IORT Following Breast Conserving Surgery for Early Stage Breast Cancer Registry

November 25, 2024 updated by: Mount Carmel Health System

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

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

168

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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)
Time Frame: 5 years
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
Time Frame: 5 years
Overall Survival
5 years
Late Toxicity
Time Frame: 5 years

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
Time Frame: 3 months

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
Time Frame: 5 yeras
Disease Free Survival
5 yeras

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mount Carmel Health System

Investigators

  • Principal Investigator: Malolan Rajagopalan, MD, 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 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)

November 27, 2024

Last Update Submitted That Met QC Criteria

November 25, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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