Recruiting

IORT

Sponsor:

Mount Carmel Health System

Code:

NCT03536897

Conditions

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 65+

Healthy Volunteers: Not accepted

Interventions

IORT

Study Details

Brief 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.

Conditions

Breast Cancer

Study ID

NCT03536897

Start date

Feb 27, 2018

Status verified date

Nov, 2024

Completion date

Feb 27, 2028

Anticipated

Primary completion date

Feb 27, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 65+

Healthy Volunteers: Not accepted

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 Design

Enrollment

168 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

IORT

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Lynn Shaffer, PhD

614-234-3625Lynn.Shaffer@mchs.com

Locations

Mount Carmel West Hospital

Recruiting

Columbus, Ohio, United States, 43222

Contacts

Malolan S Rajagopalan, MD

614-234-5402malolan.rajagopalan@mchs.com

More Information

Sponsor

Mount Carmel Health System

Last update posted

Nov 27, 2024

Last verified

Nov, 2024

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mount Carmel Health System on 2024-11-27.