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Recruiting NCT03536897

IORT Following Breast Conserving Surgery for Early Stage Breast Cancer Registry

— Observational Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: IORT.
Who it may be relevant to
Registry conditions: Breast Cancer. Basic parameters: from 65 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • In-Breast Tumor Recurrence (IBTR) [Time frame: 5 years]
Secondary outcome measures (4)
  • 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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Mount Carmel West Hospital — Columbus

Identifiers

NCT: NCT03536897 · 180212-1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗