Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
250 participants
INTERVENTIONAL
2012-02-29
2022-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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IORT Arm
Intraoperative radiotherapy (IORT) is delivered after completion of the lumpectomy and sentinel node procedure.
Intraoperative Radiotherapy
Intraoperative radiotherapy (IORT) is delivered after completion of the lumpectomy and sentinel node procedure. IORT is performed on mobile or fixed linacs with variable electron energies in the range of 6-12 MeV prescribed to a dose of 21 Gy, with the prescription dose covering at least 90% of the Planning Target Volume (PTV). PTV is defined as a 3D volume of 1-2 cm beyond the former macroscopic tumor edge (excluding skin, limit to anterior rib surface: 5 Gy). The choice of electron energy as well as the cone applicator size has to account for minimum PTV requirements. Tissue depth measurement will be documented by intraoperative sonography.
Interventions
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Intraoperative Radiotherapy
Intraoperative radiotherapy (IORT) is delivered after completion of the lumpectomy and sentinel node procedure. IORT is performed on mobile or fixed linacs with variable electron energies in the range of 6-12 MeV prescribed to a dose of 21 Gy, with the prescription dose covering at least 90% of the Planning Target Volume (PTV). PTV is defined as a 3D volume of 1-2 cm beyond the former macroscopic tumor edge (excluding skin, limit to anterior rib surface: 5 Gy). The choice of electron energy as well as the cone applicator size has to account for minimum PTV requirements. Tissue depth measurement will be documented by intraoperative sonography.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age \> 40 years
* Karnofsky performance status \> 70%
* Tumor. Single discrete tumor or focal microcalcifications that can be imaged on a specimen radiograph or multifocal disease within the same quadrant with a maximum dimension of equal to or less than 2.5 cm
* Nodal Status: preoperatively N0
* Clear surgical margins: R0
* All grades G1 - G3
* Any hormonal receptor and HER-2 status
* Informed consent
Exclusion Criteria
* Tumor size: more than 2.5 cm
* Nodal status greater than or equal to N1 pathologically
* Multicentricity
* Previous radiotherapy to the involved breast
* Karnofsky Index \< 70%
* Mixed connective tissue diseases e.g. rheumatoid poly arthritis, thromboangitis obliterans, systemic lupus
* Distant metastases
* Pregnancy in woman of child bearing age
* Unable to provide written consent
41 Years
90 Years
FEMALE
No
Sponsors
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St. Joseph Hospital of Orange
OTHER
Responsible Party
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Principal Investigators
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Lawrence Wagman, M.D.
Role: STUDY_CHAIR
St. Joseph Hospital of Orange
Locations
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St. Joseph Hospital of Orange
Orange, California, United States
Countries
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Other Identifiers
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12-001 Single Fraction IORT
Identifier Type: -
Identifier Source: org_study_id
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