Intraoperative Boost Radiotherapy With Electrons (IOERT) Followed By Hypofractionated Whole-Breast Irradiation (WBRT)
Study Overview
Status
Conditions
Detailed Description
The purpose of this research study is to find out the effects (good and bad) of adding a dose of radiation to the area of the cancer during surgery to whole breast radiation therapy (WBRT) after surgery. IOERT is the application of electron radiation directly to the residual tumor or tumor bed during cancer surgery. WBRT is a type of radiation therapy used to treat patients who have cancer in the breast covering the entire breast tissue. Both immediate and long-term effects will be measured.
For patients with certain types of breast cancer, one standard treatment is removal of the area of cancer and a small amount of normal tissue around it followed by breast radiation. The radiation treatment in this situation usually lasts 3 to 5 1/2 weeks of WBRT followed by 5-8 daily radiation treatments at the site where the lump was removed called a "boost". During this study, the single dose of electron irradiation (IOERT) given at the surgical site during the operation will replace the usual 5-8 days of localized radiation and the whole breast radiation will last 3 weeks.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Orange, California, United States, 92868
- St. Joseph Hospital of Orange
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Histological proven invasive breast carcinoma (ductal and lobular)
- Age > 40 years
- Karnofsky performance status >70%
- Single discrete tumor or focal microcalcifications that can be imaged on a specimen radiograph or multifocal disease within the same quadrant with a maximum dimension of 4 cm (invasive foci)
- Nodal Status: NO-1
- Clear surgical margins: R0; min 2mm. Re-excision after IOERT is permitted but not required to achieve (-) margin.
- All grades G1 - G3
- Any hormonal receptor and Her-2 status
- Informed consent
Exclusion Criteria:
- In-situ Carcinoma without invasive component or multifocal disease > 4 cm
- Tumor stage: T3 or 4
- Nodal Status > N1 pathologically
- Surgical margins < 2mm
- Multicentricity
- Previous radiotherapy to the involved breast
- Karnofsky Index < 70%
- Mixed connective tissue diseases e.g. rheumatoid polyarthritis, thromboangitis obliterans, systemic lupus.
- Distant metastases
- Unable to provide written consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Intraoperative Electron Radiation Therapy
A single dose of electron irradiation given at the surgical site during the operation to remove the cancerous tumor will replace the usual 5-8 days of localized radiation.
Hypofractionated Whole Breast Radiation Therapy must start within 14-56 days post operatively.
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Hypofractionated Whole Breast Radiation Therapy must start within 14-56 days postoperatively (week 2-8 post-op)
Intraoperative Electron Radiation Therapy (IOERT) is delivered after completion of the lumpectomy and sentinel node procedure.
IOERT is performed on mobile or fixed linac with variable electron energies in the range of 4-12 MeV
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assessment of acute and late toxicity
Time Frame: 5 years
|
Assessment of acute toxicity of breast irradiation according to CTC-toxicity Scoring - systems:
Assessment of late toxicity according to NSABP scoring - systems at 6, 12, 24, 36, 48, and 60 months |
5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cosmetic Evaluation
Time Frame: 5 years
|
Assessment of cosmetic outcome according to 5-point scoring system
|
5 years
|
|
Disease Free Survival
Time Frame: 5 years
|
Recurrence assessments as documented at post-op follow-ups per protcol.
|
5 years
|
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Overall Survival
Time Frame: 5 Years
|
The length of time from the start of treatment to death within the 5 year period.
|
5 Years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Afshin Forouzannia, M.D., The Center for Cancer Prevention & Treatment at St. Joseph Hospital of Orange
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11-003 Mobetron
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