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NCT02927912 · ClinicalTrials.gov registry record · Phase 2
Intraoperative Electron Beam Radiotherapy Boost in Treating Patients With Stage I-II Breast Cancer Undergoing Surgery With Reconstruction
A Phase 2 study of Stage IIA Breast Cancer and Stage IIB Breast Cancer, sponsored by Ohio State University Comprehensive Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 108
- Enrollment target
- 5
- Study locations
NCT02927912: Active Phase 2 study of Stage IIA Breast Cancer and Stage IIB Breast Cancer, sponsored by Ohio State University Comprehensive Cancer Center.
NCT02927912 is a Phase 2 study of Stage IIA Breast Cancer and Stage IIB Breast Cancer that is active but no longer recruiting, run by Ohio State University Comprehensive Cancer Center. The registered enrollment target is 108 participants, below the 252-participant average among 17 other Stage IIA Breast Cancer trials with a reported enrollment target (57% lower). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02927912, a Phase 2 study of Stage IIA Breast Cancer and Stage IIB Breast Cancer, is active but no longer recruiting, sponsored by Ohio State University Comprehensive Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 108 participants
- Enrollment target
- 5
- Study locations
Study 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.
Primary Outcome
If 4 or more complications in the first 10 patients, 7 or more out of the first 20 patients or 9 or more out of 30 patients are observed, then the study will be deemed not safe to continue. Summary statistics will be used to report all complications.
Conditions Studied
Interventions
- OTHER Quality-of-Life Assessment
- OTHER Questionnaire Administration
- RADIATION Radiation Therapy
- PROCEDURE Lumpectomy
- RADIATION Electron Beam Therapy
Study Locations (5)
Ohio
- University Hospitals - Cleveland
- Ohio State University Comprehensive Cancer Center - Columbus
North Carolina
- University of North Carolina - Chapel Hill
South Dakota
- Avera Cancer Institute - Sioux Falls
Montreal
- Centre Hospitalier de I'Universite de Montreal - Québec
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 108 participants |
| Start Date | 2017-10-16 |
| Est. Completion | 2026-11-30 |
| Phase | Phase 2 |
What the registry record for NCT02927912 still lists
NCT02927912 is an interventional study that assigns participants to a tested intervention. The registered 108 participants enrollment target is mid-sized for trials with a published cap, below the 252-participant average among 17 other Stage IIA Breast Cancer trials with a reported enrollment target (57% lower).
The record links to 4 conditions, with Stage IIA Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which Quality-of-Life Assessment is the first listed.
NCT02927912 lists 5 locations in 4 states (Ohio, North Carolina, South Dakota).
Frequently Asked Questions
What is clinical trial NCT02927912 about?
NCT02927912 is a clinical study titled "Intraoperative Electron Beam Radiotherapy Boost in Treating Patients With Stage I-II Breast Cancer Undergoing Surgery With Reconstruction". 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 breas...
What is the current status of trial NCT02927912?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 108 participants. The study started on 2017-10-16. Estimated completion is 2026-11-30.
What conditions does trial NCT02927912 study?
This clinical trial studies the following conditions: Stage IIA Breast Cancer, Stage IIB Breast Cancer, Stage IA Breast Cancer, Stage IB Breast Cancer.
What interventions are being tested in trial NCT02927912?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Questionnaire Administration (OTHER), Radiation Therapy (RADIATION), Lumpectomy (PROCEDURE), Electron Beam Therapy (RADIATION).
Who is sponsoring clinical trial NCT02927912?
This trial is sponsored by Ohio State University Comprehensive Cancer Center, which has 341 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02927912 being conducted?
This trial has 5 study locations across North Carolina, Ohio, South Dakota, Montreal. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Stage IIA Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02927912's enrollment target sits among peer trials
108 7th of 17 higher than 11 of 17 other Stage IIA Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage IIA Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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