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

NCT ID: NCT05289466

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-16

Study Completion Date

2024-10-23

Brief Summary

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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

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Conditions

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IORT-Intra-Operative Radiation Therapy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Prospective, Non-randomized, Single-arm
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single-arm

Intraoperative Radiotherapy (Xoft, 20 Gy single dose)

Group Type OTHER

Intraoperative Radiotherapy

Intervention Type RADIATION

Intraoperative Radiotherapy (Xoft, 20 Gy single dose)

Oncoplastic partial mastectomy

Intervention Type PROCEDURE

Breast Conserving Therapy

Interventions

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Intraoperative Radiotherapy

Intraoperative Radiotherapy (Xoft, 20 Gy single dose)

Intervention Type RADIATION

Oncoplastic partial mastectomy

Breast Conserving Therapy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Saint John's Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Janie Grumley

Director, Margie Petersen Breast Center; Associate Professor of Surgery, Saint John's Cancer Institute

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Janie L Weng Grumley, MD

Role: PRINCIPAL_INVESTIGATOR

Saint John's Cancer Institute

Locations

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Providence Saint John's Hospital

Santa Monica, California, United States

Site Status

Countries

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United States

Other Identifiers

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JWCI OBCS WITH IORT

Identifier Type: -

Identifier Source: org_study_id