Radiation Therapy in Treating Women With Locally Recurrent Breast Cancer Previously Treated With Repeat Breast-Preserving Surgery
NCT ID: NCT01082211
Last Updated: 2022-06-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
65 participants
INTERVENTIONAL
2010-06-30
2022-05-20
Brief Summary
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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.
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Detailed Description
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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 occurring after 1 year from the completion of re-irradiation and at any time.
* 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Partial Breast Re-Irradiation
Partial Breast Re-Irradiation (PBrI) 3D-Conformal External Beam 1.5 Gy x 15 (BID) to 45 Gy Total
3D-Conformal External Beam
Radiation was to be delivered in 2 fractions per day, each of 1.5 Gy, separated by at least six hours, given in 15 consecutive working days to a total of 30 fractions and 45 Gy. Radiation was to be prescribed to the treatment unit isocenter, positioned at the approximate center of the planning target volume.
Interventions
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3D-Conformal External Beam
Radiation was to be delivered in 2 fractions per day, each of 1.5 Gy, separated by at least six hours, given in 15 consecutive working days to a total of 30 fractions and 45 Gy. Radiation was to be prescribed to the treatment unit isocenter, positioned at the approximate center of the planning target volume.
Eligibility Criteria
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Inclusion Criteria
* 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
* For invasive in-breast recurrence, no more than 120 days since whole-body (positron emission tomography) 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
18 Years
120 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
NRG Oncology
OTHER
Radiation Therapy Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Douglas W. Arthur, MD
Role: PRINCIPAL_INVESTIGATOR
Massey Cancer Center
Locations
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Arizona Center for Cancer Care - Peoria
Peoria, Arizona, United States
Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center
Burbank, California, United States
University of Colorado Cancer Center at UC Health Sciences Center
Aurora, Colorado, United States
JFK Medical Center
Atlantis, Florida, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States
Cancer Institute at St. John's Hospital
Springfield, Illinois, United States
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States
St. Agnes Hospital Cancer Center
Baltimore, Maryland, United States
Central Maryland Oncology Center
Columbia, Maryland, United States
Tate Cancer Center at Baltimore Washington Medical Center
Glen Burnie, Maryland, United States
Cape Cod Hospital
Hyannis, Massachusetts, United States
Saint Joseph Mercy Cancer Center
Ann Arbor, Michigan, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Battle Creek Health System Cancer Care Center
Battle Creek, Michigan, United States
McLaren Cancer Institute
Flint, Michigan, United States
Butterworth Hospital at Spectrum Health
Grand Rapids, Michigan, United States
Lacks Cancer Center at Saint Mary's Health Care
Grand Rapids, Michigan, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, United States
West Michigan Cancer Center
Kalamazoo, Michigan, United States
William Beaumont Hospital - Royal Oak Campus
Royal Oak, Michigan, United States
Seton Cancer Institute at Saint Mary's - Saginaw
Saginaw, Michigan, United States
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
St Louis, Missouri, United States
Barnes-Jewish West County Hospital
St Louis, Missouri, United States
Memorial Sloan-Kettering Cancer Center - Basking Ridge
Basking Ridge, New Jersey, United States
St. Barnabas Medical Center Cancer Center
Livingston, New Jersey, United States
Monmouth Medical Center
Long Branch, New Jersey, United States
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
Marlton, New Jersey, United States
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees Township, New Jersey, United States
Sands Cancer Center
Canandaigua, New York, United States
Memorial Sloan-Kettering Cancer Center
Commack, New York, United States
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
New York, New York, United States
Highland Hospital of Rochester
Rochester, New York, United States
University Radiation Oncology at Parkridge Hospital
Rochester, New York, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States
Memorial Sloan-Kettering Cancer Center - Rockville Centre
Rockville Centre, New York, United States
Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center
Sleepy Hollow, New York, United States
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
McDowell Cancer Center at Akron General Medical Center
Akron, Ohio, United States
Summa Center for Cancer Care at Akron City Hospital
Akron, Ohio, United States
Barberton Citizens Hospital
Barberton, Ohio, United States
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, United States
Flower Hospital Cancer Center
Sylvania, Ohio, United States
Rosenfeld Cancer Center at Abington Memorial Hospital
Abington, Pennsylvania, United States
Delaware County Regional Cancer Center at Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, United States
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, United States
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
Reading, Pennsylvania, United States
Rapid City Regional Hospital
Rapid City, South Dakota, United States
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, United States
Community Memorial Hospital Cancer Care Center
Menomonee Falls, Wisconsin, United States
Columbia Saint Mary's Hospital - Ozaukee
Mequon, Wisconsin, United States
Columbia-Saint Mary's Cancer Care Center
Milwaukee, Wisconsin, United States
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States
Cross Cancer Institute at University of Alberta
Edmonton, Alberta, Canada
Countries
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Other Identifiers
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CDR0000666991
Identifier Type: -
Identifier Source: secondary_id
RTOG 1014
Identifier Type: -
Identifier Source: org_study_id
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