- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01960803
Lumpectomy Followed By Intraoperative Electron Radiation Therapy (IOERT)
July 23, 2019 updated by: Barbara Krueger, MD, Advocate Health Care
Lumpectomy Followed By Intraoperative Electron Radiation Therapy (IOERT) As A Single, Full Dose Partial Breast Irradiation For Early Stage, Node Negative, Invasive Breast Cancer
The overall objective of this study is to determine the feasibility and tolerability of single dose Intraoperative Electron Radiation Treatment ("IOERT") as definitive therapy when administered at the time of breast conserving surgery for patients with early stage breast cancer.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Evaluate local and distant recurrence rates and cosmetic outcomes. Both clinical evaluation of cosmetic outcome by the Surgeon, and subjective impression of cosmetic outcome by the patient, are evaluated using questionnaire.
Local recurrence is evaluated under the same imaging protocol used for Whole breast radiation.
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Illinois
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Oak Lawn, Illinois, United States, 60453
- Advocate Christ Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 95 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Patient agrees to breast conservation therapy (segmental resection, partial mastectomy, and radiation therapy) as the treatment for their breast cancer
- Patient agrees to evaluation of the axilla with sentinel lymph node biopsy
- Peri or post-menopausal women age > 50, defined as women who have experienced no menstrual period in the past 6 months or more
- BRCA1 and 2 gene mutation negative, if tested. [genetic testing is NOT required based upon personal or family history]
- Unifocal (unicentric), invasive ductal carcinoma or favorable sub-types (mucinous, tubular, colloid) < 2.0 cm in diameter, primary T-stage of Tis or T1 (AJCC criteria)
- Grade 1, 2, or 3 acceptable
- Associated LCIS is allowed
- Pure DCIS allowed if <2.5 cm, low to intermediate nuclear grade and resected margins negative at > 3 mm (per ASTRO criteria)
- Estrogen receptor (ER) status of positive
- Patient has clear margins >2 mm on gross pathologic examination
- Patient is node-negative, defined as N0 (i-) or N0 (i+)
- Patient must be deemed functionally and mentally competent to understand and sign the informed consent
- Neoadjuvant hormonal therapy is allowed if all other ASTRO suitable criteria have been met prior to onset of hormonal therapy
Exclusion Criteria:
- Prior breast malignancy or other malignancy if metastatic, or with expected survival of < 5 years
- Immunocompromised status
- Pregnancy
- Women with an active connective tissue disorder (i.e. scleroderma, lupus and others)
- Breast cancer that involves the skin or chest wall, locally advanced breast cancer
- Invasive lobular carcinoma
- Evidence of lymphovascular invasion (LVI)
- Invasive carcinoma with extensive intraductal component (EIC)
- Neoadjuvant chemotherapy
- Patients with 1 or more positive lymph node determined during surgery with sentinel node and/or axillary dissection
- Someone who is not a candidate for breast conserving management, i.e., prior whole breast radiation therapy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: IOERT arm
Intraoperative electron radiotherapy (IOERT) is delivered after completion of the lumpectomy and sentinel node procedure.
IOERT is performed on a mobile self-shielded magnetron-driven X-band linear accelerator specifically developed for use in the operating room.
This machine produces megavoltage electron beams of energy ranging between 4 and 12 MeV.
The radiation is delivered from the device to the tumor bed through an attached applicator.
A single dose of 21 Gy calculated to the 90% depth posterior to the tumor bed will be administered and will last approximately 2.5 minutes.
|
Intraoperative Electron Radiotherapy (IOERT) is delivered after completion of the lumpectomy and sentinel node procedure.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To evaluate change over time on the incidence of local and distance recurrence rates.
Time Frame: 1 month, 3 months, 6 months, 12 months, and then annually for 10 years.
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Subjects will be followed for recurrence rates at one month, three months, six months, twelve months, and then annually for up to 10 years.
This will include: history and physical exam, as well as radiographic images at physician discretion and per study protocol.
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1 month, 3 months, 6 months, 12 months, and then annually for 10 years.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To evaluate changes in the short-term and long-term side effects related to IOERT
Time Frame: 1 month, 3 months, 6 months, 12 months, and then annually for 10 years.
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Assessment of the overall patient satisfaction related to the therapy and cosmetic outcome.
Cosmesis will be scored by both the physician and patient using the RTOG cosmesis rating system at one month, three months, six months, twelve months, and 24 months.
The secondary outcome measure will only take place in the first two years of the 10 year time frame for patient follow up.
After 24 month evaluations, patients will only be followed for incidence of local and distance recurrence rates.
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1 month, 3 months, 6 months, 12 months, and then annually for 10 years.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Barbara Krueger, MD FACS, Advocate Health Care - Advocate Christ Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2013
Primary Completion (Actual)
July 1, 2019
Study Completion (Actual)
July 1, 2019
Study Registration Dates
First Submitted
September 25, 2013
First Submitted That Met QC Criteria
October 9, 2013
First Posted (Estimate)
October 11, 2013
Study Record Updates
Last Update Posted (Actual)
July 24, 2019
Last Update Submitted That Met QC Criteria
July 23, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ACI-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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