External-Beam Radiation Therapy Plus Implanted Radiation Therapy in Treating Patients With Prostate Cancer
NCT ID: NCT00006365
Last Updated: 2020-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
138 participants
INTERVENTIONAL
2000-11-30
2013-11-30
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of external-beam radiation therapy followed by implanted radiation therapy in treating patients who have prostate cancer.
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Detailed Description
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OUTLINE: This is a multicenter study. Patients undergo external beam radiotherapy (EBRT) to the pelvis 5 days a week for 5 weeks. Permanent source brachytherapy comprised of ultrasound-guided implantation of iodine I 125 seeds into the prostate is performed 2-6 weeks after completion of EBRT. Patients are followed at 1, 3, 6, 9, and 12 months, then every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 110 patients will be accrued for this study within 1 year.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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EBRT to the prostate followed by brachytherapy
Patients received 45 Gy of external beam radiation therapy (EBRT)to the prostate followed (within 2 to 6 weeks) by permanent iodine (I-125) brachytherapy 108 Gy.
brachytherapy
iodine I 125
radiation therapy
Interventions
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brachytherapy
iodine I 125
radiation therapy
Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: Over 18 Performance status: Zubrod 0-1 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No hip prosthesis No other malignancy within the past 5 years except basal cell or squamous cell skin cancer No major medical or psychiatric illness that would preclude study Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Prior induction hormonal therapy allowed only if started no more than 6 months prior to study Radiotherapy: See Disease Characteristics No prior radiotherapy to pelvis Surgery: No prior transurethral resection of prostate No radical surgery for carcinoma of the prostate
18 Years
120 Years
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Radiation Therapy Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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W. Robert Lee, MD
Role: STUDY_CHAIR
Wake Forest University Health Sciences
Locations
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University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States
Huntsville Hospital System
Huntsville, Alabama, United States
Comprehensive Cancer Institute of Huntsville
Huntsville, Alabama, United States
MBCCOP - Gulf Coast
Mobile, Alabama, United States
Alabama Oncology, LLC
Montgomery, Alabama, United States
Radiation Oncology Associates of West Alabama
Tuscaloosa, Alabama, United States
Providence Alaska Medical Center
Anchorage, Alaska, United States
Arizona Cancer Center
Tucson, Arizona, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Mount Diablo Medical Center
Concord, California, United States
Cancer Center and Beckman Research Institute, City of Hope
Duarte, California, United States
California Cancer Center
Fresno, California, United States
Saint Agnes Cancer Center
Fresno, California, United States
Glendale Memorial Hospital and Health Center
Glendale, California, United States
Sutter Health West Cancer Research Group
Greenbrae, California, United States
University of California San Diego Cancer Center
La Jolla, California, United States
Loma Linda University Medical Center
Loma Linda, California, United States
Veterans Affairs Medical Center - Long Beach
Long Beach, California, United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States
CCOP - Bay Area Tumor Institute
Oakland, California, United States
Huntington Cancer Center
Pasadena, California, United States
Cancer Care Center
Pomona, California, United States
Radiation Oncology Center - Sacramento
Sacramento, California, United States
Radiation Medical Group, Inc.
San Diego, California, United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, United States
O'Connor Hospital
San Jose, California, United States
CCOP - Santa Rosa Memorial Hospital
Santa Rosa, California, United States
David Grant Medical Center
Travis Air Force Base, California, United States
Memorial Hospital Cancer Center
Colorado Springs, Colorado, United States
University of Colorado Cancer Center
Denver, Colorado, United States
Saint Mary's Hospital and Medical Center
Grand Junction, Colorado, United States
CCOP - Christiana Care Health Services
Wilmington, Delaware, United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States
Lykes Center for Radiation Therapy
Clearwater, Florida, United States
Halifax Medical Center
Daytona Beach, Florida, United States
Radiation Therapy Associates - Fort Myers
Fort Myers, Florida, United States
University of Florida Health Science Center
Gainesville, Florida, United States
Health First Holmes Regional Medical Center
Melbourne, Florida, United States
Veterans Affairs Medical Center - Miami
Miami, Florida, United States
Sylvester Cancer Center, University of Miami
Miami, Florida, United States
Baptist Hospital of Miami
Miami, Florida, United States
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States
Florida Radiation Oncology Group
Orange Park, Florida, United States
MD Anderson Cancer Center Orlando
Orlando, Florida, United States
Bay Medical Center
Panama City, Florida, United States
Gulf Coast Cancer Treatment Center
Panama City, Florida, United States
Sarasota Radiation and Medical Oncology Center
Sarasota, Florida, United States
Tallahassee Memorial Healthcare
Tallahassee, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Emory University Hospital - Atlanta
Atlanta, Georgia, United States
CCOP - Atlanta Regional
Atlanta, Georgia, United States
Medical Center/John B. Amos Community Cancer Center
Columbus, Georgia, United States
InterCommunity Cancer Center at Rome
Rome, Georgia, United States
Northwest Community Hospital
Arlington Heights, Illinois, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
University of Chicago Cancer Research Center
Chicago, Illinois, United States
CCOP - Central Illinois
Decatur, Illinois, United States
Provena St. Joseph Hospital- Regional Cancer Care Center
Elgin, Illinois, United States
Ingalls Memorial Hospital
Harvey, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Lutheran General Cancer Care Center
Park Ridge, Illinois, United States
Methodist Medical Center of Illinois
Peoria, Illinois, United States
St. John's Medical Center
Anderson, Indiana, United States
Bloomington Hospital
Bloomington, Indiana, United States
Veterans Affairs Medical Center - Indianapolis (Roudebush)
Indianapolis, Indiana, United States
Clarion Health Partners Inc.
Indianapolis, Indiana, United States
Community Hospitals of Indianapolis - Regional Cancer Center
Indianapolis, Indiana, United States
Ball Memorial Hospital
Muncie, Indiana, United States
Wendt Regional Cancer Center of Finley Hospital
Dubuque, Iowa, United States
Holden Comprehensive Cancer Center at The University of Iowa
Iowa City, Iowa, United States
Central Baptist Hospital
Lexington, Kentucky, United States
Veterans Affairs Medical Center - Lexington
Lexington, Kentucky, United States
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, United States
James Graham Brown Cancer Center
Louisville, Kentucky, United States
Louisville Radiation Oncology
Louisville, Kentucky, United States
Merle M. Mahr Cancer Center
Madisonville, Kentucky, United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, United States
Romagosa Radiation Oncology Center
Lafayette, Louisiana, United States
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, United States
Tulane University School of Medicine
New Orleans, Louisiana, United States
CCOP - Ochsner
New Orleans, Louisiana, United States
Maine Medical Center
Portland, Maine, United States
Anne Arundel Oncology Center
Annapolis, Maryland, United States
Greater Baltimore Medical Center and Cancer Center
Baltimore, Maryland, United States
Harbor Hospital Center
Baltimore, Maryland, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, United States
Johns Hopkins Oncology Center
Baltimore, Maryland, United States
Radiation Oncology Affiliates of Maryland, P.A.
Baltimore, Maryland, United States
Peninsula Regional Medical Center
Salisbury, Maryland, United States
Cape Cod Hospital
Hyannis, Massachusetts, United States
Veterans Affairs Medical Center - Boston (Jamaica Plain)
Jamaica Plain, Massachusetts, United States
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
McLaren Regional Cancer Center
Flint, Michigan, United States
Hurley Medical Center
Flint, Michigan, United States
CCOP - Kalamazoo
Kalamazoo, Michigan, United States
Marquette General Hospital
Marquette, Michigan, United States
MidMichigan Medical Center - Midland
Midland, Michigan, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
St. Mary's Medical Center
Saginaw, Michigan, United States
William Beaumont Hospital - Troy
Troy, Michigan, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States
North Mississippi Medical Center/Cancer Center
Tupelo, Mississippi, United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, United States
CCOP - Kansas City
Kansas City, Missouri, United States
Cancer Research for the Ozarks
Springfield, Missouri, United States
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States
St. Louis University Health Sciences Center
St Louis, Missouri, United States
Mallinckrodt Institute of Radiology
St Louis, Missouri, United States
CCOP - Montana Cancer Consortium
Billings, Montana, United States
Nebraska Health System
Omaha, Nebraska, United States
Methodist Cancer Center - Omaha
Omaha, Nebraska, United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, United States
Elliot Regional Cancer Center
Manchester, New Hampshire, United States
Veterans Affairs Medical Center - East Orange
East Orange, New Jersey, United States
John F. Kennedy Medical Center
Edison, New Jersey, United States
Trinitas Hospital - Jersey Street Campus
Elizabeth, New Jersey, United States
Monmouth Medical Center
Long Branch, New Jersey, United States
South Jersey Regional Cancer Center
Millville, New Jersey, United States
Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County
Mount Holly, New Jersey, United States
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Newark Beth Israel Medical Center
Newark, New Jersey, United States
Atlantic City Medical Center
Pomona, New Jersey, United States
Valley Hospital
Ridgewood, New Jersey, United States
Community Medical Center
Toms River, New Jersey, United States
St. Francis Medical Center
Trenton, New Jersey, United States
Associated Radiologists, P.A.
Warren Township, New Jersey, United States
Saint Joseph Medical Center
Albuquerque, New Mexico, United States
Cancer Center of Albany Medical Center
Albany, New York, United States
State University of New York Health Science Center at Brooklyn
Brooklyn, New York, United States
New York Methodist Hospital
Brooklyn, New York, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Finger Lakes Radiation Oncology, P.C.
Clifton Springs, New York, United States
CCOP - North Shore University Hospital
Manhasset, New York, United States
Beth Israel Medical Center
New York, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Herbert Irving Comprehensive Cancer Center
New York, New York, United States
Champlain Valley Physicians Hospital Medical Center
Plattsburgh, New York, United States
Vassar Brothers Hospital
Poughkeepsie, New York, United States
University of Rochester Cancer Center
Rochester, New York, United States
Albert Einstein Comprehensive Cancer Center
The Bronx, New York, United States
New York Medical College
Valhalla, New York, United States
Riverhill Radiation Oncology
Yonkers, New York, United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States
Northeast Medical Center
Concord, North Carolina, United States
East Carolina University School of Medicine
Greenville, North Carolina, United States
Catawba Memorial Hospital
Hickory, North Carolina, United States
CCOP - Southeast Cancer Control Consortium
Winston-Salem, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States
Bowman Gray School of Medicine
Winston-Salem, North Carolina, United States
Meritcare Roger Maris Cancer Center
Fargo, North Dakota, United States
Trinity Cancer Care Center
Minot, North Dakota, United States
Akron General Medical Center
Akron, Ohio, United States
Akron City Hospital
Akron, Ohio, United States
Barrett Cancer Center, The University Hospital
Cincinnati, Ohio, United States
Christ Hospital
Cincinnati, Ohio, United States
Ireland Cancer Center
Cleveland, Ohio, United States
University Hospitals of Cleveland
Cleveland, Ohio, United States
CCOP - Columbus
Columbus, Ohio, United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States
CCOP - Dayton
Kettering, Ohio, United States
CCOP - Toledo Community Hospital Oncology Program
Toledo, Ohio, United States
St. Anthony Hospital
Oklahoma City, Oklahoma, United States
Oklahoma University Medical Center
Oklahoma City, Oklahoma, United States
St. John Health System
Tulsa, Oklahoma, United States
CCOP - Columbia River Program
Portland, Oregon, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, United States
St. Luke's Hospital Regional Cancer Center
Bethlehem, Pennsylvania, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Fitzgerald Mercy Hospital
Darby, Pennsylvania, United States
Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, United States
Pocono Cancer Center
East Stroudsburg, Pennsylvania, United States
Penn State Geisinger Cancer Center
Hershey, Pennsylvania, United States
Hahnemann University Hospital
Philadelphia, Pennsylvania, United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States
Veterans Affairs Medical Center - Philadelphia
Philadelphia, Pennsylvania, United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, United States
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States
Mercy Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States
Reading Hospital and Medical Center
Reading, Pennsylvania, United States
Mercy Hospital Cancer Center - Scranton
Scranton, Pennsylvania, United States
Grand View Hospital
Sellersville, Pennsylvania, United States
Wilkes Barre General Hospital
Wilkes-Barre, Pennsylvania, United States
CCOP - MainLine Health
Wynnewood, Pennsylvania, United States
York Hospital
York, Pennsylvania, United States
Roger Williams Medical Center/BUSM
Providence, Rhode Island, United States
Medical University of South Carolina
Charleston, South Carolina, United States
CCOP - Greenville
Greenville, South Carolina, United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States
Rapid City Regional Hospital
Rapid City, South Dakota, United States
Jackson-Madison County General Hospital
Jackson, Tennessee, United States
University of Tennessee, Memphis Cancer Center
Memphis, Tennessee, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Harrington Cancer Center
Amarillo, Texas, United States
Julie and Ben Rogers Cancer Institute
Beaumont, Texas, United States
University of Texas Medical Branch
Galveston, Texas, United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
Wilford Hall - 59th Medical Wing
Lackland Air Force Base, Texas, United States
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, United States
Bayshore Medical Center
Pasadena, Texas, United States
East Texas Medical Center - Cancer Institute
Tyler, Texas, United States
University of Utah Health Sciences Center
Salt Lake City, Utah, United States
LDS Hospital
Salt Lake City, Utah, United States
Dixie Regional Medical Center
St. George, Utah, United States
CCOP - Southwestern Vermont Regional Cancer Center
Bennington, Vermont, United States
Vermont Cancer Center
Burlington, Vermont, United States
Martha Jefferson Hospital
Charlottesville, Virginia, United States
Cancer Center at the University of Virginia
Charlottesville, Virginia, United States
RMH Regional Canter Center
Harrisonburg, Virginia, United States
Naval Medical Center, Portsmouth
Portsmouth, Virginia, United States
Bon-Secours - St. Mary's Hospital
Richmond, Virginia, United States
Massey Cancer Center
Richmond, Virginia, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Deaconess Medical Center
Spokane, Washington, United States
Yakima Valley Memorial Hospital
Yakima, Washington, United States
Schiffler Cancer Center
Wheeling, West Virginia, United States
St. Vincent Hospital
Green Bay, Wisconsin, United States
Gundersen Lutheran Medical Foundation
La Crosse, Wisconsin, United States
Southern Wisconsin Radiotherapy Center
Madison, Wisconsin, United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States
Marshfield Clinic
Marshfield, Wisconsin, United States
Community Memorial Hospital
Menomonee Falls, Wisconsin, United States
St. Joseph's Hospital
Milwaukee, Wisconsin, United States
Columbia Hospital
Milwaukee, Wisconsin, United States
St. Luke's Medical Center
Milwaukee, Wisconsin, United States
Veterans Affairs Medical Center - Milwaukee (Zablocki)
Milwaukee, Wisconsin, United States
Southeastern Wisconsin Regional Cancer Center
Racine, Wisconsin, United States
Waukesha Memorial Hospital
Waukesha, Wisconsin, United States
Tom Baker Cancer Center - Calgary
Calgary, Alberta, Canada
British Columbia Cancer Agency
Vancouver, British Columbia, Canada
Saint John Regional Hospital
Saint John, New Brunswick, Canada
Newfoundland Cancer Treatment and Research Foundation
St. John's, Newfoundland and Labrador, Canada
Nova Scotia Cancer Centre
Halifax, Nova Scotia, Canada
Northeastern Ontario Regional Cancer Centre, Sudbury
Greater Sudbury, Ontario, Canada
Cancer Care Ontario-Hamilton Regional Cancer Centre
Hamilton, Ontario, Canada
Kingston Regional Cancer Centre
Kingston, Ontario, Canada
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, Canada
Ottawa Regional Cancer Centre - General Campus
Ottawa, Ontario, Canada
Northwestern Ontario Regional Cancer Centre, Thunder Bay
Thunder Bay, Ontario, Canada
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
CHUS-Hopital Fleurimont
Fleurimont, Quebec, Canada
McGill University
Montreal, Quebec, Canada
CHU de Quebec - L'Hotel-Dieu de Quebec
Québec, Quebec, Canada
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada
Countries
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References
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Lee W, Bae K, Lawton C, et al.: Biochemical recurrence and late toxicity following external beam radiotherapy combined with permanent source prostate brachytherapy: analysis of RTOG 0019. [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-100, S57, 2006.
Lee W, Bae K, Lawton CF, et al.: A descriptive analysis of postimplant dosimetric parameters from RTOG P0019. [Abstract] 2006 Prostate Cancer Symposium, February 24-26, 2006, San Francisco, CA. A-83, 2006.
Lee WR, DeSilvio M, Lawton C, Gillin M, Morton G, Firat S, Baikadi M, Kuettel M, Greven K, Sandler H. A phase II study of external beam radiotherapy combined with permanent source brachytherapy for intermediate-risk, clinically localized adenocarcinoma of the prostate: preliminary results of RTOG P-0019. Int J Radiat Oncol Biol Phys. 2006 Mar 1;64(3):804-9. doi: 10.1016/j.ijrobp.2005.09.002. Epub 2005 Nov 14.
Lee W, DeSilvio M, Lawton C, et al.: Is postimplant dosimetry associated with late morbidity? A secondary analysis of RTOG P-0019. [Abstract] American Society of Clinical Oncology 2005 Prostate Cancer Symposium, 17-19 February 2005, Orlando, Florida. A-96, 2005.
Lee WR, Bae K, Lawton CA, Gillin MT, Morton G, Firat S, Baikadi M, Kuettel M, Greven K, Sandler H. A descriptive analysis of postimplant dosimetric parameters from Radiation Therapy Oncology Group P0019. Brachytherapy. 2006 Oct-Dec;5(4):239-43. doi: 10.1016/j.brachy.2006.08.005.
Lawton CA, Yan Y, Lee WR, Gillin M, Firat S, Baikadi M, Crook J, Kuettel M, Morton G, Sandler H. Long-term results of an RTOG Phase II trial (00-19) of external-beam radiation therapy combined with permanent source brachytherapy for intermediate-risk clinically localized adenocarcinoma of the prostate. Int J Radiat Oncol Biol Phys. 2012 Apr 1;82(5):e795-801. doi: 10.1016/j.ijrobp.2011.11.040. Epub 2012 Feb 11.
Lee WR, Bae K, Lawton C, Gillin M, Morton G, Firat S, Baikadi M, Kuettel M, Greven K, Sandler H. Late toxicity and biochemical recurrence after external-beam radiotherapy combined with permanent-source prostate brachytherapy: analysis of Radiation Therapy Oncology Group study 0019. Cancer. 2007 Apr 15;109(8):1506-12. doi: 10.1002/cncr.22560.
Other Identifiers
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CDR0000068238
Identifier Type: -
Identifier Source: secondary_id
RTOG-P-0019
Identifier Type: -
Identifier Source: org_study_id
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