A Randomized Clinical Trial Of Adjuvant Chemotherapy For Radically Resected Loco-Regional Relapse Of Breast Cancer
OBJECTIVES:
Primary
- Determine the efficacy of adjuvant chemotherapy, in terms of disease-free survival, in
women with radically resected loco-regional relapsed breast cancer.
Secondary
- Determine the systemic disease-free and overall survival of patients treated with this
regimen.
- Determine the sites of recurrence, incidence of second (non-breast) malignancies, and
causes of death without relapse of breast cancer in patients treated with this regimen.
- Determine the quality of life of patients treated with this regimen (QOL portion closed
11/13/08).
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior
chemotherapy (yes vs no), estrogen receptor (ER) positive and/or progesterone receptor (PR)
positive (yes vs no), and location of recurrence (breast vs mastectomy scar/chest wall vs
regional lymph nodes). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive radiotherapy* within 6 months after surgery.
- Arm II: Within 10 weeks after surgery, patients receive at least 3 courses of an
adjuvant chemotherapy regimen as determined by the investigator. Patients also receive
radiotherapy* within 6 months after surgery and after the completion of chemotherapy OR
integrated with chemotherapy.
NOTE: *Patients with clear margins (R0) who received prior adjuvant radiotherapy are not
required to receive further radiotherapy
Patients with ER and/or PR positive tumors also receive standard hormonal therapy.
Quality of life is assessed at baseline and at 9 and 12 months (QOL portion closed
11/13/08).
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.
PROJECTED ACCRUAL: A total of 265 patients will be accrued for this study within 4 years.
Interventional
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Disease-free survival
10 years after randomization
No
Stefan Aebi, MD
Study Chair
Inselspital Bern, Switzerland
United States: Federal Government
CDR0000343619
NCT00074152
July 2002
December 2015
Name | Location |
---|---|
Walter Reed Army Medical Center | Washington, District of Columbia 20307-5000 |
CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
CCOP - Wichita | Wichita, Kansas 67214-3882 |
Hurley Medical Center | Flint, Michigan 48503 |
Mercy Medical Center - Sioux City | Sioux City, Iowa 51104 |
Siouxland Hematology-Oncology Associates, LLP | Sioux City, Iowa 51101 |
St. Luke's Regional Medical Center | Sioux City, Iowa 51104 |
Tufts-NEMC Cancer Center | Boston, Massachusetts 02111 |
CCOP - Michigan Cancer Research Consortium | Ann Arbor, Michigan 48106 |
Saint Joseph Mercy Cancer Center | Ann Arbor, Michigan 48106-0995 |
Oakwood Cancer Center at Oakwood Hospital and Medical Center | Dearborn, Michigan 48123-2500 |
Genesys Hurley Cancer Institute | Flint, Michigan 48503 |
Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods, Michigan 48236 |
Sparrow Regional Cancer Center | Lansing, Michigan 48912-1811 |
St. John Macomb Hospital | Warren, Michigan 48093 |
Aultman Cancer Center at Aultman Hospital | Canton, Ohio 44710-1799 |
MetroHealth Cancer Care Center at MetroHealth Medical Center | Cleveland, Ohio 44109 |
St. Rita's Medical Center | Lima, Ohio 45801 |
Geisinger Medical Group - Scenery Park | State College, Pennsylvania 16801 |
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center | Wilkes-Barre, Pennsylvania 18711 |
Marshfield Clinic - Marshfield Center | Marshfield, Wisconsin 54449 |
Marshfield Clinic - Indianhead Center | Rice Lake, Wisconsin 54868 |
Memorial Hospital of South Bend | South Bend, Indiana 46601 |
CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
Newark Beth Israel Medical Center | Newark, New Jersey 07112 |
Mercy Hospital Cancer Center - Scranton | Scranton, Pennsylvania 18501 |
Joe Arrington Cancer Research and Treatment Center | Lubbock, Texas 79410-1894 |
CCOP - Northern Indiana CR Consortium | South Bend, Indiana 46601 |
Saint Joseph Regional Medical Center | South Bend, Indiana 46617 |
Holden Comprehensive Cancer Center at University of Iowa | Iowa City, Iowa 52242-1002 |
Kaiser Permanente Medical Center - Vallejo | Vallejo, California 94589 |
Wesley Medical Center | Wichita, Kansas 67214 |
Kaiser Permanente Medical Center - San Francisco Geary Campus | San Francisco, California 94115 |
St. Vincent Mercy Medical Center | Toledo, Ohio 43608 |
Josephine Ford Cancer Center at Henry Ford Hospital | Detroit, Michigan 48202 |
CCOP - Toledo Community Hospital | Toledo, Ohio 43623-3456 |
Kaiser Permanente Medical Center - Oakland | Sacramento, California 95825 |
Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita, Kansas 67214 |
Albert Einstein Cancer Center at Albert Einstein College of Medicine | Bronx, New York 10461 |
Wake Forest University Comprehensive Cancer Center | Winston-Salem, North Carolina 27157-1096 |
Medical University of Ohio Cancer Center | Toledo, Ohio 43614 |
Toledo Hospital | Toledo, Ohio 43606 |
Hollings Cancer Center at Medical University of South Carolina | Charleston, South Carolina 29425 |
CCOP - Hematology-Oncology Associates of Central New York | East Syracuse, New York 13057 |
Batte Cancer Center at Northeast Medical Center | Concord, North Carolina 28025 |
Baptist Cancer Institute - Jacksonville | Jacksonville, Florida 32207 |
Southwest Medical Center | Liberal, Kansas 67901 |
Northern Rockies Radiation Oncology Center | Billings, Montana 59101 |
Hematology-Oncology Centers of the Northern Rockies - Billings | Billings, Montana 59101 |
St. Peter's Hospital | Helena, Montana 59601 |
Kalispell Regional Medical Center | Kalispell, Montana 59901 |
Glacier Oncology, PLLC | Kalispell, Montana 59901 |
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Missoula, Montana 59802 |
Montana Cancer Specialists at Montana Cancer Center | Missoula, Montana 59802 |
Community Medical Center | Missoula, Montana 59801 |
Wayne Memorial Hospital, Incorporated | Goldsboro, North Carolina 27534 |
Kaiser Permanente Medical Center - Santa Clara Kiely Campus | Santa Clara, California 95051-5386 |
Lucille P. Markey Cancer Center at University of Kentucky | Lexington, Kentucky 40536-0093 |
CCOP - Nevada Cancer Research Foundation | Las Vegas, Nevada 89109-2306 |
Geisinger Cancer Institute at Geisinger Health | Danville, Pennsylvania 17822-0001 |
Gundersen Lutheran Center for Cancer and Blood | La Crosse, Wisconsin 54601 |
Kaiser Permanente Medical Center - Sacramento | Sacramento, California 95825 |
Elkhart General Hospital | Elkhart, Indiana 46515 |
Howard Community Hospital | Kokomo, Indiana 46904 |
South Bend Clinic | South Bend, Indiana 46617 |
Lakeland Regional Cancer Care Center - St. Joseph | St. Joseph, Michigan 49085 |
Hope A Women's Cancer Center | Asheville, North Carolina 28801 |
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest | Allentown, Pennsylvania 18105 |
Front Range Cancer Specialists | Fort Collins, Colorado 80528 |
University Medical Center of Southern Nevada | Las Vegas, Nevada 89102 |
Kaiser Permanente - Fremont | Fremont, California 94538 |
Kaiser Permanente Medical Center - Hayward | Hayward, California 94545 |
Kaiser Permanente Medical Center - Redwood City | Redwood City, California 94063 |
Kaiser Permanente Medical Center - Richmond | Richmond, California 94801 |
Kaiser Permanente Medical Center - Roseville | Roseville, California 95661 |
South Sacramento Kaiser-Permanente Medical Center | Sacramento, California 95823 |
Kaiser Permanente Medical Center - Santa Teresa | San Jose, California 95119 |
Kaiser Foundation Hospital - San Rafael | San Rafael, California 94903 |
Kaiser Permanente Medical Center - Santa Rosa | Santa Rosa, California 95403 |
Kaiser Permanente Medical Center - South San Francisco | South San Francisco, California 94080 |
Kaiser Permanente Medical Facility - Stockton | Stockton, California 95210 |
Kaiser Permanente Medical Center - Walnut Creek | Walnut Creek, California 94596 |
Poudre Valley Hospital | Fort Collins, Colorado 80524 |
Edward Hospital Cancer Center | Naperville, Illinois 60540 |
Center for Cancer Therapy at LaPorte Hospital and Health Services | La Porte, Indiana 46350 |
Genesis Medical Center - West Campus | Davenport, Iowa 52804 |
Genesis Regional Cancer Center at Genesis Medical Center | Davenport, Iowa 52803 |
Cancer Center of Kansas, PA - Dodge City | Dodge City, Kansas 67801 |
Hickman Cancer Center at Bixby Medical Center | Adrian, Michigan 49221 |
Community Cancer Center of Monroe | Monroe, Michigan 48162 |
Wood County Oncology Center | Bowling Green, Ohio 43402 |
Lima Memorial Hospital | Lima, Ohio 45804 |
St. Luke's Hospital | Maumee, Ohio 43537 |
Northwest Ohio Oncology Center | Maumee, Ohio 43537 |
Toledo Clinic - Oregon | Oregon, Ohio 43616 |
St. Charles Mercy Hospital | Oregon, Ohio 43616 |
North Coast Cancer Care, Incorporated | Sandusky, Ohio 44870 |
Mercy Hospital of Tiffin | Tiffin, Ohio 44883 |
Toledo Clinic, Incorporated - Main Clinic | Toledo, Ohio 43623 |
Fulton County Health Center | Wauseon, Ohio 43567 |
Kaiser Permanente Health Care - Portland | Portland, Oregon 97232 |
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center | Kingsport, Tennessee 37662 |
Doctor's Hospital of Laredo | Laredo, Texas 78041 |
Danville Regional Medical Center | Danville, Virginia 24541 |
Welch Cancer Center at Sheridan Memorial Hospital | Sheridan, Wyoming 82801 |
Northeast Georgia Medical Center | Gainesville, Georgia 30501 |
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital | Pittsburgh, Pennsylvania 15224-1791 |
Kaiser Permanente - Deer Valley | Antioch, California 94531 |
Stanford Cancer Center | Stanford, California 94305-5824 |
McFarland Clinic, PC | Ames, Iowa 50010 |
Cancer Center of Kansas, PA - Chanute | Chanute, Kansas 66720 |
Cancer Center of Kansas, PA - El Dorado | El Dorado, Kansas 67042 |
Cancer Center of Kansas - Fort Scott | Fort Scott, Kansas 66701 |
Cancer Center of Kansas-Independence | Independence, Kansas 67301 |
Cancer Center of Kansas, PA - Kingman | Kingman, Kansas 67068 |
Lawrence Memorial Hospital | Lawrence, Kansas 66044 |
Cancer Center of Kansas, PA - Newton | Newton, Kansas 67114 |
Cancer Center of Kansas, PA - Parsons | Parsons, Kansas 67357 |
Cancer Center of Kansas, PA - Pratt | Pratt, Kansas 67124 |
Cancer Center of Kansas, PA - Salina | Salina, Kansas 67401 |
Cancer Center of Kansas, PA - Wellington | Wellington, Kansas 67152 |
Cancer Center of Kansas, PA - Wichita | Wichita, Kansas 67214 |
Associates in Womens Health, PA - North Review | Wichita, Kansas 67208 |
Cancer Center of Kansas, PA - Medical Arts Tower | Wichita, Kansas 67208 |
Cancer Center of Kansas, PA - Winfield | Winfield, Kansas 67156 |
Foote Memorial Hospital | Jackson, Michigan 49201 |
Haematology-Oncology Associates of Ohio and Michigan, PC | Lambertville, Michigan 48144 |
St. Mary Mercy Hospital | Livonia, Michigan 48154 |
Mercy Memorial Hospital - Monroe | Monroe, Michigan 48162 |
St. Joseph Mercy Oakland | Pontiac, Michigan 48341-2985 |
Mercy Regional Cancer Center at Mercy Hospital | Port Huron, Michigan 48060 |
Seton Cancer Institute at Saint Mary's - Saginaw | Saginaw, Michigan 48601 |
Billings Clinic - Downtown | Billings, Montana 59107-7000 |
Bozeman Deaconess Cancer Center | Bozeman, Montana 59715 |
St. James Healthcare Cancer Care | Butte, Montana 59701 |
Great Falls Clinic - Main Facility | Great Falls, Montana 59405 |
Northern Montana Hospital | Havre, Montana 59501 |
Kalispell Medical Oncology at KRMC | Kalispell, Montana 59901 |
North Coast Cancer Care - Clyde | Clyde, Ohio 43410 |
Hematology Oncology Center | Elyria, Ohio 44035 |
Flower Hospital Cancer Center | Sylvania, Ohio 43560 |
St. Anne Mercy Hospital | Toledo, Ohio 43623 |
Hematology and Oncology Associates of Northeastern Pennsylvania | Scranton, Pennsylvania 18510 |
Fredericksburg Oncology, Incorporated | Fredericksburg, Virginia 22401 |
Southwest Virginia Regional Cancer Center at Wellmonth Health | Norton, Virginia 24273 |
Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital | Parkersburg, West Virginia 26102 |
Marshfield Clinic Cancer Care at Regional Cancer Center | Eau Claire, Wisconsin 54701 |
Saint Joseph's Hospital | Marshfield, Wisconsin 54449 |
Marshfield Clinic - Lakeland Center | Minocqua, Wisconsin 54548 |
Ministry Medical Group at Saint Mary's Hospital | Rhinelander, Wisconsin 54501 |
Marshfield Clinic at Saint Michael's Hospital | Stevens Point, Wisconsin 54481 |
Saint Michael's Hospital Cancer Center | Stevens Point, Wisconsin 54481 |
Marshfield Clinic - Wausau Center | Wausau, Wisconsin 54401 |
Marshfield Clinic - Weston Center | Weston, Wisconsin 54476 |
Diagnostic and Treatment Center | Weston, Wisconsin 54476 |
Regional Cancer Center at Memorial Medical Center | Springfield, Illinois 62781-0001 |
Good Samaritan Cancer Center at Good Samaritan Hospital | Kearney, Nebraska 68848-1990 |
Rutherford Hospital | Rutherfordton, North Carolina 28139 |
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg, South Carolina 29303 |
La Grange Memorial Hospital | La Grange, Illinois 60525 |
Great Falls, Montana 59405 | |
Guardian Oncology and Center for Wellness | Missoula, Montana 59804 |
St. Vincent Healthcare Cancer Care Services | Billings, Montana 59101 |
AnMed Cancer Center | Anderson, South Carolina 29621 |
Southeastern Medical Oncology Center - Goldsboro | Goldsboro, North Carolina 27534 |
Kent General Hospital | Dover, Delaware 19901 |