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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.

NCT05289466 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2025-12-31

No results posted yet for this study

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

Interventions

RADIATION

Intraoperative Radiotherapy

Intraoperative Radiotherapy (Xoft, 20 Gy single dose)

PROCEDURE

Oncoplastic partial mastectomy

Breast Conserving Therapy

Sponsors & Collaborators

  • Saint John's Cancer Institute

    lead OTHER

Principal Investigators

  • Janie L Weng Grumley, MD · Saint John's Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-16
Primary Completion
2024-10-23
Completion
2024-10-23
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05289466 on ClinicalTrials.gov