks followed by boost radiotherapy 5 days a week for 1.6 weeks.
Patients with biopsy-proven persistent disease at least 6 weeks after completion of radiotherapy undergo salvage surgery with neck dissection (at the discretion of the surgeon).
Patients are followed at 4 weeks, every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 240 patients will be accrued for this study within 3.2 years.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
250
Fase
- Fase 3
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Alberta
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Calgary, Alberta, Canada, T2N 4N2
- Tom Baker Cancer Center - Calgary
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Edmonton, Alberta, Canada, T6G 1Z2
- Cross Cancer Institute
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New Brunswick
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Saint John, New Brunswick, Canada, E2L 4L2
- Saint John Regional Hospital
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Newfoundland and Labrador
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St. Johns, Newfoundland and Labrador, Canada, A1B 3V6
- Newfoundland Cancer Treatment and Research Foundation
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 1V7
- Nova Scotia Cancer Centre
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Ontario
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Hamilton, Ontario, Canada, L8V 5C2
- Cancer Care Ontario-Hamilton Regional Cancer Centre
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Kingston, Ontario, Canada, K7L 5P9
- Kingston Regional Cancer Centre
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London, Ontario, Canada, N6A 4L6
- Cancer Care Ontario-London Regional Cancer Centre
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Ottawa, Ontario, Canada, K1H 1C4
- Ottawa Regional Cancer Centre
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Sudbury, Ontario, Canada, P3E 5J1
- Northeastern Ontario Regional Cancer Centre, Sudbury
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Thunder Bay, Ontario, Canada, P7A 7T1
- Northwestern Ontario Regional Cancer Centre, Thunder Bay
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Toronto, Ontario, Canada, M4N 3M5
- Toronto Sunnybrook Regional Cancer Centre
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Toronto, Ontario, Canada, M5G 2M9
- Princess Margaret Hospital
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Quebec
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Fleurimont, Quebec, Canada, J1H 5N4
- CHUS-Hopital Fleurimont
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Montreal, Quebec, Canada, H2W 1S6
- McGill University
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Montreal, Quebec, Canada, H2L 4MI
- Centre Hospitalier de l'Université de Montréal
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Quebec City, Quebec, Canada, G1R 2J6
- Centre Hospitalier Universitaire de Quebec
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Saskatchewan
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Regina, Saskatchewan, Canada, S4T 7T1
- Allan Blair Cancer Centre
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Saskatoon, Saskatchewan, Canada, S7N 4H4
- Saskatoon Cancer Centre
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Alabama
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Birmingham, Alabama, Stati Uniti, 35294-3300
- University of Alabama at Birmingham Comprehensive Cancer Center
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Huntsville, Alabama, Stati Uniti, 35801
- Comprehensive Cancer Institute of Huntsville
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Huntsville, Alabama, Stati Uniti, 35807
- Huntsville Hospital System
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Mobile, Alabama, Stati Uniti, 36688
- MBCCOP - Gulf Coast
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Montgomery, Alabama, Stati Uniti, 36106-3657
- Alabama Oncology, LLC
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Tuscaloosa, Alabama, Stati Uniti, 35401
- DCH Cancer Treatment Center
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Arizona
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Phoenix, Arizona, Stati Uniti, 85013
- Foundation for Cancer Research and Education
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California
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Concord, California, Stati Uniti, 94524-4110
- Mount Diablo Medical Center
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Duarte, California, Stati Uniti, 91010-3000
- City of Hope Comprehensive Cancer Center
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Fresno, California, Stati Uniti, 93720
- Saint Agnes Cancer Center
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Fresno, California, Stati Uniti, 93729-5100
- California Cancer Center
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Greenbrae, California, Stati Uniti, 94904
- Sutter Health West Cancer Research Group
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Loma Linda, California, Stati Uniti, 92354
- Loma Linda University Medical Center
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Long Beach, California, Stati Uniti, 90822
- Veterans Affairs Medical Center - Long Beach
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Los Angeles, California, Stati Uniti, 90033-0804
- USC/Norris Comprehensive Cancer Center and Hospital
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Los Angeles, California, Stati Uniti, 90025-1781
- Jonsson Comprehensive Cancer Center, UCLA
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Oakland, California, Stati Uniti, 94609-3305
- CCOP - Bay Area Tumor Institute
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Pasadena, California, Stati Uniti, 91105
- Huntington Cancer Center
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Pomona, California, Stati Uniti, 91767
- Robert and Beverly Lewis Family Cancer Care Center
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Sacramento, California, Stati Uniti, 95816
- Radiation Oncology Center - Sacramento
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San Diego, California, Stati Uniti, 92101
- Radiation Medical Group, Incorporated
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San Francisco, California, Stati Uniti, 94143-0128
- UCSF Comprehensive Cancer Center
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San Jose, California, Stati Uniti, 95128
- O'Connor Hospital
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Santa Rosa, California, Stati Uniti, 95403
- CCOP - Santa Rosa Memorial Hospital
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Travis Air Force Base, California, Stati Uniti, 94535
- David Grant Medical Center
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Colorado
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Colorado Springs, Colorado, Stati Uniti, 80909
- Memorial Hospital Cancer Center
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Denver, Colorado, Stati Uniti, 80010
- University of Colorado Cancer Center
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Denver, Colorado, Stati Uniti, 80224
- CCOP - Colorado Cancer Research Program, Incorporated
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Grand Junction, Colorado, Stati Uniti, 81502-1628
- Saint Mary's Hospital and Medical Center
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Connecticut
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New Haven, Connecticut, Stati Uniti, 06511
- Hospital of St. Raphael
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Delaware
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Newark, Delaware, Stati Uniti, 19713
- CCOP - Christiana Care Health Services
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Florida
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Gainesville, Florida, Stati Uniti, 32610-0385
- University of Florida Health Science Center
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Jacksonville, Florida, Stati Uniti, 32207
- Florida Radiation Oncology Group
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Melbourne, Florida, Stati Uniti, 32901-3276
- Holmes Regional Medical Center
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Miami, Florida, Stati Uniti, 33136
- Sylvester Cancer Center, University of Miami
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Miami, Florida, Stati Uniti, 33125
- Veterans Affairs Medical Center - Miami
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Miami, Florida, Stati Uniti, 33256-2110
- Baptist Hospital of Miami
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Miami Beach, Florida, Stati Uniti, 33140
- CCOP - Mount Sinai Medical Center
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Orlando, Florida, Stati Uniti, 32806-2134
- MD Anderson Cancer Center Orlando
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Panama City, Florida, Stati Uniti, 32405-4587
- Gulf Coast Cancer Treatment Center
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Panama City, Florida, Stati Uniti, 32401
- Bay Medical Center
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Sarasota, Florida, Stati Uniti, 34233
- Sarasota Radiation and Medical Oncology Center
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Tallahassee, Florida, Stati Uniti, 32308
- Tallahassee Memorial HealthCare
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Tampa, Florida, Stati Uniti, 33612-9497
- H. Lee Moffitt Cancer Center and Research Institute
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Georgia
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Atlanta, Georgia, Stati Uniti, 30322
- Emory University Hospital - Atlanta
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Atlanta, Georgia, Stati Uniti, 30342-1701
- CCOP - Atlanta Regional
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Columbus, Georgia, Stati Uniti, 31901
- Medical Center/John B. Amos Community Cancer Center
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Rome, Georgia, Stati Uniti, 30165
- Regional Radiation Oncology Center at Rome
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Hawaii
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Honolulu, Hawaii, Stati Uniti, 96813
- MBCCOP - Hawaii
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Illinois
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Arlington Heights, Illinois, Stati Uniti, 60005
- Northwest Community Hospital
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Chicago, Illinois, Stati Uniti, 60611
- Northwestern Memorial Hospital
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Decatur, Illinois, Stati Uniti, 62526
- CCOP - Central Illinois
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Harvey, Illinois, Stati Uniti, 60426
- Ingalls Memorial Hospital
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Maywood, Illinois, Stati Uniti, 60153
- Loyola University Medical Center
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Park Ridge, Illinois, Stati Uniti, 60068
- Lutheran General Cancer Care Center
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Peoria, Illinois, Stati Uniti, 61636
- Methodist Medical Center of Illinois
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Indiana
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Anderson, Indiana, Stati Uniti, 46016
- St. John's Medical Center
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Bloomington, Indiana, Stati Uniti, 47402
- Bloomington Hospital
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Indianapolis, Indiana, Stati Uniti, 46202
- Veterans Affairs Medical Center - Indianapolis (Roudebush)
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Indianapolis, Indiana, Stati Uniti, 46206-1367
- Clarian Health Partners Inc.
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Indianapolis, Indiana, Stati Uniti, 46219
- Community Regional Cancer Care
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Muncie, Indiana, Stati Uniti, 47303-3499
- Ball Memorial Hospital
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South Bend, Indiana, Stati Uniti, 46601
- CCOP - Northern Indiana CR Consortium
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Iowa
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Dubuque, Iowa, Stati Uniti, 52001
- Wendt Regional Cancer Center of Finley Hospital
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Kentucky
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Lexington, Kentucky, Stati Uniti, 40536-0084
- Albert B. Chandler Medical Center, University of Kentucky
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Lexington, Kentucky, Stati Uniti, 40503
- Central Baptist Hospital
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Louisville, Kentucky, Stati Uniti, 40202
- James Graham Brown Cancer Center
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Louisville, Kentucky, Stati Uniti, 40215
- Louisville Radiation Oncology
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Madisonville, Kentucky, Stati Uniti, 42431
- Merle M. Mahr Cancer Center
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Louisiana
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Baton Rouge, Louisiana, Stati Uniti, 70809
- Mary Bird Perkins Cancer Center
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New Orleans, Louisiana, Stati Uniti, 70121
- CCOP - Ochsner
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New Orleans, Louisiana, Stati Uniti, 70112
- MBCCOP - LSU Health Sciences Center
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New Orleans, Louisiana, Stati Uniti, 70112-2699
- Tulane University School of Medicine
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Maine
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Portland, Maine, Stati Uniti, 04102
- Maine Medical Center
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Maryland
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Annapolis, Maryland, Stati Uniti, 21401
- Anne Arundel Oncology Center
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Baltimore, Maryland, Stati Uniti, 21231-2410
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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Baltimore, Maryland, Stati Uniti, 21215
- Sinai Hospital of Baltimore
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Baltimore, Maryland, Stati Uniti, 21201
- Marlene and Stewart Greenebaum Cancer Center, University of Maryland
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Baltimore, Maryland, Stati Uniti, 21204
- Greater Baltimore Medical Center and Cancer Center
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Baltimore, Maryland, Stati Uniti, 21215-1290
- Harbor Hospital Center
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Salisbury, Maryland, Stati Uniti, 21801
- Peninsula Regional Medical Center
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Massachusetts
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Boston, Massachusetts, Stati Uniti, 02115
- Dana-Farber Cancer Institute
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Hyannis, Massachusetts, Stati Uniti, 02601
- Cape Cod Hospital
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Jamaica Plain, Massachusetts, Stati Uniti, 02130
- Veterans Affairs Medical Center - Boston (Jamaica Plain)
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Michigan
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Ann Arbor, Michigan, Stati Uniti, 48106
- CCOP - Michigan Cancer Research Consortium
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Ann Arbor, Michigan, Stati Uniti, 48109-0010
- University Of Michigan Comprehensive Cancer Center
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Detroit, Michigan, Stati Uniti, 48202
- Henry Ford Hospital
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Detroit, Michigan, Stati Uniti, 48201-1379
- Barbara Ann Karmanos Cancer Institute
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Flint, Michigan, Stati Uniti, 48503
- Hurley Medical Center
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Flint, Michigan, Stati Uniti, 48532-3685
- McLaren Regional Cancer Center
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Kalamazoo, Michigan, Stati Uniti, 49007-3731
- CCOP - Kalamazoo
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Marquette, Michigan, Stati Uniti, 49855
- Marquette General Hospital
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Midland, Michigan, Stati Uniti, 48670
- MidMichigan Medical Center - Midland
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Royal Oak, Michigan, Stati Uniti, 48073-6769
- CCOP - Beaumont
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Royal Oak, Michigan, Stati Uniti, 48073
- William Beaumont Hospital
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Troy, Michigan, Stati Uniti, 48098
- William Beaumont Hospital - Troy
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Minnesota
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Rochester, Minnesota, Stati Uniti, 55905
- Mayo Clinic Cancer Center
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Saint Louis Park, Minnesota, Stati Uniti, 55416
- CCOP - Metro-Minnesota
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Missouri
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Columbia, Missouri, Stati Uniti, 65203
- Ellis Fischel Cancer Center - Columbia
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Kansas City, Missouri, Stati Uniti, 64131
- CCOP - Kansas City
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Saint Louis, Missouri, Stati Uniti, 63110-0250
- St. Louis University Health Sciences Center
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Saint Louis, Missouri, Stati Uniti, 63108
- Mallinckrodt Institute of Radiology
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Springfield, Missouri, Stati Uniti, 65807
- CCOP - Cancer Research for the Ozarks
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Springfield, Missouri, Stati Uniti, 65807
- Cancer Research for the Ozarks
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Montana
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Billings, Montana, Stati Uniti, 59101
- CCOP - Montana Cancer Consortium
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Nebraska
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Omaha, Nebraska, Stati Uniti, 68106
- CCOP - Missouri Valley Cancer Consortium
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Omaha, Nebraska, Stati Uniti, 68114
- Methodist Hospital Cancer Center - Omaha
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Omaha, Nebraska, Stati Uniti, 68198-7460
- Nebraska Health System
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Nevada
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Las Vegas, Nevada, Stati Uniti, 89106
- CCOP - Southern Nevada Cancer Research Foundation
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New Hampshire
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Lebanon, New Hampshire, Stati Uniti, 03756-0002
- Norris Cotton Cancer Center
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Manchester, New Hampshire, Stati Uniti, 03103
- Elliot Regional Cancer Center
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New Jersey
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East Orange, New Jersey, Stati Uniti, 07019
- Veterans Affairs Medical Center - East Orange
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Edison, New Jersey, Stati Uniti, 08818
- John F. Kennedy Medical Center
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Elizabeth, New Jersey, Stati Uniti, 07201
- Trinitas Hospital - Jersey Street Campus
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Long Branch, New Jersey, Stati Uniti, 07740-6395
- Monmouth Medical Center
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Millville, New Jersey, Stati Uniti, 08332
- South Jersey Regional Cancer Center
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Mount Holly, New Jersey, Stati Uniti, 08060
- Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital
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New Brunswick, New Jersey, Stati Uniti, 38103-2807
- Cancer Institute Of New Jersey
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Newark, New Jersey, Stati Uniti, 07112
- Newark Beth Israel Medical Center
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Pomona, New Jersey, Stati Uniti, 08240
- Atlantic City Medical Center
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Ridgewood, New Jersey, Stati Uniti, 07450
- Valley Hospital
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Toms River, New Jersey, Stati Uniti, 08755
- Community Medical Center
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Trenton, New Jersey, Stati Uniti, 08629
- St. Francis Medical Center
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Warren, New Jersey, Stati Uniti, 07059
- Associated Radiologists, P.A.
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New Mexico
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Albuquerque, New Mexico, Stati Uniti, 87109
- Radiation Oncology Associates of Albuquerque
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New York
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Albany, New York, Stati Uniti, 12208
- Cancer Center of Albany Medical Center
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Brooklyn, New York, Stati Uniti, 11203
- State University of New York Health Science Center at Brooklyn
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Brooklyn, New York, Stati Uniti, 11215
- New York Methodist Hospital
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Buffalo, New York, Stati Uniti, 14263-0001
- Roswell Park Cancer Institute
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Clifton Springs, New York, Stati Uniti, 14432
- Finger Lakes Radiation Oncology Center
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Manhasset, New York, Stati Uniti, 11030
- CCOP - North Shore University Hospital
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New York, New York, Stati Uniti, 10032
- Herbert Irving Comprehensive Cancer Center
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Plattsburgh, New York, Stati Uniti, 12901
- Champlain Valley Physicians Hospital Medical Center
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Poughkeepsie, New York, Stati Uniti, 12601
- Vassar Brothers Medical Center
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Rochester, New York, Stati Uniti, 14642
- James P. Wilmot Cancer Center
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Syracuse, New York, Stati Uniti, 13217
- CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
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Yonkers, New York, Stati Uniti, 10701
- Riverhill Radiation Oncology
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North Carolina
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Chapel Hill, North Carolina, Stati Uniti, 27599-7295
- Lineberger Comprehensive Cancer Center, UNC
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Concord, North Carolina, Stati Uniti, 28025
- Northeast Medical Center
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Greenville, North Carolina, Stati Uniti, 27858-4354
- East Carolina University School of Medicine
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Winston-Salem, North Carolina, Stati Uniti, 27104-4241
- CCOP - Southeast Cancer Control Consortium
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Winston-Salem, North Carolina, Stati Uniti, 27157-1082
- Comprehensive Cancer Center at Wake Forest University
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North Dakota
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Minot, North Dakota, Stati Uniti, 58701
- Trinity Cancer Care Center
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Ohio
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Akron, Ohio, Stati Uniti, 44302
- Akron General Medical Center
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Akron, Ohio, Stati Uniti, 44304
- Akron City Hospital
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Cincinnati, Ohio, Stati Uniti, 45219
- Christ Hospital
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Cincinnati, Ohio, Stati Uniti, 45267-0502
- Barrett Cancer Center
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Cleveland, Ohio, Stati Uniti, 44195
- Cleveland Clinic Taussig Cancer Center
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Cleveland, Ohio, Stati Uniti, 44106
- University Hospitals of Cleveland
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Cleveland, Ohio, Stati Uniti, 44106-5065
- Ireland Cancer Center
-
Columbus, Ohio, Stati Uniti, 43210-1240
- Arthur G. James Cancer Hospital - Ohio State University
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Columbus, Ohio, Stati Uniti, 43206
- CCOP - Columbus
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Dayton, Ohio, Stati Uniti, 45429
- CCOP - Dayton
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Toledo, Ohio, Stati Uniti, 43623-3456
- CCOP - Toledo Community Hospital
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Oklahoma
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Oklahoma City, Oklahoma, Stati Uniti, 73104
- University of Oklahoma Health Sciences Center
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Oklahoma City, Oklahoma, Stati Uniti, 73101
- St. Anthony Hospital
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Tulsa, Oklahoma, Stati Uniti, 74136
- CCOP - Oklahoma
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Tulsa, Oklahoma, Stati Uniti, 74104
- St. John Health System
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Oregon
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Portland, Oregon, Stati Uniti, 97225
- CCOP - Columbia River Program
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Pennsylvania
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Allentown, Pennsylvania, Stati Uniti, 18105
- LeHigh Valley Hospital
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Bethlehem, Pennsylvania, Stati Uniti, 18015
- St. Luke's Hospital Cancer Center
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Danville, Pennsylvania, Stati Uniti, 17822-2001
- Geisinger Medical Center
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Darby, Pennsylvania, Stati Uniti, 19023
- Mercy Fitzgerald Hospital
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Drexel Hill, Pennsylvania, Stati Uniti, 19026
- Delaware County Memorial Hospital
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East Stroudsburg, Pennsylvania, Stati Uniti, 18301
- Pocono Cancer Center
-
Hershey, Pennsylvania, Stati Uniti, 17033-0850
- Milton S. Hershey Medical Center
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Philadelphia, Pennsylvania, Stati Uniti, 19111
- Fox Chase Cancer Center
-
Philadelphia, Pennsylvania, Stati Uniti, 19104-4283
- Abramson Cancer Center of the University of Pennsylvania
-
Philadelphia, Pennsylvania, Stati Uniti, 19104
- Veterans Affairs Medical Center - Philadelphia
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Philadelphia, Pennsylvania, Stati Uniti, 19107-5541
- Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
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Philadelphia, Pennsylvania, Stati Uniti, 19141-3098
- Albert Einstein Cancer Center
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Pittsburgh, Pennsylvania, Stati Uniti, 15224
- Western Pennsylvania Hospital
-
Pittsburgh, Pennsylvania, Stati Uniti, 15219
- Mercy Hospital of Pittsburgh
-
Pittsburgh, Pennsylvania, Stati Uniti, 15236
- University of Pittsburgh Cancer Institute
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Reading, Pennsylvania, Stati Uniti, 19612-6052
- Reading Hospital and Medical Center
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Scranton, Pennsylvania, Stati Uniti, 18501
- Mercy Hospital Cancer Center - Scranton
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Wilkes-Barre, Pennsylvania, Stati Uniti, 18764
- Wilkes Barre General Hospital
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York, Pennsylvania, Stati Uniti, 17403
- York Cancer Center
-
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Rhode Island
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Providence, Rhode Island, Stati Uniti, 02908-4735
- Roger Williams Medical Center/BUSM
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South Carolina
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Greenville, South Carolina, Stati Uniti, 29615
- CCOP - Greenville
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Spartanburg, South Carolina, Stati Uniti, 29303
- CCOP - Upstate Carolina
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South Dakota
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Rapid City, South Dakota, Stati Uniti, 57709
- Rapid City Regional Hospital
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Tennessee
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Jackson, Tennessee, Stati Uniti, 38301-3956
- Jackson-Madison County General Hospital
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Memphis, Tennessee, Stati Uniti, 38103
- University of Tennessee Cancer Institute
-
Nashville, Tennessee, Stati Uniti, 37232-5671
- Vanderbilt-Ingram Cancer Center
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Texas
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Amarillo, Texas, Stati Uniti, 79106
- Harrington Cancer Center
-
Galveston, Texas, Stati Uniti, 77555-0209
- University of Texas Medical Branch
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Houston, Texas, Stati Uniti, 77030-4009
- University of Texas - MD Anderson Cancer Center
-
Lackland Air Force Base, Texas, Stati Uniti, 78236-5300
- Wilford Hall Medical Center
-
Lubbock, Texas, Stati Uniti, 79410-1894
- Joe Arrington Cancer Research and Treatment Center
-
Pasadena, Texas, Stati Uniti, 77504
- Bayshore Medical Center
-
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Utah
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Saint George, Utah, Stati Uniti, 84770
- Dixie Regional Medical Center
-
Salt Lake City, Utah, Stati Uniti, 84132
- University of Utah Health Sciences Center
-
Salt Lake City, Utah, Stati Uniti, 84143
- Latter Day Saints Hospital
-
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Vermont
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Burlington, Vermont, Stati Uniti, 05401
- Green Mountain Oncology Group
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Burlington, Vermont, Stati Uniti, 05405-0075
- Vermont Cancer Center
-
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Virginia
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Charlottesville, Virginia, Stati Uniti, 22908
- Cancer Center at the University of Virginia
-
Harrisonburg, Virginia, Stati Uniti, 22801
- RMH Regional Cancer Center
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Portsmouth, Virginia, Stati Uniti, 23708-2197
- Naval Medical Center, Portsmouth
-
Richmond, Virginia, Stati Uniti, 23226
- Bon Secours - St. Mary's Hospital
-
Richmond, Virginia, Stati Uniti, 23298-0058
- Massey Cancer Center
-
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Washington
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Seattle, Washington, Stati Uniti, 98111
- Virginia Mason Medical Center
-
Spokane, Washington, Stati Uniti, 99204
- Deaconess Medical Center
-
Yakima, Washington, Stati Uniti, 98902
- Yakima Valley Memorial Hospital
-
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West Virginia
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Wheeling, West Virginia, Stati Uniti, 26003
- Schiffler Cancer Center
-
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Wisconsin
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Green Bay, Wisconsin, Stati Uniti, 54301
- CCOP - St. Vincent Hospital Cancer Center, Green Bay
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Green Bay, Wisconsin, Stati Uniti, 54307-3508
- St. Vincent Hospital
-
La Crosse, Wisconsin, Stati Uniti, 54601
- Gundersen Lutheran Medical Foundation
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Madison, Wisconsin, Stati Uniti, 53792
- University of Wisconsin Comprehensive Cancer Center
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Madison, Wisconsin, Stati Uniti, 53713
- Southern Wisconsin Radiotherapy Center
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Marshfield, Wisconsin, Stati Uniti, 54449
- Marshfield Clinic
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Menomonee Falls, Wisconsin, Stati Uniti, 53051
- Community Memorial Hospital
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Milwaukee, Wisconsin, Stati Uniti, 53211
- Columbia Hospital
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Milwaukee, Wisconsin, Stati Uniti, 53215
- St. Luke's Medical Center
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Milwaukee, Wisconsin, Stati Uniti, 53295
- Veterans Affairs Medical Center - Milwaukee (Zablocki)
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Milwaukee, Wisconsin, Stati Uniti, 53226
- Medical College of Wisconsin Cancer Center
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Racine, Wisconsin, Stati Uniti, 53405
- All Saints Cancer Center
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Waukesha, Wisconsin, Stati Uniti, 53188
- Waukesha Memorial Hospital Regional Cancer Center
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 120 anni (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
DISEASE CHARACTERISTICS:
Histologically proven invasive squamous cell carcinoma of the true vocal cord
- Stage II (T2a/b N0) disease with bulk of tumor present on vocal cord (i.e., the epicenter) with extension to adjacent areas
- No verrucal carcinoma or adenocarcinoma
- No extension to pre-epiglottic space or pyriform sinus
- No fixed cord or cartilage invasion
No evidence of adenopathy, including any of the following:
- Nodes larger than 1 cm by radiography
- Nodes containing a low central density consistent with necrosis by radiography
- Clinically palpable nodes larger than 1 cm and firm in consistency
- No recurrent or persistent disease
- No evidence or suspicion of distant metastases
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 60-100%
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
Other:
- No other malignancy within the past 5 years except nonmelanomatous skin cancer
- Not pregnant or nursing
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- No prior radiotherapy to the mid-neck or larynx
Surgery:
- No prior complete stripping or laser excision of all gross disease
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: Radiation therapy - conventional fractionation
Radiation therapy - conventional fractionation (70 Gy/2 Gy once per day/7 Weeks) 35 fractions
|
|
|
Sperimentale: Radiation therapy - hyperfractionation
Radiation therapy - hyperfractionation (79.2 Gy/1.2 b.i.d/6.5 weeks) 66 fractions
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Local Control
Lasso di tempo: From randomization to date of failure (local progression) or death or last follow-up. Analysis occurs after all patients have been potentially followed for 2 years.
|
From randomization to date of failure (local progression) or death or last follow-up. Analysis occurs after all patients have been potentially followed for 2 years.
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Acute Toxicity
Lasso di tempo: From start of treatment to 90 days
|
From start of treatment to 90 days
|
|
Late Toxicity
Lasso di tempo: From 91 days after start of treatment to last follow-up.
|
From 91 days after start of treatment to last follow-up.
|
|
Overall Survival
Lasso di tempo: From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 2 years
|
From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 2 years
|
|
Disease-free Survival
Lasso di tempo: From randomization to date of failure (local, regional, or distant progression, second primary tumor, or death) or last follow-up. Analysis occurs after all patients have been potentially followed for 2 years.
|
From randomization to date of failure (local, regional, or distant progression, second primary tumor, or death) or last follow-up. Analysis occurs after all patients have been potentially followed for 2 years.
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Collaboratori
Investigatori
- Cattedra di studio: Andy M. Trotti, MD, H. Lee Moffitt Cancer Center and Research Institute
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 aprile 1996
Completamento primario (Effettivo)
1 ottobre 2005
Completamento dello studio (Effettivo)
1 dicembre 2016
Date di iscrizione allo studio
Primo inviato
1 novembre 1999
Primo inviato che soddisfa i criteri di controllo qualità
26 gennaio 2003
Primo Inserito (Stima)
27 gennaio 2003
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
4 gennaio 2017
Ultimo aggiornamento inviato che soddisfa i criteri QC
30 dicembre 2016
Ultimo verificato
1 dicembre 2016
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- RTOG-9512
- CDR0000064597
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .