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

NCT ID: NCT00003857

Last Updated: 2022-05-25

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

636 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-12-31

Study Completion Date

2022-05-20

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Observation +/- tamoxifen for 5 years

Observation +/- tamoxifen 20 mg per day for 5 years

Group Type ACTIVE_COMPARATOR

tamoxifen citrate

Intervention Type DRUG

adjuvant therapy

Intervention Type PROCEDURE

Radiation therapy +/- tamoxifen for 5 years

Radiation therapy to the whole breast +/- tamoxifen 20 mg per day for 5 years

Group Type EXPERIMENTAL

tamoxifen citrate

Intervention Type DRUG

adjuvant therapy

Intervention Type PROCEDURE

radiation therapy

Intervention Type RADIATION

Interventions

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tamoxifen citrate

Intervention Type DRUG

adjuvant therapy

Intervention Type PROCEDURE

radiation therapy

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

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
Minimum Eligible Age

26 Years

Maximum Eligible Age

120 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Cancer and Leukemia Group B

NETWORK

Sponsor Role collaborator

NCIC Clinical Trials Group

NETWORK

Sponsor Role collaborator

NRG Oncology

OTHER

Sponsor Role collaborator

Radiation Therapy Oncology Group

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Beryl McCormick, MD

Role: STUDY_CHAIR

Memorial Sloan Kettering Cancer Center

Clifford A. Hudis, MD

Role:

Memorial Sloan Kettering Cancer Center

Barbara L. Smith, MD, PhD

Role: STUDY_CHAIR

Massachusetts General Hospital

Timothy J. Whelan, MD

Role: STUDY_CHAIR

Margaret and Charles Juravinski Cancer Centre

Eileen Rakovitch, MD

Role:

Toronto Sunnybrook Regional Cancer Centre

Locations

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Mobile Infirmary Medical Center

Mobile, Alabama, United States

Site Status

Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital

Fairbanks, Alaska, United States

Site Status

Arizona Oncology Services Foundation

Phoenix, Arizona, United States

Site Status

Saint Joseph's Mercy Cancer Center

Hot Springs, Arkansas, United States

Site Status

Providence Saint Joseph Medical Center - Burbank

Burbank, California, United States

Site Status

Enloe Cancer Center at Enloe Medical Center

Chico, California, United States

Site Status

Mount Diablo Regional Cancer Center

Concord, California, United States

Site Status

North Bay Cancer Center

Fairfield, California, United States

Site Status

Washington Township Hospital

Fremont, California, United States

Site Status

Saint Agnes Medical Center

Fresno, California, United States

Site Status

Cancer Care Consultants Medical Associates at Daniel Freeman Memorial Hospital

Inglewood, California, United States

Site Status

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, United States

Site Status

Providence Holy Cross Cancer Center

Mission Hills, California, United States

Site Status

Memorial Medical Center Cancer Services

Modesto, California, United States

Site Status

CCOP - Bay Area Tumor Institute

Oakland, California, United States

Site Status

Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center

Pomona, California, United States

Site Status

Radiological Associates of Sacramento Medical Group, Incorporated

Sacramento, California, United States

Site Status

University of California Davis Cancer Center

Sacramento, California, United States

Site Status

CCOP - Santa Rosa Memorial Hospital

Santa Rosa, California, United States

Site Status

Torrance Memorial Medical Center

Torrance, California, United States

Site Status

John Muir/Mt. Diablo Comprehensive Cancer Center

Walnut Creek, California, United States

Site Status

Ruby L. Golleher Cancer Program at Presbyterian Intercommunity Hospital

Whittier, California, United States

Site Status

St. Vincent's Medical Center

Bridgeport, Connecticut, United States

Site Status

Hospital of Saint Raphael

New Haven, Connecticut, United States

Site Status

Eastern Connecticut Hematology and Oncology Associates

Norwich, Connecticut, United States

Site Status

CCOP - Christiana Care Health Services

Newark, Delaware, United States

Site Status

Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

Washington D.C., District of Columbia, United States

Site Status

University of Florida Shands Cancer Center

Gainesville, Florida, United States

Site Status

Mayo Clinic - Jacksonville

Jacksonville, Florida, United States

Site Status

Lakeland Regional Cancer Center at Lakeland Regional Medical Center

Lakeland, Florida, United States

Site Status

University of Miami Sylvester Comprehensive Cancer Center

Miami, Florida, United States

Site Status

Baptist-South Miami Regional Cancer Program

Miami, Florida, United States

Site Status

Northeast Georgia Medical Center

Gainesville, Georgia, United States

Site Status

Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler

Savannah, Georgia, United States

Site Status

Cancer Research Center of Hawaii

Honolulu, Hawaii, United States

Site Status

Queen's Cancer Institute at Queen's Medical Center

Honolulu, Hawaii, United States

Site Status

St. Francis Medical Center

Honolulu, Hawaii, United States

Site Status

Tripler Army Medical Center

Honolulu, Hawaii, United States

Site Status

Leeward Radiation Oncology Center

‘Ewa Beach, Hawaii, United States

Site Status

St. Luke's Mountain States Tumor Institute - Boise

Boise, Idaho, United States

Site Status

Hematology Oncology Associates of Eastern Idaho

Idaho Falls, Idaho, United States

Site Status

Northwest Community Hospital

Arlington Heights, Illinois, United States

Site Status

Rush-Copley Cancer Care Center

Aurora, Illinois, United States

Site Status

Good Shepherd Hospital

Barrington, Illinois, United States

Site Status

St. Joseph Medical Center

Bloomington, Illinois, United States

Site Status

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, United States

Site Status

John H. Stroger, Jr. Hospital of Cook County

Chicago, Illinois, United States

Site Status

Creticos Cancer Center at Advocate Illinois Masonic Medical Center

Chicago, Illinois, United States

Site Status

Advocate Good Samaritan Hospital

Downers Grove, Illinois, United States

Site Status

InterCommunity Cancer Center of Western Illinois

Galesburg, Illinois, United States

Site Status

Joliet Oncology-Hematology Associates, Limited - West

Joliet, Illinois, United States

Site Status

Cardinal Bernardin Cancer Center at Loyola University Medical Center

Maywood, Illinois, United States

Site Status

BroMenn Regional Medical Center

Normal, Illinois, United States

Site Status

Community Cancer Center

Normal, Illinois, United States

Site Status

Lutheran General Cancer Care Center

Park Ridge, Illinois, United States

Site Status

Cancer Treatment Center at Pekin Hospital

Pekin, Illinois, United States

Site Status

CCOP - Illinois Oncology Research Association

Peoria, Illinois, United States

Site Status

Oncology Hematology Associates of Central Illinois, PC - Peoria

Peoria, Illinois, United States

Site Status

Methodist Medical Center of Illinois

Peoria, Illinois, United States

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OSF St. Francis Medical Center

Peoria, Illinois, United States

Site Status

Valley Cancer Center

Spring Valley, Illinois, United States

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Carle Cancer Center at Carle Foundation Hospital

Urbana, Illinois, United States

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CCOP - Carle Cancer Center

Urbana, Illinois, United States

Site Status

St. John's Cancer Center at St. John's Medical Center

Anderson, Indiana, United States

Site Status

Regional Cancer Institute at Bloomington Hospital

Bloomington, Indiana, United States

Site Status

Elkhart General Hospital

Elkhart, Indiana, United States

Site Status

Parkview Regional Cancer Center at Parkview Health

Fort Wayne, Indiana, United States

Site Status

Indiana University Cancer Center

Indianapolis, Indiana, United States

Site Status

Howard Community Hospital at Howard Regional Health System

Kokomo, Indiana, United States

Site Status

Center for Cancer Therapy at LaPorte Hospital and Health Services

La Porte, Indiana, United States

Site Status

Saint Anthony Memorial Health Centers

Michigan City, Indiana, United States

Site Status

CCOP - Northern Indiana CR Consortium

South Bend, Indiana, United States

Site Status

Memorial Hospital of South Bend

South Bend, Indiana, United States

Site Status

St. Luke's Hospital

Cedar Rapids, Iowa, United States

Site Status

Cedar Rapids Oncology Associates

Cedar Rapids, Iowa, United States

Site Status

Mercy Regional Cancer Center at Mercy Medical Center

Cedar Rapids, Iowa, United States

Site Status

Stormont-Vail Cancer Center

Topeka, Kansas, United States

Site Status

St. Francis Comprehensive Cancer Center

Topeka, Kansas, United States

Site Status

Cancer Treatment Center for Southern Kentucky

Bowling Green, Kentucky, United States

Site Status

Central Baptist Hospital

Lexington, Kentucky, United States

Site Status

Merle M. Mahr Cancer Center at Regional Medical Center of Hopkins County

Madisonville, Kentucky, United States

Site Status

Central Maine Medical Center

Lewiston, Maine, United States

Site Status

Maine Medical Center - Bramhall Campus

Portland, Maine, United States

Site Status

DeCesaris Cancer Institute at Anne Arundel Medical Center

Annapolis, Maryland, United States

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Greater Baltimore Medical Center

Baltimore, Maryland, United States

Site Status

Suburban Hospital

Bethesda, Maryland, United States

Site Status

Peninsula Regional Medical Center

Salisbury, Maryland, United States

Site Status

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States

Site Status

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

Boston, Massachusetts, United States

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Cancer Research Center at Boston Medical Center

Boston, Massachusetts, United States

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Lahey Clinic Medical Center - Burlington

Burlington, Massachusetts, United States

Site Status

Bethke Cancer Center at Emerson Hospital

Concord, Massachusetts, United States

Site Status

Hudner Oncology Center at Saint Anne's Hospital

Fall River, Massachusetts, United States

Site Status

MetroWest Medical Center - Framingham Union Hospital

Framingham, Massachusetts, United States

Site Status

Cape Cod Hospital

Hyannis, Massachusetts, United States

Site Status

Lowell General Hospital

Lowell, Massachusetts, United States

Site Status

Community Cancer Care at Milford Regional Medical Center

Milford, Massachusetts, United States

Site Status

Caritas Norwood Hospital

Norwood, Massachusetts, United States

Site Status

Baystate Regional Cancer Program at D'Amour Center for Cancer Care

Springfield, Massachusetts, United States

Site Status

Hickman Cancer Center at Bixby Medical Center

Adrian, Michigan, United States

Site Status

St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital

Ann Arbor, Michigan, United States

Site Status

CCOP - Michigan Cancer Research Consortium

Ann Arbor, Michigan, United States

Site Status

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Site Status

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

Site Status

Josephine Ford Cancer Center at Henry Ford Hospital

Detroit, Michigan, United States

Site Status

Green Bay Oncology, Limited - Escanaba

Escanaba, Michigan, United States

Site Status

Genesys Hurley Cancer Institute

Flint, Michigan, United States

Site Status

Great Lakes Cancer Institute at McLaren Regional Medical Center

Flint, Michigan, United States

Site Status

CCOP - Grand Rapids

Grand Rapids, Michigan, United States

Site Status

Lacks Cancer Center at Saint Mary's Mercy Medical Center

Grand Rapids, Michigan, United States

Site Status

Spectrum Health Cancer Care - Butterworth Campus

Grand Rapids, Michigan, United States

Site Status

Van Elslander Cancer Center at St. John Hospital and Medical Center

Grosse Pointe Woods, Michigan, United States

Site Status

Green Bay Oncology, Limited - Iron Mountain

Iron Mountain, Michigan, United States

Site Status

Foote Hospital

Jackson, Michigan, United States

Site Status

Borgess Medical Center

Kalamazoo, Michigan, United States

Site Status

West Michigan Cancer Center

Kalamazoo, Michigan, United States

Site Status

Bronson Methodist Hospital

Kalamazoo, Michigan, United States

Site Status

Breslin Cancer Center at Ingham Regional Medical Center

Lansing, Michigan, United States

Site Status

Upper Michigan Cancer Center at Marquette General Hospital

Marquette, Michigan, United States

Site Status

MidMichigan Medical Center - Midland

Midland, Michigan, United States

Site Status

Northern Michigan Hospital

Petoskey, Michigan, United States

Site Status

William Beaumont Hospital - Royal Oak Campus

Royal Oak, Michigan, United States

Site Status

Seton Cancer Institute - Saginaw

Saginaw, Michigan, United States

Site Status

Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph

Saint Joseph, Michigan, United States

Site Status

Munson Medical Center

Traverse City, Michigan, United States

Site Status

St. John Macomb Hospital

Warren, Michigan, United States

Site Status

Fairview Ridges Hospital

Burnsville, Minnesota, United States

Site Status

Mercy and Unity Cancer Center at Mercy Hospital

Coon Rapids, Minnesota, United States

Site Status

St. Mary's - Duluth Clinic Cancer Center

Duluth, Minnesota, United States

Site Status

Fairview Southdale Hospital

Edina, Minnesota, United States

Site Status

Mercy and Unity Cancer Center at Unity Hospital

Fridley, Minnesota, United States

Site Status

Immanuel St. Joseph's Clinic

Mankato, Minnesota, United States

Site Status

Virginia Piper Cancer Institute at Abbott-Northwestern Hospital

Minneapolis, Minnesota, United States

Site Status

Hubert H. Humphrey Cancer Center at North Memorial Medical Center

Robbinsdale, Minnesota, United States

Site Status

Mayo Clinic Cancer Center

Rochester, Minnesota, United States

Site Status

CentraCare Clinic - River Campus

Saint Cloud, Minnesota, United States

Site Status

Coborn Cancer Center

Saint Cloud, Minnesota, United States

Site Status

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, United States

Site Status

Park Nicollet Health Services

Saint Louis Park, Minnesota, United States

Site Status

Regions Hospital Cancer Care Center

Saint Paul, Minnesota, United States

Site Status

United Hospital

Saint Paul, Minnesota, United States

Site Status

Ridgeview Medical Center

Waconia, Minnesota, United States

Site Status

University of Mississippi Medical Center

Jackson, Mississippi, United States

Site Status

Ellis Fischel Cancer Center at University of Missouri - Columbia

Columbia, Missouri, United States

Site Status

CCOP - Kansas City

Kansas City, Missouri, United States

Site Status

CCOP - Montana Cancer Consortium

Billings, Montana, United States

Site Status

Northern Rockies Radiation Oncology Center

Billings, Montana, United States

Site Status

Deaconess Billings Clinic - Downtown

Billings, Montana, United States

Site Status

Great Falls Clinic

Great Falls, Montana, United States

Site Status

Good Samaritan Cancer Center at Good Samaritan Hospital

Kearney, Nebraska, United States

Site Status

Methodist Cancer Center at Methodist Hospital - Omaha

Omaha, Nebraska, United States

Site Status

CCOP - Nevada Cancer Research Foundation

Las Vegas, Nevada, United States

Site Status

Dartmouth - Hitchcock Concord

Concord, New Hampshire, United States

Site Status

Seacoast Cancer Center at Wentworth-Douglass Hospital

Dover, New Hampshire, United States

Site Status

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

Elliot Regional Cancer Center at Elliot Hospital

Manchester, New Hampshire, United States

Site Status

Veterans Affairs Medical Center - East Orange

East Orange, New Jersey, United States

Site Status

John F. Kennedy Medical Center

Edison, New Jersey, United States

Site Status

Dizzy Gillespie Cancer Institute at Englewood Hospital and Medical Center

Englewood, New Jersey, United States

Site Status

Monmouth Medical Center

Long Branch, New Jersey, United States

Site Status

Fox Chase Virtua Health Cancer Program - Marlton

Marlton, New Jersey, United States

Site Status

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

New Brunswick, New Jersey, United States

Site Status

Saint Peter's University Hospital

New Brunswick, New Jersey, United States

Site Status

Newark Beth Israel Medical Center

Newark, New Jersey, United States

Site Status

AtlantiCare Regional Medical Center

Pomona, New Jersey, United States

Site Status

Booker Cancer Center at Riverview Medical Center

Red Bank, New Jersey, United States

Site Status

Fox Chase Cancer Center at St. Francis Medical Center

Trenton, New Jersey, United States

Site Status

Cancer Institute of New Jersey at Cooper - Voorhees

Voorhees Township, New Jersey, United States

Site Status

Albuquerque Regional Medical Center at Lovelace Sandia Health System

Albuquerque, New Mexico, United States

Site Status

University of New Mexico Cancer Research and Treatment Center

Albuquerque, New Mexico, United States

Site Status

Long Island College Hospital

Brooklyn, New York, United States

Site Status

Roswell Park Cancer Institute

Buffalo, New York, United States

Site Status

CCOP - North Shore University Hospital

Manhasset, New York, United States

Site Status

North Shore University Hospital

Manhasset, New York, United States

Site Status

Tucker Center for Cancer Care at Orange Regional Medical Center

Middletown, New York, United States

Site Status

Long Island Jewish Medical Center

New Hyde Park, New York, United States

Site Status

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Site Status

CCOP - Hematology-Oncology Associates of Central New York

Syracuse, New York, United States

Site Status

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, United States

Site Status

Blumenthal Cancer Center at Carolinas Medical Center

Charlotte, North Carolina, United States

Site Status

Batte Cancer Center at Northeast Medical Center

Concord, North Carolina, United States

Site Status

Duke Comprehensive Cancer Center

Durham, North Carolina, United States

Site Status

Wayne Memorial Hospital, Incorporated

Goldsboro, North Carolina, United States

Site Status

Wayne Radiation Oncology

Goldsboro, North Carolina, United States

Site Status

Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital

Greenville, North Carolina, United States

Site Status

Pardee Memorial Hospital

Hendersonville, North Carolina, United States

Site Status

Lenoir Memorial Cancer Center

Kinston, North Carolina, United States

Site Status

Moore Regional Community Hospital Comprehensive Cancer Center

Pinehurst, North Carolina, United States

Site Status

Rex Cancer Center at Rex Hospital

Raleigh, North Carolina, United States

Site Status

Rutherford Hospital

Rutherfordton, North Carolina, United States

Site Status

Zimmer Cancer Center at New Hanover Regional Medical Center

Wilmington, North Carolina, United States

Site Status

Wilmed Radiation Oncology Services

Wilson, North Carolina, United States

Site Status

Trinity Cancer Care Center

Minot, North Dakota, United States

Site Status

McDowell Cancer Center at Akron General Medical Center

Akron, Ohio, United States

Site Status

Mercy Cancer Center at Mercy Medical Center

Canton, Ohio, United States

Site Status

Adena Regional Medical Center

Chillicothe, Ohio, United States

Site Status

Cancer Treatment Center at Good Samaritan Hospital

Cincinnati, Ohio, United States

Site Status

Bethesda North Hospital

Cincinnati, Ohio, United States

Site Status

Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Site Status

MetroHealth's Cancer Care Center at MetroHealth Medical Center

Cleveland, Ohio, United States

Site Status

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, United States

Site Status

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University

Columbus, Ohio, United States

Site Status

Riverside Methodist Hospital Cancer Care

Columbus, Ohio, United States

Site Status

CCOP - Columbus

Columbus, Ohio, United States

Site Status

Mount Carmel Health - West Hospital

Columbus, Ohio, United States

Site Status

Grady Memorial Hospital

Delaware, Ohio, United States

Site Status

Blanchard Valley Medical Associates

Findlay, Ohio, United States

Site Status

St. Rita's Medical Center

Lima, Ohio, United States

Site Status

Lima Memorial Hospital

Lima, Ohio, United States

Site Status

Strecker Cancer Center at Marietta Memorial Hospital

Marietta, Ohio, United States

Site Status

Northwest Ohio Oncology Center

Maumee, Ohio, United States

Site Status

Hillcrest Cancer Center at Hillcrest Hospital

Mayfield Heights, Ohio, United States

Site Status

Licking Memorial Cancer Care Program at Licking Memorial Hospital

Newark, Ohio, United States

Site Status

St. Charles Mercy Hospital

Oregon, Ohio, United States

Site Status

Firelands Regional Medical Center

Sandusky, Ohio, United States

Site Status

Mercy Medical Center

Springfield, Ohio, United States

Site Status

Promedica Cancer Center at Flower Hospital

Sylvania, Ohio, United States

Site Status

St. Vincent Mercy Medical Center

Toledo, Ohio, United States

Site Status

Medical University of Ohio Cancer Center

Toledo, Ohio, United States

Site Status

CCOP - Toledo Community Hospital

Toledo, Ohio, United States

Site Status

Toledo Clinic, Incorporated - Main Clinic

Toledo, Ohio, United States

Site Status

St. Joseph Cancer Center at St. Joseph Health Center

Warren, Ohio, United States

Site Status

Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital

Westerville, Ohio, United States

Site Status

Natalie Warren Bryant Cancer Center at St. Francis Hospital

Tulsa, Oklahoma, United States

Site Status

Three Rivers Community Hospital

Grants Pass, Oregon, United States

Site Status

Legacy Mount Hood Medical Center

Gresham, Oregon, United States

Site Status

Dubs Cancer Center at Rogue Valley Medical Center

Medford, Oregon, United States

Site Status

Providence Medford Medical Center

Medford, Oregon, United States

Site Status

Providence Milwaukie Hospital

Milwaukie, Oregon, United States

Site Status

Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center

Portland, Oregon, United States

Site Status

Providence Cancer Center at Providence Portland Medical Center

Portland, Oregon, United States

Site Status

CCOP - Columbia River Oncology Program

Portland, Oregon, United States

Site Status

Providence St. Vincent Medical Center

Portland, Oregon, United States

Site Status

Legacy Emanuel Hospital and Health Center & Children's Hospital

Portland, Oregon, United States

Site Status

Cancer Institute at Oregon Health and Science University

Portland, Oregon, United States

Site Status

Legacy Meridian Park Hospital

Tualatin, Oregon, United States

Site Status

Rosenfeld Cancer Center at Abington Memorial Hospital

Abington, Pennsylvania, United States

Site Status

St. Luke's Hospital Cancer Center

Bethlehem, Pennsylvania, United States

Site Status

Bryn Mawr Hospital

Bryn Mawr, Pennsylvania, United States

Site Status

Geisinger Medical Center

Danville, Pennsylvania, United States

Site Status

Mercy Fitzgerald Hospital

Darby, Pennsylvania, United States

Site Status

Easton Regional Cancer Center at Easton Hospital

Easton, Pennsylvania, United States

Site Status

St. Mary Regional Cancer Center

Langhorne, Pennsylvania, United States

Site Status

Paoli Memorial Hospital

Paoli, Pennsylvania, United States

Site Status

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

Fox Chase-Temple Cancer Center CCOP Research Base

Philadelphia, Pennsylvania, United States

Site Status

Mercy Cancer Institute at Mercy Hospital

Pittsburgh, Pennsylvania, United States

Site Status

Hillman Cancer Center at University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, United States

Site Status

Reading Hospital and Medical Center

Reading, Pennsylvania, United States

Site Status

Mercy Hospital Cancer Center - Scranton

Scranton, Pennsylvania, United States

Site Status

Mount Nittany Medical Center

State College, Pennsylvania, United States

Site Status

Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center

Wilkes-Barre, Pennsylvania, United States

Site Status

CCOP - MainLine Health

Wynnewood, Pennsylvania, United States

Site Status

Lankenau Cancer Center at Lankenau Hospital

Wynnewood, Pennsylvania, United States

Site Status

York Cancer Center at Wellspan Health

York, Pennsylvania, United States

Site Status

AnMed Health Cancer Center

Anderson, South Carolina, United States

Site Status

Palmetto Health South Carolina Cancer Center

Columbia, South Carolina, United States

Site Status

Bon Secours St. Francis Health System

Greenville, South Carolina, United States

Site Status

CCOP - Greenville

Greenville, South Carolina, United States

Site Status

CCOP - Upstate Carolina

Spartanburg, South Carolina, United States

Site Status

Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

Spartanburg, South Carolina, United States

Site Status

Rapid City Regional Hospital

Rapid City, South Dakota, United States

Site Status

Medical X-Ray Center, PC

Sioux Falls, South Dakota, United States

Site Status

Sioux Valley Hospital and University of South Dakota Medical Center

Sioux Falls, South Dakota, United States

Site Status

University of Texas Medical Branch

Galveston, Texas, United States

Site Status

M.D. Anderson Cancer Center at University of Texas

Houston, Texas, United States

Site Status

Doctor's Hospital of Laredo

Laredo, Texas, United States

Site Status

Joe Arrington Cancer Research and Treatment Center

Lubbock, Texas, United States

Site Status

Cottonwood Hospital Medical Center

Murray, Utah, United States

Site Status

McKay-Dee Hospital Center

Ogden, Utah, United States

Site Status

Utah Valley Regional Medical Center - Provo

Provo, Utah, United States

Site Status

Utah Cancer Specialists at UCS Cancer Center

Salt Lake City, Utah, United States

Site Status

LDS Hospital

Salt Lake City, Utah, United States

Site Status

Dixie Regional Medical Center - East Campus

St. George, Utah, United States

Site Status

Fletcher Allen Health Care - University Health Center Campus

Burlington, Vermont, United States

Site Status

Community Cancer Center at Rutland Regional Medical Center

Rutland, Vermont, United States

Site Status

Martha Jefferson Hospital Cancer Care Center

Charlottesville, Virginia, United States

Site Status

Naval Medical Center - Portsmouth

Portsmouth, Virginia, United States

Site Status

St. Francis Hospital

Federal Way, Washington, United States

Site Status

Cascade Cancer Center at Evergreen Hospital Medical Center

Kirkland, Washington, United States

Site Status

CCOP - Virginia Mason Research Center

Seattle, Washington, United States

Site Status

Group Health Central Hospital

Seattle, Washington, United States

Site Status

Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

Seattle, Washington, United States

Site Status

University Cancer Center at University of Washington Medical Center

Seattle, Washington, United States

Site Status

Cancer Care Northwest - Spokane South

Spokane, Washington, United States

Site Status

Madigan Army Medical Center - Tacoma

Tacoma, Washington, United States

Site Status

Southwest Washington Medical Center Cancer Center

Vancouver, Washington, United States

Site Status

Theda Care Cancer Institute

Appleton, Wisconsin, United States

Site Status

Green Bay Oncology, Limited at St. Vincent Hospital

Green Bay, Wisconsin, United States

Site Status

Green Bay Oncology, Limited at St. Mary's Hospital

Green Bay, Wisconsin, United States

Site Status

St. Mary's Hospital Medical Center - Green Bay

Green Bay, Wisconsin, United States

Site Status

St. Vincent Hospital Regional Cancer Center

Green Bay, Wisconsin, United States

Site Status

Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center

Green Bay, Wisconsin, United States

Site Status

Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center

La Crosse, Wisconsin, United States

Site Status

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, United States

Site Status

Bay Area Cancer Care Center at Bay Area Medical Center

Marinette, Wisconsin, United States

Site Status

Community Memorial Hospital Cancer Care Center

Menomonee Falls, Wisconsin, United States

Site Status

Columbia St. Mary's Cancer Care Center

Milwaukee, Wisconsin, United States

Site Status

Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, United States

Site Status

Regional Cancer Center at Oconomowoc Memorial Hospital

Oconomowoc, Wisconsin, United States

Site Status

Green Bay Oncology, Limited - Oconto Falls

Oconto Falls, Wisconsin, United States

Site Status

Green Bay Oncology, Limited - Sturgeon Bay

Sturgeon Bay, Wisconsin, United States

Site Status

Waukesha Memorial Hospital Regional Cancer Center

Waukesha, Wisconsin, United States

Site Status

West Allis Memorial Hospital

West Milwaukee, Wisconsin, United States

Site Status

Cross Cancer Institute at University of Alberta

Edmonton, Alberta, Canada

Site Status

Lethbridge Cancer Centre

Lethbridge, Alberta, Canada

Site Status

British Columbia Cancer Agency - Centre for the Southern Interior

Kelowna, British Columbia, Canada

Site Status

Nanaimo Cancer Clinic at Nanaimo Regional General Hospital

Nanaimo, British Columbia, Canada

Site Status

Lions Gate Hospital

North Vancouver, British Columbia, Canada

Site Status

BCCA - Fraser Valley Cancer Centre

Surrey, British Columbia, Canada

Site Status

Prostate Centre at Vancouver General Hospital

Vancouver, British Columbia, Canada

Site Status

British Columbia Cancer Agency - Vancouver Cancer Centre

Vancouver, British Columbia, Canada

Site Status

Providence Health Care - Vancouver

Vancouver, British Columbia, Canada

Site Status

British Columbia Cancer Agency - Vancouver Island Cancer Centre

Victoria, British Columbia, Canada

Site Status

G. Steinhoff Clinical Research

Victoria, British Columbia, Canada

Site Status

CancerCare Manitoba

Winnipeg, Manitoba, Canada

Site Status

Moncton Hospital

Moncton, New Brunswick, Canada

Site Status

Saint John Regional Hospital

Saint John, New Brunswick, Canada

Site Status

Newfoundland Cancer Treatment and Research Foundation

St. John's, Newfoundland and Labrador, Canada

Site Status

Nova Scotia Cancer Centre

Halifax, Nova Scotia, Canada

Site Status

Cape Breton Cancer Centre

Sydney, Nova Scotia, Canada

Site Status

Royal Victoria Hospital of Barrie

Barrie, Ontario, Canada

Site Status

William Osler Health Centre

Brampton, Ontario, Canada

Site Status

Northeastern Ontario Regional Cancer Centre

Greater Sudbury, Ontario, Canada

Site Status

St. Joseph's Hospital

Hamilton, Ontario, Canada

Site Status

Margaret and Charles Juravinski Cancer Centre

Hamilton, Ontario, Canada

Site Status

Cancer Centre of Southeastern Ontario at Kingston General Hospital

Kingston, Ontario, Canada

Site Status

Grand River Regional Cancer Centre at Grand River Hospital

Kitchner, Ontario, Canada

Site Status

London Regional Cancer Program at London Health Sciences Centre

London, Ontario, Canada

Site Status

Markham Stouffville Hospital

Markham, Ontario, Canada

Site Status

Trillium Health Centre - Mississauga Site

Mississauga, Ontario, Canada

Site Status

Southlake Regional Health Centre

Newmarket, Ontario, Canada

Site Status

North York General Hospital - Ontario

North York, Ontario, Canada

Site Status

Male Health Centre - Oakville

Oakville, Ontario, Canada

Site Status

R. S. McLaughlin Durham Regional Cancer Centre at Lakeridge Health Oshawa

Oshawa, Ontario, Canada

Site Status

Ottawa Hospital Regional Cancer Centre - General Campus

Ottawa, Ontario, Canada

Site Status

Peterborough Oncology Clinic

Peterborough, Ontario, Canada

Site Status

Algoma Regional Cancer Program at Sault Area Hospital

Sault Ste. Marie, Ontario, Canada

Site Status

Scarborough Hospital - General Campus

Scarborough Village, Ontario, Canada

Site Status

St. Catharines General Hospital at Niagara Health System

St. Catharines, Ontario, Canada

Site Status

Northwestern Ontario Regional Cancer Care at Thunder Bay Regional Health Sciences Centre

Thunder Bay, Ontario, Canada

Site Status

Toronto East General Hospital

Toronto, Ontario, Canada

Site Status

Toronto Sunnybrook Regional Cancer Centre at Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Site Status

St. Michael's Hospital - Toronto

Toronto, Ontario, Canada

Site Status

Mount Sinai Hospital - Toronto

Toronto, Ontario, Canada

Site Status

Princess Margaret Hospital

Toronto, Ontario, Canada

Site Status

Male Health Centre - North York

Toronto, Ontario, Canada

Site Status

St. Joseph's Health Centre - Toronto

Toronto, Ontario, Canada

Site Status

Humber River Regional Hospital - Weston

Weston, Ontario, Canada

Site Status

Windsor Regional Cancer Centre at Windsor Regional Hospital

Windsor, Ontario, Canada

Site Status

Prince Edward Island Cancer Centre at Queen Elizabeth Hospital

Charlottetown, Prince Edward Island, Canada

Site Status

Centre de Sante et de Services Sociaux de Chicoutimi

Chicoutimi, Quebec, Canada

Site Status

CHUS-Hopital Fleurimont

Fleurimont, Quebec, Canada

Site Status

Doctor Leon Richard Oncology Centre

Greenfield Park, Quebec, Canada

Site Status

Hopital Charles Lemoyne

Greenfield Park, Quebec, Canada

Site Status

Centre Hospitalier Regional de Lanaudiere

Joliette, Quebec, Canada

Site Status

Hotel-Dieu de Levis

Lévis, Quebec, Canada

Site Status

Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, Canada

Site Status

Maisonneuve-Rosemont Hospital

Montreal, Quebec, Canada

Site Status

Hotel Dieu de Montreal

Montreal, Quebec, Canada

Site Status

Hopital Sainte Justine

Montreal, Quebec, Canada

Site Status

Hopital Du Sacre-Coeur de Montreal

Montreal, Quebec, Canada

Site Status

Centre Hospitalier Universitaire de Quebec

Québec, Quebec, Canada

Site Status

Hopital du Saint-Sacrement - Quebec

Québec, Quebec, Canada

Site Status

L'Hopital Laval

Ste-Foy, Quebec, Canada

Site Status

Allan Blair Cancer Centre at Pasqua Hospital

Regina, Saskatchewan, Canada

Site Status

Saskatoon Cancer Centre at the University of Saskatchewan

Saskatoon, Saskatchewan, Canada

Site Status

Centre Hospitalier Regional de Rimouski

Québec, , Canada

Site Status

Countries

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United States Canada

References

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McCormick B, Winter K, Hudis C, Kuerer HM, Rakovitch E, Smith BL, Sneige N, Moughan J, Shah A, Germain I, Hartford AC, Rashtian A, Walker EM, Yuen A, Strom EA, Wilcox JL, Vallow LA, Small W Jr, Pu AT, Kerlin K, White J. RTOG 9804: a prospective randomized trial for good-risk ductal carcinoma in situ comparing radiotherapy with observation. J Clin Oncol. 2015 Mar 1;33(7):709-15. doi: 10.1200/JCO.2014.57.9029. Epub 2015 Jan 20.

Reference Type RESULT
PMID: 25605856 (View on PubMed)

McCormick B, Winter KA, Woodward W, Kuerer HM, Sneige N, Rakovitch E, Smith BL, Germain I, Hartford AC, O'Rourke MA, Walker EM, Strom EA, Hopkins JO, Pierce LJ, Pu AT, Sumida KNM, Vesprini D, Moughan J, White JR. Randomized Phase III Trial Evaluating Radiation Following Surgical Excision for Good-Risk Ductal Carcinoma In Situ: Long-Term Report From NRG Oncology/RTOG 9804. J Clin Oncol. 2021 Nov 10;39(32):3574-3582. doi: 10.1200/JCO.21.01083. Epub 2021 Aug 18.

Reference Type DERIVED
PMID: 34406870 (View on PubMed)

Related Links

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https://nctn-data-archive.nci.nih.gov/

Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive.

Other Identifiers

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CDR0000067020

Identifier Type: -

Identifier Source: secondary_id

CAN-NCIC-MA26

Identifier Type: -

Identifier Source: secondary_id

CALGB-49801

Identifier Type: -

Identifier Source: secondary_id

NCI-2011-02038

Identifier Type: REGISTRY

Identifier Source: secondary_id

RTOG-9804

Identifier Type: -

Identifier Source: org_study_id

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