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Intraoperative Radiotherapy for Early Stage Breast Cancer (IORT)

Primary Purpose

Breast Cancer

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Intraoperative Radiotherapy

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring breast, IORT, electronic brachytherapy

Eligibility Criteria

48 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Informed Consent. Each eligible patient must willingly give written consent after being informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential benefits, side effects, risks, and discomforts.
Histology. Patients must have biopsy-proven invasive ductal or lobular carcinoma of the breast.
Female, age ≥ 48 years.
Clinically and/or histologically negative axillary lymph nodes.
No imaging or clinical findings that indicate metastatic disease.
Procedure deemed appropriate based upon factors such as breast size by the treating surgeon and radiation oncologist.

Exclusion Criteria:

Male sex
Age < 48
Non-epithelial breast malignancies such as sarcoma, lymphoma, or metastatic breast cancer
Pregnancy or lactation
Serious psychiatric or addictive disorders
More than one obvious cancer in the same breast as diagnosed by clinical examination, mammography, ultrasonography, and/or CE-MRI.
Bilateral breast cancer at the time of diagnosis, unless agreed upon by the surgeon and radiation oncologist.
Ipsilateral breast with a previous cancer and/or irradiation.
Extensive Intraductal Component (DCIS ≥ 25% of the tumor).
Patients presenting with gross nodal disease considered to be clinically malignant by scanning or proven cytologically or by sentinel node biopsy will be cancelled.
Previous history of malignant disease does not preclude entry if the expectation of relapse-free survival at 10 years is 90% or greater.
Lymphovascular invasion on needle biopsy.
Patients undergoing primary medical treatment (hormones or chemotherapy) as initial treatment with intent to reduce tumor size.

Sites / Locations

Hoag Memorial Hospital Presbyterian - Cancer Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

IORT

Arm Description

Treated with Intraoperative Radiation Therapy

Outcomes

Primary Outcome Measures

Proportion of Participants Receiving Additional Surgery Because of Positive or Close Margins as a Measure of the Accuracy of Pre-Operative Assessment

Invasive cancer margins <1 mm and/or non-invasive cancer margins < 2 mm are considered close or positive. Approximately 15% of patients treated with IORT have close or positive margins on pathologic assessment following IORT therapy and are recommended for additional therapy including re-excision, whole breast radiation or both.

Secondary Outcome Measures

Proportion of Participants Recommended to Have Additional Whole Breast Radiation Therapy (WBRT) Because of High Risk Features Found on Final Pathology as a Measure of the Accuracy of Pre-Operative Assessment

Patients treated with IORT that have high risk features on final pathologic exam, including close/positive margins, tumor size >30 mm, positive lymph nodes and lympho-vascular invasion (LVI) are recommended for additional therapy including re-excision, whole breast radiation or both.

Proportion of Participants with Tumor Size Larger than the Entry Criteria Size and/or Positive Lymph Nodes as a Measure of the Accuracy of Pre-Operative Assessment

Both tumor size and lymph node status are estimated prior to surgery using mammography, ultrasound and MRI (unless excluded for medical reasons). Patients with estimated tumor spans > 30 mm or positive lymph nodes are excluded from IORT.

Proportion of Participants with Serious Adverse Events and/or Complications as a Measure of the Safety of the Treatment Algorithm

We will be monitoring acute side effects attributed directly to IORT. These includ erythemia, hyperpigmentation, fibrosis, seromas, infection and wound breakdown.

Cosmesis Scores by Physician and Self-Assessment

The first 213 IORT patients treated will be asked to fill out a yearly cosmesis assessment. Patients filled out these assessments for an average of 2-3 years.

Progression Free Survival in the First Five Years

We will follow progression free survival for 5 years

Full Information

NCT ID

NCT01189851

First Posted

June 21, 2010

Last Updated

August 1, 2022

Sponsor

Hoag Memorial Hospital Presbyterian

1. Study Identification

Unique Protocol Identification Number

NCT01189851

Brief Title

Intraoperative Radiotherapy for Early Stage Breast Cancer

Acronym

IORT

Official Title

Intraoperative Radiotherapy (IORT) for the Management of Carcinoma of the Breast: Use of Mammography, Ultrasonography,and Contrast-Enhanced Magnetic Resonance Imaging (CE-MRI) to Identify Candidates for IORT

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

June 2010 (Actual)

Primary Completion Date

September 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hoag Memorial Hospital Presbyterian

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Up to 200 patients with biopsy proven early stage breast cancer selecting Wide Local Excision (WLE) will undergo mammography, ultrasound (of affected breast and ipsilateral axilla) and contrast enhanced-magnetic resonance imaging (CE-MRI) of the affected breast to evaluate the extent of disease.

Detailed Description

Patients will be deemed eligible for immediate IORT if the invasive cancer lesion is estimated to measure ≤ 3.0 centimeters maximum dimension by mammogram, ultrasound, and CE-MRI and is thought to be resectable with WLE and clear surgical margins, with clinically staged N0M0 disease, minimum age of 48, and histology of invasive ductal or lobular carcinoma of the breast. The lesion size determined by imaging will be compared with lesion size and surgical margin status obtained from the surgical pathology specimen to evaluate the ability of mammography combined with ultrasound and CE-MRI to identify suitable candidates for immediate IORT.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

breast, IORT, electronic brachytherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

IORT

Arm Type

Other

Arm Description

Treated with Intraoperative Radiation Therapy

Intervention Type

Device

Intervention Name(s)

Intraoperative Radiotherapy

Other Intervention Name(s)

510(k) Number K050843, Axxent™ Electronic Brachytherapy System

Intervention Description

The Axxent eBx™ System utilizes a miniaturized high dose rate (HDR) X-ray source to apply radiation directly to the cancerous tumor bed and provides brachytherapy when the physician chooses to deliver intracavitary or interstitial radiation to the surgical margins following lumpectomy for breast cancer.

Primary Outcome Measure Information:

Title

Proportion of Participants Receiving Additional Surgery Because of Positive or Close Margins as a Measure of the Accuracy of Pre-Operative Assessment

Description

Time Frame

10 years

Secondary Outcome Measure Information:

Title

Description

Time Frame

5 years

Title

Proportion of Participants with Tumor Size Larger than the Entry Criteria Size and/or Positive Lymph Nodes as a Measure of the Accuracy of Pre-Operative Assessment

Description

Time Frame

5 years

Title

Proportion of Participants with Serious Adverse Events and/or Complications as a Measure of the Safety of the Treatment Algorithm

Description

We will be monitoring acute side effects attributed directly to IORT. These includ erythemia, hyperpigmentation, fibrosis, seromas, infection and wound breakdown.

Time Frame

5 years

Title

Cosmesis Scores by Physician and Self-Assessment

Description

The first 213 IORT patients treated will be asked to fill out a yearly cosmesis assessment. Patients filled out these assessments for an average of 2-3 years.

Time Frame

5 years

Title

Progression Free Survival in the First Five Years

Description

We will follow progression free survival for 5 years

Time Frame

5 years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

48 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Informed Consent. Each eligible patient must willingly give written consent after being informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential benefits, side effects, risks, and discomforts. Histology. Patients must have biopsy-proven invasive ductal or lobular carcinoma of the breast. Female, age ≥ 48 years. Clinically and/or histologically negative axillary lymph nodes. No imaging or clinical findings that indicate metastatic disease. Procedure deemed appropriate based upon factors such as breast size by the treating surgeon and radiation oncologist. Exclusion Criteria: Male sex Age < 48 Non-epithelial breast malignancies such as sarcoma, lymphoma, or metastatic breast cancer Pregnancy or lactation Serious psychiatric or addictive disorders More than one obvious cancer in the same breast as diagnosed by clinical examination, mammography, ultrasonography, and/or CE-MRI. Bilateral breast cancer at the time of diagnosis, unless agreed upon by the surgeon and radiation oncologist. Ipsilateral breast with a previous cancer and/or irradiation. Extensive Intraductal Component (DCIS ≥ 25% of the tumor). Patients presenting with gross nodal disease considered to be clinically malignant by scanning or proven cytologically or by sentinel node biopsy will be cancelled. Previous history of malignant disease does not preclude entry if the expectation of relapse-free survival at 10 years is 90% or greater. Lymphovascular invasion on needle biopsy. Patients undergoing primary medical treatment (hormones or chemotherapy) as initial treatment with intent to reduce tumor size.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Peter V Chen, MD

Organizational Affiliation

Hoag Memorial Hospital Presbyterian

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hoag Memorial Hospital Presbyterian - Cancer Center

City

Newport Beach

State/Province

California

ZIP/Postal Code

92658

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Intraoperative Radiotherapy for Early Stage Breast Cancer

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