Radiation Therapy in Treating Women With Locally Recurrent Breast Cancer Previously Treated With Repeat Breast-Preserving Surgery
This trial is active, not recruiting.
|Treatments||circulating tumor cell analysis, laboratory biomarker analysis, questionnaire administration, adjuvant therapy, 3-dimensional conformal accelerated partial breast irradiation|
|Sponsor||Radiation Therapy Oncology Group|
|Collaborator||National Cancer Institute (NCI)|
|Start date||June 2010|
|End date||November 2014|
|Trial size||65 participants|
|Trial identifier||NCT01082211, CDR0000666991, RTOG 1014|
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy after surgery kill any remaining tumor cells and may be an effective treatment for breast cancer.
PURPOSE: This phase II trial is studying how well radiation therapy works in treating women with locally recurrent breast cancer previously treated with repeat breast-conserving surgery.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Peoria, AZ||Arizona Center for Cancer Care - Peoria||no longer recruiting|
|Burbank, CA||Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center||no longer recruiting|
|Aurora, CO||University of Colorado Cancer Center at UC Health Sciences Center||no longer recruiting|
|Atlantis, FL||JFK Medical Center||no longer recruiting|
|Chicago, IL||Robert H. Lurie Comprehensive Cancer Center at Northwestern University||no longer recruiting|
|Springfield, IL||Cancer Institute at St. John's Hospital||no longer recruiting|
|Baltimore, MD||Greenebaum Cancer Center at University of Maryland Medical Center||no longer recruiting|
|Baltimore, MD||St. Agnes Hospital Cancer Center||no longer recruiting|
|Columbia, MD||Central Maryland Oncology Center||no longer recruiting|
|Glen Burnie, MD||Tate Cancer Center at Baltimore Washington Medical Center||no longer recruiting|
|Hyannis, MA||Cape Cod Hospital||no longer recruiting|
|Ann Arbor, MI||Saint Joseph Mercy Cancer Center||no longer recruiting|
|Ann Arbor, MI||University of Michigan Comprehensive Cancer Center||no longer recruiting|
|Battle Creek, MI||Battle Creek Health System Cancer Care Center||no longer recruiting|
|Flint, MI||McLaren Cancer Institute||no longer recruiting|
|Grand Rapids, MI||Butterworth Hospital at Spectrum Health||no longer recruiting|
|Grand Rapids, MI||Lacks Cancer Center at Saint Mary's Health Care||no longer recruiting|
|Grosse Pointe Woods, MI||Van Elslander Cancer Center at St. John Hospital and Medical Center||no longer recruiting|
|Kalamazoo, MI||West Michigan Cancer Center||no longer recruiting|
|Royal Oak, MI||William Beaumont Hospital - Royal Oak Campus||no longer recruiting|
|Saginaw, MI||Seton Cancer Institute at Saint Mary's - Saginaw||no longer recruiting|
|Saint Louis, MO||Barnes-Jewish West County Hospital||no longer recruiting|
|Saint Louis, MO||Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis||no longer recruiting|
|Basking Ridge, NJ||Memorial Sloan-Kettering Cancer Center - Basking Ridge||no longer recruiting|
|Livingston, NJ||St. Barnabas Medical Center Cancer Center||no longer recruiting|
|Long Branch, NJ||Monmouth Medical Center||no longer recruiting|
|Marlton, NJ||Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton||no longer recruiting|
|New Brunswick, NJ||Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School||no longer recruiting|
|Voorhees, NJ||Cancer Institute of New Jersey at Cooper - Voorhees||no longer recruiting|
|Canandiaqua, NY||Sands Cancer Center||no longer recruiting|
|Commack, NY||Memorial Sloan-Kettering Cancer Center||no longer recruiting|
|New York, NY||Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center||no longer recruiting|
|Rochester, NY||Highland Hospital of Rochester||no longer recruiting|
|Rochester, NY||James P. Wilmot Cancer Center at University of Rochester Medical Center||no longer recruiting|
|Rochester, NY||University Radiation Oncology at Parkridge Hospital||no longer recruiting|
|Rockville Centre, NY||Memorial Sloan-Kettering Cancer Center - Rockville Centre||no longer recruiting|
|Sleepy Hollow, NY||Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center||no longer recruiting|
|Winston-Salem, NC||Wake Forest University Comprehensive Cancer Center||no longer recruiting|
|Akron, OH||McDowell Cancer Center at Akron General Medical Center||no longer recruiting|
|Akron, OH||Summa Center for Cancer Care at Akron City Hospital||no longer recruiting|
|Barberton, OH||Barberton Citizens Hospital||no longer recruiting|
|Cincinnati, OH||Charles M. Barrett Cancer Center at University Hospital||no longer recruiting|
|Sylvania, OH||Flower Hospital Cancer Center||no longer recruiting|
|Abington, PA||Rosenfeld Cancer Center at Abington Memorial Hospital||no longer recruiting|
|Drexel Hill, PA||Delaware County Regional Cancer Center at Delaware County Memorial Hospital||no longer recruiting|
|Philadelphia, PA||Albert Einstein Cancer Center||no longer recruiting|
|Philadelphia, PA||Fox Chase Cancer Center - Philadelphia||no longer recruiting|
|Philadelphia, PA||Kimmel Cancer Center at Thomas Jefferson University - Philadelphia||no longer recruiting|
|Reading, PA||McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center||no longer recruiting|
|Rapid City, SD||Rapid City Regional Hospital||no longer recruiting|
|Dallas, TX||Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas||no longer recruiting|
|Houston, TX||M. D. Anderson Cancer Center at University of Texas||no longer recruiting|
|Richmond, VA||Virginia Commonwealth University Massey Cancer Center||no longer recruiting|
|Menomonee Falls, WI||Community Memorial Hospital Cancer Care Center||no longer recruiting|
|Mequon, WI||Columbia Saint Mary's Hospital - Ozaukee||no longer recruiting|
|Milwaukee, WI||Columbia-Saint Mary's Cancer Care Center||no longer recruiting|
|Milwaukee, WI||Medical College of Wisconsin Cancer Center||no longer recruiting|
|Edmonton, Canada||Cross Cancer Institute at University of Alberta||no longer recruiting|
|Intervention model||single group assignment|
Grade 3+ treatment-related skin, fibrosis, and breast pain adverse events
time frame: From the end of radiation to 1 year.
time frame: From registration to date of recurrence or last follow-up. Analysis occurs after all patients have been potentially followed for 3 years.
Freedom from mastectomy
time frame: From registration to date of mastectomy or last follow-up. Analysis occurs after all patients have been potentially followed for 3 years.
Rate of circulating tumor cells
time frame: Prior to the start of radiation and 3 weeks after last radiation treatment.
All treatment-related adverse events
time frame: After 1 year from the end of radiation and from the end of radiation to end of follow-up.
time frame: After surgery prior to the start of radiation, 1 year from the end of radiation and 3 years from the end of radiation. Analysis occurs after all patients have been potentially followed for 3 years.
Distant metastasis-free survival
time frame: From registration to date of distant metastasis, death or last follow-up. Analysis occurs after all patient have been potientially followed for 3 years.
time frame: From registration to date of mastectomy, death or last follow-up. Analysis occurs after all patients have been potentially followed for 3 years.
time frame: From registration to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 3 years.
Female participants from 18 years up to 120 years old.
DISEASE CHARACTERISTICS: - Histologically confirmed locally recurrent breast carcinoma consistent with the following cell types: - Invasive ductal breast carcinoma - Medullary ductal breast carcinoma - Tubular ductal breast carcinoma - Mucinous ductal breast carcinoma - Lobular breast carcinoma - Ductal carcinoma in situ (DCIS) - No Paget disease of the nipple - Initial lumpectomy followed by whole-breast radiotherapy performed over 1 year ago - Repeat lumpectomy performed within the past 42 days - Target lumpectomy cavity must be clearly defined and the target lumpectomy cavity/ whole-breast reference volume must be < 30% based on a post-operative, pre-treatment CT scan - Histopathologic confirmation via lumpectomy of local in-breast ipsilateral recurrence within the past 120 days and the following must be true: - Tumor size ≤ 3 cm in greatest dimension on pathologic specimen - Negative histologic margins of resection and no tumor on ink following breast-preserving surgery - Re-excision to achieve negative margins allowed - Axilla negative or ≤ 3 positive lymph nodes without extracapsular extension - If the in-breast recurrence is DCIS and/or microinvasive disease, a sentinel lymph node (SLN) evaluation is not required, but if performed: - Patients with a negative sentinal lymph node (SLN) biopsy are eligible for enrollment - Patients with a positive SLN biopsy require an axillary lymph node (ALN) dissection (ALND is not required if the SLN is not identified) - Patient is eligible if 0-3 positive ALNs without extracapsular extension is documented - If the in-breast recurrence is invasive disease and: - No prior ALN dissection or SLN dissection only: - Patient is required to undergo axillary evaluation with either a SLN or ALN dissection - If the SLN is not identified or if the SLN is positive for metastatic disease then an ALN dissection is required - Patient is eligible for enrollment if encounter 0-3 positive lymph nodes without extracapsular extension - • Prior ALN dissection: negative clinical exam: patient is eligible for enrollment - It is recommended, but not required, that the patient undergo ultrasound evaluation of the axilla and the lymph node draining regions of the breast; any suspicious areas are to be biopsied and if positive followed with an ALN dissection - Patient is eligible for enrollment if biopsies are negative or 0-3 axillary lymph nodes without extracapsular extension are encountered - Prior ALN dissection: positive clinical exam: biopsy required - If biopsy is negative, patient is eligible for enrollment - If biopsy is positive an ALN dissection is required - Patient is eligible for enrollment if biopsies are negative or 0-3 axillary lymph nodes without extracapsular extension encountered - Ipsilateral breast mammogram and MRI within 120 days prior to study entry - Contralateral breast mammogram within 12 months of study entry - No more than 120 days since whole-body PET-CT scan OR CT scan of the chest, abdomen, and pelvis, and bone scan - No multicentric ipsilateral breast recurrence or regional recurrence (other than axilla) - Patients must have a breast technically amenable to partial-breast irradiation - No metastatic disease documented by physical exam or radiographic evaluation (for patients with invasive disease) - No skin involvement - No prior contralateral mastectomy - Estrogen and progesterone status must be known PATIENT CHARACTERISTICS: - Zubrod performance status 0-1 - Menopausal status not specified - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No other invasive malignancy within the past 3 years except ipsilateral breast cancer and/or nonmelanoma skin cancer - No collagenous diseases, specifically systemic lupus erythematosus, scleroderma, or dermatomyositis - No psychiatric or addictive disorders that would preclude obtaining informed consent PRIOR CONCURRENT THERAPY: - See Disease Characteristics - More than 2 weeks since prior chemotherapy and recovered - No concurrent intensity-modulated radiotherapy - No concurrent chemotherapeutic agents, including trastuzumab
|Official title||A Phase II Study of Repeat Breast Preserving Surgery and 3D-Conformal Partial Breast Re-Irradiation (PBrI) for Local Recurrence of Breast Carcinoma|
|Principal investigator||Douglas W. Arthur, MD|
|Description||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.|
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