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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01255553 |
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Date of registration:
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22/11/2010 |
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Primary sponsor: |
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Public title:
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Partial Breast Irradiation in a Low-risk Population Screened With MRI
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Scientific title:
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Image Guided Partial Breast Irradiation (PBL) In A Low-Risk Population Screened With Magnetic Resonance Imaging (MRI) |
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Date of first enrolment:
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June 2009 |
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Target sample size:
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217 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01255553 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Steven Chmura, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Chicago |
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Key inclusion & exclusion 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
Age minimum:
40 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Breast Cancer
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Intervention(s)
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Radiation: Partial Breast Irradiation
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Primary Outcome(s)
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Rates of toxicity (breast edema/pain, hyperpigmentation, erythema) for patients receiving partial breast irradiation (PBI) compared to historical rates of toxicity of patients receiving whole breast irradiation (WBI)
[Time Frame: During radiation therapy (5-10 days)]
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Rates of toxicity (breast edema/pain, hyperpigmentation, erythema) for patients receiving PBI compared to historical rates of toxicity of patients receiving WBI
[Time Frame: Post therapy (until death)]
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Secondary Outcome(s)
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Cosmetic outcomes of breast PBI
[Time Frame: 3 years]
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Survival Rates
[Time Frame: 5 years]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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