NCT02370797

Brief Summary

The purpose of this study is to determine if lumpectomy followed by Intraoperative Electron Radiation Therapy (IOeRT) as a single, full dose partial breast irradiation will have as good or better results in preventing recurrence of local breast cancer, cosmetic appearance and early and late side effects.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
36mo left

Started Feb 2015

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress79%
Feb 2015May 2029

Study Start

First participant enrolled

February 1, 2015

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

February 3, 2015

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 25, 2015

Completed
13.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2029

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2029

Last Updated

January 28, 2025

Status Verified

January 1, 2025

Enrollment Period

14 years

First QC Date

February 3, 2015

Last Update Submit

January 27, 2025

Conditions

Breast Cancer

Keywords

IOERTRadiationSingle fractionLumpectomyRadiation therapyAvera

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients who are free of breast cancer.

    Patients will be followed by standard of care breast imaging along with appointments with breast surgeon, radiation oncologist and medical oncologist if indicated.

    10 years

Secondary Outcomes (1)

  • Local recurrance rate with acute toxicity and cosmetic evaluations

    10 years

Study Arms (1)

Single Fraction IOeRT

EXPERIMENTAL

A single dose of 21 Gy calculated such that the 90% isodose line encompasses the posterior of the tumor bed will be administered.

Radiation: Single Fraction IOeRT

Interventions

Single Fraction IOeRTRADIATION

A single dose of 21 Gy calculated such that the 90% isodose line encompasses the posterior of the tumor bed will be administered.

Also known as: Intra-Operative electron radiation therapy
Single Fraction IOeRT

Eligibility Criteria

Age60 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient agrees to breast conservation therapy (segmental resection, partial mastectomy, and radiation therapy) as the treatment for their breast cancer
  • Patient agrees to evaluation of the axilla with sentinel lymph node biopsy
  • Post-menopausal women age \> 60, defined as women who have experienced no menstrual period in the past 12 months.
  • BRCA1 and 2 gene mutation negative, if tested. \[genetic testing is NOT required based upon personal or family history\]
  • Unifocal (unicentric), invasive ductal carcinoma or favorable sub-types (mucinous, tubular, colloid) \< 2.0 cm in diameter, primary T-stage of T1 (AJCC criteria)
  • Grade 1, 2 acceptable
  • Associated LCIS is allowed
  • Estrogen receptor (ER) status of positive
  • Negative margins at ink on gross pathologic examination
  • Patient is node-negative, defined as N0 (i-) or N0 (i+)
  • Patient must be deemed functionally and mentally competent to understand and sign the informed consent

You may not qualify if:

  • Prior breast malignancy or other malignancy if metastatic, or with expected survival of \< 5 years
  • Immuno-compromised status
  • Pregnancy
  • Women with an active connective tissue disorder (i.e. scleroderma, lupus and others)
  • Breast cancer that involves the skin or chest wall, locally advanced breast cancer
  • Pure DCIS, all grades
  • Invasive lobular carcinoma
  • Evidence of lymphovascular invasion (LVI)
  • Invasive carcinoma with extensive intraductal component (EIC)
  • Neoadjuvant chemotherapy indicated
  • Patients with 1 or more positive lymph node determined during surgery with sentinel node and/or axillary dissection
  • Not eligible for breast conserving management, i.e., prior whole breast radiation therapy
  • Estrogen receptor negative
  • Her2 positive
  • Grade 3

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Avera Cancer Institute

Sioux Falls, South Dakota, 57105, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Kyle Arneson, MD

    Avera Cancer Insitute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2015

First Posted

February 25, 2015

Study Start

February 1, 2015

Primary Completion (Estimated)

February 1, 2029

Study Completion (Estimated)

May 1, 2029

Last Updated

January 28, 2025

Record last verified: 2025-01

Locations

US(1)