IORT Following Breast Conserving Surgery for Early Stage Breast Cancer Registry

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Mount Carmel Health System
Study ID
NCT03536897
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
65 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • IORT — RADIATION
    Intraoperative radiation therapy with INTRABEAM system to a dose of 20 Gy

Study Details

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.

Key Dates

Start date
Feb 27, 2018
Status verified
Nov 2024
Primary completion
Feb 27, 2028
Completion
Feb 27, 2028

Study Design

Enrollment
168 participants (estimated)

Arms

  • Arm: IORT
    All patients will undergo a partial mastectomy with sentinel lymph node biopsy with the goal of achieving a margin-negative resection while maintaining good cosmetic outcome. Immediately following partial mastectomy and frozen section evaluation of the sentinel lymph nodes, IORT is to be delivered. Intraoperative radiation therapy will involve 50 kV xrays to a dose of 20 Gy during breast conserving surgery. After surgery, patients are followed based on the standard schedule determined by their surgeon for 5 years.

Primary Outcome Measure

In-Breast Tumor Recurrence (IBTR) [ Time Frame: 5 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mount Carmel West HospitalColumbusOhio43222
Malolan S Rajagopalan, MD
[email protected]
614-234-5402

Find similar trials in Columbus, OH

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Mount Carmel West Hospital· Columbus, OH

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