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| 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 |
| Estimated Enrollment: | 1822 |
| Study Start Date: | April 2000 |
OBJECTIVES:
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
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 |
DISEASE CHARACTERISTICS:
Histologically proven invasive carcinoma of the breast
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
Patients with prior sentinel node dissection eligible if node negative, but still meet high-risk criteria
High risk of regional and systemic recurrence due to one of the following:
Pathologically negative axillary lymph nodes with one of the following:
Primary tumor greater than 2 cm and less than 10 axillary lymph nodes excised and one of the following:
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
No other malignancy except:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations
Hide Study 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 | |
| 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
| 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 |
|
stage I breast cancer stage II breast cancer |
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Neoplasms Neoplasms by Site Skin Diseases Breast Neoplasms Breast Diseases |