Back to resultsSingle Fraction Intraoperative Radiotherapy
Primary Purpose
Invasive Ductal and Invasive Lobular Breast Carcinoma, Stage 0 Breast Carcinoma, Stage I Breast Carcinoma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intraoperative Radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Invasive Ductal and Invasive Lobular Breast Carcinoma focused on measuring Breast Cancer, Carcinoma, Radiotherapy, Intraoperative Radiotherapy, IORT
Eligibility Criteria
Inclusion Criteria:
- Histological proven invasive breast carcinoma ductal, lobular and/or Ductal Carcinoma in situ
- Age > 40 years
- Karnofsky performance status > 70%
- Tumor. 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 equal to or less than 2.5 cm
- Nodal Status: preoperatively N0
- Clear surgical margins: R0
- All grades G1 - G3
- Any hormonal receptor and HER-2 status
- Informed consent
Exclusion Criteria:
- Gender: male
- Tumor size: more than 2.5 cm
- Nodal status greater than or equal to N1 pathologically
- Multicentricity
- Previous radiotherapy to the involved breast
- Karnofsky Index < 70%
- Mixed connective tissue diseases e.g. rheumatoid poly arthritis, thromboangitis obliterans, systemic lupus
- Distant metastases
- Pregnancy in woman of child bearing age
- Unable to provide written consent
Sites / Locations
- St. Joseph Hospital of Orange
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
IORT Arm
Arm Description
Intraoperative radiotherapy (IORT) is delivered after completion of the lumpectomy and sentinel node procedure.
Outcomes
Primary Outcome Measures
Toxicity Assessment
Assessment of acute toxicity of breast irradiation according to CTC-toxicity Scoring - system:
End of initial surgical phase: Week 1, 4
First Follow-up investigation: Month 2 Assessment of late toxicity according to NSABP scoring-systems at 6, 12, 24, 36, 48, and 60 months
Secondary Outcome Measures
Cosmetic Evaluation
Assessment of cosmetic outcome according to 5-point scoring system
Week 1, 2; Month 2, 6, 12, 24, 36, 48, 60
At yearly follow-up (photodocumentation in standardized positions) for 5 years
Recurrence Assessment
Recurrence is assessed at month 6, 12, 24, 36, 48, 60
Full Information
NCT ID
NCT01688388
First Posted
September 12, 2012
Last Updated
May 9, 2022
Sponsor
St. Joseph Hospital of Orange
1. Study Identification
Unique Protocol Identification Number
NCT01688388
Brief Title
Single Fraction Intraoperative Radiotherapy
Official Title
Single Fraction Intraoperative Radiotherapy With Electrons: An Option in Breast-Conserving Operable Breast Cancer Stages 0, I and II - Prospective, Single-arm Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Joseph Hospital of Orange
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This clinical trial is being conducted to find out the effects (good and bad) of giving the full radiation treatment for breast cancer as a single dose of radiation during surgery for breast cancer. This single fraction intraoperative radiotherapy with electrons will study the toxicity, local control and cosmetic outcome.
Detailed Description
For patients with certain types of breast cancer, one standard treatment is breast conserving surgery or lumpectomy (surgery to remove abnormal tissue or cancer from the breast 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 followed by 5-8 daily localized irradiation (or boost) treatments at the site where the lump was removed. During this study, the single dose of electron irradiation given at the surgical site during the operation will replace the radiation given after surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Invasive Ductal and Invasive Lobular Breast Carcinoma, Stage 0 Breast Carcinoma, Stage I Breast Carcinoma, Stage II Breast Carcinoma
Keywords
Breast Cancer, Carcinoma, Radiotherapy, Intraoperative Radiotherapy, IORT
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
250 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IORT Arm
Arm Type
Experimental
Arm Description
Intraoperative radiotherapy (IORT) is delivered after completion of the lumpectomy and sentinel node procedure.
Intervention Type
Procedure
Intervention Name(s)
Intraoperative Radiotherapy
Other Intervention Name(s)
IORT
Intervention Description
Intraoperative radiotherapy (IORT) is delivered after completion of the lumpectomy and sentinel node procedure. IORT is performed on mobile or fixed linacs with variable electron energies in the range of 6-12 MeV prescribed to a dose of 21 Gy, with the prescription dose covering at least 90% of the Planning Target Volume (PTV). PTV is defined as a 3D volume of 1-2 cm beyond the former macroscopic tumor edge (excluding skin, limit to anterior rib surface: 5 Gy). The choice of electron energy as well as the cone applicator size has to account for minimum PTV requirements. Tissue depth measurement will be documented by intraoperative sonography.
Primary Outcome Measure Information:
Title
Toxicity Assessment
Description
Assessment of acute toxicity of breast irradiation according to CTC-toxicity Scoring - system:
End of initial surgical phase: Week 1, 4
First Follow-up investigation: Month 2 Assessment of late toxicity according to NSABP scoring-systems at 6, 12, 24, 36, 48, and 60 months
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Cosmetic Evaluation
Description
Assessment of cosmetic outcome according to 5-point scoring system
Week 1, 2; Month 2, 6, 12, 24, 36, 48, 60
At yearly follow-up (photodocumentation in standardized positions) for 5 years
Time Frame
5 years
Title
Recurrence Assessment
Description
Recurrence is assessed at month 6, 12, 24, 36, 48, 60
Time Frame
5 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
41 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histological proven invasive breast carcinoma ductal, lobular and/or Ductal Carcinoma in situ
Age > 40 years
Karnofsky performance status > 70%
Tumor. 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 equal to or less than 2.5 cm
Nodal Status: preoperatively N0
Clear surgical margins: R0
All grades G1 - G3
Any hormonal receptor and HER-2 status
Informed consent
Exclusion Criteria:
Gender: male
Tumor size: more than 2.5 cm
Nodal status greater than or equal to N1 pathologically
Multicentricity
Previous radiotherapy to the involved breast
Karnofsky Index < 70%
Mixed connective tissue diseases e.g. rheumatoid poly arthritis, thromboangitis obliterans, systemic lupus
Distant metastases
Pregnancy in woman of child bearing age
Unable to provide written consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lawrence Wagman, M.D.
Organizational Affiliation
St. Joseph Hospital of Orange
Official's Role
Study Chair
Facility Information:
Facility Name
St. Joseph Hospital of Orange
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
12. IPD Sharing Statement
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Single Fraction Intraoperative Radiotherapy
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