Invasive Ductal and Invasive Lobular Breast CarcinomaNCT01688388
Single Fraction Intraoperative Radiotherapy
A study testing Intraoperative Radiotherapy in people with Invasive Ductal and Invasive Lobular Breast Carcinoma and Stage 0 Breast Carcinoma, run by St. Joseph Hospital of Orange at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 41 to 90 years, women only
- Conditions the study is for
- Invasive Ductal and Invasive Lobular Breast Carcinoma, Stage 0 Breast Carcinoma, Stage I Breast Carcinoma
- What is being tested?
- Intraoperative Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Feb 2022
- 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 41 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- All grades G1 - G3
- Any hormonal receptor and HER-2 status
- Informed consent
Who cannot join
- 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%
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Joseph Hospital of Orange
Orange, California, 92868
About this study
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
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.
Read the 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.
- Conditions
- Invasive Ductal and Invasive Lobular Breast Carcinoma, Stage 0 Breast Carcinoma, Stage I Breast Carcinoma, Stage II Breast Carcinoma
- Being tested
- Intraoperative Radiotherapy
- Keywords
- Breast Cancer, Carcinoma, Radiotherapy, Intraoperative Radiotherapy, IORT
- Medical subject headings
- Carcinoma, Lobular, Breast Carcinoma In Situ, Breast Neoplasms, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative RadiotherapyProcedure or surgery
Also called IORT
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.
| Study group | Role | What they receive |
|---|---|---|
| IORT Arm | Experimental | Intraoperative radiotherapy (IORT) is delivered after completion of the lumpectomy and sentinel node procedure. Receives: Procedure: Intraoperative Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 years
Secondary outcomes (2)
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
Measured: 5 years
Recurrence Assessment
Recurrence is assessed at month 6, 12, 24, 36, 48, 60
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 posted19 Sep 2012 (estimated)
- Study startFeb 2012
- Primary completionFeb 2016
- Study completionFeb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive Ductal and Invasive Lobular Breast CarcinomaStudies 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
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Joseph Hospital of Orange
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lawrence Wagman, M.D., Study chair, St. Joseph Hospital of Orange
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01688388
- Sponsor's protocol ID
- 12-001 Single Fraction IORT
- Status last verified
- May 2022
- First submitted
- 12 Sep 2012
- Last updated
- 11 May 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01688388
- Acronym / sponsor ID
- 12-001 Single Fraction IORT
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- St. Joseph Hospital of OrangeUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2022 (actual)
- First posted
- 19 Sep 2012 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IORT Arm | Experimental | Procedure: Intraoperative RadiotherapyIntraoperative radiotherapy (IORT) is delivered after completion of the lumpectomy and sentinel node procedure. |
Who may qualify
- Ages
- 41 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (10 listed)
- 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
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: IORTIntraoperative 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. | Procedure or surgery | IORT Arm |
Primary outcome
Toxicity Assessment
Time frame: 5 years
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
2 secondary outcomes
Cosmetic Evaluation
Time frame: 5 years
Recurrence Assessment
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 11 May 2022.
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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.
Lawrence Wagman, M.D. study chair
St. Joseph Hospital of Orange
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 Invasive Ductal and Invasive Lobular Breast Carcinoma and Stage 0 Breast Carcinoma, run by St. Joseph Hospital of Orange 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 9 inclusion and 10 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 11 May 2022. 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?
Toxicity Assessment (time frame: 5 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 11 May 2022.