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

NCT05289466 | Terminated FDA Device

• 1 other identifier: JWCI OBCS WITH IORT
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

IORT-Intra-Operative Radiation Therapy

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (6)

• Effectiveness of partial mastectomy with IORT, measured by local recurrence.

  5 years

• Effectiveness of partial mastectomy with IORT, measured by regional recurrence.

  5 years

• Effectiveness of partial mastectomy with IORT, measured by distant recurrence.

  5 years

• Effectiveness of partial mastectomy with IORT, measured by mastectomy rate.

  5 years

• Effectiveness of partial mastectomy with IORT, measured by disease-specific survival.

  5 years

Study Arms (1)

Single-arm

OTHER

Intraoperative Radiotherapy (Xoft, 20 Gy single dose)

Radiation: Intraoperative Radiotherapy; Procedure: Oncoplastic partial mastectomy

Interventions

Intraoperative Radiotherapy RADIATION

Intraoperative Radiotherapy (Xoft, 20 Gy single dose)

Single-arm

Oncoplastic partial mastectomy PROCEDURE

Breast Conserving Therapy

Single-arm

Eligibility Criteria

• Age: 50 Years+
• Gender Eligibility Details: Biological Female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Saint John's Cancer Institute: lead

Study Sites (1)

Providence Saint John's Hospital

Santa Monica, California, 90404, United States

Location

Study Officials

• Janie L Weng Grumley, MD

  Saint John's Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Margie Petersen Breast Center; Associate Professor of Surgery, Saint John's Cancer Institute

Model Details: Prospective, Non-randomized, Single-arm

Study Record Dates

• First Submitted: March 8, 2022
• First Posted: March 21, 2022
• Study Start: December 16, 2021
• Primary Completion: October 23, 2024
• Study Completion: October 23, 2024
• Last Updated: December 31, 2025

Record last verified: 2025-12

Locations

US (1)