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NCT01928589 · ClinicalTrials.gov registry record · NA
Partial Irradiation and Sequential vs. Concurrent Chemo Early Breast Cancer
A NA study of Breast Cancer and Adenocarcinoma of the Breast, sponsored by Richard Zellars.
- Active
- Registry status
- NA
- Development phase
- 81
- Enrollment target
- 10
- Study locations
NCT01928589: Active NA study of Breast Cancer and Adenocarcinoma of the Breast, sponsored by Richard Zellars.
NCT01928589 is a NA study of Breast Cancer and Adenocarcinoma of the Breast that is active but no longer recruiting, run by Richard Zellars. The registered enrollment target is 81 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (97% lower). The trial reports 10 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01928589, a NA study of Breast Cancer and Adenocarcinoma of the Breast, is active but no longer recruiting, sponsored by Richard Zellars.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 81 participants
- Enrollment target
- 10
- Study locations
Study Summary
In a small study at Johns Hopkins, women were treated with partial breast irradiation and chemotherapy given at the same time. We are now testing in a bigger study whether giving partial breast irradiation and chemotherapy at the same time (our new method) has the same side effects and outcomes as giving partial breast irradiation and chemotherapy at different times(older method). In this study women who had their breast cancer removed but need radiation to the breast will be randomized to partial breast irradiation at the same time as chemotherapy or partial breast radiation at a different time than chemotherapy. Randomization is like flipping a coin but in this study about 2 of every 3 women will get the new method.
Primary Outcome
The primary endpoint will be short term (from baseline to the 6-7 month follow-up) grade 3 or 4 toxicity: confluent moist desquamation, pitting edema, ulceration, hemorrhage or necrosis. Our primary objective is to determine if chemotherapy and PBI can be given concurrently with short term toxicity comparable to standard of care, whole breast radiation (WBR) without chemotherapy, and not inferior to that of PBI plus chemotherapy given sequentially.
Conditions Studied
Interventions
- OTHER PBI with sequential chemotherapy
- OTHER PBI with concurrent chemotherapy
Study Locations (10)
Indiana
- Parkview Regional Medical Center - Fort Wayne
- Indiana University Health Hospital - Indianapolis
- Indiana University Health Melvin and Bren Simon Comprehensive Cancer Center - Indianapolis
- IU Health Arnett - Lafayette
Maryland
- John Hopkins University - Baltimore
- Suburban Hospital - Bethesda
Pennsylvania
- Reading Hospital - West Reading
- York Cancer Center - York
District of Columbia
- Sibley Memorial Hospital - Washington D.C.
Texas
- University of Texas-San Antonio - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2014-01-16 |
| Est. Completion | 2028-12 |
| Phase | NA |
What the registry record for NCT01928589 still lists
NCT01928589 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 81 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 PBI with sequential chemotherapy is the first listed.
NCT01928589 lists 10 locations in 5 states (Indiana, Maryland, Pennsylvania).
Frequently Asked Questions
What is clinical trial NCT01928589 about?
NCT01928589 is a clinical study titled "Partial Irradiation and Sequential vs. Concurrent Chemo Early Breast Cancer". In a small study at Johns Hopkins, women were treated with partial breast irradiation and chemotherapy given at the same time. We are now testing in a bigger study whether giving partial breast irradiation and chemotherapy at the same time (our new method) has the same side effects and outcomes as ...
What is the current status of trial NCT01928589?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 81 participants. The study started on 2014-01-16. Estimated completion is 2028-12.
What conditions does trial NCT01928589 study?
This clinical trial studies the following conditions: Breast Cancer, Adenocarcinoma of the Breast.
What interventions are being tested in trial NCT01928589?
The interventions under investigation include: PBI with sequential chemotherapy (OTHER), PBI with concurrent chemotherapy (OTHER).
Who is sponsoring clinical trial NCT01928589?
This trial is sponsored by Richard Zellars, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01928589 being conducted?
This trial has 10 study locations across District of Columbia, Indiana, Maryland, Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT01928589's enrollment target sits among peer trials
81 644th of 1224 higher than 577 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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