Radiation Therapy in Treating Patients With Stage II Cancer of the Vocal Cord
2016년 12월 30일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (실제)
250
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Alabama
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Birmingham, Alabama, 미국, 35294-3300
- University of Alabama at Birmingham Comprehensive Cancer Center
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Huntsville, Alabama, 미국, 35801
- Comprehensive Cancer Institute of Huntsville
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Huntsville, Alabama, 미국, 35807
- Huntsville Hospital System
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Mobile, Alabama, 미국, 36688
- MBCCOP - Gulf Coast
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Montgomery, Alabama, 미국, 36106-3657
- Alabama Oncology, LLC
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Tuscaloosa, Alabama, 미국, 35401
- DCH Cancer Treatment Center
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Arizona
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Phoenix, Arizona, 미국, 85013
- Foundation for Cancer Research and Education
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California
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Concord, California, 미국, 94524-4110
- Mount Diablo Medical Center
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Duarte, California, 미국, 91010-3000
- City of Hope Comprehensive Cancer Center
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Fresno, California, 미국, 93720
- Saint Agnes Cancer Center
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Fresno, California, 미국, 93729-5100
- California Cancer Center
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Greenbrae, California, 미국, 94904
- Sutter Health West Cancer Research Group
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Loma Linda, California, 미국, 92354
- Loma Linda University Medical Center
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Long Beach, California, 미국, 90822
- Veterans Affairs Medical Center - Long Beach
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Los Angeles, California, 미국, 90033-0804
- USC/Norris Comprehensive Cancer Center and Hospital
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Los Angeles, California, 미국, 90025-1781
- Jonsson Comprehensive Cancer Center, UCLA
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Oakland, California, 미국, 94609-3305
- CCOP - Bay Area Tumor Institute
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Pasadena, California, 미국, 91105
- Huntington Cancer Center
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Pomona, California, 미국, 91767
- Robert and Beverly Lewis Family Cancer Care Center
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Sacramento, California, 미국, 95816
- Radiation Oncology Center - Sacramento
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San Diego, California, 미국, 92101
- Radiation Medical Group, Incorporated
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San Francisco, California, 미국, 94143-0128
- UCSF Comprehensive Cancer Center
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San Jose, California, 미국, 95128
- O'Connor Hospital
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Santa Rosa, California, 미국, 95403
- CCOP - Santa Rosa Memorial Hospital
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Travis Air Force Base, California, 미국, 94535
- David Grant Medical Center
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Colorado
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Colorado Springs, Colorado, 미국, 80909
- Memorial Hospital Cancer Center
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Denver, Colorado, 미국, 80010
- University of Colorado Cancer Center
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Denver, Colorado, 미국, 80224
- CCOP - Colorado Cancer Research Program, Incorporated
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Grand Junction, Colorado, 미국, 81502-1628
- Saint Mary's Hospital and Medical Center
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Connecticut
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New Haven, Connecticut, 미국, 06511
- Hospital of St. Raphael
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Delaware
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Newark, Delaware, 미국, 19713
- CCOP - Christiana Care Health Services
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Florida
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Gainesville, Florida, 미국, 32610-0385
- University of Florida Health Science Center
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Jacksonville, Florida, 미국, 32207
- Florida Radiation Oncology Group
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Melbourne, Florida, 미국, 32901-3276
- Holmes Regional Medical Center
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Miami, Florida, 미국, 33136
- Sylvester Cancer Center, University of Miami
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Miami, Florida, 미국, 33125
- Veterans Affairs Medical Center - Miami
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Miami, Florida, 미국, 33256-2110
- Baptist Hospital of Miami
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Miami Beach, Florida, 미국, 33140
- CCOP - Mount Sinai Medical Center
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Orlando, Florida, 미국, 32806-2134
- MD Anderson Cancer Center Orlando
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Panama City, Florida, 미국, 32405-4587
- Gulf Coast Cancer Treatment Center
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Panama City, Florida, 미국, 32401
- Bay Medical Center
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Sarasota, Florida, 미국, 34233
- Sarasota Radiation and Medical Oncology Center
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Tallahassee, Florida, 미국, 32308
- Tallahassee Memorial HealthCare
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Tampa, Florida, 미국, 33612-9497
- H. Lee Moffitt Cancer Center and Research Institute
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Georgia
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Atlanta, Georgia, 미국, 30322
- Emory University Hospital - Atlanta
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Atlanta, Georgia, 미국, 30342-1701
- CCOP - Atlanta Regional
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Columbus, Georgia, 미국, 31901
- Medical Center/John B. Amos Community Cancer Center
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Rome, Georgia, 미국, 30165
- Regional Radiation Oncology Center at Rome
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Hawaii
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Honolulu, Hawaii, 미국, 96813
- MBCCOP - Hawaii
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Illinois
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Arlington Heights, Illinois, 미국, 60005
- Northwest Community Hospital
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Chicago, Illinois, 미국, 60611
- Northwestern Memorial Hospital
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Decatur, Illinois, 미국, 62526
- CCOP - Central Illinois
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Harvey, Illinois, 미국, 60426
- Ingalls Memorial Hospital
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Maywood, Illinois, 미국, 60153
- Loyola University Medical Center
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Park Ridge, Illinois, 미국, 60068
- Lutheran General Cancer Care Center
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Peoria, Illinois, 미국, 61636
- Methodist Medical Center of Illinois
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Indiana
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Anderson, Indiana, 미국, 46016
- St. John's Medical Center
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Bloomington, Indiana, 미국, 47402
- Bloomington Hospital
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Indianapolis, Indiana, 미국, 46202
- Veterans Affairs Medical Center - Indianapolis (Roudebush)
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Indianapolis, Indiana, 미국, 46206-1367
- Clarian Health Partners Inc.
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Indianapolis, Indiana, 미국, 46219
- Community Regional Cancer Care
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Muncie, Indiana, 미국, 47303-3499
- Ball Memorial Hospital
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South Bend, Indiana, 미국, 46601
- CCOP - Northern Indiana CR Consortium
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Iowa
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Dubuque, Iowa, 미국, 52001
- Wendt Regional Cancer Center of Finley Hospital
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Kentucky
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Lexington, Kentucky, 미국, 40536-0084
- Albert B. Chandler Medical Center, University of Kentucky
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Lexington, Kentucky, 미국, 40503
- Central Baptist Hospital
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Louisville, Kentucky, 미국, 40202
- James Graham Brown Cancer Center
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Louisville, Kentucky, 미국, 40215
- Louisville Radiation Oncology
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Madisonville, Kentucky, 미국, 42431
- Merle M. Mahr Cancer Center
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Louisiana
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Baton Rouge, Louisiana, 미국, 70809
- Mary Bird Perkins Cancer Center
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New Orleans, Louisiana, 미국, 70121
- CCOP - Ochsner
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New Orleans, Louisiana, 미국, 70112
- MBCCOP - LSU Health Sciences Center
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New Orleans, Louisiana, 미국, 70112-2699
- Tulane University School of Medicine
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Maine
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Portland, Maine, 미국, 04102
- Maine Medical Center
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Maryland
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Annapolis, Maryland, 미국, 21401
- Anne Arundel Oncology Center
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Baltimore, Maryland, 미국, 21231-2410
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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Baltimore, Maryland, 미국, 21215
- Sinai Hospital of Baltimore
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Baltimore, Maryland, 미국, 21201
- Marlene and Stewart Greenebaum Cancer Center, University of Maryland
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Baltimore, Maryland, 미국, 21204
- Greater Baltimore Medical Center and Cancer Center
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Baltimore, Maryland, 미국, 21215-1290
- Harbor Hospital Center
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Salisbury, Maryland, 미국, 21801
- Peninsula Regional Medical Center
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Massachusetts
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Boston, Massachusetts, 미국, 02115
- Dana-Farber Cancer Institute
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Hyannis, Massachusetts, 미국, 02601
- Cape Cod Hospital
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Jamaica Plain, Massachusetts, 미국, 02130
- Veterans Affairs Medical Center - Boston (Jamaica Plain)
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Michigan
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Ann Arbor, Michigan, 미국, 48106
- CCOP - Michigan Cancer Research Consortium
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Ann Arbor, Michigan, 미국, 48109-0010
- University Of Michigan Comprehensive Cancer Center
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Detroit, Michigan, 미국, 48202
- Henry Ford Hospital
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Detroit, Michigan, 미국, 48201-1379
- Barbara Ann Karmanos Cancer Institute
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Flint, Michigan, 미국, 48503
- Hurley Medical Center
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Flint, Michigan, 미국, 48532-3685
- McLaren Regional Cancer Center
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Kalamazoo, Michigan, 미국, 49007-3731
- CCOP - Kalamazoo
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Marquette, Michigan, 미국, 49855
- Marquette General Hospital
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Midland, Michigan, 미국, 48670
- MidMichigan Medical Center - Midland
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Royal Oak, Michigan, 미국, 48073-6769
- CCOP - Beaumont
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Royal Oak, Michigan, 미국, 48073
- William Beaumont Hospital
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Troy, Michigan, 미국, 48098
- William Beaumont Hospital - Troy
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Minnesota
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Rochester, Minnesota, 미국, 55905
- Mayo Clinic Cancer Center
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Saint Louis Park, Minnesota, 미국, 55416
- CCOP - Metro-Minnesota
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Missouri
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Columbia, Missouri, 미국, 65203
- Ellis Fischel Cancer Center - Columbia
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Kansas City, Missouri, 미국, 64131
- CCOP - Kansas City
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Saint Louis, Missouri, 미국, 63110-0250
- St. Louis University Health Sciences Center
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Saint Louis, Missouri, 미국, 63108
- Mallinckrodt Institute of Radiology
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Springfield, Missouri, 미국, 65807
- CCOP - Cancer Research for the Ozarks
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Springfield, Missouri, 미국, 65807
- Cancer Research for the Ozarks
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Montana
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Billings, Montana, 미국, 59101
- CCOP - Montana Cancer Consortium
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Nebraska
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Omaha, Nebraska, 미국, 68106
- CCOP - Missouri Valley Cancer Consortium
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Omaha, Nebraska, 미국, 68114
- Methodist Hospital Cancer Center - Omaha
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Omaha, Nebraska, 미국, 68198-7460
- Nebraska Health System
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Nevada
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Las Vegas, Nevada, 미국, 89106
- CCOP - Southern Nevada Cancer Research Foundation
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New Hampshire
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Lebanon, New Hampshire, 미국, 03756-0002
- Norris Cotton Cancer Center
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Manchester, New Hampshire, 미국, 03103
- Elliot Regional Cancer Center
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New Jersey
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East Orange, New Jersey, 미국, 07019
- Veterans Affairs Medical Center - East Orange
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Edison, New Jersey, 미국, 08818
- John F. Kennedy Medical Center
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Elizabeth, New Jersey, 미국, 07201
- Trinitas Hospital - Jersey Street Campus
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Long Branch, New Jersey, 미국, 07740-6395
- Monmouth Medical Center
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Millville, New Jersey, 미국, 08332
- South Jersey Regional Cancer Center
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Mount Holly, New Jersey, 미국, 08060
- Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital
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New Brunswick, New Jersey, 미국, 38103-2807
- Cancer Institute Of New Jersey
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Newark, New Jersey, 미국, 07112
- Newark Beth Israel Medical Center
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Pomona, New Jersey, 미국, 08240
- Atlantic City Medical Center
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Ridgewood, New Jersey, 미국, 07450
- Valley Hospital
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Toms River, New Jersey, 미국, 08755
- Community Medical Center
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Trenton, New Jersey, 미국, 08629
- St. Francis Medical Center
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Warren, New Jersey, 미국, 07059
- Associated Radiologists, P.A.
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New Mexico
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Albuquerque, New Mexico, 미국, 87109
- Radiation Oncology Associates of Albuquerque
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New York
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Albany, New York, 미국, 12208
- Cancer Center of Albany Medical Center
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Brooklyn, New York, 미국, 11203
- State University of New York Health Science Center at Brooklyn
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Brooklyn, New York, 미국, 11215
- New York Methodist Hospital
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Buffalo, New York, 미국, 14263-0001
- Roswell Park Cancer Institute
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Clifton Springs, New York, 미국, 14432
- Finger Lakes Radiation Oncology Center
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Manhasset, New York, 미국, 11030
- CCOP - North Shore University Hospital
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New York, New York, 미국, 10032
- Herbert Irving Comprehensive Cancer Center
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Plattsburgh, New York, 미국, 12901
- Champlain Valley Physicians Hospital Medical Center
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Poughkeepsie, New York, 미국, 12601
- Vassar Brothers Medical Center
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Rochester, New York, 미국, 14642
- James P. Wilmot Cancer Center
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Syracuse, New York, 미국, 13217
- CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
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Yonkers, New York, 미국, 10701
- Riverhill Radiation Oncology
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North Carolina
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Chapel Hill, North Carolina, 미국, 27599-7295
- Lineberger Comprehensive Cancer Center, UNC
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Concord, North Carolina, 미국, 28025
- Northeast Medical Center
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Greenville, North Carolina, 미국, 27858-4354
- East Carolina University School of Medicine
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Winston-Salem, North Carolina, 미국, 27104-4241
- CCOP - Southeast Cancer Control Consortium
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Winston-Salem, North Carolina, 미국, 27157-1082
- Comprehensive Cancer Center at Wake Forest University
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North Dakota
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Minot, North Dakota, 미국, 58701
- Trinity Cancer Care Center
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Ohio
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Akron, Ohio, 미국, 44302
- Akron General Medical Center
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Akron, Ohio, 미국, 44304
- Akron City Hospital
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Cincinnati, Ohio, 미국, 45219
- Christ Hospital
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Cincinnati, Ohio, 미국, 45267-0502
- Barrett Cancer Center
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Cleveland, Ohio, 미국, 44195
- Cleveland Clinic Taussig Cancer Center
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Cleveland, Ohio, 미국, 44106
- University Hospitals of Cleveland
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Cleveland, Ohio, 미국, 44106-5065
- Ireland Cancer Center
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Columbus, Ohio, 미국, 43210-1240
- Arthur G. James Cancer Hospital - Ohio State University
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Columbus, Ohio, 미국, 43206
- CCOP - Columbus
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Dayton, Ohio, 미국, 45429
- CCOP - Dayton
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Toledo, Ohio, 미국, 43623-3456
- CCOP - Toledo Community Hospital
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Oklahoma
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Oklahoma City, Oklahoma, 미국, 73104
- University of Oklahoma Health Sciences Center
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Oklahoma City, Oklahoma, 미국, 73101
- St. Anthony Hospital
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Tulsa, Oklahoma, 미국, 74136
- CCOP - Oklahoma
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Tulsa, Oklahoma, 미국, 74104
- St. John Health System
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Oregon
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Portland, Oregon, 미국, 97225
- CCOP - Columbia River Program
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Pennsylvania
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Allentown, Pennsylvania, 미국, 18105
- LeHigh Valley Hospital
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Bethlehem, Pennsylvania, 미국, 18015
- St. Luke's Hospital Cancer Center
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Danville, Pennsylvania, 미국, 17822-2001
- Geisinger Medical Center
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Darby, Pennsylvania, 미국, 19023
- Mercy Fitzgerald Hospital
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Drexel Hill, Pennsylvania, 미국, 19026
- Delaware County Memorial Hospital
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East Stroudsburg, Pennsylvania, 미국, 18301
- Pocono Cancer Center
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Hershey, Pennsylvania, 미국, 17033-0850
- Milton S. Hershey Medical Center
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Philadelphia, Pennsylvania, 미국, 19111
- Fox Chase Cancer Center
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Philadelphia, Pennsylvania, 미국, 19104-4283
- Abramson Cancer Center of the University of Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19104
- Veterans Affairs Medical Center - Philadelphia
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Philadelphia, Pennsylvania, 미국, 19107-5541
- Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
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Philadelphia, Pennsylvania, 미국, 19141-3098
- Albert Einstein Cancer Center
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Pittsburgh, Pennsylvania, 미국, 15224
- Western Pennsylvania Hospital
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Pittsburgh, Pennsylvania, 미국, 15219
- Mercy Hospital of Pittsburgh
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Pittsburgh, Pennsylvania, 미국, 15236
- University of Pittsburgh Cancer Institute
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Reading, Pennsylvania, 미국, 19612-6052
- Reading Hospital and Medical Center
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Scranton, Pennsylvania, 미국, 18501
- Mercy Hospital Cancer Center - Scranton
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Wilkes-Barre, Pennsylvania, 미국, 18764
- Wilkes Barre General Hospital
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York, Pennsylvania, 미국, 17403
- York Cancer Center
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Rhode Island
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Providence, Rhode Island, 미국, 02908-4735
- Roger Williams Medical Center/BUSM
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South Carolina
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Greenville, South Carolina, 미국, 29615
- CCOP - Greenville
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Spartanburg, South Carolina, 미국, 29303
- CCOP - Upstate Carolina
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South Dakota
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Rapid City, South Dakota, 미국, 57709
- Rapid City Regional Hospital
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Tennessee
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Jackson, Tennessee, 미국, 38301-3956
- Jackson-Madison County General Hospital
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Memphis, Tennessee, 미국, 38103
- University of Tennessee Cancer Institute
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Nashville, Tennessee, 미국, 37232-5671
- Vanderbilt-Ingram Cancer Center
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Texas
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Amarillo, Texas, 미국, 79106
- Harrington Cancer Center
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Galveston, Texas, 미국, 77555-0209
- University of Texas Medical Branch
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Houston, Texas, 미국, 77030-4009
- University of Texas - MD Anderson Cancer Center
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Lackland Air Force Base, Texas, 미국, 78236-5300
- Wilford Hall Medical Center
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Lubbock, Texas, 미국, 79410-1894
- Joe Arrington Cancer Research and Treatment Center
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Pasadena, Texas, 미국, 77504
- Bayshore Medical Center
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Utah
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Saint George, Utah, 미국, 84770
- Dixie Regional Medical Center
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Salt Lake City, Utah, 미국, 84132
- University of Utah Health Sciences Center
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Salt Lake City, Utah, 미국, 84143
- Latter Day Saints Hospital
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Vermont
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Burlington, Vermont, 미국, 05401
- Green Mountain Oncology Group
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Burlington, Vermont, 미국, 05405-0075
- Vermont Cancer Center
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Virginia
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Charlottesville, Virginia, 미국, 22908
- Cancer Center at the University of Virginia
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Harrisonburg, Virginia, 미국, 22801
- RMH Regional Cancer Center
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Portsmouth, Virginia, 미국, 23708-2197
- Naval Medical Center, Portsmouth
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Richmond, Virginia, 미국, 23226
- Bon Secours - St. Mary's Hospital
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Richmond, Virginia, 미국, 23298-0058
- Massey Cancer Center
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Washington
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Seattle, Washington, 미국, 98111
- Virginia Mason Medical Center
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Spokane, Washington, 미국, 99204
- Deaconess Medical Center
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Yakima, Washington, 미국, 98902
- Yakima Valley Memorial Hospital
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West Virginia
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Wheeling, West Virginia, 미국, 26003
- Schiffler Cancer Center
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Wisconsin
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Green Bay, Wisconsin, 미국, 54301
- CCOP - St. Vincent Hospital Cancer Center, Green Bay
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Green Bay, Wisconsin, 미국, 54307-3508
- St. Vincent Hospital
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La Crosse, Wisconsin, 미국, 54601
- Gundersen Lutheran Medical Foundation
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Madison, Wisconsin, 미국, 53792
- University of Wisconsin Comprehensive Cancer Center
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Madison, Wisconsin, 미국, 53713
- Southern Wisconsin Radiotherapy Center
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Marshfield, Wisconsin, 미국, 54449
- Marshfield Clinic
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Menomonee Falls, Wisconsin, 미국, 53051
- Community Memorial Hospital
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Milwaukee, Wisconsin, 미국, 53211
- Columbia Hospital
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Milwaukee, Wisconsin, 미국, 53215
- St. Luke's Medical Center
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Milwaukee, Wisconsin, 미국, 53295
- Veterans Affairs Medical Center - Milwaukee (Zablocki)
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Milwaukee, Wisconsin, 미국, 53226
- Medical College of Wisconsin Cancer Center
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Racine, Wisconsin, 미국, 53405
- All Saints Cancer Center
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Waukesha, Wisconsin, 미국, 53188
- Waukesha Memorial Hospital Regional Cancer Center
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Alberta
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Calgary, Alberta, 캐나다, T2N 4N2
- Tom Baker Cancer Center - Calgary
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Edmonton, Alberta, 캐나다, T6G 1Z2
- Cross Cancer Institute
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New Brunswick
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Saint John, New Brunswick, 캐나다, E2L 4L2
- Saint John Regional Hospital
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Newfoundland and Labrador
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St. Johns, Newfoundland and Labrador, 캐나다, A1B 3V6
- Newfoundland Cancer Treatment and Research Foundation
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Nova Scotia
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Halifax, Nova Scotia, 캐나다, B3H 1V7
- Nova Scotia Cancer Centre
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Ontario
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Hamilton, Ontario, 캐나다, L8V 5C2
- Cancer Care Ontario-Hamilton Regional Cancer Centre
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Kingston, Ontario, 캐나다, K7L 5P9
- Kingston Regional Cancer Centre
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London, Ontario, 캐나다, N6A 4L6
- Cancer Care Ontario-London Regional Cancer Centre
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Ottawa, Ontario, 캐나다, K1H 1C4
- Ottawa Regional Cancer Centre
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Sudbury, Ontario, 캐나다, P3E 5J1
- Northeastern Ontario Regional Cancer Centre, Sudbury
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Thunder Bay, Ontario, 캐나다, P7A 7T1
- Northwestern Ontario Regional Cancer Centre, Thunder Bay
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Toronto, Ontario, 캐나다, M4N 3M5
- Toronto Sunnybrook Regional Cancer Centre
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Toronto, Ontario, 캐나다, M5G 2M9
- Princess Margaret Hospital
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Quebec
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Fleurimont, Quebec, 캐나다, J1H 5N4
- CHUS-Hopital Fleurimont
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Montreal, Quebec, 캐나다, H2W 1S6
- McGill University
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Montreal, Quebec, 캐나다, H2L 4MI
- Centre Hospitalier de l'Université de Montréal
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Quebec City, Quebec, 캐나다, G1R 2J6
- Centre Hospitalier Universitaire de Quebec
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Saskatchewan
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Regina, Saskatchewan, 캐나다, S4T 7T1
- Allan Blair Cancer Centre
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Saskatoon, Saskatchewan, 캐나다, S7N 4H4
- Saskatoon Cancer Centre
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: Radiation therapy - conventional fractionation
Radiation therapy - conventional fractionation (70 Gy/2 Gy once per day/7 Weeks) 35 fractions
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실험적: Radiation therapy - hyperfractionation
Radiation therapy - hyperfractionation (79.2 Gy/1.2 b.i.d/6.5 weeks) 66 fractions
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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Local Control
기간: 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.
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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.
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Acute Toxicity
기간: From start of treatment to 90 days
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From start of treatment to 90 days
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Late Toxicity
기간: From 91 days after start of treatment to last follow-up.
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From 91 days after start of treatment to last follow-up.
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Overall Survival
기간: From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 2 years
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From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 2 years
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Disease-free Survival
기간: 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.
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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.
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 의자: Andy M. Trotti, MD, H. Lee Moffitt Cancer Center and Research Institute
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
1996년 4월 1일
기본 완료 (실제)
2005년 10월 1일
연구 완료 (실제)
2016년 12월 1일
연구 등록 날짜
최초 제출
1999년 11월 1일
QC 기준을 충족하는 최초 제출
2003년 1월 26일
처음 게시됨 (추정)
2003년 1월 27일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2017년 1월 4일
QC 기준을 충족하는 마지막 업데이트 제출
2016년 12월 30일
마지막으로 확인됨
2016년 12월 1일
추가 정보
이 연구와 관련된 용어
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .