Registry for Intra-Operative Radiotherapy During Breast Conserving Surgery

This study is a registry for women with early-stage breast cancer who are receiving Intraoperative Radiation Therapy (IORT) during breast-conserving surgery. IORT involves a single dose of radiation (50kV X-rays to a dose of 20 Gy) given during surgery. The purpose is to track the long-term effects of this treatment, including any complications, if the cancer comes back (recurrence), and how long patients live without the disease or overall. You might be able to join if you have early-stage breast cancer (Tis, T1, or T2, N0, M0), the cancer is in one spot (unifocal), and your medical team recommends breast-conserving surgery. The study aims to see how effective and safe IORT is over time, with success measured by whether the disease recurs after 5 years. The current recruitment status is unclear.

Study design
This is an observational study, meaning researchers will collect information about your treatment and health outcomes. It plans to include 1000 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your health will be tracked to see if the disease recurs, with measurements taken at 5 years.

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NCT04603209

Registry for Intra-Operative Radiotherapy During Breast Conserving Surgery in Patients With Early Stage Breast Cancer

Recruiting
Not specifiedAges 18+Observational
Saint John's Cancer Institute
~1,000 participants
Updated 2024-04-16 on ClinicalTrials.gov
What's tested:Intraoperative Radiation Therapy (IORT)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Disease Recurrence
Measured over 5 years
Early-stage Breast Cancer
Breast Carcinoma in Situ
Breast Neoplasms
1 sites across 1 states
California1
  • Janie Grumley, MD · PRINCIPAL_INVESTIGATOR · John Wayne Cancer Institute, Providence Saint John's Health Center

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Eligibility criteria

Inclusion

Clinical stage Tis, T1, or T2(≤ 3cm), N0, M0 (AJCC Classification)
Unifocal Disease
Candidate for breast-conserving surgery
Recommended treatment by multidisciplinary team

Exclusion

Clinical stage T3-4, N1-3, M1
Multifocal disease
  • Disease Recurrence5 years

    Presence of recurrent tumor in ipsilateral breast or distant site