View Clinical Trial (Medical Research Study)
Image Guided Partial Breast Irradiation (PBL) In A Low-Risk Population Screened With Magnetic Resonance Imaging (MRI)
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Chicago |
| State: |
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Illinois |
| Zip Code: |
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60637 |
| Conditions: |
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Breast Cancer |
| Purpose: |
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This is a pilot study to determine if partial breast irradiation (PBI) limited to the region
of the tumor bed following lumpectomy in patients screened with MRI provides historically
similar rates of local failure, limited acute skin toxicity, late complications and cosmetic
outcome when compared to patients treated with standard 3D-CRT to the whole breast.
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| Study Summary: |
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| Criteria: |
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Inclusion Criteria:
- Stage 0 or I breast carcinoma
- 40 years or older
- Post menopausal
- Lumpectomy with clear margins (>2mm)
- Patients with invasive disease must have undergone an axillary staging by axillary
dissection (with a minimum of 6 axillary nodes) or sentinal node biopsy
- Gross disease must be unifocal with pathological tumor size 2cm or less
- Target lumpectomy cavity must be clearly marked with surgical clips (the target
lumpectomy cavity/whole breast reference volume must be <=30% based on the
postoperative imaging)
- Bilateral MRI of the breasts within previous 6 months of radiation therapy (RT)
planning
- If patient is eligible based on postoperative imaging, partial breast irradiation
(PBI) is judged to be technically deliverable
- Patients with a history of malignancies are eligible if they have stable disease as
determined by their attending oncologist
- Patient must have signed the consent form
Exclusion Criteria:
- Men are not eligible
- Patients with Stage II, II, or IV breast cancer
- Pre- or peri-menopausal patients
- Patients with positive lymph nodes
- Patients with suspicious microcalcifications, densities, or palpable abnormalities
unless biopsied and found to be benign
- Patients with multifocal, multicentric, or bilateral breast cancer
- Surgical margins that cannot be microscopically assessed or are positive at
pathological evaluation
- Patients with a history of breast cancer
- Clear delineation of the extent of the target lumpectomy cavity is not possible
- Breast implants (patients who have had implants removed are eligible)
- Prior breast or thoracic RT for any condition
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| NCT ID: |
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NCT01255553 |
| Primary Contact: |
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Principal Investigator
Steven Chmura, MD
University of Chicago
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| Backup Contact: |
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N/A |
| Location Contact: |
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Chicago, Illinois 60637
United States
Steven Chmura, MD
Phone: 773-702-7919
Email: schmura@radonc.uchicago.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 22, 2013 |
| Modifications to this listing: |
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