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

Primary Purpose

Breast Cancer

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

tamoxifen citrate

adjuvant therapy

radiation therapy

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring breast cancer in situ, ductal breast carcinoma in situ

Eligibility Criteria

26 Years - 120 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Mobile Infirmary Medical Center
Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital
Arizona Oncology Services Foundation
Saint Joseph's Mercy Cancer Center
Providence Saint Joseph Medical Center - Burbank
Enloe Cancer Center at Enloe Medical Center
Mount Diablo Regional Cancer Center
North Bay Cancer Center
Washington Township Hospital
Saint Agnes Medical Center
Cancer Care Consultants Medical Associates at Daniel Freeman Memorial Hospital
USC/Norris Comprehensive Cancer Center and Hospital
Providence Holy Cross Cancer Center
Memorial Medical Center Cancer Services
CCOP - Bay Area Tumor Institute
Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center
Radiological Associates of Sacramento Medical Group, Incorporated
University of California Davis Cancer Center
CCOP - Santa Rosa Memorial Hospital
Torrance Memorial Medical Center
John Muir/Mt. Diablo Comprehensive Cancer Center
Ruby L. Golleher Cancer Program at Presbyterian Intercommunity Hospital
St. Vincent's Medical Center
Hospital of Saint Raphael
Eastern Connecticut Hematology and Oncology Associates
CCOP - Christiana Care Health Services
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
University of Florida Shands Cancer Center
Mayo Clinic - Jacksonville
Lakeland Regional Cancer Center at Lakeland Regional Medical Center
University of Miami Sylvester Comprehensive Cancer Center
Baptist-South Miami Regional Cancer Program
Northeast Georgia Medical Center
Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
Leeward Radiation Oncology Center
Cancer Research Center of Hawaii
Queen's Cancer Institute at Queen's Medical Center
St. Francis Medical Center
Tripler Army Medical Center
St. Luke's Mountain States Tumor Institute - Boise
Hematology Oncology Associates of Eastern Idaho
Northwest Community Hospital
Rush-Copley Cancer Care Center
Good Shepherd Hospital
St. Joseph Medical Center
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
John H. Stroger, Jr. Hospital of Cook County
Creticos Cancer Center at Advocate Illinois Masonic Medical Center
Advocate Good Samaritan Hospital
InterCommunity Cancer Center of Western Illinois
Joliet Oncology-Hematology Associates, Limited - West
Cardinal Bernardin Cancer Center at Loyola University Medical Center
BroMenn Regional Medical Center
Community Cancer Center
Lutheran General Cancer Care Center
Cancer Treatment Center at Pekin Hospital
CCOP - Illinois Oncology Research Association
Oncology Hematology Associates of Central Illinois, PC - Peoria
Methodist Medical Center of Illinois
OSF St. Francis Medical Center
Valley Cancer Center
Carle Cancer Center at Carle Foundation Hospital
CCOP - Carle Cancer Center
St. John's Cancer Center at St. John's Medical Center
Regional Cancer Institute at Bloomington Hospital
Elkhart General Hospital
Parkview Regional Cancer Center at Parkview Health
Indiana University Cancer Center
Howard Community Hospital at Howard Regional Health System
Center for Cancer Therapy at LaPorte Hospital and Health Services
Saint Anthony Memorial Health Centers
CCOP - Northern Indiana CR Consortium
Memorial Hospital of South Bend
St. Luke's Hospital
Cedar Rapids Oncology Associates
Mercy Regional Cancer Center at Mercy Medical Center
Stormont-Vail Cancer Center
St. Francis Comprehensive Cancer Center
Cancer Treatment Center for Southern Kentucky
Central Baptist Hospital
Merle M. Mahr Cancer Center at Regional Medical Center of Hopkins County
Central Maine Medical Center
Maine Medical Center - Bramhall Campus
DeCesaris Cancer Institute at Anne Arundel Medical Center
Greater Baltimore Medical Center
Suburban Hospital
Peninsula Regional Medical Center
Massachusetts General Hospital Cancer Center
Brigham and Women's Hospital
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Cancer Research Center at Boston Medical Center
Lahey Clinic Medical Center - Burlington
Bethke Cancer Center at Emerson Hospital
Hudner Oncology Center at Saint Anne's Hospital
MetroWest Medical Center - Framingham Union Hospital
Cape Cod Hospital
Lowell General Hospital
Community Cancer Care at Milford Regional Medical Center
Caritas Norwood Hospital
Baystate Regional Cancer Program at D'Amour Center for Cancer Care
Hickman Cancer Center at Bixby Medical Center
St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital
CCOP - Michigan Cancer Research Consortium
University of Michigan Comprehensive Cancer Center
Barbara Ann Karmanos Cancer Institute
Josephine Ford Cancer Center at Henry Ford Hospital
Green Bay Oncology, Limited - Escanaba
Genesys Hurley Cancer Institute
Great Lakes Cancer Institute at McLaren Regional Medical Center
CCOP - Grand Rapids
Lacks Cancer Center at Saint Mary's Mercy Medical Center
Spectrum Health Cancer Care - Butterworth Campus
Van Elslander Cancer Center at St. John Hospital and Medical Center
Green Bay Oncology, Limited - Iron Mountain
Foote Hospital
Borgess Medical Center
West Michigan Cancer Center
Bronson Methodist Hospital
Breslin Cancer Center at Ingham Regional Medical Center
Upper Michigan Cancer Center at Marquette General Hospital
MidMichigan Medical Center - Midland
Northern Michigan Hospital
William Beaumont Hospital - Royal Oak Campus
Seton Cancer Institute - Saginaw
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
Munson Medical Center
St. John Macomb Hospital
Fairview Ridges Hospital
Mercy and Unity Cancer Center at Mercy Hospital
St. Mary's - Duluth Clinic Cancer Center
Fairview Southdale Hospital
Mercy and Unity Cancer Center at Unity Hospital
Immanuel St. Joseph's Clinic
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
Hubert H. Humphrey Cancer Center at North Memorial Medical Center
Mayo Clinic Cancer Center
CentraCare Clinic - River Campus
Coborn Cancer Center
CCOP - Metro-Minnesota
Park Nicollet Health Services
Regions Hospital Cancer Care Center
United Hospital
Ridgeview Medical Center
University of Mississippi Medical Center
Ellis Fischel Cancer Center at University of Missouri - Columbia
CCOP - Kansas City
CCOP - Montana Cancer Consortium
Northern Rockies Radiation Oncology Center
Deaconess Billings Clinic - Downtown
Great Falls Clinic
Good Samaritan Cancer Center at Good Samaritan Hospital
Methodist Cancer Center at Methodist Hospital - Omaha
CCOP - Nevada Cancer Research Foundation
Dartmouth - Hitchcock Concord
Seacoast Cancer Center at Wentworth-Douglass Hospital
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Elliot Regional Cancer Center at Elliot Hospital
Veterans Affairs Medical Center - East Orange
John F. Kennedy Medical Center
Dizzy Gillespie Cancer Institute at Englewood Hospital and Medical Center
Monmouth Medical Center
Fox Chase Virtua Health Cancer Program - Marlton
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
Saint Peter's University Hospital
Newark Beth Israel Medical Center
AtlantiCare Regional Medical Center
Booker Cancer Center at Riverview Medical Center
Fox Chase Cancer Center at St. Francis Medical Center
Cancer Institute of New Jersey at Cooper - Voorhees
Albuquerque Regional Medical Center at Lovelace Sandia Health System
University of New Mexico Cancer Research and Treatment Center
Long Island College Hospital
Roswell Park Cancer Institute
CCOP - North Shore University Hospital
North Shore University Hospital
Tucker Center for Cancer Care at Orange Regional Medical Center
Long Island Jewish Medical Center
Memorial Sloan-Kettering Cancer Center
CCOP - Hematology-Oncology Associates of Central New York
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Blumenthal Cancer Center at Carolinas Medical Center
Batte Cancer Center at Northeast Medical Center
Duke Comprehensive Cancer Center
Wayne Memorial Hospital, Incorporated
Wayne Radiation Oncology
Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital
Pardee Memorial Hospital
Lenoir Memorial Cancer Center
Moore Regional Community Hospital Comprehensive Cancer Center
Rex Cancer Center at Rex Hospital
Rutherford Hospital
Zimmer Cancer Center at New Hanover Regional Medical Center
Wilmed Radiation Oncology Services
Trinity Cancer Care Center
McDowell Cancer Center at Akron General Medical Center
Mercy Cancer Center at Mercy Medical Center
Adena Regional Medical Center
Cancer Treatment Center at Good Samaritan Hospital
Bethesda North Hospital
Case Comprehensive Cancer Center
MetroHealth's Cancer Care Center at MetroHealth Medical Center
Cleveland Clinic Taussig Cancer Center
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
Riverside Methodist Hospital Cancer Care
CCOP - Columbus
Mount Carmel Health - West Hospital
Grady Memorial Hospital
Blanchard Valley Medical Associates
St. Rita's Medical Center
Lima Memorial Hospital
Strecker Cancer Center at Marietta Memorial Hospital
Northwest Ohio Oncology Center
Hillcrest Cancer Center at Hillcrest Hospital
Licking Memorial Cancer Care Program at Licking Memorial Hospital
St. Charles Mercy Hospital
Firelands Regional Medical Center
Mercy Medical Center
Promedica Cancer Center at Flower Hospital
St. Vincent Mercy Medical Center
Medical University of Ohio Cancer Center
CCOP - Toledo Community Hospital
Toledo Clinic, Incorporated - Main Clinic
St. Joseph Cancer Center at St. Joseph Health Center
Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital
Natalie Warren Bryant Cancer Center at St. Francis Hospital
Three Rivers Community Hospital
Legacy Mount Hood Medical Center
Dubs Cancer Center at Rogue Valley Medical Center
Providence Medford Medical Center
Providence Milwaukie Hospital
Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center
Providence Cancer Center at Providence Portland Medical Center
CCOP - Columbia River Oncology Program
Providence St. Vincent Medical Center
Legacy Emanuel Hospital and Health Center & Children's Hospital
Cancer Institute at Oregon Health and Science University
Legacy Meridian Park Hospital
Rosenfeld Cancer Center at Abington Memorial Hospital
St. Luke's Hospital Cancer Center
Bryn Mawr Hospital
Geisinger Medical Center
Mercy Fitzgerald Hospital
Easton Regional Cancer Center at Easton Hospital
St. Mary Regional Cancer Center
Paoli Memorial Hospital
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Fox Chase-Temple Cancer Center CCOP Research Base
Mercy Cancer Institute at Mercy Hospital
Hillman Cancer Center at University of Pittsburgh Cancer Institute
Reading Hospital and Medical Center
Mercy Hospital Cancer Center - Scranton
Mount Nittany Medical Center
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
CCOP - MainLine Health
Lankenau Cancer Center at Lankenau Hospital
York Cancer Center at Wellspan Health
AnMed Health Cancer Center
Palmetto Health South Carolina Cancer Center
Bon Secours St. Francis Health System
CCOP - Greenville
CCOP - Upstate Carolina
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Rapid City Regional Hospital
Medical X-Ray Center, PC
Sioux Valley Hospital and University of South Dakota Medical Center
University of Texas Medical Branch
M.D. Anderson Cancer Center at University of Texas
Doctor's Hospital of Laredo
Joe Arrington Cancer Research and Treatment Center
Cottonwood Hospital Medical Center
McKay-Dee Hospital Center
Utah Valley Regional Medical Center - Provo
Dixie Regional Medical Center - East Campus
Utah Cancer Specialists at UCS Cancer Center
LDS Hospital
Fletcher Allen Health Care - University Health Center Campus
Community Cancer Center at Rutland Regional Medical Center
Martha Jefferson Hospital Cancer Care Center
Naval Medical Center - Portsmouth
St. Francis Hospital
Cascade Cancer Center at Evergreen Hospital Medical Center
CCOP - Virginia Mason Research Center
Group Health Central Hospital
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
University Cancer Center at University of Washington Medical Center
Cancer Care Northwest - Spokane South
Madigan Army Medical Center - Tacoma
Southwest Washington Medical Center Cancer Center
Theda Care Cancer Institute
Green Bay Oncology, Limited at St. Vincent Hospital
Green Bay Oncology, Limited at St. Mary's Hospital
St. Mary's Hospital Medical Center - Green Bay
St. Vincent Hospital Regional Cancer Center
Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
University of Wisconsin Comprehensive Cancer Center
Bay Area Cancer Care Center at Bay Area Medical Center
Community Memorial Hospital Cancer Care Center
Columbia St. Mary's Cancer Care Center
Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center
Regional Cancer Center at Oconomowoc Memorial Hospital
Green Bay Oncology, Limited - Oconto Falls
Green Bay Oncology, Limited - Sturgeon Bay
Waukesha Memorial Hospital Regional Cancer Center
West Allis Memorial Hospital
Cross Cancer Institute at University of Alberta
Lethbridge Cancer Centre
British Columbia Cancer Agency - Centre for the Southern Interior
Nanaimo Cancer Clinic at Nanaimo Regional General Hospital
Lions Gate Hospital
BCCA - Fraser Valley Cancer Centre
Prostate Centre at Vancouver General Hospital
British Columbia Cancer Agency - Vancouver Cancer Centre
Providence Health Care - Vancouver
British Columbia Cancer Agency - Vancouver Island Cancer Centre
G. Steinhoff Clinical Research
CancerCare Manitoba
Moncton Hospital
Saint John Regional Hospital
Newfoundland Cancer Treatment and Research Foundation
Nova Scotia Cancer Centre
Cape Breton Cancer Centre
Royal Victoria Hospital of Barrie
William Osler Health Centre
St. Joseph's Hospital
Margaret and Charles Juravinski Cancer Centre
Cancer Centre of Southeastern Ontario at Kingston General Hospital
Grand River Regional Cancer Centre at Grand River Hospital
London Regional Cancer Program at London Health Sciences Centre
Markham Stouffville Hospital
Trillium Health Centre - Mississauga Site
Southlake Regional Health Centre
North York General Hospital - Ontario
Male Health Centre - Oakville
R. S. McLaughlin Durham Regional Cancer Centre at Lakeridge Health Oshawa
Ottawa Hospital Regional Cancer Centre - General Campus
Peterborough Oncology Clinic
Algoma Regional Cancer Program at Sault Area Hospital
Scarborough Hospital - General Campus
St. Catharines General Hospital at Niagara Health System
Northeastern Ontario Regional Cancer Centre
Northwestern Ontario Regional Cancer Care at Thunder Bay Regional Health Sciences Centre
Toronto East General Hospital
Toronto Sunnybrook Regional Cancer Centre at Sunnybrook Health Sciences Centre
St. Michael's Hospital - Toronto
Mount Sinai Hospital - Toronto
Princess Margaret Hospital
Male Health Centre - North York
St. Joseph's Health Centre - Toronto
Humber River Regional Hospital - Weston
Windsor Regional Cancer Centre at Windsor Regional Hospital
Prince Edward Island Cancer Centre at Queen Elizabeth Hospital
Centre de Sante et de Services Sociaux de Chicoutimi
CHUS-Hopital Fleurimont
Doctor Leon Richard Oncology Centre
Hopital Charles Lemoyne
Centre Hospitalier Regional de Lanaudiere
Hotel-Dieu de Levis
Centre Hospitalier de l'Universite de Montreal
Maisonneuve-Rosemont Hospital
Hotel Dieu de Montreal
Hopital Sainte Justine
Hopital Du Sacre-Coeur de Montreal
Centre Hospitalier Universitaire de Quebec
Hopital du Saint-Sacrement - Quebec
L'Hopital Laval
Allan Blair Cancer Centre at Pasqua Hospital
Saskatoon Cancer Centre at the University of Saskatchewan
Centre Hospitalier Regional de Rimouski

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Observation +/- tamoxifen for 5 years

Radiation therapy +/- tamoxifen for 5 years

Arm Description

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

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

Outcomes

Primary Outcome Measures

Local recurrence (e.g., invasive or noninvasive recurrence)

Secondary Outcome Measures

Overall survival

Time to distant metastasis

Invasive local recurrence

Salvage mastectomy rate

Full Information

NCT ID

NCT00003857

First Posted

November 1, 1999

Last Updated

May 23, 2022

Sponsor

Radiation Therapy Oncology Group

Collaborators

National Cancer Institute (NCI), Cancer and Leukemia Group B, NCIC Clinical Trials Group, NRG Oncology

1. Study Identification

Unique Protocol Identification Number

NCT00003857

Brief Title

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

Official Title

Phase III Trial of Tamoxifen Alone vs. Tamoxifen Plus Radiation Therapy for Good Risk Duct Carcinoma In-Situ (DCIS) of the Female Breast

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Completed

Study Start Date

December 1999 (Actual)

Primary Completion Date

February 2004 (Actual)

Study Completion Date

May 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Radiation Therapy Oncology Group

Collaborators

National Cancer Institute (NCI), Cancer and Leukemia Group B, NCIC Clinical Trials Group, NRG Oncology

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

breast cancer in situ, ductal breast carcinoma in situ

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

636 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Observation +/- tamoxifen for 5 years

Arm Type

Active Comparator

Arm Description

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

Arm Title

Radiation therapy +/- tamoxifen for 5 years

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

tamoxifen citrate

Intervention Type

Procedure

Intervention Name(s)

adjuvant therapy

Intervention Type

Radiation

Intervention Name(s)

radiation therapy

Primary Outcome Measure Information:

Title

Local recurrence (e.g., invasive or noninvasive recurrence)

Time Frame

From randomization to date of local failure in the treated breast or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years.

Secondary Outcome Measure Information:

Title

Overall survival

Time Frame

From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years.

Title

Time to distant metastasis

Time Frame

From randomization to date of distant metastasis or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years.

Title

Invasive local recurrence

Time Frame

From randomization to date of invasive local failure in the treated breast or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years.

Title

Salvage mastectomy rate

Time Frame

Analysis occurs after all patients have been potentially followed for 5 years.

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

26 Years

Maximum Age & Unit of Time

120 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials: