RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen by the tumor cells. It is not yet known if radiation therapy is more effective than observation, with or without tamoxifen, in treating ductal carcinoma in situ. PURPOSE:...
Date First Received: November 1, 1999
Last Updated: June 21, 2008
Verified by: National Cancer Institute (NCI), July 2006
Clinical Trial Phase: Phase 3 | Start Date: December 1999
Overall Status: Active, not recruiting
Estimated Enrollment: 1790
Brief Summary
Official Title: “Phase III Trial of Tamoxifen Alone vs. Tamoxifen Plus RT for Good Risk Duct Carcinoma In-Situ (DCIS) of the Female Breast”
Condition Keyword(s):
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen by the tumor cells. It is not yet known if radiation therapy is more effective than observation, with or without tamoxifen, in treating ductal carcinoma in situ.
PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with that of observation, with or without tamoxifen, in treating women who have ductal carcinoma in situ.
Study Type: Interventional
Study Design: Treatment, Randomized, Active Control
Detailed Clinical Trial Description
OBJECTIVES: - Compare the efficacy of whole breast radiotherapy vs observation with or without optional tamoxifen in decreasing or delaying the appearance of local failure (both invasive and in situ) and preventing the need for mastectomy in women with good-risk ductal carcinoma in situ (DCIS) of the breast. - Compare distant disease-free survival of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (under 50 vs 50 and over), final path margins (negative vs 3-9 mm vs at least 10 mm), mammographic size of primary (no greater than 1 cm vs greater than 1 cm to 2.5 cm), nuclei grade (low vs intermediate), and tamoxifen use (yes vs no). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients undergo observation and may receive optional oral tamoxifen once daily (at the discretion of the physician) for 5 years. - Arm II: Beginning within 12 weeks after final surgery, patients receive radiotherapy to the whole breast once daily, 5 days a week, for 3.5-5.5 weeks. Patients may receive optional tamoxifen as in arm I.
Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 1,790 patients will be accrued for this study within 6 years.
Outcome Measures for this Clinical Trial
Primary:
- Local recurrence (e.g., invasive or noninvasive recurrence) No
Secondary:
- Overall survival No
- Time to distant metastasis No
- Invasive local recurrence No
- Salvage mastectomy rate No
Criteria for Participation in this Clinical Trial
DISEASE CHARACTERISTICS:
- Ductal carcinoma in situ (DCIS) of the breast detected by mammogram at the time of diagnosis
- Unicentric
- Lesions ≤ 2.5 cm
- Low nuclei grade (NG1) or intermediate nuclei grade (NG2) with necrosis in < one third of the involved ducts
- Inked margins ≥ 3 mm
- Clinically node negative
- Non-palpable
- No suspicious areas on post-operative mammogram taken within 12 weeks after final surgery
- No bloody nipple discharge
- No more than 12 weeks since prior final surgery (arm II only)
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age:
- 26 and over
Sex:
- Female
Menopausal status:
- Not specified
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
Other:
- Not pregnant or nursing
- No active connective tissue disorders (e.g., lupus or scleroderma)
- No prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy
Endocrine therapy:
- No other concurrent hormonal therapy (e.g., raloxifene, hormone replacement therapy, or birth control pills)
Radiotherapy:
- No prior radiotherapy
Surgery:
- See Disease Characteristics
Clinical Trials Locations, Contact Details, and Sponsors
Lead Sponsor: Radiation Therapy Oncology Group
Mobile Infirmary Medical Center
Mobile Alabama 36652-2144 United States
Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital
Fairbanks Alaska 99701 United States
Arizona Oncology Services Foundation
Phoenix Arizona 85013 United States
Saint Joseph's Mercy Cancer Center
Hot Springs Arkansas 71913 United States
Cancer Care Consultants Medical Associates at Daniel Freeman Memorial Hospital
Inglewood California 90301 United States
CCOP - Bay Area Tumor Institute
Oakland California 94609 United States
CCOP - Santa Rosa Memorial Hospital
Sana Rosa California 95405 United States
Enloe Cancer Center at Enloe Medical Center
Chico California 95926 United States
John Muir/Mt. Diablo Comprehensive Cancer Center
Walnut Creek California 94598 United States
Memorial Medical Center Cancer Services
Modesto California 95355 United States
Mount Diablo Regional Cancer Center
Concord California 94524-4110 United States
North Bay Cancer Center
Fairfield California 94533 United States
Providence Holy Cross Cancer Center
Mission Hills California 91346-9600 United States
Providence Saint Joseph Medical Center - Burbank
Burbank California 91505 United States
Radiological Associates of Sacramento Medical Group, Incorporated
Sacramento California 95815 United States
Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center
Pomona California 91767 United States
Ruby L. Golleher Cancer Program at Presbyterian Intercommunity Hospital
Whittier California 90602 United States
Saint Agnes Medical Center
Fresno California 93720-3397 United States
Torrance Memorial Medical Center
Torrance California 90509 United States
University of California Davis Cancer Center
Sacramento California 95817 United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles California 90089-9181 United States
Washington Township Hospital
Fremont California 94538 United States
Eastern Connecticut Hematology and Oncology Associates
Norwich Connecticut 06360 United States
Hospital of Saint Raphael
New Haven Connecticut 06511 United States
St. Vincent's Medical Center
Bridgeport Connecticut 06606 United States
CCOP - Christiana Care Health Services
Newark Delaware 19713 United States
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Washington District of Columbia 20007 United States
Baptist-South Miami Regional Cancer Program
Miami Florida 33176 United States
Lakeland Regional Cancer Center at Lakeland Regional Medical Center
Lakeland Florida 33805 United States
Mayo Clinic - Jacksonville
Jacksonville Florida 32224 United States
University of Florida Shands Cancer Center
Gainesville Florida 32610-0232 United States
University of Miami Sylvester Comprehensive Cancer Center
Miami Florida 33136 United States
Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
Savannah Georgia 31405 United States
Northeast Georgia Medical Center
Gainesville Georgia 30501 United States
Cancer Research Center of Hawaii
Honolula Hawaii 96813 United States
Leeward Radiation Oncology Center
Ewa Beach Hawaii 96706 United States
Queen's Cancer Institute at Queen's Medical Center
Honolulu Hawaii 96813 United States
St. Francis Medical Center
Honolulu Hawaii 96817 United States
Tripler Army Medical Center
Honolulu Hawaii 96859 United States
Hematology Oncology Associates of Eastern Idaho
Idaho Falls Idaho 83404 United States
St. Luke's Mountain States Tumor Institute - Boise
Boise Idaho 83712 United States
Advocate Good Samaritan Hospital
Downers Grove Illinois 60515 United States
BroMenn Regional Medical Center
Normal Illinois 61761 United States
Cancer Treatment Center at Pekin Hospital
Pekin Illinois 61554 United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood Illinois 60153 United States
Carle Cancer Center at Carle Foundation Hospital
Urbana Illinois 61801 United States
CCOP - Carle Cancer Center
Urbana Illinois 61801 United States
CCOP - Illinois Oncology Research Association
Peoria Illinois 61615 United States
Community Cancer Center
Normal Illinois 61761 United States
Creticos Cancer Center at Advocate Illinois Masonic Medical Center
Chicago Illinois 60657 United States
Good Shepherd Hospital
Barrington Illinois 60010 United States
InterCommunity Cancer Center of Western Illinois
Galesburg Illinois 61401 United States
John H. Stroger, Jr. Hospital of Cook County
Chicago Illinois 60612-3785 United States
Joliet Oncology-Hematology Associates, Limited - West
Joliet Illinois 60435 United States
Lutheran General Cancer Care Center
Park Ridge Illinois 60068 United States
Methodist Medical Center of Illinois
Peoria Illinois 61636 United States
Northwest Community Hospital
Arlington Heights Illinois 60005 United States
Oncology Hematology Associates of Central Illinois, PC - Peoria
Peoria Illinois 61615 United States
OSF St. Francis Medical Center
Peoria Illinois 61637 United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago Illinois 60611-3013 United States
Rush-Copley Cancer Care Center
Aurora Illinois 60507 United States
St. Joseph Medical Center
Bloomington Illinois 61701 United States
Valley Cancer Center
Spring Valley Illinois 61362 United States
CCOP - Northern Indiana CR Consortium
South Bend Indiana 46601 United States
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte Indiana 46350 United States
Elkhart General Hospital
Elkhart Indiana 46515 United States
Howard Community Hospital at Howard Regional Health System
Kokomo Indiana 46904 United States
Indiana University Cancer Center
Indianapolis Indiana 46202-5289 United States
Memorial Hospital of South Bend
South Bend Indiana 46601 United States
Parkview Regional Cancer Center at Parkview Health
Fort Wayne Indiana 46805 United States
Regional Cancer Institute at Bloomington Hospital
Bloomington Indiana 47403 United States
Saint Anthony Memorial Health Centers
Michigan City Indiana 46360 United States
St. John's Cancer Center at St. John's Medical Center
Anderson Indiana 46016 United States
Cedar Rapids Oncology Associates
Cedar Rapids Iowa 52403 United States
Mercy Regional Cancer Center at Mercy Medical Center
Cedar Rapids Iowa 52403 United States
St. Luke's Hospital
Cedar Rapids Iowa 52402 United States
St. Francis Comprehensive Cancer Center
Topeka Kansas 66606 United States
Stormont-Vail Cancer Center
Topeka Kansas 66604 United States
Cancer Treatment Center for Southern Kentucky
Bowling Green Kentucky 42101 United States
Central Baptist Hospital
Lexington Kentucky 40503-9985 United States
Merle M. Mahr Cancer Center at Regional Medical Center of Hopkins County
Madisonville Kentucky 42431 United States
Central Maine Medical Center
Lewiston Maine 04240 United States
Maine Medical Center - Bramhall Campus
Portland Maine 04102 United States
DeCesaris Cancer Institute at Anne Arundel Medical Center
Annapolis Maryland 21401 United States
Greater Baltimore Medical Center
Baltimore Maryland 21204 United States
Peninsula Regional Medical Center
Salisbury Maryland 21801 United States
Suburban Hospital
Bethesda Maryland 20814 United States
Baystate Regional Cancer Program at D'Amour Center for Cancer Care
Springfield Massachusetts 01199 United States
Bethke Cancer Center at Emerson Hospital
Concord Massachusetts 01742 United States
Brigham and Women's Hospital
Boston Massachusetts 02115 United States
Cancer Research Center at Boston Medical Center
Boston Massachusetts 02118 United States
Cape Cod Hospital
Hyannis Massachusetts 02601 United States
Caritas Norwood Hospital
Norwood Massachusetts 02062 United States
Community Cancer Care at Milford Regional Medical Center
Milford Massachusetts 01757 United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston Massachusetts 02115 United States
Hudner Oncology Center at Saint Anne's Hospital
Fall River Massachusetts 02721 United States
Lahey Clinic Medical Center - Burlington
Burlington Massachusetts 01805 United States
Lowell General Hospital
Lowell Massachusetts 01854 United States
Massachusetts General Hospital Cancer Center
Boston Massachusetts 02114 United States
MetroWest Medical Center - Framingham Union Hospital
Framingham Massachusetts 01702 United States
Barbara Ann Karmanos Cancer Institute
Detroit Michigan 48201-1379 United States
Borgess Medical Center
Kalamazooaa Michigan 49001 United States
Breslin Cancer Center at Ingham Regional Medical Center
Lansing Michigan 48910 United States
Bronson Methodist Hospital
Kalamazoo Michigan 49007 United States
CCOP - Grand Rapids
Grand Rapids Michigan 49503 United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor Michigan 48106 United States
Foote Hospital
Jackson Michigan 49201 United States
Genesys Hurley Cancer Institute
Flint Michigan 48503 United States
Great Lakes Cancer Institute at McLaren Regional Medical Center
Flint Michigan 48532 United States
Green Bay Oncology, Limited - Escanaba
Escanaba Michigan 49431 United States
Green Bay Oncology, Limited - Iron Mountain
Iron Mountain Michigan 49801 United States
Hickman Cancer Center at Bixby Medical Center
Adrian Michigan 49221 United States
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit Michigan 48202 United States
Lacks Cancer Center at Saint Mary's Mercy Medical Center
Grand Rapids Michigan 49503 United States
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
St. Joseph Michigan 49085 United States
MidMichigan Medical Center - Midland
Midland Michigan 48670 United States
Munson Medical Center
Traverse City Michigan 49684 United States
Northern Michigan Hospital
Petoskey Michigan 49770 United States
Seton Cancer Institute - Saginaw
Saginaw Michigan 48601 United States
Spectrum Health Cancer Care - Butterworth Campus
Grand Rapids Michigan 49503 United States
St. John Macomb Hospital
Warren Michigan 48093 United States
St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital
Ann Arbor Michigan 48106-0995 United States
University of Michigan Comprehensive Cancer Center
Ann Arbor Michigan 48109-0942 United States
Upper Michigan Cancer Center at Marquette General Hospital
Marquette Michigan 49855 United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods Michigan 48236 United States
West Michigan Cancer Center
Kalamazoo Michigan 49007-3731 United States
William Beaumont Hospital - Royal Oak Campus
Royal Oak Michigan 48073 United States
CCOP - Metro-Minnesota
Saint Louis Park Minnesota 55416 United States
CentraCare Clinic - River Campus
St. Cloud Minnesota 56303 United States
Coborn Cancer Center
Saint Cloud Minnesota 56303 United States
Fairview Ridges Hospital
Burnsville Minnesota 55337 United States
Fairview Southdale Hospital
Edina Minnesota 55435 United States
Hubert H. Humphrey Cancer Center at North Memorial Medical Center
Robbinsdale Minnesota 55422-2900 United States
Immanuel St. Joseph's Clinic
Mankato Minnesota 56002 United States
Mayo Clinic Cancer Center
Rochester Minnesota 55905 United States
Mercy and Unity Cancer Center at Unity Hospital
Fridley Minnesota 55432 United States
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids Minnesota 55433 United States
Park Nicollet Health Services
St. Louis Park Minnesota 55416 United States
Regions Hospital Cancer Care Center
St. Paul Minnesota 55101 United States
Ridgeview Medical Center
Waconia Minnesota 55387 United States
St. Mary's - Duluth Clinic Cancer Center
Duluth Minnesota 55805 United States
United Hospital
St. Paul Minnesota 55102 United States
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
Minneapolis Minnesota 55407 United States
University of Mississippi Medical Center
Jackson Mississippi 39216 United States
CCOP - Kansas City
Kansas City Missouri 64131 United States
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia Missouri 65203 United States
CCOP - Montana Cancer Consortium
Billings Montana 59101 United States
Deaconess Billings Clinic - Downtown
Billings Montana 59107-7000 United States
Great Falls Clinic
Great Falls Montana 59405 United States
Northern Rockies Radiation Oncology Center
Billings Montana 59101 United States
Good Samaritan Cancer Center at Good Samaritan Hospital
Kearney Nebraska 68848-1990 United States
Methodist Cancer Center at Methodist Hospital - Omaha
Omaha Nebraska 68114 United States
CCOP - Nevada Cancer Research Foundation
Las Vegas Nevada 89106 United States
Dartmouth - Hitchcock Concord
Concord New Hampshire 03301 United States
Elliot Regional Cancer Center at Elliot Hospital
Manchester New Hampshire 03103 United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon New Hampshire 03756-0002 United States
Seacoast Cancer Center at Wentworth-Douglass Hospital
Dover New Hampshire 03820 United States
AtlantiCare Regional Medical Center
Pomona New Jersey 08240 United States
Booker Cancer Center at Riverview Medical Center
Red Bank New Jersey 07701 United States
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees New Jersey 08043 United States
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick New Jersey 08903 United States
Dizzy Gillespie Cancer Institute at Englewood Hospital and Medical Center
Englewood New Jersey 07631 United States
Fox Chase Cancer Center at St. Francis Medical Center
Trenton New Jersey 08629 United States
Fox Chase Virtua Health Cancer Program - Marlton
Marlton New Jersey 08053 United States
John F. Kennedy Medical Center
Edison New Jersey 08818 United States
Monmouth Medical Center
Long Branch New Jersey 07740-6395 United States
Newark Beth Israel Medical Center
Newark New Jersey 07112 United States
Saint Peter's University Hospital
New Brunswick New Jersey 08903 United States
Veterans Affairs Medical Center - East Orange
East Orange New Jersey 07018-1095 United States
Albuquerque Regional Medical Center at Lovelace Sandia Health System
Albuquerque New Mexico 87102 United States
University of New Mexico Cancer Research and Treatment Center
Albuquerque New Mexico 87131-5636 United States
CCOP - Hematology-Oncology Associates of Central New York
Syracuse New York 13057 United States
CCOP - North Shore University Hospital
Manhasset New York 11030 United States
Long Island College Hospital
Brooklyn New York 11201 United States
Long Island Jewish Medical Center
New Hyde Park New York 11042 United States
Memorial Sloan-Kettering Cancer Center
New York New York 10021 United States
North Shore University Hospital
Manhasset New York 11030 United States
Roswell Park Cancer Institute
Buffalo New York 14263-0001 United States
Tucker Center for Cancer Care at Orange Regional Medical Center
Middletown New York 10940-4199 United States
Batte Cancer Center at Northeast Medical Center
Concord North Carolina 28025 United States
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte North Carolina 28232-2861 United States
Duke Comprehensive Cancer Center
Durham North Carolina 27710 United States
Lenoir Memorial Cancer Center
Kinston North Carolina 28501 United States
Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital
Greenville North Carolina 27835-6028 United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill North Carolina 27599-7295 United States
Moore Regional Community Hospital Comprehensive Cancer Center
Pinehurst North Carolina 28374 United States
Pardee Memorial Hospital
Hendersonville North Carolina 28791 United States
Rex Cancer Center at Rex Hospital
Raleigh North Carolina 27607 United States
Rutherford Hospital
Rutherfordton North Carolina 28139 United States
Wayne Memorial Hospital, Incorporated
Goldsboro North Carolina 27534 United States
Wayne Radiation Oncology
Goldsboro North Carolina 27534 United States
Wilmed Radiation Oncology Services
Wilson North Carolina 27893 United States
Zimmer Cancer Center at New Hanover Regional Medical Center
Wilmington North Carolina 28401 United States
Trinity Cancer Care Center
Minot North Dakota 58701 United States
Adena Regional Medical Center
Chillicothe Ohio 45601 United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
Columbus Ohio 43210-1240 United States
Bethesda North Hospital
Cincinnati Ohio 45242 United States
Blanchard Valley Medical Associates
Findlay Ohio 45840 United States
Cancer Treatment Center at Good Samaritan Hospital
Cincinnati Ohio 45220 United States
Case Comprehensive Cancer Center
Cleveland Ohio 44106 United States
CCOP - Columbus
Columbus Ohio 43215 United States
CCOP - Toledo Community Hospital
Toledo Ohio 43623 United States
Cleveland Clinic Taussig Cancer Center
Cleveland Ohio 44195 United States
Firelands Regional Medical Center
Sandusky Ohio 44870 United States
Grady Memorial Hospital
Delaware Ohio 43015 United States
Hillcrest Cancer Center at Hillcrest Hospital
Mayfield Heights Ohio 44124 United States
Licking Memorial Cancer Care Program at Licking Memorial Hospital
Newark Ohio 43055 United States
Lima Memorial Hospital
Lima Ohio 45804 United States
McDowell Cancer Center at Akron General Medical Center
Akron Ohio 44307 United States
Medical University of Ohio Cancer Center
Toledo Ohio 43614 United States
Mercy Cancer Center at Mercy Medical Center
Canton Ohio 44708 United States
Mercy Medical Center
Springfield Ohio 45504 United States
MetroHealth's Cancer Care Center at MetroHealth Medical Center
Cleveland Ohio 44109 United States
Mount Carmel Health - West Hospital
Columbus Ohio 43222 United States
Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital
Westerville Ohio 43081 United States
Northwest Ohio Oncology Center
Maumee Ohio 43623 United States
Promedica Cancer Center at Flower Hospital
Sylvania Ohio 43560 United States
Riverside Methodist Hospital Cancer Care
Columbus Ohio 43214-3998 United States
St. Charles Mercy Hospital
Oregon Ohio 43616 United States
St. Joseph Cancer Center at St. Joseph Health Center
Warren Ohio 44484 United States
St. Rita's Medical Center
Lima Ohio 45801 United States
St. Vincent Mercy Medical Center
Toledo Ohio 43608 United States
Strecker Cancer Center at Marietta Memorial Hospital
Marietta Ohio 45750 United States
Toledo Clinic, Incorporated - Main Clinic
Toledo Ohio 43623 United States
Natalie Warren Bryant Cancer Center at St. Francis Hospital
Tulsa Oklahoma 74136 United States
Cancer Institute at Oregon Health and Science University
Portland Oregon 97239-3098 United States
CCOP - Columbia River Oncology Program
Portland Oregon 97225 United States
Dubs Cancer Center at Rogue Valley Medical Center
Medford Oregon 97504 United States
Legacy Emanuel Hospital and Health Center & Children's Hospital
Portland Oregon 97227 United States
Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center
Portland Oregon 97210 United States
Legacy Meridian Park Hospital
Tualatin Oregon 97062 United States
Legacy Mount Hood Medical Center
Gresham Oregon 97030 United States
Providence Cancer Center at Providence Portland Medical Center
Portland Oregon 97213-2967 United States
Providence Medford Medical Center
Medford Oregon 97504 United States
Providence Milwaukie Hospital
Milwaukie Oregon 97222 United States
Providence St. Vincent Medical Center
Portland Oregon 97225 United States
Three Rivers Community Hospital
Grants Pass Oregon 97527 United States
Bryn Mawr Hospital
Bryn Mawr Pennsylvania 19010 United States
CCOP - MainLine Health
Wynnewood Pennsylvania 19096 United States
Easton Regional Cancer Center at Easton Hospital
Easton Pennsylvania 18042 United States
Fox Chase-Temple Cancer Center CCOP Research Base
Philadelphia Pennsylvania 19140 United States
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
Wilkes-Barre Pennsylvania 18711 United States
Geisinger Medical Center
Danville Pennsylvania 17822-0001 United States
Hillman Cancer Center at University of Pittsburgh Cancer Institute
Pittsburgh Pennsylvania 15232 United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia Pennsylvania 19107-5541 United States
Lankenau Cancer Center at Lankenau Hospital
Wynnewood Pennsylvania 19096 United States
Mercy Cancer Institute at Mercy Hospital
Pittsburgh Pennsylvania 15219 United States
Mercy Fitzgerald Hospital
Darby Pennsylvania 19023 United States
Mercy Hospital Cancer Center - Scranton
Scranton Pennsylvania 18501 United States
Mount Nittany Medical Center
State College Pennsylvania 16803 United States
Paoli Memorial Hospital
Paoli Pennsylvania 19301-1792 United States
Reading Hospital and Medical Center
Reading Pennsylvania 19612-6052 United States
Rosenfeld Cancer Center at Abington Memorial Hospital
Abington Pennsylvania 19001 United States
St. Luke's Hospital Cancer Center
Bethlehem Pennsylvania 18015 United States
St. Mary Regional Cancer Center
Langhorne Pennsylvania 19047 United States
York Cancer Center at Wellspan Health
York Pennsylvania 17403 United States
AnMed Health Cancer Center
Anderson South Carolina 29621 United States
Bon Secours St. Francis Health System
Greenville South Carolina 29601 United States
CCOP - Greenville
Greenville South Carolina 29615 United States
CCOP - Upstate Carolina
Spartanburg South Carolina 29303 United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg South Carolina 29303 United States
Palmetto Health South Carolina Cancer Center
Columbia South Carolina 29203 United States
Medical X-Ray Center, PC
Sioux Falls South Dakota 57105 United States
Rapid City Regional Hospital
Rapid City South Dakota 57701 United States
Sioux Valley Hospital and University of South Dakota Medical Center
Sioux Falls South Dakota 57117-5039 United States
Doctor's Hospital of Laredo
Laredo Texas 78041 United States
Joe Arrington Cancer Research and Treatment Center
Lubbock Texas 79410-1894 United States
M.D. Anderson Cancer Center at University of Texas
Houston Texas 77030-4009 United States
University of Texas Medical Branch
Galveston Texas 77555-0209 United States
Cottonwood Hospital Medical Center
Murray Utah 84107 United States
Dixie Regional Medical Center - East Campus
Saint George Utah 84770 United States
LDS Hospital
Salt Lake City Utah 84143 United States
McKay-Dee Hospital Center
Ogden Utah 84403 United States
Utah Cancer Specialists at UCS Cancer Center
Salt Lake City Utah 84106 United States
Utah Valley Regional Medical Center - Provo
Provo Utah 84604 United States
Community Cancer Center at Rutland Regional Medical Center
Rutland Vermont 05701 United States
Fletcher Allen Health Care - University Health Center Campus
Burlington Vermont 05401 United States
Martha Jefferson Hospital Cancer Care Center
Charlottesville Virginia 22901 United States
Naval Medical Center - Portsmouth
Portsmouth Virginia 23708-2197 United States
Cancer Care Northwest - Spokane South
Spokane Washington 99202 United States
Cascade Cancer Center at Evergreen Hospital Medical Center
Kirkland Washington 98033 United States
CCOP - Virginia Mason Research Center
Seattle Washington 98101 United States
Group Health Central Hospital
Seattle Washington 98112 United States
Madigan Army Medical Center - Tacoma
Tacoma Washington 98431 United States
Southwest Washington Medical Center Cancer Center
Vancouver Washington 98668 United States
St. Francis Hospital
Federal Way Washington 98003 United States
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle Washington 98122-4307 United States
University Cancer Center at University of Washington Medical Center
Seattle Washington 98195-6043 United States
Bay Area Cancer Care Center at Bay Area Medical Center
Marinette Wisconsin 54143 United States
Columbia St. Mary's Cancer Care Center
Milwaukee Wisconsin 53211 United States
Community Memorial Hospital Cancer Care Center
Menomonee Falls Wisconsin 53051 United States
Green Bay Oncology, Limited - Oconto Falls
Oconto Falls Wisconsin 54154 United States
Green Bay Oncology, Limited - Sturgeon Bay
Sturgeon Bay Wisconsin 54235 United States
Green Bay Oncology, Limited at St. Mary's Hospital
Green Bay Wisconsin 54303 United States
Green Bay Oncology, Limited at St. Vincent Hospital
Green Bay Wisconsin 54301-3526 United States
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
La Crosse Wisconsin 54601 United States
Regional Cancer Center at Oconomowoc Memorial Hospital
Oconomowoc Wisconsin 53066 United States
St. Mary's Hospital Medical Center - Green Bay
Green Bay Wisconsin 54303 United States
St. Vincent Hospital Regional Cancer Center
Green Bay Wisconsin 54307-3508 United States
Theda Care Cancer Institute
Appleton Wisconsin 54911 United States
University of Wisconsin Comprehensive Cancer Center
Madison Wisconsin 53792-6164 United States
Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center
Green Bay Wisconsin 54311 United States
Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center
Milwaukee Wisconsin 53215 United States
Waukesha Memorial Hospital Regional Cancer Center
Waukesha Wisconsin 53188 United States
West Allis Memorial Hospital
West Milwaukee Wisconsin 53227 United States
Centre Hospitalier Regional de Rimouski
Quebec G1S 4L8 Canada
Cross Cancer Institute at University of Alberta
Edmonton Alberta T6G 1Z2 Canada
Lethbridge Cancer Centre
Lethbridge Alberta T1J 1W5 Canada
BCCA - Fraser Valley Cancer Centre
Surrey British Columbia V3V 1Z2 Canada
British Columbia Cancer Agency - Centre for the Southern Interior
Kelowna British Columbia V1Y 5L3 Canada
British Columbia Cancer Agency - Vancouver Cancer Centre
Vancouver British Columbia V5Z 4E6 Canada
British Columbia Cancer Agency - Vancouver Island Cancer Centre
Victoria British Columbia V8R 6V5 Canada
G. Steinhoff Clinical Research
Victoria British Columbia V8V 3N1 Canada
Lions Gate Hospital
North Vancouver British Columbia V7L 2P9 Canada
Nanaimo Cancer Clinic at Nanaimo Regional General Hospital
Nanaimo British Columbia V9S 2B7 Canada
Prostate Centre at Vancouver General Hospital
Vancouver British Columbia V5Z 3J5 Canada
Providence Health Care - Vancouver
Vancouver British Columbia V6Z 1Y6 Canada
CancerCare Manitoba
Winnipeg Manitoba R3E 0V9 Canada
Moncton Hospital
Moncton New Brunswick E1C 6ZB Canada
Saint John Regional Hospital
Saint John New Brunswick E2L 4L2 Canada
Newfoundland Cancer Treatment and Research Foundation
St. Johns Newfoundland and Labrador A1B 3V6 Canada
Cape Breton Cancer Centre
Sydney Nova Scotia B1P 1P3 Canada
Nova Scotia Cancer Centre
Halifax Nova Scotia B3H 1V7 Canada
Algoma Regional Cancer Program at Sault Area Hospital
Sault Sainte Marie Ontario P6A 2C4 Canada
Cancer Centre of Southeastern Ontario at Kingston General Hospital
Kingston Ontario K7L 5P9 Canada
Grand River Regional Cancer Centre at Grand River Hospital
Kitchner Ontario N2G 1G3 Canada
Humber River Regional Hospital - Weston
Weston Ontario M9N 1N8 Canada
London Regional Cancer Program at London Health Sciences Centre
London Ontario N6A 4L6 Canada
Male Health Centre - North York
Toronto Ontario M6A 3B5 Canada
Male Health Centre - Oakville
Oakville Ontario L6H 3PI Canada
Margaret and Charles Juravinski Cancer Centre
Hamilton Ontario L8V 5C2 Canada
Markham Stouffville Hospital
Markham Ontario L6B IAI Canada
Mount Sinai Hospital - Toronto
Toronto Ontario M5G 1X5 Canada
North York General Hospital - Ontario
North York Ontario M2K 1E1 Canada
Northeastern Ontario Regional Cancer Centre
Sudbury Ontario P3E 5J1 Canada
Northwestern Ontario Regional Cancer Care at Thunder Bay Regional Health Sciences Centre
Thunder Bay Ontario P7B 6V4 Canada
Ottawa Hospital Regional Cancer Centre - General Campus
Ottawa Ontario K1H 8L6 Canada
Peterborough Oncology Clinic
Peterborough Ontario K9H 7B6 Canada
Princess Margaret Hospital
Toronto Ontario M5G 2M9 Canada
R. S. McLaughlin Durham Regional Cancer Centre at Lakeridge Health Oshawa
Oshawa Ontario L1G 2B9 Canada
Royal Victoria Hospital of Barrie
Barrie Ontario L4M 6M2 Canada
Scarborough Hospital - General Campus
Scarborough Ontario M1P 2V5 Canada
Southlake Regional Health Centre
Newmarket Ontario L3Y 2P9 Canada
St. Catharines General Hospital at Niagara Health System
St. Catharines Ontario L2R 5K3 Canada
St. Joseph's Health Centre - Toronto
Toronto Ontario M6R 1B5 Canada
St. Joseph's Hospital
Hamilton Ontario L8N 4A6 Canada
St. Michael's Hospital - Toronto
Toronto Ontario M5B 1W8 Canada
Toronto East General Hospital
Toronto Ontario M4C 3E7 Canada
Toronto Sunnybrook Regional Cancer Centre at Sunnybrook Health Sciences Centre
Toronto Ontario M4N 3M5 Canada
Trillium Health Centre - Mississauga Site
Mississauga Ontario L5B 1B8 Canada
William Osler Health Centre
Brampton Ontario L6W 2Z8 Canada
Windsor Regional Cancer Centre at Windsor Regional Hospital
Windsor Ontario N8W 2X3 Canada
Prince Edward Island Cancer Centre at Queen Elizabeth Hospital
Charlottetown Prince Edward Island C1A 8T5 Canada
Centre de Sante et de Services Sociaux de Chicoutimi
Chicoutimi Quebec G7H 5H6 Canada
Centre Hospitalier de l'Universite de Montreal
Montreal Quebec (P.Q.) H2X 3J4 Canada
Centre Hospitalier Regional de Lanaudiere
Joliette Quebec J6E 6J2 Canada
Centre Hospitalier Universitaire de Quebec
Quebec City Quebec G1R 2J6 Canada
CHUS-Hopital Fleurimont
Fleurimont Quebec J1H 5N4 Canada
Doctor Leon Richard Oncology Centre
Greenfield Park Quebec J4V 2H1 Canada
Hopital Charles Lemoyne
Greenfield Park Quebec J4V 2H1 Canada
Hopital Du Sacre-Coeur de Montreal
Montreal Quebec H4J 1C5 Canada
Hopital du Saint-Sacrement - Quebec
Quebec City Quebec G1S 4L8 Canada
Hopital Sainte Justine
Montreal Quebec H3T 1C5 Canada
Hotel Dieu de Montreal
Montreal Quebec H2W 1T8 Canada
Hotel-Dieu de Levis
Levis Quebec G6V 3Z1 Canada
L'Hopital Laval
Ste-Foy Quebec G1V 4G5 Canada
Maisonneuve-Rosemont Hospital
Montreal Quebec H1T 2M4 Canada
Allan Blair Cancer Centre at Pasqua Hospital
Regina Saskatchewan S4T 7T1 Canada
Saskatoon Cancer Centre at the University of Saskatchewan
Saskatoon Saskatchewan S7N 4H4 Canada
Overall Clinical Trial Officials and Contacts
Beryl McCormick, MD Study Chair Memorial Sloan-Kettering Cancer Center
Additional Information
Information obtained from ClinicalTrials.gov on July 23, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00003857
Study ID Number: CDR0000067020
ClinicalTrials.gov Identifier: NCT00003857
Health Authority: United States: Federal Government
Clinical trial summary from the National Cancer Institute's PDQ® database
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.