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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 is a Phase 1 study that has completed, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 54 participants.
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.
Interventions
- RADIATION IMRT
- RADIATION 3D
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2006-04 |
| Est. Completion | 2016-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00581256
The ClinicalTrials.gov registry entry for NCT00581256 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Michigan Rogel Cancer Center, which has 292 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which IMRT is the first listed.
NCT00581256 reports 0 study locations.
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.
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