Back to resultsIntraoperative Radiation Therapy in Treating Patients With Breast Cancer Undergoing Breast-Conserving Surgery
Primary Purpose
Stage IA Breast Cancer, Stage IIA Breast Cancer
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intraoperative Radiation Therapy
Laboratory Biomarker Analysis
Sponsored by
About this trial
This is an interventional treatment trial for Stage IA Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- Suitable for breast conserving surgery
- T1 and T2 (< 3.5 cm), N0, M0
Exclusion Criteria:
- Axillary lymph node positive breast cancer
- Tumor size > 3.5 cm
- Extensive intraductal component (EIC >= 25% of the lumpectomy specimen involved with ductal carcinoma in situ), as assessed on surgical pathologic lumpectomy specimen
- Multicentric cancer in the same breast as diagnosed by clinical examination, mammography, ultrasound; magnetic resonance imaging (MRI) or pathologic assessment, not amenable to excision with negative margins with a single lumpectomy
- Inability to assess pathologic margin status
- Synchronous bilateral breast cancer at the time of diagnosis
- Ipsilateral breast had a previous cancer and/or prior in-field radiation
- Patients known to have BRCA1/2 gene mutations (testing for gene mutations is not required)
- Patients undergoing primary systemic treatment (hormones or chemotherapy) as initial treatment with neoadjuvant reducing tumor size
- Previous history of malignant disease does not preclude entry if the expectation of relapse-free survival at 10 years or greater
- Any factor included as exclusion criteria in the participating center's treatment policy statement
Additional exclusion criteria for University of California San Francisco (UCSF) (as laid out in the Treatment Policy):
- Patients under the age of 50
- Estrogen receptor negative (as defined in Treatment Policy under "Pathology")
- Human epidermal growth factor receptor 2 (HER2) positive (as defined in Treatment Policy under "HER2")
- Lymphovascular invasion
- High grade
- Tumors > 3 cm
- Node positive patients
- Prior chemotherapy or hormone therapy
Sites / Locations
- Alta Bates Summit Medical Center-Herrick Campus
- University of California, Irvine
- Dignity Health - California Hospital Medical Center
- University of California, San Francisco
- John Muir Medical Center-Walnut CreekRecruiting
- Greenwich HospitalRecruiting
- MedStar Georgetown University HospitalRecruiting
- MedStar Washington Hospital CenterRecruiting
- Cleveland Clinic
- Holy Cross Hospital
- Memorial Health University Medical Center
- Northwestern University
- Loyola University Medical CenterRecruiting
- Community Cancer Center South
- Mercy Medical CenterRecruiting
- Lahey Hospital and Medical Center
- Marie Yeager Cancer Center, Spectrum Health LakelandRecruiting
- Community Hospital at Dobbs FerryRecruiting
- Cornell University
- Columbia University/Herbert Irving Cancer CenterRecruiting
- Vassar Brothers Medical Center
- Saint Luke's Hospital-Anderson Campus
- Inova Fairfax Hospital Cancer Center
- Sentara Port Warwick
- Aurora BayCare Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment (IORT)
Arm Description
Patients undergo IORT in a single fraction over 15-40 minutes at the time of standard of care lumpectomy.
Outcomes
Primary Outcome Measures
Incidence of local recurrence
Local tumor control is defined as no recurrent tumor in the ipsilateral breast. Patients will be regularly monitored as per the individual center's policy provided this meets the minimum trial criteria for follow-up with physical examination at least every 6 months for 3 years and yearly at 4 and 5 years post-treatment. Confirmation of recurrence will follow clinical examination and cytology or biopsy. The two patient cohorts will not be separated for the analysis regarding local control.
Frequency of site of relapse within the breast
Site of relapse within the breast will be recorded in order to assess whether the recurrence is at the site of initial tumor or at a new site and whether it has occurred within the treated field (IORT).
Percentage of participants with treatment-related adverse events
Local toxicity and morbidity will be recorded as adverse events related to the primary treatment of the breast cancer. These were recorded in the randomized trial and outcomes showed no significant difference in clinical complications for the IORT as compared to standard external beam radiation. However, all expected toxicities of hematoma, seroma, wound infection, wound breakdown and delayed wound healing will be assessed according to Radiation Therapy Oncology Group (RTOG) criteria. Late skin reactions, rash, telangiectasia and pain due to radiation and all other toxicities will be recorded and graded according to standard NCI-CTCAE V. 4 criteria
Median Relapse-free survival
Relapse-free survival will be recorded as the time interval between trial entry and the date of confirmation of any recurrence. The actual date to be used is the clinic day on which the investigations that led to a confirmed diagnosis of the recurrence were requested. Relapse-free survival would include any recurrence of breast cancer (local, regional or distant) or death without prior report a relapse. All patients will be analyzed under an "Intent to Treat" policy
Median Overall Survival
Overall survival will be the time interval between enrollment and death.
Secondary Outcome Measures
Full Information
NCT ID
NCT01570998
First Posted
March 2, 2012
Last Updated
June 16, 2023
Sponsor
University of California, San Francisco
Collaborators
Carl Zeiss Meditec AG
1. Study Identification
Unique Protocol Identification Number
NCT01570998
Brief Title
Intraoperative Radiation Therapy in Treating Patients With Breast Cancer Undergoing Breast-Conserving Surgery
Official Title
Targeted Intraoperative Radiotherapy United States (TARGIT-US) Phase IV Registry Trial: A Registry Trial of Targeted Intraoperative Radiation Therapy Following Breast-conserving Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 18, 2012 (Actual)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
Carl Zeiss Meditec AG
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This phase IV trial studies the side effects of intraoperative radiation therapy and how well it works in treating patients with breast cancer undergoing breast-conserving surgery. Delivering radiation one time to the area where the tumor was removed while the patient is still in the operating room may kill any residual tumor cells and may be as effective as standard radiation therapy in patients with early stage breast cancer.
Detailed Description
PRIMARY OBJECTIVES:
I. To establish eligibility criteria based on previously published trials and studies in order to allow women who meet these criteria to receive intraoperative radiation therapy (IORT) on an Institutional Review Board (IRB)-approved protocol.
II. To systematically collect and assess acute and long-term toxicity and outcomes in larger cohort of patients.
III. To study the efficacy and toxicity of breast radiotherapy given intra-operatively as a single fraction after breast conserving surgery, with or without whole breast radiation, as indicated by pathologic risk factors, in women with early stage breast cancer.
IV. In-breast local failure and patterns of in-breast failure. V. Ipsilateral regional nodal failure. VI. Toxicity and morbidity. VII. Relapse-free survival. VIII. Overall survival.
OUTLINE:
Patients undergo IORT in a single fraction over 15-40 minutes at the time of standard of care lumpectomy.
After completion of study treatment, patients are followed up within 6 weeks and then every 6 months for 3 years and yearly for 2 years.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage IA Breast Cancer, Stage IIA Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment (IORT)
Arm Type
Experimental
Arm Description
Patients undergo IORT in a single fraction over 15-40 minutes at the time of standard of care lumpectomy.
Intervention Type
Radiation
Intervention Name(s)
Intraoperative Radiation Therapy
Other Intervention Name(s)
Intraoperative Radiotherapy, IORT, radiotherapy, intraoperative
Intervention Description
Undergo IORT
Intervention Type
Other
Intervention Name(s)
Laboratory Biomarker Analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Incidence of local recurrence
Description
Local tumor control is defined as no recurrent tumor in the ipsilateral breast. Patients will be regularly monitored as per the individual center's policy provided this meets the minimum trial criteria for follow-up with physical examination at least every 6 months for 3 years and yearly at 4 and 5 years post-treatment. Confirmation of recurrence will follow clinical examination and cytology or biopsy. The two patient cohorts will not be separated for the analysis regarding local control.
Time Frame
Up to 5 years
Title
Frequency of site of relapse within the breast
Description
Site of relapse within the breast will be recorded in order to assess whether the recurrence is at the site of initial tumor or at a new site and whether it has occurred within the treated field (IORT).
Time Frame
Up to 5 years
Title
Percentage of participants with treatment-related adverse events
Description
Local toxicity and morbidity will be recorded as adverse events related to the primary treatment of the breast cancer. These were recorded in the randomized trial and outcomes showed no significant difference in clinical complications for the IORT as compared to standard external beam radiation. However, all expected toxicities of hematoma, seroma, wound infection, wound breakdown and delayed wound healing will be assessed according to Radiation Therapy Oncology Group (RTOG) criteria. Late skin reactions, rash, telangiectasia and pain due to radiation and all other toxicities will be recorded and graded according to standard NCI-CTCAE V. 4 criteria
Time Frame
Up to 5 years
Title
Median Relapse-free survival
Description
Relapse-free survival will be recorded as the time interval between trial entry and the date of confirmation of any recurrence. The actual date to be used is the clinic day on which the investigations that led to a confirmed diagnosis of the recurrence were requested. Relapse-free survival would include any recurrence of breast cancer (local, regional or distant) or death without prior report a relapse. All patients will be analyzed under an "Intent to Treat" policy
Time Frame
Up to 5 years
Title
Median Overall Survival
Description
Overall survival will be the time interval between enrollment and death.
Time Frame
Up to 5 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Suitable for breast conserving surgery
T1 and T2 (< 3.5 cm), N0, M0
Exclusion Criteria:
Axillary lymph node positive breast cancer
Tumor size > 3.5 cm
Extensive intraductal component (EIC >= 25% of the lumpectomy specimen involved with ductal carcinoma in situ), as assessed on surgical pathologic lumpectomy specimen
Multicentric cancer in the same breast as diagnosed by clinical examination, mammography, ultrasound; magnetic resonance imaging (MRI) or pathologic assessment, not amenable to excision with negative margins with a single lumpectomy
Inability to assess pathologic margin status
Synchronous bilateral breast cancer at the time of diagnosis
Ipsilateral breast had a previous cancer and/or prior in-field radiation
Patients known to have BRCA1/2 gene mutations (testing for gene mutations is not required)
Patients undergoing primary systemic treatment (hormones or chemotherapy) as initial treatment with neoadjuvant reducing tumor size
Previous history of malignant disease does not preclude entry if the expectation of relapse-free survival at 10 years or greater
Any factor included as exclusion criteria in the participating center's treatment policy statement
Additional exclusion criteria for University of California San Francisco (UCSF) (as laid out in the Treatment Policy):
Patients under the age of 50
Estrogen receptor negative (as defined in Treatment Policy under "Pathology")
Human epidermal growth factor receptor 2 (HER2) positive (as defined in Treatment Policy under "HER2")
Lymphovascular invasion
High grade
Tumors > 3 cm
Node positive patients
Prior chemotherapy or hormone therapy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Catherine Dugan
Phone
415-502-8910
Email
Catherine.Dugan@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Alvarado, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alta Bates Summit Medical Center-Herrick Campus
City
Berkeley
State/Province
California
ZIP/Postal Code
94704
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University of California, Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92617
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Dignity Health - California Hospital Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90015
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
John Muir Medical Center-Walnut Creek
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marjaneh Moini
Phone
925-947-3250
Email
marjaneh.moini_MD@johnmuirhealth.com
First Name & Middle Initial & Last Name & Degree
Marjaneh Moini
Facility Name
Greenwich Hospital
City
Greenwich
State/Province
Connecticut
ZIP/Postal Code
06830
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniela Addeo, MD
Phone
203-863-3773
Email
Daniela.Addeo@greenwichhospital.org
First Name & Middle Initial & Last Name & Degree
Daniela Addeo, MD
Facility Name
MedStar Georgetown University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shawna C. Willey
Phone
202-444-0241
Email
scw9@gunet.georgetown.edu
First Name & Middle Initial & Last Name & Degree
Shawna C. Willey
Facility Name
MedStar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc E. Boisvert
Phone
202-877-7937
Email
marc.e.boisvert@medstar.net
First Name & Middle Initial & Last Name & Degree
Marc E. Boisvert
Facility Name
Cleveland Clinic
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Holy Cross Hospital
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joseph J. Casey
Phone
954-772-6700
Email
joseph.casey@holy-cross.com
First Name & Middle Initial & Last Name & Degree
Joseph J. Casey
Facility Name
Memorial Health University Medical Center
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31404
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
William Small
Phone
708-216-2559
Email
wmsamll@lumc.edu
First Name & Middle Initial & Last Name & Degree
William Small
Facility Name
Community Cancer Center South
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46227
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Mercy Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Neil B. Friedman
Phone
410-332-9330
Email
nfriedman@mdmercy.com
First Name & Middle Initial & Last Name & Degree
Neil B. Friedman
Facility Name
Lahey Hospital and Medical Center
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Marie Yeager Cancer Center, Spectrum Health Lakeland
City
Saint Joseph
State/Province
Michigan
ZIP/Postal Code
49085
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benjamin Gielda
Email
benjamin.gielda@spectrumhealth.org
First Name & Middle Initial & Last Name & Degree
Benjamin Gielda, MD
Facility Name
Community Hospital at Dobbs Ferry
City
Dobbs Ferry
State/Province
New York
ZIP/Postal Code
10522
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pond R. Kelemen
Phone
914-693-5025
Email
prkelemen@hotmail.com
First Name & Middle Initial & Last Name & Degree
Pond R. Kelemen
Facility Name
Cornell University
City
Ithaca
State/Province
New York
ZIP/Postal Code
14850-2488
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Columbia University/Herbert Irving Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eileen P. Connolly
Phone
212-305-5547
Email
epc2116@cumc.columbia.edu
First Name & Middle Initial & Last Name & Degree
Eileen P. Connolly
Facility Name
Vassar Brothers Medical Center
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12601
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Saint Luke's Hospital-Anderson Campus
City
Easton
State/Province
Pennsylvania
ZIP/Postal Code
18045
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Inova Fairfax Hospital Cancer Center
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Sentara Port Warwick
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23606
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Aurora BayCare Medical Center
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54311
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
William L. Owens
Phone
920-288-8480
Email
william.owens@aurora.org
First Name & Middle Initial & Last Name & Degree
William L. Owens
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Intraoperative Radiation Therapy in Treating Patients With Breast Cancer Undergoing Breast-Conserving Surgery
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