Shave Margins in Breast Conservation Therapy
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 85 |
| Updated: | 1/9/2019 |
| Start Date: | June 13, 2016 |
| End Date: | October 31, 2019 |
Shave Margins in Breast Conservation Therapy (SMART): A Randomized Controlled Trial
The investigators propose a randomized controlled superiority trial of standard
breast-conserving surgery (BCS) versus BCS with cavity shave margins (CSM). The main
objectives of this trial will be to evaluate prospectively the impact of routine standardized
CSM on margin status following primary surgery for early stage breast cancer (Stage 0 - II),
on post-operative patient satisfaction and cosmetic outcomes, and on general intraoperative
time and operative costs. A parallel group format will be implemented to compare this
modified surgical therapy - BCS with CSM - with BCS alone, which is the current standard of
care.
breast-conserving surgery (BCS) versus BCS with cavity shave margins (CSM). The main
objectives of this trial will be to evaluate prospectively the impact of routine standardized
CSM on margin status following primary surgery for early stage breast cancer (Stage 0 - II),
on post-operative patient satisfaction and cosmetic outcomes, and on general intraoperative
time and operative costs. A parallel group format will be implemented to compare this
modified surgical therapy - BCS with CSM - with BCS alone, which is the current standard of
care.
Inclusion Criteria:
- Newly diagnosed, biopsy-proven stage 0-II breast cancer.
- Planning to undergo breast-conserving surgery.
- At least 18 years of age and no more than 85 years of age.
- Female.
- Able to understand and willing to sign an IRB-approved written informed consent
document.
Exclusion Criteria:
- Prior surgical treatment for this diagnosis.
- Undergone neoadjuvant chemotherapy.
- History of prior chest radiation therapy.
- Known metastatic disease.
- Pregnant.
- Preference for mastectomy instead of breast-conserving surgery.
- History of ipsilateral breast cancer.
- Goggle assessment substudy: Iodine or seafood allergies.
We found this trial at
1
site
660 S Euclid Ave
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: Julie Margenthaler, M.D.
Phone: 314-362-7534
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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