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NCT00593346 · ClinicalTrials.gov registry record · NA
Evaluation of Accelerated Partial Breast Brachytherapy
A NA study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- NA
- Development phase
- 151
- Enrollment target
NCT00593346 is a NA study that has completed, run by Washington University School of Medicine. The registered enrollment target is 151 participants.
The verdict
NCT00593346, a NA study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- NA
- Development phase
- 151 participants
- Enrollment target
Study Summary
Over the past two decades, breast conserving therapy (BCT) has become a major treatment modality for Stage I and II breast carcinoma. The major advantages of breast conserving therapy are superior cosmetic outcome and the reduced emotional and psychological trauma afforded by this procedure compared with conventional mastectomy. The principal disadvantage of BCT is its more complex and prolonged treatment regimen requiring approximately 6 weeks of external beam radiation therapy that poses problems for some patients such as the working woman, elderly patients, and those who live at a significant distance from a treatment center. These factors, along with the patient's geographic location, result in a smaller fraction of the patients who currently meet eligibility criteria for BCT actually receiving it, despite its cosmetic and probable psychological advantages. The logistical problems of BCT are primarily related to the protracted course of external beam radiation therapy to the whole breast. While some investigators reported what they believe to be acceptable local control rates in carefully selected patients treated by wide local excision without radiation therapy, the criteria for patient selection are controversial and poorly defined and probably restrict the access of many patients to breast conserving therapy. If previous observations are valid and breast irradiation following tylectomy exerts its maximal effect in eradicating occult disease remaining in the immediate vicinity of the tylectomy site, can radiation therapy be directed only to the tissue surrounding the excision cavity of the breast, using brachytherapy alone? If so, the entire course of radiation therapy could be delivered over a 4 to 7 day period immediately following tylectomy and/or axillary dissection, thus markedly reducing treatment time. Brachytherapy also inherently provides a higher central dose to the volume most at risk for recurrence. Cosmetic outcome after the use of a brachytherap
Interventions
- RADIATION brachytherapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 151 participants |
| Start Date | 2004-03 |
| Est. Completion | 2013-11 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00593346
The ClinicalTrials.gov registry entry for NCT00593346 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 151 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which brachytherapy is the first listed.
NCT00593346 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00593346 about?
NCT00593346 is a clinical study titled "Evaluation of Accelerated Partial Breast Brachytherapy". Over the past two decades, breast conserving therapy (BCT) has become a major treatment modality for Stage I and II breast carcinoma. The major advantages of breast conserving therapy are superior cosmetic outcome and the reduced emotional and psychological trauma afforded by this procedure compared...
What is the current status of trial NCT00593346?
This trial is currently completed. It is a NA study. The enrollment target is 151 participants. The study started on 2004-03. Estimated completion is 2013-11.
What interventions are being tested in trial NCT00593346?
The interventions under investigation include: brachytherapy (RADIATION).
Who is sponsoring clinical trial NCT00593346?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
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