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Radiation Therapy in Treating Women Who Have Undergone Surgery for Early-Stage Invasive Breast Cancer
This study is ongoing, but not recruiting participants.
First Received: July 5, 2000   Last Updated: February 6, 2009   History of Changes
Sponsor: NCIC Clinical Trials Group
Collaborators: National Cancer Institute (NCI)
National Surgical Adjuvant Breast and Bowel Project (NSABP)
Radiation Therapy Oncology Group
Southwest Oncology Group
Trans-Tasman Radiation Oncology Group (TROG)
North Central Cancer Treatment Group
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005957
  Purpose

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Radiation to the tumor site and surrounding area may kill more tumor cells. It is not yet known if radiation therapy to the breast alone following surgery is more effective than radiation therapy to the breast plus surrounding tissue in treating invasive breast cancer.

PURPOSE: This randomized phase III trial is studying radiation therapy to the breast alone to see how well it works compared to radiation therapy to the breast plus surrounding tissue in treating women who have undergone surgery for early-stage invasive breast cancer.


Condition Intervention Phase
Breast Cancer
Procedure: adjuvant therapy
Radiation: radiation therapy
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Active Control
Official Title: A Phase III Study of Regional Radiation Therapy in Early Breast Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Overall survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Disease-free survival (including locoregional and distant disease) [ Designated as safety issue: No ]
  • Toxicity assessed by NCI CTC v2.0 [ Designated as safety issue: Yes ]
  • Quality of life assessed by the EORTC QLQ-C30, OCOG Breast Cancer Questionnaire [ Designated as safety issue: No ]
  • Cosmetic outcome according to the EORTC Breast Cancer Rating System for Cosmetic Results of Breast Conserving Treatment [ Designated as safety issue: No ]

Estimated Enrollment: 1822
Study Start Date: April 2000
Detailed Description:

OBJECTIVES:

  • Compare the overall survival, disease-free survival, isolated local regional disease-free survival, and distant disease-free survival in women with previously resected, early stage, invasive breast cancer treated with breast radiotherapy with or without regional radiotherapy.
  • Compare the toxic effects of these regimens in these patients.
  • Compare the quality of life of patients (in certain participating centers) treated with these regimens.
  • Compare the cosmetic outcomes in patients (in certain participating centers) treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to number of positive nodes (0 vs 1-3 vs more than 3), type of chemotherapy (anthracycline containing vs other vs none), hormonal therapy (yes vs no), number of axillary lymph nodes excised*, and participating center. Patients are randomized to one of two treatment arms.

NOTE: * Patients with a negative sentinel node dissection with or without an axillary dissection will be stratified according to the total number of nodes removed

  • Arm I: Patients undergo standard breast radiotherapy alone 5 days a week for 5 weeks in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients undergo breast and regional radiotherapy 5 days a week for 5 weeks in the absence of disease progression or unacceptable toxicity.

Radiotherapy in both arms begins as soon as possible after randomization. Radiotherapy must begin within 8 weeks after completion of adjuvant IV chemotherapy, unless radiotherapy is administered concurrently with chemotherapy (i.e., cyclophosphamide, methotrexate, and fluorouracil [CMF]), or within 16 weeks after the last breast surgery for patients treated with hormonal therapy alone.

Quality of life is assessed (in patients in certain participating centers) within 2 weeks prior to randomization, during the last week of radiotherapy, at 3 and 9 months after completion of radiotherapy, and then annually until first distant disease recurrence.

Cosmetic outcome is assessed (in patients in certain participating centers) within 2 weeks prior to randomization, and then at 3 and 5 years after completion of radiotherapy or until first distant disease recurrence.

Patients are followed at 3, 6, and 9 months, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: Approximately 1,822 patients will be accrued for this study within approximately 4 years.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically proven invasive carcinoma of the breast

    • No evidence of T4, N2-3, or M1 disease prior to surgery
    • Node positive or high-risk node negative
  • Prior breast-conserving therapy (BCT) (e.g., lumpectomy, partial mastectomy, or segmental mastectomy) and axillary node dissection or sentinel node biopsy required and must be a candidate for breast radiotherapy after BCT

    • Normally patients should have microscopically clear resection margins and those with positive margins should undergo reexcision
    • Patients with microscopically focally positive margins (defined as no greater than 3 times high power fields) are candidates for breast radiotherapy plus a boost to the lumpectomy site
    • Patients with prior sentinel node dissection eligible if node negative, but still meet high-risk criteria

      • If node positive, then a level I and II axillary dissection must be performed
    • No evidence of residual disease in axilla after dissection
  • Must be treated with currently accepted adjuvant systemic chemotherapy and/or hormonal therapy
  • High risk of regional and systemic recurrence due to one of the following:

    • Pathologically positive axillary lymph nodes
    • Pathologically negative axillary lymph nodes with one of the following:

      • Primary tumor greater than 5 cm
      • Primary tumor greater than 2 cm and less than 10 axillary lymph nodes excised and one of the following:

        • Estrogen receptor negative
        • Skarf-Bloom-Richardson grade 3
        • Lymphovascular invasion
  • Hormone receptor status:

    • Estrogen and progesterone receptor status known

PATIENT CHARACTERISTICS:

Age:

  • 16 and over

Sex:

  • Female

Menopausal status:

  • Premenopausal or postmenopausal

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 5 years

Hematopoietic:

  • Not specified

Hepatic:

  • SGOT and/or SGPT no greater than 3 times upper limit of normal (ULN)*
  • Alkaline phosphatase no greater than 3 times ULN* NOTE: * Patients with laboratory values greater than 3 times ULN may still be eligible if no metastatic disease by imaging examinations

Renal:

  • No serious nonmalignant renal disease

Cardiovascular:

  • No serious nonmalignant cardiovascular disease

Pulmonary:

  • No serious nonmalignant pulmonary disease

Other:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No other serious nonmalignant disease (e.g., systemic lupus erythematosus or scleroderma) that would preclude definitive surgery or radiotherapy
  • No other malignancy except:

    • Nonmelanomatous skin cancer
    • Carcinoma in situ of the cervix or endometrium
    • Contralateral noninvasive breast cancer (unless prior radiotherapy to the contralateral breast)
    • Invasive carcinoma of the cervix, endometrium, colon, thyroid, or melanoma that was curatively treated at least 5 years prior to study participation
  • No psychiatric or addictive disorder that would preclude informed consent or study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • See Disease Characteristics
  • Concurrent standard adjuvant chemotherapy allowed

Endocrine therapy:

  • See Disease Characteristics
  • Concurrent standard adjuvant hormonal therapy allowed

Radiotherapy:

  • See Disease Characteristics

Surgery:

  • See Disease Characteristics
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005957

  Hide Study Locations
Locations
United States, Arizona
Banner Good Samaritan Medical Center
Phoenix, Arizona, United States, 85006
United States, Arkansas
St. Joseph's Mercy Cancer Center
Hot Springs, Arkansas, United States, 71913
United States, California
Alta Bates Comprehensive Cancer Center
Berkeley, California, United States, 94704
California Pacific Medical Center - California Campus
San Francisco, California, United States, 94118
Sutter Health - Western Division Cancer Research Group
Greenbrae, California, United States, 94904
CCOP - Bay Area Tumor Institute
Oakland, California, United States, 94609
Peninsula Medical Center
Burlingame, California, United States, 94010
Cancer Care Consultants Medical Associates at Daniel Freeman Memorial Hospital
Inglewood, California, United States, 90301
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90089-9181
Washington Township Hospital
Fremont, California, United States, 94538
United States, Colorado
McKee Medical Center
Loveland, Colorado, United States, 80539
Memorial Hospital
Colorado Springs, Colorado, United States, 80909
North Colorado Medical Center
Greeley, Colorado, United States, 80631
United States, Florida
Lynn Regional Cancer Center at Boca Raton Community Hospital - Main Center
Boca Raton, Florida, United States, 33486
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States, 32224
United States, Illinois
BroMenn Regional Medical Center
Normal, Illinois, United States, 61761
Carle Cancer Center at Carle Foundation Hospital
Urbana, Illinois, United States, 61801
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
Community Cancer Center
Normal, Illinois, United States, 61761
InterCommunity Cancer Center of Western Illinois
Galesburg, Illinois, United States, 61401
John H. Stroger, Jr. Hospital of Cook County
Chicago, Illinois, United States, 60612-3785
Joliet Oncology-Hematology Associates, Limited - West
Joliet, Illinois, United States, 60435
Swedish-American Regional Cancer Center
Rockford, Illinois, United States, 61104-2315
Rush-Copley Cancer Care Center
Aurora, Illinois, United States, 60507
St. Joseph Medical Center
Bloomington, Illinois, United States, 61701
OSF St. Francis Medical Center
Peoria, Illinois, United States, 61637
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
United States, Indiana
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana, United States, 46350
Elkhart General Hospital
Elkhart, Indiana, United States, 46515
Memorial Hospital of South Bend
South Bend, Indiana, United States, 46601
Saint Anthony Memorial Health Centers
Michigan City, Indiana, United States, 46360
United States, Iowa
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States, 50309
John Stoddard Cancer Center at Iowa Lutheran Hospital
Des Moines, Iowa, United States, 50316-2301
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
Mercy Cancer Center at Mercy Medical Center - Des Moines
Des Moines, Iowa, United States, 50314
Mercy Capitol Hospital
Des Moines, Iowa, United States, 50307
United States, Maine
Central Maine Comprehensive Cancer Center at Central Maine Medical Center
Lewiston, Maine, United States, 04240
United States, Maryland
Suburban Hospital
Bethesda, Maryland, United States, 20814
United States, Massachusetts
Tufts-NEMC Cancer Center
Boston, Massachusetts, United States, 02111
United States, Michigan
Hickman Cancer Center at Bixby Medical Center
Adrian, Michigan, United States, 49221
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States, 48106
Foote Hospital
Jackson, Michigan, United States, 49201
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
St. Joseph, Michigan, United States, 49085
Saint Joseph Mercy Cancer Center
Ann Arbor, Michigan, United States, 48106-0995
Sparrow Regional Cancer Center
Lansing, Michigan, United States, 48909
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0942
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007-3731
William Beaumont Hospital - Royal Oak Campus
Royal Oak, Michigan, United States, 48073
United States, Minnesota
CCOP - Duluth
Duluth, Minnesota, United States, 55805
CentraCare Clinic - River Campus
St. Cloud, Minnesota, United States, 56303
Mayo Clinic - Gonda Building
Rochester, Minnesota, United States, 55905
MeritCare Clinic - Bemidji
Bemidji, Minnesota, United States, 56601
Willmar Cancer Center at Rice Memorial Hospital
Willmar, Minnesota, United States, 56201
United States, Mississippi
Regional Cancer Center at Singing River Hospital
Pascagoula, Mississippi, United States, 39581
United States, Missouri
Siteman Cancer Center at Barnes-Jewish Hospital
St Louis, Missouri, United States, 63110
United States, Montana
CCOP - Montana Cancer Consortium
Billings, Montana, United States, 59101
Sletten Regional Cancer Institute at Benefis Healthcare
Great Falls, Montana, United States, 59405
Great Falls Clinic
Great Falls, Montana, United States, 59405
Northern Rockies Radiation Oncology Center
Billings, Montana, United States, 59101
Deaconess Billings Clinic - Downtown
Billings, Montana, United States, 59107-7000
United States, Nebraska
Good Samaritan Cancer Center at Good Samaritan Hospital
Kearney, Nebraska, United States, 68848-1990
United States, New Jersey
Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare
Vineland, New Jersey, United States, 08360
John F. Kennedy Medical Center
Edison, New Jersey, United States, 08818
United States, New York
Lipson Cancer and Blood Center at Rochester General Hospital
Rochester, New York, United States, 14621
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Tucker Center for Cancer Care at Orange Regional Medical Center
Middletown, New York, United States, 10940-4199
United States, North Carolina
Forsyth Regional Cancer Center at Forsyth Medical Center
Winston-Salem, North Carolina, United States, 27103
Lenoir Memorial Cancer Center
Kinston, North Carolina, United States, 28501
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, United States, 27534
Wilson Medical Center
Wilson, North Carolina, United States, 27893-3428
United States, North Dakota
CCOP - MeritCare Hospital
Fargo, North Dakota, United States, 58122
MeritCare Medical Group
Fargo, North Dakota, United States, 58122
United States, Ohio
Adena Regional Medical Center
Chillicothe, Ohio, United States, 45601
CCOP - Columbus
Columbus, Ohio, United States, 43215
Mercy Medical Center
Springfield, Ohio, United States, 45504
Licking Memorial Cancer Care Program at Licking Memorial Hospital
Newark, Ohio, United States, 43055
Lima Memorial Hospital
Lima, Ohio, United States, 45804
Flower Hospital Cancer Center
Sylvania, Ohio, United States, 43560
Northwest Ohio Oncology Center
Maumee, Ohio, United States, 43623
Riverside Methodist Hospital Cancer Care
Columbus, Ohio, United States, 43214-3998
St. Charles Mercy Hospital
Oregon, Ohio, United States, 43616
Strecker Cancer Center at Marietta Memorial Hospital
Marietta, Ohio, United States, 45750
Toledo Clinic, Incorporated - Main Clinic
Toledo, Ohio, United States, 43623
United States, Oregon
Oregon Health & Science University Cancer Institute
Portland, Oregon, United States, 97239-3098
United States, South Carolina
CCOP - Greenville
Greenville, South Carolina, United States, 29615
United States, South Dakota
Medical X-Ray Center, PC
Sioux Falls, South Dakota, United States, 57105
Sioux Valley Hospital and University of South Dakota Medical Center
Sioux Falls, South Dakota, United States, 57117-5039
United States, Texas
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, United States, 79410-1894
United States, Utah
Cottonwood Hospital Medical Center
Murray, Utah, United States, 84107
Dixie Regional Medical Center - East Campus
Saint George, Utah, United States, 84770
Latter Day Saints Hospital
Salt Lake City, Utah, United States, 84143
McKay-Dee Hospital Center
Ogden, Utah, United States, 84403
Utah Cancer Specialists at UCS Cancer Center
Salt Lake City, Utah, United States, 84106
Utah Valley Regional Medical Center - Provo
Provo, Utah, United States, 84604
United States, Virginia
Bon Secours Cancer Institute at St. Mary's Hospital
Richmond, Virginia, United States, 23226
Danville Regional Medical Center
Danville, Virginia, United States, 24541
United States, Washington
Cancer Care Northwest - Spokane South
Spokane, Washington, United States, 99202
Group Health Central Hospital
Seattle, Washington, United States, 98112
St. Joseph Cancer Center
Bellingham, Washington, United States, 98225
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle, Washington, United States, 98122-4307
University Cancer Center at University of Washington Medical Center
Seattle, Washington, United States, 98195-6043
United States, Wisconsin
Community Memorial Hospital Cancer Care Center
Menomonee Falls, Wisconsin, United States, 53051
Columbia Saint Mary's Hospital - Ozaukee
Mequon, Wisconsin, United States, 53097
Columbia-Saint Mary's Cancer Care Center
Milwaukee, Wisconsin, United States, 53211
All Saints Cancer Center at Wheaton Franciscan Healthcare
Racine, Wisconsin, United States, 53405
Green Bay Oncology, Limited at St. Mary's Hospital
Green Bay, Wisconsin, United States, 54303
Green Bay Oncology, Limited at St. Vincent Hospital
Green Bay, Wisconsin, United States, 54301-3526
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States, 53226
Regional Cancer Center at Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, United States, 53066
St. Mary's Hospital Medical Center - Green Bay
Green Bay, Wisconsin, United States, 54303
Waukesha Memorial Hospital Regional Cancer Center
Waukesha, Wisconsin, United States, 53188
Theda Care Cancer Institute
Appleton, Wisconsin, United States, 54911
Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center
Green Bay, Wisconsin, United States, 54311
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States, 54307-3508
Canada, Alberta
Cross Cancer Institute at University of Alberta
Edmonton, Alberta, Canada, T6G 1Z2
Tom Baker Cancer Centre - Calgary
Calgary, Alberta, Canada, T2N 4N2
Canada, British Columbia
BCCA - Fraser Valley Cancer Centre
Surrey, British Columbia, Canada, V3V 1Z2
British Columbia Cancer Agency - Vancouver Cancer Centre
Vancouver, British Columbia, Canada, V5Z 4E6
British Columbia Cancer Agency - Vancouver Island Centre
Victoria, British Columbia, Canada, V8R 6V5
Canada, Manitoba
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, New Brunswick
Doctor Leon Richard Oncology Centre
Moncton, New Brunswick, Canada, E1C 8X3
Saint John Regional Hospital
Saint John, New Brunswick, Canada, E2L 4L2
Canada, Newfoundland and Labrador
Doctor H. Bliss Murphy Cancer Centre
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Nova Scotia
Nova Scotia Cancer Centre
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
Cancer Care Program at Thunder Bay Regional Health Sciences
Thunder Bay, Ontario, Canada, P7B 6V4
Grand River Regional Cancer Centre at Grand River Hospital
Kitchner, Ontario, Canada, N2G 1G3
London Regional Cancer Program at London Health Sciences Centre
London, Ontario, Canada, N6A 4L6
Margaret and Charles Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
St. Catharines General Hospital at Niagara Health System
St. Catharines, Ontario, Canada, L2R 5K3
Ottawa Hospital Regional Cancer Centre - General Campus
Ottawa, Ontario, Canada, K1H 8L6
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Northeastern Ontario Regional Cancer Centre
Sudbury, Ontario, Canada, P3E 5J1
Toronto Sunnybrook Regional Cancer Centre at Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
Centre de sante et de Services Sociaux de Gatineau
Gatineau, Quebec, Canada, J8P 7H2
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada, H2L-4M1
Centre Hospitalier Universitaire de Quebec
Quebec City, Quebec, Canada, G1R 2J6
CHUS-Hopital Fleurimont
Sherbrooke, Quebec, Canada, J1H 5N4
Hopital du Saint-Sacrement - Quebec
Quebec City, Quebec, Canada, G1S 4L8
McGill Cancer Centre at McGill University
Montreal, Quebec, Canada, H2W 1S6
Canada, Saskatchewan
Allan Blair Cancer Centre at Pasqua Hospital
Regina, Saskatchewan, Canada, S4T 7T1
Saskatoon Cancer Centre at the University of Saskatchewan
Saskatoon, Saskatchewan, Canada, S7N 4H4
Sponsors and Collaborators
NCIC Clinical Trials Group
National Surgical Adjuvant Breast and Bowel Project (NSABP)
Radiation Therapy Oncology Group
Southwest Oncology Group
Trans-Tasman Radiation Oncology Group (TROG)
North Central Cancer Treatment Group
Investigators
Study Chair: Timothy J. Whelan, MD Margaret and Charles Juravinski Cancer Centre
Study Chair: David S. Parda Allegheny Cancer Center at Allegheny General Hospital
Study Chair: Julia R. White, MD Medical College of Wisconsin
Study Chair: Lori J. Pierce, MD University of Michigan Cancer Center
Study Chair: Boon Chua, MD Peter MacCallum Cancer Centre, Australia
Study Chair: Laura A. Vallow, MD Mayo Clinic
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000067938, CAN-NCIC-MA20, NSABP-CAN-NCIC-MA20, NCCTG-CAN-NCIC-MA20, RTOG-CAN-NCIC-MA20, SWOG-CAN-NCIC-MA20, TROG-CAN-NCIC-MA20
Study First Received: July 5, 2000
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00005957     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I breast cancer
stage II breast cancer

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Skin Diseases
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on November 22, 2009