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NCT05289466 | RECRUITING | IORT-Intra-Operative Radiation Therapy

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

Saint John's Cancer Institute

Information provided by (Responsible Party):

Janie Grumley

Brief 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.

Condition or disease

IORT-Intra-Operative Radiation Therapy

Intervention/treatment

Intraoperative Radiotherapy

Oncoplastic partial mastectomy

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 30 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Oncoplastic Partial Mastectomy With Intraoperative Radiation Therapy (IORT) in Early Stage Breast Cancer Patients With Prior History of Chest Wall Radiation
Actual Study Start Date : 2021-12-16
Estimated Primary Completion Date : 2026-02
Estimated Study Completion Date : 2026-02

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 50 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: 1
Criteria
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
Oncoplastic Partial Mastectomy With Intraoperative Radiation Therapy (IORT) in Early Stage Breast Cancer Patients With Prior History of Chest Wall Radiation.

Location Details

NCT05289466

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Locations

RECRUITING

United States, California

Providence Saint John's Hospital

Santa Monica, California, United States, 90404