Breast CancerNCT03216421
Intraoperative Radiation Therapy (IORT) in DCIS
A study testing Quality of Life Questionnaires in people with Breast Cancer and Ductal Carcinoma in Situ, run by Columbia University at 1 site in United States.
Trial summary
The goal of this study is to examine the role of Intraoperative Radiotherapy (IORT) in Ductal Carcinoma In-Situ (DCIS) and to improve the understanding of the clinical, radiographic, and patient-related impact of adopting IORT. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Ductal Carcinoma in Situ
- What is being tested?
- Quality of Life Questionnaires
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 265 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Sep 2017to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically confirmed DCIS of the breast
- Clinical ≤ 3.0 cm unifocal lesion
- No clinical or pathological evidence of nodal involvement
- Operable DCIS, suitable for breast conserving surgery
- Plans to administer irradiation to the breast only
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-3, however grade 4 patients may be enrolled at the discretion of the treating radiation oncologist
Show all 12Show fewer
- Must have had a diagnostic mammogram or MRI performed within last 6 months
- Women of child-bearing potential must have a negative pregnancy test in accordance to institutional guidelines
- Women of child-bearing potential must agree to use adequate contraceptive precautions (defined as oral contraceptives, intrauterine devices, surgical contraceptives, or combination of condom and spermicide) from the time of negative pregnancy test through the radiation treatment period.
- English or Spanish speaking
- Able to sign informed consent
- Amenable to regular follow-up (according to research policies) for at least 5 years.
Who cannot join
- Histologic or clinical evidence of invasive breast cancer
- Multicentric cancer in the ipsilateral breast as diagnosed by clinical examination, imaging, or pathologic assessment, not amenable to excision with negative margins with a single lumpectomy
- Synchronous bilateral breast cancer at the time of diagnosis
- Pathologic or imaging evidence of lymph node involvement
- Any severe concomitant disease that may limit their life expectancy to less than 5 years.
- Prior history of breast cancer or in-field radiation in the ipsilateral breast.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant or breast feeding women
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Irving Medical Center
New York, New York, 10032
About this study
Official title: Locoregional Breast Cancer Recurrence Following Targeted Intraoperative Radiotherapy (IORT) for Ductal Carcinoma in Situ (DCIS)
The goal of this study is to examine the role of Intraoperative Radiotherapy (IORT) in Ductal Carcinoma In-Situ (DCIS) and to improve the understanding of the clinical, radiographic, and patient-related impact of adopting IORT.
Read the detailed description
With advances in technology and screening, the overdiagnosis and overtreatment of ductal carcinoma in situ (DCIS) have increased. Minimizing treatment toxicity and cost is a high priority area of research. Intraoperative Radiation Therapy (IORT)is a form of radiation where a single high dose of irradiation is applied to the tumor bed at the time of lumpectomy. Its use has not been previously studied in DCIS. Proposed advantages include decreased toxicity to adjacent tissue and organs, reduction in healthcare costs, and improved quality of life. The investigators hypothesize that IORT is a safe and patient-friendly alternative to whole breast irradiation.
- Conditions
- Breast Cancer, Ductal Carcinoma in Situ
- Being tested
- Quality of Life Questionnaires
- Keywords
- DCIS, Intraoperative Radiation (IORT), Lumpectomy, Breast Conserving Surgery
- Medical subject headings
- Breast Neoplasms, Carcinoma, Intraductal, Noninfiltrating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of Life QuestionnairesOther
Quality of Life questionnaires will be completed by each subject.
| Study group | Role | What they receive |
|---|---|---|
| Low/Intermediate Grade DCIS | Other | Subjects with Low/Intermediate Grade DCIS will complete quality of life questionnaires before and after the IORT. Receives: Other: Quality of Life Questionnaires |
| High Grade DCIS | Other | Subjects with High Grade DCIS will complete quality of life questionnaires before and after the IORT. Receives: Other: Quality of Life Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of local recurrence
Defined by ipsilateral breast tumor recurrence
Measured: 5 years
Secondary outcomes (4)
Disease-free survival
Determine incidence of any distant or local recurrence after the breast-conserving surgery (BCS) and IORT
Measured: 5 years
Overall survival
Quantify the overall survival in women with DCIS following BCS and IORT at 5 years.
Measured: 5 years
Acute Toxicities associated with IORT
Quantify the frequency of acute toxicities that occur within 6 months of having BCS and IORT. Measured using physician and patient reported toxicity surveys.
Measured: 6 months
Longterm radiation toxicity
Quantify the frequency of toxicities that occur at greater than 6 months after having BCS and IORT. Measured using using physician and patient reported toxicity surveys as well as photographic assessment of cosmetic outcome.
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 posted13 Jul 2017
- Study start12 Sep 2017
- Primary completion1 Aug 2027 (estimated)
- Study completion31 Dec 2029 (estimated)
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.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 265 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eileen Connolly, Columbia University
- Investigators
- Eileen Connolly, MD, Principal investigator, Assistant Professor of Radiation Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03216421
- Sponsor's protocol ID
- AAAQ7853
- Status last verified
- Oct 2026
- First submitted
- 11 Jul 2017
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Locoregional Breast Cancer Recurrence Following Targeted Intraoperative Radiotherapy (IORT) for Ductal Carcinoma in Situ (DCIS)
- ClinicalTrials.gov ID
- NCT03216421
- Acronym / sponsor ID
- AAAQ7853
- Conditions
- Breast Cancer, Ductal Carcinoma in Situ
- Keywords
- DCIS, Intraoperative Radiation (IORT), Lumpectomy, Breast Conserving Surgery
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 265 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 12 Sep 2017 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 13 Jul 2017 (actual)
- 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 goal of this study is to examine the role of Intraoperative Radiotherapy (IORT) in Ductal Carcinoma In-Situ (DCIS) and to improve the understanding of the clinical, radiographic, and patient-related impact of adopting IORT.
Detailed description
With advances in technology and screening, the overdiagnosis and overtreatment of ductal carcinoma in situ (DCIS) have increased. Minimizing treatment toxicity and cost is a high priority area of research. Intraoperative Radiation Therapy (IORT)is a form of radiation where a single high dose of irradiation is applied to the tumor bed at the time of lumpectomy. Its use has not been previously studied in DCIS. Proposed advantages include decreased toxicity to adjacent tissue and organs, reduction in healthcare costs, and improved quality of life. The investigators hypothesize that IORT is a safe and patient-friendly alternative to whole breast irradiation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low/Intermediate Grade DCIS | Other | Other: Quality of Life QuestionnairesSubjects with Low/Intermediate Grade DCIS will complete quality of life questionnaires before and after the IORT. |
| High Grade DCIS | Other | Other: Quality of Life QuestionnairesSubjects with High Grade DCIS will complete quality of life questionnaires before and after the IORT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Pathologically confirmed DCIS of the breast
- Clinical ≤ 3.0 cm unifocal lesion
- No clinical or pathological evidence of nodal involvement
- Operable DCIS, suitable for breast conserving surgery
- Plans to administer irradiation to the breast only
Key exclusion criteria (8 listed)
- Histologic or clinical evidence of invasive breast cancer
- Multicentric cancer in the ipsilateral breast as diagnosed by clinical examination, imaging, or pathologic assessment, not amenable to excision with negative margins with a single lumpectomy
- Synchronous bilateral breast cancer at the time of diagnosis
- Pathologic or imaging evidence of lymph node involvement
- Any severe concomitant disease that may limit their life expectancy to less than 5 years.
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 |
|---|---|---|
| Quality of Life QuestionnairesQuality of Life questionnaires will be completed by each subject. | Other | High Grade DCIS, Low/Intermediate Grade DCIS |
Primary outcome
Rate of local recurrence
Time frame: 5 years
Defined by ipsilateral breast tumor recurrence
4 secondary outcomes
Disease-free survival
Time frame: 5 years
Overall survival
Time frame: 5 years
Acute Toxicities associated with IORT
Time frame: 6 months
Longterm radiation toxicity
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Eileen Connolly, MD principal investigator
Assistant Professor of Radiation Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quality of Life Questionnaires in people with Breast Cancer and Ductal Carcinoma in Situ, run by Columbia University 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 12 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: under way, not looking for participants, as of the sponsor's last update on 21 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Rate of local recurrence (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 21 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.