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RTOG 0126 Protocol Information

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A Phase III Randomized Study of High Dose 3DCRT/IMRT versus Standard Dose 3DCRT/IMRT in Patients Treated for Localized Prostate Cancer
Protocol Documents
Current Version Date: 6/12/2014
Principal Investigator: Jeff Michalski, M.D., M.B.A.
Primary Objective:

Determine whether 3D-CRT/IMRT to 79.2 Gy in 44 fractions will lead to improved overall survival in patients treated for prostate cancer compared to a group of patients treated with 3D-CRT/ IMRT to 70.2 Gy in 39 fractions.

Patient Population:


Histologically confirmed prostate adenocarcinoma within 180 days of randomization
Zubrod Performance Scale 0-1
Prostatic biopsy tumor grading by the Gleason Score Classification
One of the following combinations of factors:
• Clinical stage T1b-T2b, Gleason score 2-6, and prostate-specific antigen > =10 but < 20
• Clinical stage T1b-T2b, Gleason score 7, and prostate-specific antigen < 15
Clinically negative lymph nodes or histologically negative by nodal sampling or dissection
No distant metastases (M0)
No previous or concurrent invasive cancers, other than localized basal cell or squamous cell skin carcinoma, unless continually disease free for at least 5 years
No prior pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy
No previous or concurrent cytotoxic chemotherapy for this cancer
No previous hormonal treatment (no finasteride or phytoestrogen preparation within 3 months prior to registration)
- No radical surgery or cryosurgery for prostate cancer
- Pretreatment evaluations must be completed as specified in Section 4.1
 

Target Accrual: 1520
Current Accrual: 1532
Status: Closed to Accrual
Date: 8/20/2008
Participating Sites:
Abington Memorial Hospital Abington PA
ACR Clinical Research Center Philadelphia PA
Advocate Good Samaritan Hospital Downers Grove IL
Advocate Good Shepherd Hospital Barrington IL
Advocate Illinois Masonic Medical Center Chicago IL
Allegiance Health Jackson MI
Alta Bates Summit Medical Center - Summit Campus Oakland CA
Aria Health Philadelphia PA
Arizona Oncology Associates-Deer Valley Center Phoenix AZ
Arizona Oncology Services Foundation Scottsdale AZ
AtlantiCare Regional Medical Center Pomona NJ
Baptist Health Madisonville/Merle Mahr Cancer Center Madisonville KY
Baton Rouge General Medical Center Baton Rouge LA
Bay Area Tumor Institute Oakland CA
Bay Medical Center Panama City FL
Beaumont Hospital-Dearborn Dearborn MI
Beth Israel Medical Center New York NY
Borgess Medical Center Kalamazoo MI
Boston Medical Center MBCCOP Boston MA
Bronson Methodist Hospital Kalamazoo MI
Brooke Army Medical Center Fort Sam Houston TX
Bryn Mawr Hospital Bryn Mawr PA
Cancer Care Center, Inc Salem OH
Cancer Care Manitoba Foundation Winnipeg, Manitoba
Cancer Institute of New Mexico Santa Fe NM
Cancer Treatment Center Wooster OH
Cape Cod Hospital Hyannis MA
Cape Radiation Oncology Cape Girardeau MO
Case Western Reserve University Cleveland OH
Cayuga Medical Center Ithaca NY
Central Maryland Radiation Oncology in Howard County Columbia MD
Centre Hospitalier de l`Universite de Montreal-Notre Dame Montreal Quebec
Champlain Valley Physicians Hospital Medical Center Plattsburgh NY
Cheshire Medical Center-Dartmouth-Hitchcock Keene Keene NH
CHI Health Good Samaritan Kearney NE
Christiana Care Health System-Christiana Hospital Newark DE
CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ) Quebec
CHUM - Centre Hospitalier de l'Universite de Montreal Montreal
CJW Medical Center - Thomas Johns Cancer Center Richmond VA
Cleveland Clinic Cancer Center/Fairview Hospital Cleveland OH
Cleveland Clinic Foundation Cleveland OH
Clifton Springs Hospital and Clinic Clifton Springs NY
Coborn Cancer Center at Saint Cloud Hospital St. Cloud MN
Columbia Saint Mary's Water Tower Medical Commons Milwaukee WI
Community Memorial Hospital Menomonee Falls WI
Concord Hospital Payson Center for Cancer Care Concord NH
Cooper Health System-Voorhees Voorhees NJ
Cooper Hospital University Medical Center Camden NJ
Cottonwood Hospital Medical Center Murray UT
Cross Cancer Institute Edmonton, Alberta
Danville Regional Medical Center Danville VA
Dartmouth Hitchcock Medical Center Lebanon NH
David Grant United States Air Force Medical Center Travis AFB CA
Delaware County Memorial Hospital Drexel Hill PA
Dixie Medical Center Regional Cancer Center East St. George UT
Doctor H. Bliss Murphy Cancer Centre St. John's, NL
Doctors Medical Center- JC Robinson Regional Cancer Center San Pablo CA
Duke Women's Cancer Care Raleigh Raleigh NC
East Bay Radiation Oncology Center Castro Valley CA
Einstein Medical Center Philadelphia Philadelphia PA
Finley Hospital Dubuque IA
Fox Chase Cancer Center Philadelphia PA
Franciscan St. James Health-Olympia Fields Campus Olympia Fields IL
Franciscan St. Margaret Health Hammond IN
Froedtert and the Medical College of Wisconsin Milwaukee WI
Geisinger Medical Center Danville PA
Geisinger Wyoming Valley/Henry Cancer Center Wilkes Barre PA
Genesys Hurley Cancer Institute Flint MI
Gundersen Lutheran Medical Center La Crosse WI
Guthrie Medical Group PC-Robert Packer Hospital Sayre PA
Harbin Clinic Rome GA
Harrison Medical Center Bremerton WA
Health Sciences North Sudbury, Ontario
Helen Denit Cancer Center Olney MD
Henry Ford Hospital Detroit MI
Highland Hospital Rochester NY
Hillcrest Hospital Cancer Center Mayfield Heights OH
Hudson Valley Oncology Associates Poughkeepsie NY
Hunter Holmes McGuire Veterans Administration Medical Center Richmond VA
Hurley Medical Center Flint MI
Huron Valley Hospital Commerce Township MI
Image-Guided Therapy QA Center (ITC) St. Louis MO
Indiana University Health Ball Memorial Hospital, Inc. Muncie IN
Indiana University Health Methodist Hospital Indianapolis IN
Indiana University/Melvin and Bren Simon Cancer Center Indianapolis IN
Ingham Regional Medical Center Lansing MI
Inspira Medical Center Vineland Vineland NJ
Intermountain Medical Center Murray UT
John B Amos Cancer Center Columbus GA
John H Stroger Jr Hospital of Cook County Chicago IL
John Muir Medical Center-Concord Concord CA
John Muir Medical Center-Walnut Creek Concord CA
Juravinski Cancer Centre at Hamilton Health Sciences Hamilton, Ontario
Kalamazoo CCOP-West Michigan Cancer Center Kalamazoo MI
Kansas City CCOP Prairie Village KS
Lake/University Seidman Cancer Center Mentor OH
Lankenau Medical Center Wynnewood PA
LDS Hospital Salt Lake City UT
Lexington Clinic Cancer Center Lexington KY
Liberty Hospital Liberty MO
Logan Regional Hospital Logan UT
London Regional Cancer Program London Ontario
Louisiana State University Health Science Center New Orleans LA
Lovelace Medical Center-Downtown Albuquerque NM
Lutheran General Hospital Park Ridge IL
Mainline Health CCOP Wynnewood PA
Marshfield Clinic Marshfield WI
Mary Bird Perkins Cancer Center Baton Rouge LA
Mayo Clinic Rochester MN
Mayo Clinic in Florida Jacksonville FL
McGill University Department of Oncology Montreal
McKay-Dee Hospital Center Ogden UT
McLaren Cancer Institute - Flint Flint MI
Memorial and Saint Elizabeth's Health Care Services LLP Swansea IL
Mercy Catholic Medical Center - Fitzgerald Darby PA
Mercy General Radiation Oncology Center Sacramento CA
Mercy Hospital Joplin Joplin MO
Mercy Hospital Saint Louis St Louis MO
Mercy San Juan Medical Center Carmichael CA
Methodist Hospital Philadelphia PA
Methodist Medical Center of Illinois Peoria IL
Michigan Cancer Research Consortium Community Clinical Oncology Program Ann Arbor MI
MNAP Oncology Center Philadelphia PA
Mobile Infirmary Medical Center Mobile AL
Moffitt Cancer Center Tampa FL
Monmouth Medical Center Long Branch NJ
Montana Cancer Consortium CCOP Billings MT
Mount Nittany Medical Center - Penn State Cancer Institute State College PA
Mount Sinai Hospital Chicago IL
Naval Medical Center San Diego CA
Naval Medical Center - Portsmouth Portsmouth VA
Nevada Cancer Research Foundation CCOP Las Vegas NV
New York-Presbyterian/Brooklyn Methodist Hospital Brooklyn NY
Norris Cotton Cancer Center Saint Johnsbury VT
North Coast Cancer Care Sandusky OH
North Shore-LIJ Health System CCOP Manhasset NY
Northeast Georgia Medical Center-Gainesville Gainesville GA
Northeast Radiation Oncology Center Dunmore PA
Northwest Community Hospital Arlington Heights IL
Northwestern Ontario Regional Cancer Centre Thunder Bay, Ontario
Novant Health Presbyterian Medical Center Charlotte NC
Ozark Health Ventures LLC-Cancer Research for The Ozarks Springfield Springfield MO
Paoli Memorial Hospital Paoli PA
Peninsula Regional Medical Center Salisbury MD
Pomona Valley Hospital Medical Center Pomona CA
Presbyterian Intercommunity Hospital Whittier CA
Providence Regional Cancer Partnership Everett WA
Radiation Oncology Associates Reno NV
Radiation Oncology Associates of Albuquerque Albuquerque NM
Radiation Oncology Center Alliance OH
Radiological Associates of Sacramento Sacramento CA
Radiological Physics Center (RPC) Houston TX
Rapid City Regional Hospital Rapid City SD
Reading Hospital Reading PA
Regional Hospital of Scranton Scranton PA
Rex Cancer Center Raleigh NC
Rex Cancer Center Raleigh NC
Richard L. Roudebush VA Medical Center Indianapolis IN
Roper Hospital Charleston SC
Roswell Park Cancer Institute Buffalo NY
Saint Agnes Medical Center Fresno CA
Saint John Hospital and Medical Center Grosse Pointe Woods MI
Saint John Macomb-Oakland Hospital Warren MI
Saint John Regional Hospital Saint John, NB
Saint Joseph Mercy Hospital Ann Arbor MI
Saint Luke's University Hospital-Bethlehem Campus Bethlehem PA
Saint Mary's Hospital and Regional Medical Center Grand Junction CO
Saint Mary's of Michigan Saginaw MI
Saint Mary's Regional Medical Center Reno NV
Saint Rita's Medical Center Lima OH
Sandra L Maxwell Cancer Center Cedar City UT
Saskatoon Cancer Centre Saskatoon, Saskatchew
Scott and White Memorial Hospital Temple TX
Singing River Hospital Pascagoula MS
Siteman Cancer Center at Saint Peters Hospital St. Peters MO
Siteman Cancer Center at West County Hospital St. Louis MO
Southeast Missouri Hospital Cape Girardeau MO
Southwest VA Regional Cancer Center Norton VA
Sparrow Hospital Lansing MI
Sparta Cancer Center Sparta NJ
St Anne's Hospital Fall River MA
St Luke's-Roosevelt Hospital Center New York NY
St. Anthony's Health Alton IL
St. Francis Medical Center Trenton NJ
State University of New York Downstate Medical Center Brooklyn NY
State University of New York Upstate Medical University Syracuse NY
Summa Akron City Hospital/Cooper Cancer Center Akron OH
Summa Barberton Hospital Barberton OH
Sutter Cancer Centers Radiation Oncology Services-Auburn Auburn CA
Sutter Cancer Centers Radiation Oncology Services-Cameron Park Cameron Park CA
Sutter Cancer Centers Radiation Oncology Services-Roseville Roseville CA
Sutter Cancer Centers Radiation Oncology Services-Vacaville Vacaville CA
Sutter Medical Center Sacramento Sacramento CA
Temple University Hospital Philadelphia PA
Texas Cancer Clinic San Antonio TX
The James Graham Brown Cancer Center at University of Louisville Louisville KY
The Research Institute of the McGill University Health Centr Montreal
Thomas Jefferson University Hospital Philadelphia PA
Thompson Cancer Survival Center Knoxville TN
Thompson Cancer Survival Center - West Knoxville TN
Thompson Cancer Survival Center at Methodist Oak Ridge TN
Tom Baker Cancer Centre Calgary, Alberta
Toronto-Sunnybrook Regional Cancer Centre Toronto, Ontario
Tulane University Medical Center New Orleans LA
UCHealth Memorial Hospital Central Colorado Springs CO
UCSF Medical Center-Mount Zion San Francisco CA
UF Cancer Center at Orlando Health Orlando FL
UH Seidman Cancer Center at Geauga Medical Center Chardon OH
UH Seidman Cancer Center at Southwest General Middleburgh OH
UHHS - Chagrin Highlands Orange Village OH
UHHS-Westlake Medical Center Westlake OH
University Hospital of Brooklyn at Long Island College Hospital Brooklyn NY
University Medical Center New Orleans New Orleans LA
University Medical Center of Princeton at Plainsboro Princeton NJ
University of California Davis Comprehensive Cancer Center Sacramento CA
University of Cincinnati/Barrett Cancer Center Cincinnati OH
University of Florida Health Science Center - Gainesville Gainesville FL
University of Florida Health Science Center - Jacksonville Jacksonville FL
University of Kentucky/Markey Cancer Center Lexington KY
University of Maryland/Greenebaum Cancer Center Baltimore MD
University of Miami Miller School of Medicine-Sylvester Cancer Center Miami FL
University of Michigan Comprehensive Cancer Center Ann Arbor MI
University of Missouri - Ellis Fischel Columbia MO
University of New Mexico Cancer Center Albuquerque NM
University of New Mexico Cancer Center Albuquerque NM
University of Oklahoma Health Sciences Center Oklahoma City OK
University of Rochester Rochester NY
University of Southwestern Moncrief Cancer Ctr-Fort Worth Fort Worth TX
University of Texas Medical Branch Galveston TX
University of Texas Southwestern Medical School Dallas TX
University of Texas Southwestern Medical School Dallas TX
University of Utah Health Science Center Salt Lake City UT
University Pointe-Precision Radiotherapy West Chester OH
UP Health System Marquette Marquette MI
UPMC Cancer Center at UPMC McKeesport McKeesport PA
UPMC-Arnold Palmer Pavilion Greensburg PA
UPMC-Cancer Center at St. Clair Hospital Pittsburgh PA
UPMC-Passavant Hospital Pittsburgh PA
UPMC-Presbyterian Hospital Pittsburgh PA
UPMC-Saint Margaret Pittsburgh PA
UPMC-Shadyside Hospital Pittsburgh PA
Utah Cancer Specialists-Salt Lake City Salt Lake City UT
Utah Valley Regional Medical Center Provo UT
Valley Medical Oncology Consultants Pleasanton CA
Veteran Affairs New York Harbor Healthcare System-Brooklyn Campus Brooklyn NY
Veterans Administration Hospital-East Orange Campus East Orange NJ
Veterans Administration Long Beach Medical Center Long Beach CA
Veteran's Administration Medical Center - Ann Arbor Ann Arbor MI
Virginia Mason CCOP Seattle WA
Virginia Mason Medical Center Seattle WA
Virtua Memorial Mount Holly NJ
Wake Forest University Health Sciences Winston-Salem NC
Washington Cancer Institute Washington DC
Washington University School of Medicine St. Louis MO
Wayne Memorial Hospital Goldsboro NC
Wayne Radiation Oncology Goldsboro NC
Wayne State University/Karmanos Cancer Institute Detroit MI
Wellmont Holston Valley Hospital and Medical Center Kingsport TN
WellSpan Health-York Hospital York PA
West Penn Hospital Pittsburgh PA
Wheaton Franciscan Cancer Care-All Saints Racine WI
Wilford Hall USAF Medical Center Lackland AFB TX
William Beaumont Hospital - Troy Troy MI
William Beaumont Hospital-Royal Oak Royal Oak MI
Wilmed Radiation Oncology Services Wilson NC
Zablocki VA Medical Center-Wood Milwaukee WI
Updated: 7/28/2014

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