IORT-Intra-Operative Radiation TherapyNCT05289466
Oncoplastic Partial Mastectomy With Intraoperative Radiation Therapy (IORT) in Early Stage Breast Cancer Patients With Prior History of Chest Wall Radiation.
A study testing Intraoperative Radiotherapy and Oncoplastic partial mastectomy in people with IORT-Intra-Operative Radiation Therapy, run by Saint John's Cancer Institute at 1 site in United States.
Trial summary
Prospective, Non-randomized, Single-arm.The objectives of this study are to evaluate cosmesis and perioperative complications associated with the use of intraoperative radiotherapy (IORT) at the time of partial mastectomy in patients with breast cancer and a prior history of radiation therapy. Read more about this study
- Who is it for?
- Ages 50 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- IORT-Intra-Operative Radiation Therapy
- What is being tested?
- Intraoperative Radiotherapy and Oncoplastic partial mastectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Dec 2021to 23 Oct 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 50 y.o.
- Histologically proven in situ and invasive ductal or lobular breast recurrence
- Prior history of whole breast/chest wall radiation therapy
- Disease span ≤ 3 cm, unifocal
- No nodal disease (N0)
- No evidence of metastatic disease (M0)
Show all 9Show fewer
- Time from initial BCT should be ≥ 1 year
- Patients have refused the standard of care of mastectomy
- Skin distance of ≥ 0.8 cm between applicator and skin
Who cannot join
- Multifocal and/or multicenter recurrence
- N1-3 status: Regional cytological or histologically proven node recurrence
- M1 status: Metastatic disease
- cT4 (Skin or muscle involvement) or Paget's disease of the nipple
- Patients undergoing mastectomy
- Patients undergoing neoadjuvant systemic therapy
- Connective tissue disease or scleroderma, contraindicating radiotherapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Providence Saint John's Hospital
Santa Monica, California, 90404
About this study
Official title: Oncoplastic Partial Mastectomy With Intraoperative Radiation Therapy (IORT) in Early Stage Breast Cancer Patients With Prior History of Chest Wall Radiation
Prospective, Non-randomized, Single-arm.The objectives of this study are to evaluate cosmesis and perioperative complications associated with the use of intraoperative radiotherapy (IORT) at the time of partial mastectomy in patients with breast cancer and a prior history of radiation therapy. Secondary objectives include evaluating effectiveness of partial mastectomy with IORT, measured by local, regional and distant recurrence, mastectomy rate, and disease-specific and overall survival.
- Conditions
- IORT-Intra-Operative Radiation Therapy
- Being tested
- Intraoperative Radiotherapy, Oncoplastic partial mastectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative RadiotherapyRadiation
Intraoperative Radiotherapy (Xoft, 20 Gy single dose)
Oncoplastic partial mastectomyProcedure or surgery
Breast Conserving Therapy
| Study group | Role | What they receive |
|---|---|---|
| Single-arm | Other | Intraoperative Radiotherapy (Xoft, 20 Gy single dose) Receives: Radiation: Intraoperative Radiotherapy; Procedure: Oncoplastic partial mastectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cosmetic Outcomes as evaluated using BREAST-Q questionnaire as a measure of patient-reported ratings.
The BREAST-Q is a validated patient-reported outcome measure of breast related satisfaction and quality of life, including psychosocial, sexual well-being, and physical domains. Data for cosmetic outcomes will be summarized at the study's completion. This data will be compared to patients included in the IORT Registry that did not have a history of prior irradiation utilizing appropriate statistical tests and models.
Measured: 5 years
Cosmetic Outcomes as evaluated using the Harvard Breast Cosmesis Grading Scale as a measure of patient-reported ratings.
Data for cosmetic outcomes will be summarized at the study's completion. This data will be compared to patients included in the IORT Registry that did not have a history of prior irradiation utilizing appropriate statistical tests and models.
Measured: 5 years
Cosmetic Outcomes as evaluated by clinician completion of the Harvard Breast Cosmesis Grading Scale
Data for cosmetic outcomes will be summarized at the study's completion. This data will be compared to patients included in the IORT Registry that did not have a history of prior irradiation utilizing appropriate statistical tests and models.
Measured: 5 years
Perioperative complications as documented using Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 (CTCAE.v5) scoring system.
Data for perioperative complications will be summarized at the study's completion. This data will be compared to patients included in the IORT Registry that did not have a history of prior irradiation utilizing appropriate statistical tests and models.
Measured: 5 years
Secondary outcomes (6)
Effectiveness of partial mastectomy with IORT, measured by local recurrence.
Tumor recurrence data will be considered a dichotomous outcome, not a time-to-event outcome.
Measured: 5 years
Effectiveness of partial mastectomy with IORT, measured by regional recurrence.
Tumor recurrence data will be considered a dichotomous outcome, not a time-to-event outcome.
Measured: 5 years
Effectiveness of partial mastectomy with IORT, measured by distant recurrence.
Tumor recurrence data will be considered a dichotomous outcome, not a time-to-event outcome.
Measured: 5 years
Effectiveness of partial mastectomy with IORT, measured by mastectomy rate.
Mastectomy rate will be measured by counting those who receive IORT and whose final pathology shows node positive or multifocal disease span >3cm post IORT, are advised to have mastectomy and have mastectomy.
Measured: 5 years
Effectiveness of partial mastectomy with IORT, measured by disease-specific survival.
Disease specific survival will be measured based on dates and causes of death.
Measured: 5 years
Effectiveness of partial mastectomy with IORT, measured by overall survival
Overall survival will be measured based on dates and causes of death.
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 posted21 Mar 2022
- Study start16 Dec 2021
- Primary completion23 Oct 2024
- Study completion23 Oct 2024
Why it stopped: Internal research admin issue required this study to be closed, will re-open an amended protocol.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IORT-Intra-Operative Radiation TherapyStudies 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
- Model description
- Prospective, Non-randomized, Single-arm
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint John's Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Janie Grumley, Saint John's Cancer Institute
- Investigators
- Janie L Weng Grumley, MD, Principal investigator, Saint John's Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05289466
- Sponsor's protocol ID
- JWCI OBCS WITH IORT
- Status last verified
- Dec 2025
- First submitted
- 8 Mar 2022
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oncoplastic Partial Mastectomy With Intraoperative Radiation Therapy (IORT) in Early Stage Breast Cancer Patients With Prior History of Chest Wall Radiation
- ClinicalTrials.gov ID
- NCT05289466
- Acronym / sponsor ID
- JWCI OBCS WITH IORT
- Conditions
- IORT-Intra-Operative Radiation Therapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Internal research admin issue required this study to be closed, will re-open an amended protocol.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Saint John's Cancer InstituteUniversity, hospital or other
- Study start
- 16 Dec 2021 (actual)
- Primary completion
- 23 Oct 2024 (actual)
- Study completion
- 23 Oct 2024 (actual)
- First posted
- 21 Mar 2022 (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.
Prospective, Non-randomized, Single-arm.The objectives of this study are to evaluate cosmesis and perioperative complications associated with the use of intraoperative radiotherapy (IORT) at the time of partial mastectomy in patients with breast cancer and a prior history of radiation therapy. Secondary objectives include evaluating effectiveness of partial mastectomy with IORT, measured by local, regional and distant recurrence, mastectomy rate, and disease-specific and overall survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, Non-randomized, Single-arm
| Arm | Type | Receives |
|---|---|---|
| Single-arm | Other | Radiation: Intraoperative Radiotherapy, Procedure: Oncoplastic partial mastectomyIntraoperative Radiotherapy (Xoft, 20 Gy single dose) |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 50 y.o.
- Histologically proven in situ and invasive ductal or lobular breast recurrence
- Prior history of whole breast/chest wall radiation therapy
- Disease span ≤ 3 cm, unifocal
- No nodal disease (N0)
Key exclusion criteria (7 listed)
- Multifocal and/or multicenter recurrence
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 RadiotherapyIntraoperative Radiotherapy (Xoft, 20 Gy single dose) | Radiation | Single-arm |
| Oncoplastic partial mastectomyBreast Conserving Therapy | Procedure or surgery | Single-arm |
Primary outcome
Cosmetic Outcomes as evaluated using BREAST-Q questionnaire as a measure of patient-reported ratings.
Time frame: 5 years
The BREAST-Q is a validated patient-reported outcome measure of breast related satisfaction and quality of life, including psychosocial, sexual well-being, and physical domains. Data for cosmetic outcomes will be summarized at the study's completion. This data will be compared to patients included in the IORT Registry that did not have a history of prior irradiation utilizing appropriate statistical tests and models.
Cosmetic Outcomes as evaluated using the Harvard Breast Cosmesis Grading Scale as a measure of patient-reported ratings.
Time frame: 5 years
Data for cosmetic outcomes will be summarized at the study's completion. This data will be compared to patients included in the IORT Registry that did not have a history of prior irradiation utilizing appropriate statistical tests and models.
Cosmetic Outcomes as evaluated by clinician completion of the Harvard Breast Cosmesis Grading Scale
Time frame: 5 years
Data for cosmetic outcomes will be summarized at the study's completion. This data will be compared to patients included in the IORT Registry that did not have a history of prior irradiation utilizing appropriate statistical tests and models.
Perioperative complications as documented using Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 (CTCAE.v5) scoring system.
Time frame: 5 years
Data for perioperative complications will be summarized at the study's completion. This data will be compared to patients included in the IORT Registry that did not have a history of prior irradiation utilizing appropriate statistical tests and models.
6 secondary outcomes
Effectiveness of partial mastectomy with IORT, measured by local recurrence.
Time frame: 5 years
Effectiveness of partial mastectomy with IORT, measured by regional recurrence.
Time frame: 5 years
Effectiveness of partial mastectomy with IORT, measured by distant recurrence.
Time frame: 5 years
Effectiveness of partial mastectomy with IORT, measured by mastectomy rate.
Time frame: 5 years
Effectiveness of partial mastectomy with IORT, measured by disease-specific survival.
Time frame: 5 years
Effectiveness of partial mastectomy with IORT, measured by overall survival
Time frame: 5 years
Results and safety
The study was stopped early (reason given: Internal research admin issue required this study to be closed, will re-open an amended protocol.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
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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 L Weng Grumley, MD principal investigator
Saint John's Cancer Institute
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 and Oncoplastic partial mastectomy in people with IORT-Intra-Operative Radiation Therapy, run by Saint John's Cancer 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 9 inclusion and 7 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: stopped early, as of the sponsor's last update on 31 Dec 2025. 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 was stopped early (reason given: Internal research admin issue required this study to be closed, will re-open an amended protocol.). Results are not available in the source record.
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?
Cosmetic Outcomes as evaluated using BREAST-Q questionnaire as a measure of patient-reported ratings. (time frame: 5 years). The study lists 4 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 31 Dec 2025.