Radiation Therapy in Treating Patients With Stage II Cancer of the Vocal Cord
30 december 2016 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
250
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Alabama
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Birmingham, Alabama, Förenta staterna, 35294-3300
- University of Alabama at Birmingham Comprehensive Cancer Center
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Huntsville, Alabama, Förenta staterna, 35801
- Comprehensive Cancer Institute of Huntsville
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Huntsville, Alabama, Förenta staterna, 35807
- Huntsville Hospital System
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Mobile, Alabama, Förenta staterna, 36688
- MBCCOP - Gulf Coast
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Montgomery, Alabama, Förenta staterna, 36106-3657
- Alabama Oncology, LLC
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Tuscaloosa, Alabama, Förenta staterna, 35401
- DCH Cancer Treatment Center
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Arizona
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Phoenix, Arizona, Förenta staterna, 85013
- Foundation for Cancer Research and Education
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California
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Concord, California, Förenta staterna, 94524-4110
- Mount Diablo Medical Center
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Duarte, California, Förenta staterna, 91010-3000
- City of Hope Comprehensive Cancer Center
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Fresno, California, Förenta staterna, 93720
- Saint Agnes Cancer Center
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Fresno, California, Förenta staterna, 93729-5100
- California Cancer Center
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Greenbrae, California, Förenta staterna, 94904
- Sutter Health West Cancer Research Group
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Loma Linda, California, Förenta staterna, 92354
- Loma Linda University Medical Center
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Long Beach, California, Förenta staterna, 90822
- Veterans Affairs Medical Center - Long Beach
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Los Angeles, California, Förenta staterna, 90033-0804
- USC/Norris Comprehensive Cancer Center and Hospital
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Los Angeles, California, Förenta staterna, 90025-1781
- Jonsson Comprehensive Cancer Center, UCLA
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Oakland, California, Förenta staterna, 94609-3305
- CCOP - Bay Area Tumor Institute
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Pasadena, California, Förenta staterna, 91105
- Huntington Cancer Center
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Pomona, California, Förenta staterna, 91767
- Robert and Beverly Lewis Family Cancer Care Center
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Sacramento, California, Förenta staterna, 95816
- Radiation Oncology Center - Sacramento
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San Diego, California, Förenta staterna, 92101
- Radiation Medical Group, Incorporated
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San Francisco, California, Förenta staterna, 94143-0128
- UCSF Comprehensive Cancer Center
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San Jose, California, Förenta staterna, 95128
- O'Connor Hospital
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Santa Rosa, California, Förenta staterna, 95403
- CCOP - Santa Rosa Memorial Hospital
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Travis Air Force Base, California, Förenta staterna, 94535
- David Grant Medical Center
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Colorado
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Colorado Springs, Colorado, Förenta staterna, 80909
- Memorial Hospital Cancer Center
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Denver, Colorado, Förenta staterna, 80010
- University of Colorado Cancer Center
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Denver, Colorado, Förenta staterna, 80224
- CCOP - Colorado Cancer Research Program, Incorporated
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Grand Junction, Colorado, Förenta staterna, 81502-1628
- Saint Mary's Hospital and Medical Center
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Connecticut
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New Haven, Connecticut, Förenta staterna, 06511
- Hospital of St. Raphael
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Delaware
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Newark, Delaware, Förenta staterna, 19713
- CCOP - Christiana Care Health Services
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Florida
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Gainesville, Florida, Förenta staterna, 32610-0385
- University of Florida Health Science Center
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Jacksonville, Florida, Förenta staterna, 32207
- Florida Radiation Oncology Group
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Melbourne, Florida, Förenta staterna, 32901-3276
- Holmes Regional Medical Center
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Miami, Florida, Förenta staterna, 33136
- Sylvester Cancer Center, University of Miami
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Miami, Florida, Förenta staterna, 33125
- Veterans Affairs Medical Center - Miami
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Miami, Florida, Förenta staterna, 33256-2110
- Baptist Hospital of Miami
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Miami Beach, Florida, Förenta staterna, 33140
- CCOP - Mount Sinai Medical Center
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Orlando, Florida, Förenta staterna, 32806-2134
- MD Anderson Cancer Center Orlando
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Panama City, Florida, Förenta staterna, 32405-4587
- Gulf Coast Cancer Treatment Center
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Panama City, Florida, Förenta staterna, 32401
- Bay Medical Center
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Sarasota, Florida, Förenta staterna, 34233
- Sarasota Radiation and Medical Oncology Center
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Tallahassee, Florida, Förenta staterna, 32308
- Tallahassee Memorial Healthcare
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Tampa, Florida, Förenta staterna, 33612-9497
- H. Lee Moffitt Cancer Center and Research Institute
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Georgia
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Atlanta, Georgia, Förenta staterna, 30322
- Emory University Hospital - Atlanta
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Atlanta, Georgia, Förenta staterna, 30342-1701
- CCOP - Atlanta Regional
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Columbus, Georgia, Förenta staterna, 31901
- Medical Center/John B. Amos Community Cancer Center
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Rome, Georgia, Förenta staterna, 30165
- Regional Radiation Oncology Center at Rome
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Hawaii
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Honolulu, Hawaii, Förenta staterna, 96813
- MBCCOP - Hawaii
-
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Illinois
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Arlington Heights, Illinois, Förenta staterna, 60005
- Northwest Community Hospital
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Chicago, Illinois, Förenta staterna, 60611
- Northwestern Memorial Hospital
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Decatur, Illinois, Förenta staterna, 62526
- CCOP - Central Illinois
-
Harvey, Illinois, Förenta staterna, 60426
- Ingalls Memorial Hospital
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Maywood, Illinois, Förenta staterna, 60153
- Loyola University Medical Center
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Park Ridge, Illinois, Förenta staterna, 60068
- Lutheran General Cancer Care Center
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Peoria, Illinois, Förenta staterna, 61636
- Methodist Medical Center of Illinois
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Indiana
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Anderson, Indiana, Förenta staterna, 46016
- St. John's Medical Center
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Bloomington, Indiana, Förenta staterna, 47402
- Bloomington Hospital
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Indianapolis, Indiana, Förenta staterna, 46202
- Veterans Affairs Medical Center - Indianapolis (Roudebush)
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Indianapolis, Indiana, Förenta staterna, 46206-1367
- Clarian Health Partners Inc.
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Indianapolis, Indiana, Förenta staterna, 46219
- Community Regional Cancer Care
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Muncie, Indiana, Förenta staterna, 47303-3499
- Ball Memorial Hospital
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South Bend, Indiana, Förenta staterna, 46601
- CCOP - Northern Indiana CR Consortium
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Iowa
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Dubuque, Iowa, Förenta staterna, 52001
- Wendt Regional Cancer Center of Finley Hospital
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Kentucky
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Lexington, Kentucky, Förenta staterna, 40536-0084
- Albert B. Chandler Medical Center, University of Kentucky
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Lexington, Kentucky, Förenta staterna, 40503
- Central Baptist Hospital
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Louisville, Kentucky, Förenta staterna, 40202
- James Graham Brown Cancer Center
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Louisville, Kentucky, Förenta staterna, 40215
- Louisville Radiation Oncology
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Madisonville, Kentucky, Förenta staterna, 42431
- Merle M. Mahr Cancer Center
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Louisiana
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Baton Rouge, Louisiana, Förenta staterna, 70809
- Mary Bird Perkins Cancer Center
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New Orleans, Louisiana, Förenta staterna, 70121
- CCOP - Ochsner
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New Orleans, Louisiana, Förenta staterna, 70112
- MBCCOP - LSU Health Sciences Center
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New Orleans, Louisiana, Förenta staterna, 70112-2699
- Tulane University School of Medicine
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Maine
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Portland, Maine, Förenta staterna, 04102
- Maine Medical Center
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Maryland
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Annapolis, Maryland, Förenta staterna, 21401
- Anne Arundel Oncology Center
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Baltimore, Maryland, Förenta staterna, 21231-2410
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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Baltimore, Maryland, Förenta staterna, 21215
- Sinai Hospital of Baltimore
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Baltimore, Maryland, Förenta staterna, 21201
- Marlene and Stewart Greenebaum Cancer Center, University of Maryland
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Baltimore, Maryland, Förenta staterna, 21204
- Greater Baltimore Medical Center and Cancer Center
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Baltimore, Maryland, Förenta staterna, 21215-1290
- Harbor Hospital Center
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Salisbury, Maryland, Förenta staterna, 21801
- Peninsula Regional Medical Center
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Massachusetts
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Boston, Massachusetts, Förenta staterna, 02115
- Dana-Farber Cancer Institute
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Hyannis, Massachusetts, Förenta staterna, 02601
- Cape Cod Hospital
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Jamaica Plain, Massachusetts, Förenta staterna, 02130
- Veterans Affairs Medical Center - Boston (Jamaica Plain)
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Michigan
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Ann Arbor, Michigan, Förenta staterna, 48106
- CCOP - Michigan Cancer Research Consortium
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Ann Arbor, Michigan, Förenta staterna, 48109-0010
- University of Michigan Comprehensive Cancer Center
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Detroit, Michigan, Förenta staterna, 48202
- Henry Ford Hospital
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Detroit, Michigan, Förenta staterna, 48201-1379
- Barbara Ann Karmanos Cancer Institute
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Flint, Michigan, Förenta staterna, 48503
- Hurley Medical Center
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Flint, Michigan, Förenta staterna, 48532-3685
- McLaren Regional Cancer Center
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Kalamazoo, Michigan, Förenta staterna, 49007-3731
- CCOP - Kalamazoo
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Marquette, Michigan, Förenta staterna, 49855
- Marquette General Hospital
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Midland, Michigan, Förenta staterna, 48670
- MidMichigan Medical Center - Midland
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Royal Oak, Michigan, Förenta staterna, 48073-6769
- CCOP - Beaumont
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Royal Oak, Michigan, Förenta staterna, 48073
- William Beaumont Hospital
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Troy, Michigan, Förenta staterna, 48098
- William Beaumont Hospital - Troy
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Minnesota
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Rochester, Minnesota, Förenta staterna, 55905
- Mayo Clinic Cancer Center
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Saint Louis Park, Minnesota, Förenta staterna, 55416
- CCOP - Metro-Minnesota
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Missouri
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Columbia, Missouri, Förenta staterna, 65203
- Ellis Fischel Cancer Center - Columbia
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Kansas City, Missouri, Förenta staterna, 64131
- CCOP - Kansas City
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Saint Louis, Missouri, Förenta staterna, 63110-0250
- St. Louis University Health Sciences Center
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Saint Louis, Missouri, Förenta staterna, 63108
- Mallinckrodt Institute of Radiology
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Springfield, Missouri, Förenta staterna, 65807
- CCOP - Cancer Research for the Ozarks
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Springfield, Missouri, Förenta staterna, 65807
- Cancer Research for the Ozarks
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Montana
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Billings, Montana, Förenta staterna, 59101
- CCOP - Montana Cancer Consortium
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Nebraska
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Omaha, Nebraska, Förenta staterna, 68106
- CCOP - Missouri Valley Cancer Consortium
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Omaha, Nebraska, Förenta staterna, 68114
- Methodist Hospital Cancer Center - Omaha
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Omaha, Nebraska, Förenta staterna, 68198-7460
- Nebraska Health System
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Nevada
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Las Vegas, Nevada, Förenta staterna, 89106
- CCOP - Southern Nevada Cancer Research Foundation
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New Hampshire
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Lebanon, New Hampshire, Förenta staterna, 03756-0002
- Norris Cotton Cancer Center
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Manchester, New Hampshire, Förenta staterna, 03103
- Elliot Regional Cancer Center
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New Jersey
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East Orange, New Jersey, Förenta staterna, 07019
- Veterans Affairs Medical Center - East Orange
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Edison, New Jersey, Förenta staterna, 08818
- John F. Kennedy Medical Center
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Elizabeth, New Jersey, Förenta staterna, 07201
- Trinitas Hospital - Jersey Street Campus
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Long Branch, New Jersey, Förenta staterna, 07740-6395
- Monmouth Medical Center
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Millville, New Jersey, Förenta staterna, 08332
- South Jersey Regional Cancer Center
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Mount Holly, New Jersey, Förenta staterna, 08060
- Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital
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New Brunswick, New Jersey, Förenta staterna, 38103-2807
- Cancer Institute of New Jersey
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Newark, New Jersey, Förenta staterna, 07112
- Newark Beth Israel Medical Center
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Pomona, New Jersey, Förenta staterna, 08240
- Atlantic City Medical Center
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Ridgewood, New Jersey, Förenta staterna, 07450
- Valley Hospital
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Toms River, New Jersey, Förenta staterna, 08755
- Community Medical Center
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Trenton, New Jersey, Förenta staterna, 08629
- St. Francis Medical Center
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Warren, New Jersey, Förenta staterna, 07059
- Associated Radiologists, P.A.
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New Mexico
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Albuquerque, New Mexico, Förenta staterna, 87109
- Radiation Oncology Associates of Albuquerque
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New York
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Albany, New York, Förenta staterna, 12208
- Cancer Center of Albany Medical Center
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Brooklyn, New York, Förenta staterna, 11203
- State University of New York Health Science Center at Brooklyn
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Brooklyn, New York, Förenta staterna, 11215
- New York Methodist Hospital
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Buffalo, New York, Förenta staterna, 14263-0001
- Roswell Park Cancer Institute
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Clifton Springs, New York, Förenta staterna, 14432
- Finger Lakes Radiation Oncology Center
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Manhasset, New York, Förenta staterna, 11030
- CCOP - North Shore University Hospital
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New York, New York, Förenta staterna, 10032
- Herbert Irving Comprehensive Cancer Center
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Plattsburgh, New York, Förenta staterna, 12901
- Champlain Valley Physicians Hospital Medical Center
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Poughkeepsie, New York, Förenta staterna, 12601
- Vassar Brothers Medical Center
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Rochester, New York, Förenta staterna, 14642
- James P. Wilmot Cancer Center
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Syracuse, New York, Förenta staterna, 13217
- CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
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Yonkers, New York, Förenta staterna, 10701
- Riverhill Radiation Oncology
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North Carolina
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Chapel Hill, North Carolina, Förenta staterna, 27599-7295
- Lineberger Comprehensive Cancer Center, UNC
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Concord, North Carolina, Förenta staterna, 28025
- Northeast Medical Center
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Greenville, North Carolina, Förenta staterna, 27858-4354
- East Carolina University School of Medicine
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Winston-Salem, North Carolina, Förenta staterna, 27104-4241
- CCOP - Southeast Cancer Control Consortium
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Winston-Salem, North Carolina, Förenta staterna, 27157-1082
- Comprehensive Cancer Center at Wake Forest University
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North Dakota
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Minot, North Dakota, Förenta staterna, 58701
- Trinity Cancer Care Center
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Ohio
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Akron, Ohio, Förenta staterna, 44302
- Akron General Medical Center
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Akron, Ohio, Förenta staterna, 44304
- Akron City Hospital
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Cincinnati, Ohio, Förenta staterna, 45219
- Christ Hospital
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Cincinnati, Ohio, Förenta staterna, 45267-0502
- Barrett Cancer Center
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Cleveland, Ohio, Förenta staterna, 44195
- Cleveland Clinic Taussig Cancer Center
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Cleveland, Ohio, Förenta staterna, 44106
- University Hospitals of Cleveland
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Cleveland, Ohio, Förenta staterna, 44106-5065
- Ireland Cancer Center
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Columbus, Ohio, Förenta staterna, 43210-1240
- Arthur G. James Cancer Hospital - Ohio State University
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Columbus, Ohio, Förenta staterna, 43206
- CCOP - Columbus
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Dayton, Ohio, Förenta staterna, 45429
- CCOP - Dayton
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Toledo, Ohio, Förenta staterna, 43623-3456
- CCOP - Toledo Community Hospital
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Oklahoma
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Oklahoma City, Oklahoma, Förenta staterna, 73104
- University of Oklahoma Health Sciences Center
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Oklahoma City, Oklahoma, Förenta staterna, 73101
- St. Anthony Hospital
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Tulsa, Oklahoma, Förenta staterna, 74136
- CCOP - Oklahoma
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Tulsa, Oklahoma, Förenta staterna, 74104
- St. John Health System
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Oregon
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Portland, Oregon, Förenta staterna, 97225
- CCOP - Columbia River Program
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Pennsylvania
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Allentown, Pennsylvania, Förenta staterna, 18105
- Lehigh Valley Hospital
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Bethlehem, Pennsylvania, Förenta staterna, 18015
- St. Luke's Hospital Cancer Center
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Danville, Pennsylvania, Förenta staterna, 17822-2001
- Geisinger Medical Center
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Darby, Pennsylvania, Förenta staterna, 19023
- Mercy Fitzgerald Hospital
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Drexel Hill, Pennsylvania, Förenta staterna, 19026
- Delaware County Memorial Hospital
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East Stroudsburg, Pennsylvania, Förenta staterna, 18301
- Pocono Cancer Center
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Hershey, Pennsylvania, Förenta staterna, 17033-0850
- Milton S. Hershey Medical Center
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Philadelphia, Pennsylvania, Förenta staterna, 19111
- Fox Chase Cancer Center
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Philadelphia, Pennsylvania, Förenta staterna, 19104-4283
- Abramson Cancer Center of the University of Pennsylvania
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Philadelphia, Pennsylvania, Förenta staterna, 19104
- Veterans Affairs Medical Center - Philadelphia
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Philadelphia, Pennsylvania, Förenta staterna, 19107-5541
- Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
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Philadelphia, Pennsylvania, Förenta staterna, 19141-3098
- Albert Einstein Cancer Center
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Pittsburgh, Pennsylvania, Förenta staterna, 15224
- Western Pennsylvania Hospital
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Pittsburgh, Pennsylvania, Förenta staterna, 15219
- Mercy Hospital of Pittsburgh
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Pittsburgh, Pennsylvania, Förenta staterna, 15236
- University of Pittsburgh Cancer Institute
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Reading, Pennsylvania, Förenta staterna, 19612-6052
- Reading Hospital and Medical Center
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Scranton, Pennsylvania, Förenta staterna, 18501
- Mercy Hospital Cancer Center - Scranton
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Wilkes-Barre, Pennsylvania, Förenta staterna, 18764
- Wilkes Barre General Hospital
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York, Pennsylvania, Förenta staterna, 17403
- York Cancer Center
-
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Rhode Island
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Providence, Rhode Island, Förenta staterna, 02908-4735
- Roger Williams Medical Center/BUSM
-
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South Carolina
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Greenville, South Carolina, Förenta staterna, 29615
- CCOP - Greenville
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Spartanburg, South Carolina, Förenta staterna, 29303
- CCOP - Upstate Carolina
-
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South Dakota
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Rapid City, South Dakota, Förenta staterna, 57709
- Rapid City Regional Hospital
-
-
Tennessee
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Jackson, Tennessee, Förenta staterna, 38301-3956
- Jackson-Madison County General Hospital
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Memphis, Tennessee, Förenta staterna, 38103
- University of Tennessee Cancer Institute
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Nashville, Tennessee, Förenta staterna, 37232-5671
- Vanderbilt-Ingram Cancer Center
-
-
Texas
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Amarillo, Texas, Förenta staterna, 79106
- Harrington Cancer Center
-
Galveston, Texas, Förenta staterna, 77555-0209
- University of Texas Medical Branch
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Houston, Texas, Förenta staterna, 77030-4009
- University of Texas - MD Anderson Cancer Center
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Lackland Air Force Base, Texas, Förenta staterna, 78236-5300
- Wilford Hall Medical Center
-
Lubbock, Texas, Förenta staterna, 79410-1894
- Joe Arrington Cancer Research and Treatment Center
-
Pasadena, Texas, Förenta staterna, 77504
- Bayshore Medical Center
-
-
Utah
-
Saint George, Utah, Förenta staterna, 84770
- Dixie Regional Medical Center
-
Salt Lake City, Utah, Förenta staterna, 84132
- University of Utah Health Sciences Center
-
Salt Lake City, Utah, Förenta staterna, 84143
- Latter Day Saints Hospital
-
-
Vermont
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Burlington, Vermont, Förenta staterna, 05401
- Green Mountain Oncology Group
-
Burlington, Vermont, Förenta staterna, 05405-0075
- Vermont Cancer Center
-
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Virginia
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Charlottesville, Virginia, Förenta staterna, 22908
- Cancer Center at the University of Virginia
-
Harrisonburg, Virginia, Förenta staterna, 22801
- RMH Regional Cancer Center
-
Portsmouth, Virginia, Förenta staterna, 23708-2197
- Naval Medical Center, Portsmouth
-
Richmond, Virginia, Förenta staterna, 23226
- Bon Secours - St. Mary's Hospital
-
Richmond, Virginia, Förenta staterna, 23298-0058
- Massey Cancer Center
-
-
Washington
-
Seattle, Washington, Förenta staterna, 98111
- Virginia Mason Medical Center
-
Spokane, Washington, Förenta staterna, 99204
- Deaconess Medical Center
-
Yakima, Washington, Förenta staterna, 98902
- Yakima Valley Memorial Hospital
-
-
West Virginia
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Wheeling, West Virginia, Förenta staterna, 26003
- Schiffler Cancer Center
-
-
Wisconsin
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Green Bay, Wisconsin, Förenta staterna, 54301
- CCOP - St. Vincent Hospital Cancer Center, Green Bay
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Green Bay, Wisconsin, Förenta staterna, 54307-3508
- St. Vincent Hospital
-
La Crosse, Wisconsin, Förenta staterna, 54601
- Gundersen Lutheran Medical Foundation
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Madison, Wisconsin, Förenta staterna, 53792
- University of Wisconsin Comprehensive Cancer Center
-
Madison, Wisconsin, Förenta staterna, 53713
- Southern Wisconsin Radiotherapy Center
-
Marshfield, Wisconsin, Förenta staterna, 54449
- Marshfield Clinic
-
Menomonee Falls, Wisconsin, Förenta staterna, 53051
- Community Memorial Hospital
-
Milwaukee, Wisconsin, Förenta staterna, 53211
- Columbia Hospital
-
Milwaukee, Wisconsin, Förenta staterna, 53215
- St. Luke's Medical Center
-
Milwaukee, Wisconsin, Förenta staterna, 53295
- Veterans Affairs Medical Center - Milwaukee (Zablocki)
-
Milwaukee, Wisconsin, Förenta staterna, 53226
- Medical College of Wisconsin Cancer Center
-
Racine, Wisconsin, Förenta staterna, 53405
- All Saints Cancer Center
-
Waukesha, Wisconsin, Förenta staterna, 53188
- Waukesha Memorial Hospital Regional Cancer Center
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-
-
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Alberta
-
Calgary, Alberta, Kanada, T2N 4N2
- Tom Baker Cancer Center - Calgary
-
Edmonton, Alberta, Kanada, T6G 1Z2
- Cross Cancer Institute
-
-
New Brunswick
-
Saint John, New Brunswick, Kanada, E2L 4L2
- Saint John Regional Hospital
-
-
Newfoundland and Labrador
-
St. Johns, Newfoundland and Labrador, Kanada, A1B 3V6
- Newfoundland Cancer Treatment and Research Foundation
-
-
Nova Scotia
-
Halifax, Nova Scotia, Kanada, B3H 1V7
- Nova Scotia Cancer Centre
-
-
Ontario
-
Hamilton, Ontario, Kanada, L8V 5C2
- Cancer Care Ontario-Hamilton Regional Cancer Centre
-
Kingston, Ontario, Kanada, K7L 5P9
- Kingston Regional Cancer Centre
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London, Ontario, Kanada, N6A 4L6
- Cancer Care Ontario-London Regional Cancer Centre
-
Ottawa, Ontario, Kanada, K1H 1C4
- Ottawa Regional Cancer Centre
-
Sudbury, Ontario, Kanada, P3E 5J1
- Northeastern Ontario Regional Cancer Centre, Sudbury
-
Thunder Bay, Ontario, Kanada, P7A 7T1
- Northwestern Ontario Regional Cancer Centre, Thunder Bay
-
Toronto, Ontario, Kanada, M4N 3M5
- Toronto Sunnybrook Regional Cancer Centre
-
Toronto, Ontario, Kanada, M5G 2M9
- Princess Margaret Hospital
-
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Quebec
-
Fleurimont, Quebec, Kanada, J1H 5N4
- CHUS-Hopital Fleurimont
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Montreal, Quebec, Kanada, H2W 1S6
- McGill University
-
Montreal, Quebec, Kanada, H2L 4MI
- Centre Hospitalier de l'Université de Montréal
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Quebec City, Quebec, Kanada, G1R 2J6
- Centre Hospitalier Universitaire de Quebec
-
-
Saskatchewan
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Regina, Saskatchewan, Kanada, S4T 7T1
- Allan Blair Cancer Centre
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Saskatoon, Saskatchewan, Kanada, S7N 4H4
- Saskatoon Cancer Centre
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 120 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Radiation therapy - conventional fractionation
Radiation therapy - conventional fractionation (70 Gy/2 Gy once per day/7 Weeks) 35 fractions
|
|
|
Experimentell: Radiation therapy - hyperfractionation
Radiation therapy - hyperfractionation (79.2 Gy/1.2 b.i.d/6.5 weeks) 66 fractions
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Local Control
Tidsram: 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.
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Acute Toxicity
Tidsram: From start of treatment to 90 days
|
From start of treatment to 90 days
|
|
Late Toxicity
Tidsram: From 91 days after start of treatment to last follow-up.
|
From 91 days after start of treatment to last follow-up.
|
|
Overall Survival
Tidsram: 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
Tidsram: 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.
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Studiestol: Andy M. Trotti, MD, H. Lee Moffitt Cancer Center and Research Institute
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 april 1996
Primärt slutförande (Faktisk)
1 oktober 2005
Avslutad studie (Faktisk)
1 december 2016
Studieregistreringsdatum
Först inskickad
1 november 1999
Först inskickad som uppfyllde QC-kriterierna
26 januari 2003
Första postat (Uppskatta)
27 januari 2003
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
4 januari 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
30 december 2016
Senast verifierad
1 december 2016
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- RTOG-9512
- CDR0000064597
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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