RECRUITING

IORT Following Breast Conserving Surgery for Early Stage Breast Cancer Registry

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2018-02-27
Study Completion:2028-02-27
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03536897

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:65 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Female
  2. * ECOG performance status 0-1
  3. * Age 65 years or older
  4. * cT1 or cT2 (≤3.0 cm)
  5. * Invasive ductal carcinoma histology
  6. * Estrogen receptor positive (ER+)
  7. * Grade 1 or Grade 2
  8. * Clinically negative lymph nodes (cN0) by examination, imaging and/or nodal sampling
  9. * Suitable for breast conserving surgery and radiation therapy
  10. * Patient must be able to provide study-specific informed consent
  1. * Multi-centric cancer not amenable to single lumpectomy
  2. * Prior ipsilateral whole breast radiation
  3. * Known BRCA 1 or BRCA 2 mutation
  4. * Status post neoadjuvant hormonal or chemotherapy
  5. * Invasive lobular histology
  6. * Pure ductal carcinoma in situ (DCIS)
  7. * Grade 3
  8. * Diffuse suspicious microcalcifications

Contacts and Locations

Study Contact

Lynn Shaffer, PhD
CONTACT
614-234-3625
Lynn.Shaffer@mchs.com

Principal Investigator

Malolan Rajagopalan, MD
PRINCIPAL_INVESTIGATOR
Mount Carmel Health System

Study Locations (Sites)

Mount Carmel West Hospital
Columbus, Ohio, 43222
United States

Collaborators and Investigators

Sponsor: Mount Carmel Health System

  • Malolan Rajagopalan, MD, PRINCIPAL_INVESTIGATOR, Mount Carmel Health System

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-02-27
Study Completion Date2028-02-27

Study Record Updates

Study Start Date2018-02-27
Study Completion Date2028-02-27

Terms related to this study

Keywords Provided by Researchers

  • breast cancer
  • invasive ductal carcinoma
  • intraoperative radiation therapy
  • iort

Additional Relevant MeSH Terms

  • Breast Cancer