Clinical trial · Interventional
Oncoplastic Partial Mastectomy With Intraoperative Radiation Therapy (IORT) in Early Stage Breast Cancer Patients With Prior History of Chest Wall Radiation.
Oncoplastic Partial Mastectomy With Intraoperative Radiation Therapy (IORT) in Early Stage Breast Cancer Patients With Prior History of Chest Wall Radiation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Internal research admin issue required this study to be closed, will re-open an amended protocol.
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| IORT-Intra-Operative Radiation Therapy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intraoperative Radiotherapy | Radiation | — | UNRESOLVED |
| Oncoplastic partial mastectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Single-arm
- description
- Intraoperative Radiotherapy (Xoft, 20 Gy single dose)
- interventionNames
- Radiation: Intraoperative Radiotherapy
- Procedure: Oncoplastic partial mastectomy
Primary outcomes (4)
- measure
- Cosmetic Outcomes as evaluated using BREAST-Q questionnaire as a measure of patient-reported ratings.
- timeFrame
- 5 years
- description
- 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.
- measure
- Cosmetic Outcomes as evaluated using the Harvard Breast Cosmesis Grading Scale as a measure of patient-reported ratings.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * 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) * 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 Exclusion Criteria: * 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
References
Publications (0)
Data not yet available