Breast CancerIORTBreastNCT02266602
Intraoperative Radiation Therapy in Early Stage Breast Cancer
A study testing Intraoperative Radiation Therapy in people with Breast Cancer, run by Benaroya Research Institute at 1 site in United States.
Trial summary
Single arm study to assess the effectiveness of single dose intraoperative radiation therapy in patient with in situ and early stage breast cancer. Read more about this study
- Who is it for?
- Ages 45 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Intraoperative Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to 31 Jul 2018
- 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 45 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- General Inclusion Criteria
- Age ≥ 45 years.
- Clinical stage Tis, T1, T2 (≤ 3cm), N0, M0 (AJCC Classification).
- Invasive ductal or lobular carcinoma, DCIS and/ or pleomorphic lobular carcinoma in situ.
Who cannot join
- Scleroderma, systemic sclerosis and active lupus.
- Participation in an investigational drug or device study.
- Previous ipsilateral radiation to the thorax or breast.
- Multifocal breast cancer.
- Pregnant patients.
- Patient not competent to provide informed consent.
- Neoadjuvant systemic therapy.
- Lymphovascular invasion on biopsy pathology
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Mason Medical Center
Seattle, Washington, 98101
About this study
Official title: Intra-Operative Radiotherapy After Breast Conserving Therapy in the Treatment of in Situ and Early Stage Breast Cancer
Single arm study to assess the effectiveness of single dose intraoperative radiation therapy in patient with in situ and early stage breast cancer.
Read the detailed description
The purpose of this clinical study is to assess the effectiveness of IORT, using an electronic brachytherapy system, in patients with limited-volume in situ and early stage breast cancer, with endpoints of:
- Local recurrence in early stage breast cancer patients treated with IORT.
- Toxicity associated with IORT.
- Long-term disease-specific and overall survival
- Cosmetic results using the Harvard Scale at start and follow-up periods in patients treated with IORT.
- Quality of life in patients treated with IORT.
- Health care costs associated with IORT.
- Conditions
- Breast Cancer
- Being tested
- Intraoperative Radiation Therapy
- Keywords
- IORT, Breast Cancer
- 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 Radiation TherapyRadiation
Also called IORT
Intraoperative radiation therapy at the time of partial mastectomy in early stage breast cancer
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Other | Patients treated with intraoperative radiation therapy at the time of partial mastectomy. Receives: Radiation: Intraoperative Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local Disease Relapse
Patients are evaluated clinically at 3 months, 6 months, 9 months, 1 year and every six months for 10 years for disease recurrence. In addition to clinical exams, yearly mammograms and other imaging studies as deemed appropriate will be obtained to rule out recurrent disease. Recurrent disease will be defined as cancer recurrence within 2cm of site of original tumor bed (marked by surgical clips).
Measured: 10 years
Secondary outcomes (1)
Disease specific and overall survival
Disease specific and overall survival will be obtained for all patients in the study.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2014 (estimated)
- Study startFeb 2012
- Primary completion30 Jul 2018
- Study completion31 Jul 2018
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
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benaroya Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michelle Yao, Benaroya Research Institute
- Investigators
- Janie Grumley, MD, Principal investigator, Virginia Mason Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02266602
- Sponsor's protocol ID
- 11143
- Acronym
- IORTBreast
- Status last verified
- Apr 2019
- First submitted
- 10 Oct 2014
- Last updated
- 26 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-Operative Radiotherapy After Breast Conserving Therapy in the Treatment of in Situ and Early Stage Breast Cancer
- ClinicalTrials.gov ID
- NCT02266602
- Acronym / sponsor ID
- IORTBreast / 11143
- Conditions
- Breast Cancer
- Keywords
- IORT, Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Benaroya Research InstituteUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- 30 Jul 2018 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 17 Oct 2014 (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.
Single arm study to assess the effectiveness of single dose intraoperative radiation therapy in patient with in situ and early stage breast cancer.
Detailed description
The purpose of this clinical study is to assess the effectiveness of IORT, using an electronic brachytherapy system, in patients with limited-volume in situ and early stage breast cancer, with endpoints of:
- Local recurrence in early stage breast cancer patients treated with IORT.
- Toxicity associated with IORT.
- Long-term disease-specific and overall survival
- Cosmetic results using the Harvard Scale at start and follow-up periods in patients treated with IORT.
- Quality of life in patients treated with IORT.
- Health care costs associated with IORT.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Other | Radiation: Intraoperative Radiation TherapyPatients treated with intraoperative radiation therapy at the time of partial mastectomy. |
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- General Inclusion Criteria
- Age ≥ 45 years.
- Clinical stage Tis, T1, T2 (≤ 3cm), N0, M0 (AJCC Classification).
- Invasive ductal or lobular carcinoma, DCIS and/ or pleomorphic lobular carcinoma in situ.
Key exclusion criteria (8 listed)
- Scleroderma, systemic sclerosis and active lupus.
- Participation in an investigational drug or device study.
- Previous ipsilateral radiation to the thorax or breast.
- Multifocal breast cancer.
- Pregnant patients.
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 Radiation TherapyAlso: IORTIntraoperative radiation therapy at the time of partial mastectomy in early stage breast cancer | Radiation | Treatment |
Primary outcome
Local Disease Relapse
Time frame: 10 years
Patients are evaluated clinically at 3 months, 6 months, 9 months, 1 year and every six months for 10 years for disease recurrence. In addition to clinical exams, yearly mammograms and other imaging studies as deemed appropriate will be obtained to rule out recurrent disease. Recurrent disease will be defined as cancer recurrence within 2cm of site of original tumor bed (marked by surgical clips).
1 secondary outcome
Disease specific and overall survival
Time frame: 10 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 26 Apr 2019.
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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.
Janie Grumley, MD principal investigator
Virginia Mason Medical Center
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 Radiation Therapy in people with Breast Cancer, run by Benaroya Research Institute 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 4 inclusion and 8 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 26 Apr 2019. 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?
Local Disease Relapse (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 26 Apr 2019.