Breast CancerNCT01988870
IORT (Intra-operative Radiation Therapy) in Early Stage Breast Cancer
A study testing Intra-operative Radiation Therapy (IORT) in people with Breast Cancer, run by Shayna Showalter, MD at 1 site in United States.
Trial summary
The purpose of this study is to evaluate an investigational way to provide radiation therapy to treat breast cancer at the time of surgery. Traditionally, the recommended treatment for early stage breast cancer is surgery to remove the tumor, followed by whole breast radiation therapy to decrease the chance of… Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Intra-operative Radiation Therapy (IORT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Nov 2015
- 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 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women 50 years of age of older
- Patient has elected breast conserving surgical treatment for early-stage breast cancer
- Patient meets American Society for Therapeutic Radiation Oncology (ASTRO) criteria for a "suitable" or "cautionary" patient
- Life expectancy of more than 2 years
- Tumor size 4cm or less
- Women of childbearing potential must agree to use adequate contraception
Who cannot join
- Male
- Pregnant or nursing
- Any contraindication to radiotherapy
- Breast cancer that involves skin or chest wall, bilateral breast cancer or history of breast cancer in ipsilateral breast
- Patient meets any of the ASTRO criteria for an "unsuitable" patient
- Patient requires chemotherapy within two weeks of IORT
Show all 9Show fewer
- Breast implants
- A serious uncontrolled medical disorder
- Significant history of uncontrolled cardiac disease or CNS disease
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia Health System
Charlottesville, Virginia, 22908
About this study
Official title: A Pilot, Single Arm, Study of the Safety and Feasibility of Single-Fraction Intraoperative Radiation Treatment (IORT) With CT-On-Rails-Guided HDR Brachytherapy for the Treatment of Early-Stage Breast Cancer
The purpose of this study is to evaluate an investigational way to provide radiation therapy to treat breast cancer at the time of surgery.
Traditionally, the recommended treatment for early stage breast cancer is surgery to remove the tumor, followed by whole breast radiation therapy to decrease the chance of recurrence of the cancer. Whole breast radiation involves daily radiation treatments for 4-6 weeks and can be associated with damage to other tissues including the skin. Recent technological advances have made it possible to provide radiation treatment during the breast cancer surgical procedure. This procedure is called intraoperative radiation therapy (IORT). The University of Virginia has a unique IORT system which allows for the inclusion of cutting edge imaging technology into the IORT procedure in order to provide delivery of radiation directly to the needed areas and to avoid radiation to other tissues.
- Conditions
- Breast Cancer
- Being tested
- Intra-operative Radiation Therapy (IORT)
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-operative Radiation Therapy (IORT)Radiation
IORT is a form of APBI (accelerated partial breast irradiation) that allows for a high degree of dose homogeneity, exclusion of non-affected structures, and reduction of the volume of breast tissue exposed.
| Study group | Role | What they receive |
|---|---|---|
| Intra-operative Radiation Therapy (IORT) | Experimental | Following breast conserving surgery, a CT-based plan will be prepared to deliver highly conformal IORT and the treatment will be administered. Receives: Radiation: Intra-operative Radiation Therapy (IORT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
IORT (Intra-operative Radiation Therapy) treatment interval
Evaluation of the time from the acquisition of the initial CT-on-rails until the time at which IORT is complete
Measured: 90 minutes or less
Overall incidence of adverse events and major toxicities
Measured: Up to 6 months following treatment
Secondary outcomes (6)
IORT treatment parameters
Gather preliminary data on planning time
Measured: up to 6 hours
Cosmetic Outcome
Digital photographs will be taken and used to assess breast characteristics (i.e. color/pigmentation, size, shape) and evaluated for cosmetic outcomes
Measured: Up to 6 months following treatment
Quality of life assessment
Patients will complete a breast cancer specific quality of life survey
Measured: Up to 6 months following treatment
IORT treatment parameters
gather preliminary data on total radiation delivery time
Measured: upto 6 hours
IORT treatment parameters
Gather preliminary data on total procedure time
Measured: upto 6 hours
IORT treatment parameters
Gather preliminary data on dosimetry
Measured: upto 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2013 (estimated)
- Study startDec 2013
- Primary completionApr 2015
- Study completionNov 2015
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
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shayna Showalter, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shayna Showalter, MD, University of Virginia
- Investigators
- Shayna Showalter, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01988870
- Sponsor's protocol ID
- 17091
- Status last verified
- Nov 2016
- First submitted
- 13 Nov 2013
- Last updated
- 22 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot, Single Arm, Study of the Safety and Feasibility of Single-Fraction Intraoperative Radiation Treatment (IORT) With CT-On-Rails-Guided HDR Brachytherapy for the Treatment of Early-Stage Breast Cancer
- ClinicalTrials.gov ID
- NCT01988870
- Acronym / sponsor ID
- 17091
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Shayna Showalter, MDUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 20 Nov 2013 (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.
The purpose of this study is to evaluate an investigational way to provide radiation therapy to treat breast cancer at the time of surgery.
Traditionally, the recommended treatment for early stage breast cancer is surgery to remove the tumor, followed by whole breast radiation therapy to decrease the chance of recurrence of the cancer. Whole breast radiation involves daily radiation treatments for 4-6 weeks and can be associated with damage to other tissues including the skin. Recent technological advances have made it possible to provide radiation treatment during the breast cancer surgical procedure. This procedure is called intraoperative radiation therapy (IORT). The University of Virginia has a unique IORT system which allows for the inclusion of cutting edge imaging technology into the IORT procedure in order to provide delivery of radiation directly to the needed areas and to avoid radiation to other tissues.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intra-operative Radiation Therapy (IORT) | Experimental | Radiation: Intra-operative Radiation Therapy (IORT)Following breast conserving surgery, a CT-based plan will be prepared to deliver highly conformal IORT and the treatment will be administered. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Women 50 years of age of older
- Patient has elected breast conserving surgical treatment for early-stage breast cancer
- Patient meets American Society for Therapeutic Radiation Oncology (ASTRO) criteria for a "suitable" or "cautionary" patient
- Life expectancy of more than 2 years
- Tumor size 4cm or less
Key exclusion criteria (9 listed)
- Male
- Pregnant or nursing
- Any contraindication to radiotherapy
- Breast cancer that involves skin or chest wall, bilateral breast cancer or history of breast cancer in ipsilateral breast
- Patient meets any of the ASTRO criteria for an "unsuitable" patient
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 |
|---|---|---|
| Intra-operative Radiation Therapy (IORT)IORT is a form of APBI (accelerated partial breast irradiation) that allows for a high degree of dose homogeneity, exclusion of non-affected structures, and reduction of the volume of breast tissue exposed. | Radiation | Intra-operative Radiation Therapy (IORT) |
Primary outcome
IORT (Intra-operative Radiation Therapy) treatment interval
Time frame: 90 minutes or less
Evaluation of the time from the acquisition of the initial CT-on-rails until the time at which IORT is complete
Overall incidence of adverse events and major toxicities
Time frame: Up to 6 months following treatment
6 secondary outcomes
IORT treatment parameters
Time frame: up to 6 hours
Cosmetic Outcome
Time frame: Up to 6 months following treatment
Quality of life assessment
Time frame: Up to 6 months following treatment
IORT treatment parameters
Time frame: upto 6 hours
IORT treatment parameters
Time frame: upto 6 hours
IORT treatment parameters
Time frame: upto 6 hours
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 22 Nov 2016.
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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.
Shayna Showalter, MD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intra-operative Radiation Therapy (IORT) in people with Breast Cancer, run by Shayna Showalter, MD 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 9 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 22 Nov 2016. 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?
IORT (Intra-operative Radiation Therapy) treatment interval (time frame: 90 minutes or less). The study lists 2 primary outcomes in all. 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 22 Nov 2016.