Oncoplastic Partial Mastectomy With Intraoperative Radiation Therapy (IORT) in Early Stage Breast Cancer Patients With Prior History of Chest Wall Radiation.

  • STATUS
    Recruiting
  • End date
    Feb 7, 2026
  • participants needed
    30
  • sponsor
    Saint John's Cancer Institute
Updated on 7 April 2022
Accepts healthy volunteers

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. 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.

Details
Condition IORT-Intra-Operative Radiation Therapy
Treatment Intraoperative Radiotherapy, Oncoplastic partial mastectomy
Clinical Study IdentifierNCT05289466
SponsorSaint John's Cancer Institute
Last Modified on7 April 2022

Eligibility

Yes No Not Sure

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
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