IORT Following Breast Conserving Surgery for Early Stage Breast Cancer Registry

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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Radiation: IORT

• Study Type: Observational
• Enrollment (Estimated): 168

Contacts and Locations

• Study Contact: Name: Lynn Shaffer, PhD; Phone Number: 614-234-3625; Email: Lynn.Shaffer@mchs.com

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43222
      • Recruiting
      • Mount Carmel West Hospital
      • Contact: Malolan S Rajagopalan, MD; Phone Number: 614-234-5402; Email: malolan.rajagopalan@mchs.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Women aged 65 and above with early stage breast cancer, ER+, low to intermediate grade invasive ductal carcinoma of the breast amenable to breast conserving surgery and radiation therapy.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival	Overall Survival	5 years
Late Toxicity	Degree of late radiation toxicity will be scored based upon RTOG/EORTC (Radiation Therapy Oncology Group/Eastern Oncology Radiation Therapy Consortium) late radiation morbidity scoring schema for subcutaneous tissue as well as cosmetic result. The RTOG/EORTC late radiation morbidity scoring schema on subcutaneous tissue is as follows: GRADE 1: Slight induration (fibrosis) and loss of subcutaneous fat; GRADE 2: Moderate fibrosis but asymptomatic; slight field contracture; <10% linear reduction; GRADE 3: Severe induration and loss of subcutaneous tissue; field contracture > 10% linear measurement; GRADE 4: Necrosis	5 years
Acute Toxicity	Acute radiation toxicity will be scored at the first follow-up visit after IORT (4-6 weeks after treatment). Radiation dermatitis will be scored based upon CTCAE (Common Terminology Criteria for Adverse Events) v4.03 scale as follows: GRADE 1: Faint erythema or dry desquamation; GRADE 2: Moderate to brisk erythema; patchy moist desquamation, mostly confined to skin folds and creases; moderate edema; GRADE 3: Moist desquamation in areas other than skin folds and creases; bleeding induced by minor trauma or abrasion; GRADE 4: Life threatening consequences; skin necrosis or ulceration of full thickness dermis; spontaneous bleeding from involved site; skin graft indicated Other acute toxicity will also be scored per the CTCAE v4.03 scale and will be rated on the relation to radiation therapy (definitely related, probably related, possibly related, unlikely related, unrelated)	3 months
Disease Free Survival	Disease Free Survival	5 yeras

Collaborators and Investigators

• Sponsor: Mount Carmel Health System
• Investigators: Principal Investigator: Malolan Rajagopalan, MD, Mount Carmel Health System

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2018
• Primary Completion (Estimated): February 27, 2028
• Study Completion (Estimated): February 27, 2028

Study Registration Dates

• First Submitted: May 7, 2018
• First Submitted That Met QC Criteria: May 23, 2018
• First Posted (Actual): May 25, 2018

Study Record Updates

• Last Update Posted (Actual): August 16, 2023
• Last Update Submitted That Met QC Criteria: August 15, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: breast cancer; intraoperative radiation therapy; invasive ductal carcinoma; iort
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 180212-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No