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Internal research admin issue required this study to be closed, will re-open an amended protocol.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single-arm | Other | Intraoperative Radiotherapy (Xoft, 20 Gy single dose) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intraoperative Radiotherapy | Radiation | Intraoperative Radiotherapy (Xoft, 20 Gy single dose) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 5 years |
| Effectiveness of partial mastectomy with IORT, measured by regional recurrence. |
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Inclusion Criteria:
Exclusion Criteria:
Multifocal and/or multicenter recurrence
Biological Female
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| Name | Affiliation | Role |
|---|---|---|
| Janie L Weng Grumley, MD | Saint John's Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Providence Saint John's Hospital | Santa Monica | California | 90404 | United States |
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Prospective, Non-randomized, Single-arm
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| Oncoplastic partial mastectomy | Procedure | Breast Conserving Therapy |
|
Tumor recurrence data will be considered a dichotomous outcome, not a time-to-event outcome. |
| 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. | 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. | 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. | 5 years |
| Effectiveness of partial mastectomy with IORT, measured by overall survival | Overall survival will be measured based on dates and causes of death. | 5 years |