IORT Following Breast Conserving Surgery for Early Stage Breast Cancer Registry

StatusActive, Not Recruiting
PhaseNot specified
Started

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Record History

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  1. Minor Enrollment closed, study ongoing
    • Eligibility criteria expanded, about 18 words
    • Secondary endpoints: details revised at 2 of 4 entries
    • Site details revised
  2. Minor 4 versions Re-verified since Feb 24, 2020, no change to tracked fieldsv2-v5
  3. Minor Study First Submitted
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a prospective, registry trial which will enroll women aged 65 and above with early stage, low risk breast cancer who will be treated with partial mastectomy and intraoperative radiation therapy (IORT). The primary aim is to determine the 5-year risk of in-breast tumor recurrence. Secondary aims include identification of acute- and late-toxicity, cosmetic result, disease-free survival and overall survival.
Trial Details
NCT Number NCT03536897
Lead Sponsor Mount Carmel Health System
Conditions
(from sponsor)
Breast Cancer
Related terms Breast Neoplasms
Enrollment 168 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov