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NCT03612648 · ClinicalTrials.gov registry record · NA
Three Fraction Accelerated Partial Breast Irradiation as the Sole Method of Radiation Therapy for Low-risk Stage 0 and I Breast Carcinoma
A NA study of Breast Cancer and Breast Carcinoma, sponsored by Washington University School of Medicine.
- Active
- Registry status
- NA
- Development phase
- 77
- Enrollment target
- 1
- Study location
NCT03612648: Active NA study of Breast Cancer and Breast Carcinoma, sponsored by Washington University School of Medicine.
NCT03612648 is a NA study of Breast Cancer and Breast Carcinoma that is active but no longer recruiting, run by Washington University School of Medicine. The registered enrollment target is 77 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03612648, a NA study of Breast Cancer and Breast Carcinoma, is active but no longer recruiting, sponsored by Washington University School of Medicine.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 77 participants
- Enrollment target
- 1
- Study location
Study Summary
The investigators proposed approach allows them to deliver a low total dose of radiation to patients with low-risk, early-stage breast cancer which would further minimize the impact of adjuvant therapy. This work has the potential to revolutionize partial breast irradiation by allowing it to take place at many radiation oncology centers with minimal specialized equipment beyond that commonly available. The investigators first step is this proposed single institution phase I/II study designed primarily to evaluate the tolerance of this approach which the investigators are choosing to call Three Fraction APBI (Tri-APBI).
Primary Outcome
* Adverse events will be graded using CTCAE Version 5.0 * Toxicities of concern include breast pain, delayed wound healing, persistent seroma fluid accumulation, breast fibrosis, and fat necrosis in the treated breast. Rare toxicities include radiation pneumonitis, coronary artery disease, and pericarditis
Conditions Studied
Interventions
- RADIATION Three Fraction Accelerated Partial Breast Irradiation
- PROCEDURE Partial mastectomy
Study Locations (1)
Missouri
- Washington University School of Medicine - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 77 participants |
| Start Date | 2018-08-30 |
| Est. Completion | 2026-03-22 |
| Phase | NA |
What the registry record for NCT03612648 still lists
NCT03612648 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 77 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (97% lower).
The record links to 2 conditions, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Three Fraction Accelerated Partial Breast Irradiation is the first listed.
NCT03612648 reports a single indexed study location in Missouri.
Frequently Asked Questions
What is clinical trial NCT03612648 about?
NCT03612648 is a clinical study titled "Three Fraction Accelerated Partial Breast Irradiation as the Sole Method of Radiation Therapy for Low-risk Stage 0 and I Breast Carcinoma". The investigators proposed approach allows them to deliver a low total dose of radiation to patients with low-risk, early-stage breast cancer which would further minimize the impact of adjuvant therapy. This work has the potential to revolutionize partial breast irradiation by allowing it to take pl...
What is the current status of trial NCT03612648?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 77 participants. The study started on 2018-08-30. Estimated completion is 2026-03-22.
What conditions does trial NCT03612648 study?
This clinical trial studies the following conditions: Breast Cancer, Breast Carcinoma.
What interventions are being tested in trial NCT03612648?
The interventions under investigation include: Three Fraction Accelerated Partial Breast Irradiation (RADIATION), Partial mastectomy (PROCEDURE).
Who is sponsoring clinical trial NCT03612648?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03612648 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for 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 NCT03612648's enrollment target sits among peer trials
77 670th of 1224 higher than 553 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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