Breast CancerIORTNCT01189851
Intraoperative Radiotherapy for Early Stage Breast Cancer
A study testing Intraoperative Radiotherapy in people with Breast Cancer, run by Hoag Memorial Hospital Presbyterian at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 48 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Intraoperative Radiotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 48 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hoag Memorial Hospital Presbyterian - Cancer Center
Newport Beach, California, 92658
About this study
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
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Intraoperative Radiotherapy
- Keywords
- breast, IORT, electronic brachytherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative RadiotherapyDevice
Also called 510(k) Number K050843, Axxent™ Electronic Brachytherapy System
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.
| Study group | Role | What they receive |
|---|---|---|
| IORT | Other | Treated with Intraoperative Radiation Therapy Receives: Device: Intraoperative Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 years
Secondary outcomes (5)
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.
Measured: 5 years
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.
Measured: 5 years
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.
Measured: 5 years
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.
Measured: 5 years
Progression Free Survival in the First Five Years
We will follow progression free survival for 5 years
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2010 (estimated)
- Study startJun 2010
- Primary completionSep 2023
- Study completionDec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hoag Memorial Hospital Presbyterian
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter V Chen, MD, Principal investigator, Hoag Memorial Hospital Presbyterian
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01189851
- Sponsor's protocol ID
- IORT
- Acronym
- IORT
- Status last verified
- Oct 2024
- First submitted
- 21 Jun 2010
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01189851
- Acronym / sponsor ID
- IORT / IORT
- Conditions
- Breast Cancer
- Keywords
- breast, IORT, electronic brachytherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hoag Memorial Hospital PresbyterianUniversity, hospital or other
- Study start
- Jun 2010 (actual)
- Primary completion
- Sep 2023 (actual)
- Study completion
- Dec 2023 (actual)
- First posted
- 27 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IORT | Other | Device: Intraoperative RadiotherapyTreated with Intraoperative Radiation Therapy |
Who may qualify
- Ages
- 48 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (13 listed)
- Male sex
- Age < 48
- Non-epithelial breast malignancies such as sarcoma, lymphoma, or metastatic breast cancer
- Pregnancy or lactation
- Serious psychiatric or addictive disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraoperative RadiotherapyAlso: 510(k) Number K050843, Axxent™ Electronic Brachytherapy SystemThe 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. | Device | IORT |
Primary outcome
Proportion of Participants Receiving Additional Surgery Because of Positive or Close Margins as a Measure of the Accuracy of Pre-Operative Assessment
Time frame: 10 years
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.
5 secondary outcomes
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
Time frame: 5 years
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
Time frame: 5 years
Proportion of Participants with Serious Adverse Events and/or Complications as a Measure of the Safety of the Treatment Algorithm
Time frame: 5 years
Cosmesis Scores by Physician and Self-Assessment
Time frame: 5 years
Progression Free Survival in the First Five Years
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter V Chen, MD principal investigator
Hoag Memorial Hospital Presbyterian
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraoperative Radiotherapy in people with Breast Cancer, run by Hoag Memorial Hospital Presbyterian at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants Receiving Additional Surgery Because of Positive or Close Margins as a Measure of the Accuracy of Pre-Operative Assessment (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.