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

Not Applicable

Recruiting

• Conditions: IORT-Intra-Operative Radiation Therapy
• Interventions: Radiation: Intraoperative Radiotherapy; Procedure: Oncoplastic partial mastectomy

• Registration Number: NCT05289466
• Lead Sponsor: Saint John's Cancer Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-16
• Study First Submitted: 2022-03-08
• Study First Submitted QC: 2022-03-18
• Study First Posted: 2022-03-21
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-10
• Last Update Posted: 2023-04-11
• Primary Completion: 2026-02
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single-arm	Oncoplastic partial mastectomy	Intraoperative Radiotherapy (Xoft, 20 Gy single dose)
Single-arm	Intraoperative Radiotherapy	Intraoperative Radiotherapy (Xoft, 20 Gy single dose)

Primary Outcome Measures

Name	Time	Method
Cosmetic Outcomes as evaluated using BREAST-Q questionnaire as a measure of patient-reported ratings.	5 years	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.
Cosmetic Outcomes as evaluated using the Harvard Breast Cosmesis Grading Scale as a measure of patient-reported ratings.	5 years	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.
Cosmetic Outcomes as evaluated by clinician completion of the Harvard Breast Cosmesis Grading Scale	5 years	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.
Perioperative complications as documented using Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 (CTCAE.v5) scoring system.	5 years	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.

Secondary Outcome Measures

Name	Time	Method
Effectiveness of partial mastectomy with IORT, measured by local recurrence.	5 years	Tumor recurrence data will be considered a dichotomous outcome, not a time-to-event outcome.
Effectiveness of partial mastectomy with IORT, measured by regional recurrence.	5 years	Tumor recurrence data will be considered a dichotomous outcome, not a time-to-event outcome.
Effectiveness of partial mastectomy with IORT, measured by distant recurrence.	5 years	Tumor recurrence data will be considered a dichotomous outcome, not a time-to-event outcome.
Effectiveness of partial mastectomy with IORT, measured by mastectomy rate.	5 years	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.
Effectiveness of partial mastectomy with IORT, measured by disease-specific survival.	5 years	Disease specific survival will be measured based on dates and causes of death.
Effectiveness of partial mastectomy with IORT, measured by overall survival	5 years	Overall survival will be measured based on dates and causes of death.

Trial Locations

Locations (1)

Providence Saint John's Hospital; 🇺🇸 Santa Monica, California, United States