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Xoft® Intraoperative Radiotherapy (IORT) for Patients With Early-Stage Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04088435
Recruitment Status : Recruiting
First Posted : September 12, 2019
Last Update Posted : September 17, 2019
Information provided by (Responsible Party):
Harriet Eldredge-Hindy, University of Louisville

Brief Summary:
Intraoperative radiotherapy (IORT) is a type of accelerated partial breast irradiation (APBI) in which radiation therapy is delivered to the breast tissue in a single treatment at the time of lumpectomy for breast cancer. The Xoft device (Axxent, Xoft, San Jose, CA) is a device that allows for IORT for breast cancer using kilovoltage (kV) photons. A central goal of this study is to report acute and late toxicities and cosmetic outcomes following breast IORT with the Xoft device in women with early-stage breast cancer treated with lumpectomy. The investigators hypothesize that IORT following lumpectomy will be safe and well tolerated with a lower rate of physician reported acute side effects than traditional whole breast radiation therapy after lumpectomy.

Condition or disease Intervention/treatment
Breast Cancer Breast Cancer, Invasive Ductal Invasive Mammary Carcinoma Breast Cancer Stage I Breast Cancer Stage IIA Radiation: Intraoperative radiotherapy

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: A Prospective Observational Trial of Xoft® Intraoperative Radiotherapy (IORT) as a Component of Breast Conserving Therapy (BCT) in Patients With Early-Stage Breast Cancer
Actual Study Start Date : September 10, 2019
Estimated Primary Completion Date : September 10, 2022
Estimated Study Completion Date : September 10, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Intervention Details:
  • Radiation: Intraoperative radiotherapy
    The IORT component of this treatment is being delivered as per standard clinical practice. 20 Gy in one fraction will be delivered at the time of lumpectomy.
    Other Name: electronic brachytherapy

Primary Outcome Measures :
  1. Percentage of patients with greater than or equal to grade 2 acute radiation toxicities [ Time Frame: within 6 months of radiotherapy ]
    Adverse side effects of radiation grade 2 or higher as per CTCAE version 5.0

Secondary Outcome Measures :
  1. Percentage of patients with greater than or equal to grade 2 late radiation toxicities [ Time Frame: starting three months after radiation and continuing for 5 years ]
    Adverse side effects of radiation grade 2 or higher as per CTCAE version 5.0

  2. Percentage of patients with good or excellent cosmetic outcome as assessed by the Harvard cosmesis scale [ Time Frame: starting immediately after radiation and continuing for 5 years ]
    Breast cosmetic changes following IORT, assessed by the physician

  3. Percentage of patients who are very satisfied or somewhat satisfied by their cosmetic outcome as determined by the Breast-Q patient satisfaction self assessment [ Time Frame: starting immediately after radiation and continuing for 5 years ]
    Patient assessed breast cosmetic changes following IORT

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with invasive breast cancer that are clinically node negative, with tumors 2.5 cm or smaller in size.

Inclusion Criteria:

  • T1 or T2 invasive carcinoma of the breast undergoing breast conserving surgery
  • Clinically lymph node negative and Memorial Sloan Kettering nomogram estimates 20% or less risk of positive sentinel node
  • Tumors 2.5 cm or less in size (clinical preoperative staging)
  • Estrogen receptor positive tumors (≥10%)
  • Her2 negative/not over-expressed
  • Patients 50 years of age or greater

Exclusion Criteria:

  • Prior malignancy not in remission
  • Active collagen vascular disease requiring active cytotoxic or immunotherapy
  • Psychiatric or mental condition which would preclude informed consent
  • Prior thoracic radiation which overlaps with IORT field
  • Pregnant patients
  • Patients <50 years
  • Risk of positive sentinel lymph node >20% based on nomogram estimates
  • Known lymph node metastases (i.e. clinically node positive)
  • Patients with invasive lobular carcinoma
  • Patients with pure DCIS
  • Known multifocal or multicentric tumor
  • Patients requiring neoadjuvant chemotherapy
  • Patients requiring or choosing mastectomy with or without reconstruction
  • Technical contraindications to IORT dose delivery including skin to balloon distance <7 mm
  • Medical contraindication to IORT, radiation or breast conservation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04088435

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United States, Kentucky
James Graham Brown Cancer Center at the University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact: Harriet B Eldredge-Hindy, MD    502-562-4316   
Sponsors and Collaborators
University of Louisville

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Responsible Party: Harriet Eldredge-Hindy, Assistant Professor of Radiation Oncology, University of Louisville Identifier: NCT04088435     History of Changes
Other Study ID Numbers: 19-0448
First Posted: September 12, 2019    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Carcinoma, Ductal, Breast
Neoplasms by Site
Breast Diseases
Skin Diseases
Carcinoma, Ductal
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Ductal, Lobular, and Medullary