A Phase II Study of Repeat Breast Preserving Surgery and 3D-Conformal Partial Breast Re-Irradiation (PBrI) for Local Recurrence of Breast Carcinoma
OBJECTIVES:
Primary
- To evaluate skin, breast, and chest wall adverse events occurring within 1 year after
completion of 3D-conformal partial-breast re-irradiation following repeat
breast-preserving surgery in patients with locally recurrent breast carcinoma.
Secondary
- To evaluate the adverse events at 1 year and at any time of this regimen in these
patients.
- To evaluate in-breast control rate in patients treated with this regimen.
- To evaluate freedom-from-mastectomy rate in these patients.
- To evaluate the rate of circulating tumor cells (CTCs) in this patient population and
to document eradication of CTCs by locoregional therapy.
- To determine whether translational objective will correlate with eradication or
presence of CTCs with in-breast recurrence and distant metastasis-free survival.
- To evaluate cosmesis as judged by the patient and independent evaluation.
- To evaluate distant metastasis-free survival, mastectomy-free survival, and overall
survival of patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients undergo 3-dimensional conformal accelerated partial-breast irradiation twice daily,
5 days a week, for 3 weeks.
Some patients undergo blood sample collection at baseline and within 3 weeks after
completion of radiotherapy for circulating tumor cells analysis.
Some patients complete questionnaires on cosmesis at baseline and at 1 and 3 years following
radiotherapy.
After completion of study therapy, patients are followed up periodically for 4-5 years and
then every year thereafter.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Grade 3+ treatment-related skin, fibrosis, and breast pain adverse events
From the end of radiation to 1 year.
Yes
Douglas W. Arthur, MD
Principal Investigator
Massey Cancer Center
United States: Federal Government
RTOG 1014
NCT01082211
June 2010
Name | Location |
---|---|
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
Saint Joseph Mercy Cancer Center | Ann Arbor, Michigan 48106-0995 |
Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods, Michigan 48236 |
West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
Medical College of Wisconsin Cancer Center | Milwaukee, Wisconsin 53226 |
Rapid City Regional Hospital | Rapid City, South Dakota 57709 |
Cape Cod Hospital | Hyannis, Massachusetts 02601 |
Albert Einstein Cancer Center | Philadelphia, Pennsylvania 19141 |
Charles M. Barrett Cancer Center at University Hospital | Cincinnati, Ohio 45267-0526 |
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | Philadelphia, Pennsylvania 19107 |
Monmouth Medical Center | Long Branch, New Jersey 07740-6395 |
McDowell Cancer Center at Akron General Medical Center | Akron, Ohio 44307 |
Wake Forest University Comprehensive Cancer Center | Winston-Salem, North Carolina 27157-1096 |
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Dallas, Texas 75390 |
James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester, New York 14642 |
Battle Creek Health System Cancer Care Center | Battle Creek, Michigan 49017 |
William Beaumont Hospital - Royal Oak Campus | Royal Oak, Michigan 48073 |
Greenebaum Cancer Center at University of Maryland Medical Center | Baltimore, Maryland 21201 |
Butterworth Hospital at Spectrum Health | Grand Rapids, Michigan 49503-2560 |
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | St. Louis, Missouri 63110 |
St. Barnabas Medical Center Cancer Center | Livingston, New Jersey 07039 |
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | New Brunswick, New Jersey 08903 |
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center | New York, New York 10032 |
M. D. Anderson Cancer Center at University of Texas | Houston, Texas 77030-4009 |
Virginia Commonwealth University Massey Cancer Center | Richmond, Virginia 23298-0037 |
Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago, Illinois 60611 |
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton | Marlton, New Jersey 08053 |
Rosenfeld Cancer Center at Abington Memorial Hospital | Abington, Pennsylvania 19001 |
Fox Chase Cancer Center - Philadelphia | Philadelphia, Pennsylvania 19111-2497 |
Cancer Institute of New Jersey at Cooper - Voorhees | Voorhees, New Jersey 08043 |
Highland Hospital of Rochester | Rochester, New York 14620 |
Delaware County Regional Cancer Center at Delaware County Memorial Hospital | Drexel Hill, Pennsylvania 19026 |
Seton Cancer Institute at Saint Mary's - Saginaw | Saginaw, Michigan 48601 |
Summa Center for Cancer Care at Akron City Hospital | Akron, Ohio 44309-2090 |
Barberton Citizens Hospital | Barberton, Ohio 44203 |
Flower Hospital Cancer Center | Sylvania, Ohio 43560 |
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center | Reading, Pennsylvania 19612-6052 |
Community Memorial Hospital Cancer Care Center | Menomonee Falls, Wisconsin 53051 |
Cancer Institute at St. John's Hospital | Springfield, Illinois 62701 |
JFK Medical Center | Atlantis, Florida 33462 |
Lacks Cancer Center at Saint Mary's Health Care | Grand Rapids, Michigan 49503 |
University of Colorado Cancer Center at UC Health Sciences Center | Aurora, Colorado 80045 |
Central Maryland Oncology Center | Columbia, Maryland 21044 |
Columbia Saint Mary's Hospital - Ozaukee | Mequon, Wisconsin 53097 |
Columbia-Saint Mary's Cancer Care Center | Milwaukee, Wisconsin 53211 |
St. Agnes Hospital Cancer Center | Baltimore, Maryland 21229 |
Barnes-Jewish West County Hospital | Saint Louis, Missouri 63141 |
Sands Cancer Center | Canandiaqua, New York 14424 |
University Radiation Oncology at Parkridge Hospital | Rochester, New York 14626 |
Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center | Burbank, California 91505 |
Arizona Center for Cancer Care - Peoria | Peoria, Arizona 85381 |
McLaren Cancer Institute | Flint, Michigan 48532 |
Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center | Sleepy Hollow, New York 10591 |
Tate Cancer Center at Baltimore Washington Medical Center | Glen Burnie, Maryland 21061 |
Memorial Sloan-Kettering Cancer Center - Basking Ridge | Basking Ridge, New Jersey 07920 |
Memorial Sloan-Kettering Cancer Center - Rockville Centre | Rockville Centre, New York 11570 |