CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 108 enrolled / 108 target
Drug / intervention
Electron Beam Therapy +5 moreradiation
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02927912
NCT02927912Phase 2ActiveUpdate Overdue (1.0/mo)Completion was 13mo ago

Multi-institution Phase II Trial of Intraoperative Electron Beam Radiotherapy Boost at the Time of Breast Conserving Surgery With Oncoplastic Reconstruction in Women With Early-Stage Breast Cancer

Ohio State University Comprehensive Cancer Center·interventional·Posted Oct 7, 2016·Updated Jun 3, 2026

In Brief

A Phase 2 clinical trial evaluating Electron Beam Therapy, Lumpectomy, and 4 other interventions for Stage IA Breast Cancer and 3 related conditions. Active but no longer recruiting, targeting 108 participants across 5 sites in 2 countries.

Signals

Enrollment appears stalled

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, United States
Collaborators--

Timeline

Phase 2Active
20172018201920202021202220232024202520262027
First PostedOct 7, 2016
Enrollment StartOct 16, 2017
Primary CompletionMay 8, 2025
Study CompletionNov 30, 2026
TodayJul 2, 2026
Enrollment to primary: 7.6 yearsPosted 9.7 years ago

Arms & Interventions

Treatment (IOERT boost)experimental

Patients undergo standard of care lumpectomy and then undergo 1 fraction of IOERT boost to the lumpectomy cavity. Patients then undergo standard of care oncoplastic reconstruction and whole breast radiation therapy.

Radiation: Electron Beam TherapyProcedure: LumpectomyOther: Quality-of-Life AssessmentOther: Questionnaire AdministrationRadiation: Radiation TherapyProcedure: Reconstructive Surgery

Interventions

Electron Beam Therapyradiation

Undergo IOERT boost

Lumpectomyprocedure

Undergo lumpectomy

Quality-of-Life Assessmentother

Ancillary studies

Questionnaire Administrationother

Ancillary studies

Radiation Therapyradiation

Undergo whole breast radiation therapy

Reconstructive Surgeryprocedure

Undergo oncoplastic reconstruction