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Intraoperative Electron Beam Radiotherapy Boost in Treating Patients With Stage I-II Breast Cancer Undergoing Surgery With Reconstruction

StatusActive, Not Recruiting
PhasePhase 2
Started2017-10-16
View on ClinicalTrials.gov ↗

Amendment history

2026-05-07
Study Status, Outcome Measures, Document Section, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events, More Information v9
Primary endpoint(s) modified2 entries, revised
WasIncidence of adverse events in the first 30 patients enrolled as graded by the National Cancer Institute Common Toxicity Criteria version 4.0, Rate of grade 3 fibrosis using the Late Effects Normal Tissue Task Force-Subjective, Objective, Management, Analytic scales
NowNumber of Dose-limiting Adverse Events in the First 30 Patients Enrolled as Graded by the National Cancer Institute Common Toxicity Criteria Version 4.0, Rate of Grade 3 Fibrosis Using the Late Effects Normal Tissue Task Force-Subjective, Objective, Management, Analytic Scales
Results first postednot stated→2026-06-03
Secondary endpoints4 entries, revised
Change in selfSelf-reported cosmesisCosmesis usingUsing the BCTOS Physician reportedReported cosmesisCosmesis usingUsing the Harvard Breast Cosmesis scaleScale and digitalDigital photographsPhotographs Quality of lifeLife assessedAssessed by Breast Cancer Treatment Outcome Scale Rate of ipsilateralIpsilateral breastBreast tumorTumor recurrenceRecurrence
2026-02-12
Study Status v8
Completion date2025-12-31→2026-11-30
2025-05-22
Study Status v7
Primary completion dateestimated 2025-12-31→confirmed 2025-05-08
2025-02-20
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v6
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2024-12-31→2025-12-31
Completion date2024-12-31→2025-12-31
Enrollment targetestimated 176→confirmed 108
Study sitesdetails revised at 5 of 5 sites
2024-05-28
Study Status v5
Primary completion date2023-12-31→2024-12-31
Completion date2023-12-31→2024-12-31
Show 4 earlier versions
2023-04-07
Study Status, Sponsor/Collaborators, Contacts/Locations, IPDSharing v4
Primary completion date2020-11-01→2023-12-31
Completion date2022-11-01→2023-12-31
Start date2017-03-23→2017-10-16
Study sites3→5
2018-12-19
Study Status, Eligibility, Contacts/Locations v3
Study sites1→3
Eligibility criteria-1,504 characters
Inclusion Criteria: Pathologically proven diagnosis of breast cancer Clinical node negative stage I (T1N0) or stage II Multifocal (T2N0) breast cancer Preoperative is allowed if the intent is to undergo resection through a single lumpectomy incision Axilla must be staged by oneultrasound of the following Sentinelaxilla nodewith biopsy aloneof (ifsuspicious sentinel nodenodes is negative) Sentinelrecommended nodeas biopsyclinically alone OR followed by axillary dissectionindicated per investigatorthe discretion for clinically node negative patients as defined below: Microscopic sentinel node po [...] [...]
2017-07-21
Study Status, Oversight, Study Design, Contacts/Locations v2
PhaseNot applicable→Phase 2
2017-03-29
Not Yet Recruiting→Recruiting Study Identification, Study Status, Sponsor/Collaborators, Oversight, Study Design, Outcome Measures, Eligibility, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
PhasePhase 2→Not applicable
Primary completion date2020-11→2020-11-01
Completion datenot stated→2022-11-01
Start date2016-11→2017-03-23
Eligibility criteria+2 characters
[...] r neoadjuvant chemotherapy prior to resection Severe active comorbitycomorbidity defined as follows: Unstable angina and/or congestive heart [...]
Secondary endpointsdetails revised at 2 of 4 entries
Study sitesdetails revised at 1 of 1 site
Collaborators-31 characters
National Cancer Institute (NCI)
2016-10-06
Original filing
This phase II trial studies the side effects of intraoperative electron beam radiotherapy boost and to see how well it works in treating patients with stage I-II breast cancer undergoing surgery with reconstruction. Giving a single dose of electron beam radiation to the tumor cavity during the breast surgery before reconstruction may be a better way to kill tumor cells and shrink tumors.
Trial Details
NCT Number NCT02927912
Lead Sponsor Ohio State University Comprehensive Cancer Center
Conditions Stage IA Breast Cancer, Stage IB Breast Cancer, Stage IIA Breast Cancer, Stage IIB Breast Cancer
Enrollment 108 participants
Start Date 2017-10-16
Primary Completion 2025-05-08 (estimated)
Study Completion 2026-11-30 (estimated)
Updated on ClinicalTrials.gov 2026-06-03