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NCT00581256 · ClinicalTrials.gov registry record · Phase 1
A Randomized Comparison of Radiation Therapy Techniques in the Management of Node Positive Breast Cancer
A Phase 1 study, sponsored by University of Michigan Rogel Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 54
- Enrollment target
NCT00581256: Completed Phase 1 study, sponsored by University of Michigan Rogel Cancer Center.
NCT00581256 is a Phase 1 study that has completed, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 54 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00581256, a Phase 1 study, has completed, sponsored by University of Michigan Rogel Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 54 participants
- Enrollment target
Study Summary
Radiotherapy has been shown to reduce breast-cancer specific mortality in patients at high risk for distant dissemination. It has also been shown to increase rates of non-breast cancer deaths and morbidity due to cardiovascular and pulmonary toxicity. Although treatment planning has improved significantly through the years, recent reports still demonstrate treatment-related morbidity even with 3-dimensional planned techniques. Thus, while 3D planning represents the state of the art treatment for loco-regional radiotherapy for breast cancer, further improvement is needed to continue to decrease heart and lung exposure. The ultimate goal of the proposed research is to determine whether treatment planning using intensity-modulated radiotherapy (IMRT), the "next generation" of radiation treatment delivery systems, results in less radiation exposure to the heart and lungs than the best current RT technique in women with node positive breast cancer. This proposal will test the potential clinical value of IMRT compared to the best standard 3D plan (partially wide tangent fields, PWTF) in the treatment of breast cancer. These two treatment techniques will be studied in a Phase II randomized trial using quantitative indicators of potential cardiac and lung toxicity. The preliminary data generated from this trial will be used to ultimately justify a multi-institutional comparison of the two treatment techniques with long-term clinical cardiac and pulmonary toxicity as endpoints.
Primary Outcome
To compare the extent of new myocardial perfusion defects following breast cancer radiotherapy using the best standard 3-D radiotherapy technique, partially wide tangent fields, versus the best optimized technique. Perfusion defects (PD) were assessed by comparing normalized perfusion distributions against our institution's normal polar map databases for the left anterior descending artery (LAD) using thresholds of 2.5-SD (standard deviation) and 1.5-SD below the normal mean. On the basis of int
Interventions
- RADIATION IMRT
- RADIATION 3D
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2006-04 |
| Est. Completion | 2016-04 |
| Phase | Phase 1 |
What the finished NCT00581256 record still lists
NCT00581256 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% lower).
The record links to 0 conditions, and to 2 interventions - of which IMRT is the first listed.
NCT00581256 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00581256 about?
NCT00581256 is a clinical study titled "A Randomized Comparison of Radiation Therapy Techniques in the Management of Node Positive Breast Cancer". Radiotherapy has been shown to reduce breast-cancer specific mortality in patients at high risk for distant dissemination. It has also been shown to increase rates of non-breast cancer deaths and morbidity due to cardiovascular and pulmonary toxicity. Although treatment planning has improved signifi...
What is the current status of trial NCT00581256?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 54 participants. The study started on 2006-04. Estimated completion is 2016-04.
What interventions are being tested in trial NCT00581256?
The interventions under investigation include: IMRT (RADIATION), 3D (RADIATION).
Who is sponsoring clinical trial NCT00581256?
This trial is sponsored by University of Michigan Rogel Cancer Center, which has 292 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00581256's enrollment target sits among peer trials
54 931st of 2000 higher than 1,053 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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