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RecruitingObservational

Intraoperative Radiation Therapy (IORT) Following Breast Conserving Surgery for Early Stage Breast Cancer Registry

NCT ID: NCT03536897Sponsor: Mount Carmel Health SystemLast updated: 2024-11-27

Summary

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.

Arms & interventions

  • RadiationIORT

    Intraoperative radiation therapy with INTRABEAM system to a dose of 20 Gy

Outcome measures

Primary

  • In-Breast Tumor Recurrence (IBTR)

    Ipsilateral In-Breast Tumor Recurrence (IBTR): defined as biopsy-proved invasive or in situ breast cancer (except LCIS) in the ipsilateral breast.

    Time frame: 5 years

Secondary

  • Late Toxicity

    Time frame: 5 years

  • Acute Toxicity

    Time frame: 3 months

  • Disease Free Survival

    Time frame: 5 yeras

  • Overall Survival

    Time frame: 5 years

Eligibility criteria

Sex: FemaleAge: 65 Years and olderHealthy volunteers: No
Inclusion Criteria: * Female * ECOG performance status 0-1 * Age 65 years or older * cT1 or cT2 (≤3.0 cm) * Invasive ductal carcinoma histology * Estrogen receptor positive (ER+) * Grade 1 or Grade 2 * Clinically negative lymph nodes (cN0) by examination, imaging and/or nodal sampling * Suitable for breast conserving surgery and radiation therapy * Patient must be able to provide study-specific informed consent Exclusion Criteria: * Multi-centric cancer not amenable to single lumpectomy * Prior ipsilateral whole breast radiation * Known BRCA 1 or BRCA 2 mutation * Status post neoadjuvant hormonal or chemotherapy * Invasive lobular histology * Pure ductal carcinoma in situ (DCIS) * Grade 3 * Diffuse suspicious microcalcifications

Study locations (1)

Mount Carmel West Hospital

Columbus, Ohio, 43222

Recruiting
Malolan S Rajagopalan, MD · Contact
614-234-5402malolan.rajagopalan@mchs.com
IORT Following Breast Conserving Surgery for Early Stage Breast Cancer Registry | Cancerify