- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02040493
Intra-Operative Radiation Therapy Immediately Following Resection of Early Stage Breast Cancer
Intra-Operative Radiation Therapy (IORT) Treatment Immediately Following Resection of Early Stage Breast Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Breast Conserving Therapy (BCT) is a standard treatment option for patients with stage I or II breast cancer. Breast conserving therapy consists of surgical removal of the tumor with negative margins, axillary lymph node dissection or sentinel node biopsy and radiation therapy. Several studies have shown BCT to be comparable to mastectomy in terms of overall and disease free survival for patients. The major advantage to BCT over mastectomy is breast preservation and reduced psychological trauma to the patient. The major disadvantage to BCT is prolonged time of treatment. The whole breast radiation portion of BCT can add 7 weeks to the treatment time. This additional treatment time can be a detriment to women who logistically may not be able to meet the demands of daily irradiation for 6-7 weeks. A new form of treatment, breast brachytherapy, was developed to decrease the treatment time required for breast irradiation. This treatment uses the Xoft Axxent system to administer intra-operative breast brachytherapy in one treatment, at the time of lumpectomy in the operating room.
This study has been designed to assess local recurrence, serious adverse events, adverse events and their severity, and cosmesis following intra-operative radiation therapy (IORT) using the Xoft Axxent System and balloon applicators. The study device is FDA cleared. The purpose of this clinical study is to compile data on the treatment of patients using the Xoft Axxent System for the delivery of radiation therapy in the intra-operative setting as part of breast conserving therapy in women with resected, early stage breast cancer.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Arizona
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Casa Grande, Arizona, United States, 85122
- Cancer Treatment Services Arizona
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California
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Long Beach, California, United States, 90806
- Long Beach Memorial Medical Center
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Pleasant Hill, California, United States, 94523
- Diablo Valley Oncology Hematology
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Illinois
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Evergreen Park, Illinois, United States, 60805
- Little Company of Mary Hospital
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Rockford, Illinois, United States, 61103
- Rockford Memorial Hospital
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New Hampshire
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Exeter, New Hampshire, United States, 03833
- Exeter Hospital
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Tennessee
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Chattanooga, Tennessee, United States, 37404
- Parkridge
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
General Inclusion Criteria
- Age > 45 years
- Tumor with Tis, T1, T2 (≤ 3cm), N0, M0 - (AJC Classification)
- Invasive ductal carcinoma and / or DCIS
Intra-operative Inclusion Criteria
- Negative sentinel node assessment
- Balloon surface to skin distance of at least 1-cm and adequate conformance via Intra-operative ultrasound
Post procedure Inclusion Criteria 1. Negative microscopic surgical margins**
**If positive margins patient my undergo re-excision and/or additional radiation at the treating physician's discretion but the patient will be excluded from the protocol data analysis.
General Exclusion Criteria
- Scleroderma, systemic sclerosis and active lupus
- Participation in an investigational drug or device study
- Previous ipsilateral radiation to the thorax or breast
Intra-operative Exclusion Criteria
- Intra-operative positive sentinel lymph node biopsy
- Inadequate conformance (greater than 10% of PTV encompassed by fluid or air on physician assessment of intraOp ultrasound image)
- Skin spacing less than 1-cm via intraOp ultrasound.
- A cavity size that is not appropriate for a 40 -70 cc balloon.
- Patient becomes unstable and physician determines patient is not a good candidate at time of lumpectomy.
Study Plan
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: Intra-operative radiation therapy (IORT)
IORT
|
All subjects will receive IORT at the time of lumpectomy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Local recurrence in patients treated with intra-operative electronic brachytherapy for early stage breast cancer.
Time Frame: 5 Years
|
Local recurrence will be assessed at one (1) month, six (6) months, one (1) year, two (2) years, three (3) years, four (4) years, and five (5) years post IORT.
|
5 Years
|
Occurence of serious adverse events during and following IORT treatment.
Time Frame: 5 Years
|
Serious adverse events are defined as a serious injury or illness that:
|
5 Years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cosmesis
Time Frame: 5 Years
|
Cosmesis will be evaluated with the Harvard scale at one (1) month, six (6) months, and at one (1) year, two (2) years, three (3) years, four (4) years, and five (5) years post IORT.
|
5 Years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Adam Dickler, MD, Little Company of Mary Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
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
- LCMH-001
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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