Radiation Therapy With or Without Optional Tamoxifen in Treating Women With Ductal Carcinoma in Situ

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.