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Completed

NCT Number: NCT01988870

IORT (Intra-operative Radiation Therapy) in Early Stage Breast Cancer

The purpose of this study is to evaluate an investigational way to provide radiation therapy to treat breast cancer at the time of surgery.

Traditionally, the recommended treatment for early stage breast cancer is surgery to remove the tumor, followed by whole breast radiation therapy to decrease the chance of recurrence of the cancer. Whole breast radiation involves daily radiation treatments for 4-6 weeks and can be associated with damage to other tissues including the skin. Recent technological advances have made it possible to provide radiation treatment during the breast cancer surgical procedure. This procedure is called intraoperative radiation therapy (IORT). The University of Virginia has a unique IORT system which allows for the inclusion of cutting edge imaging technology into the IORT procedure in order to provide delivery of radiation directly to the needed areas and to avoid radiation to other tissues.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

50 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women 50 years of age of older
  • Patient has elected breast conserving surgical treatment for early-stage breast cancer
  • Patient meets American Society for Therapeutic Radiation Oncology (ASTRO) criteria for a "suitable" or "cautionary" patient
  • Life expectancy of more than 2 years
  • Tumor size 4cm or less
  • Women of childbearing potential must agree to use adequate contraception

Exclusion criteria

  • Male
  • Pregnant or nursing
  • Any contraindication to radiotherapy
  • Breast cancer that involves skin or chest wall, bilateral breast cancer or history of breast cancer in ipsilateral breast
  • Patient meets any of the ASTRO criteria for an "unsuitable" patient
  • Patient requires chemotherapy within two weeks of IORT
  • Breast implants
  • A serious uncontrolled medical disorder
  • Significant history of uncontrolled cardiac disease or CNS disease

Treatment and study plan

Intra-operative Radiation Therapy (IORT)

Radiation

IORT is a form of APBI (accelerated partial breast irradiation) that allows for a high degree of dose homogeneity, exclusion of non-affected structures, and reduction of the volume of breast tissue exposed.

Primary outcomes

  1. IORT (Intra-operative Radiation Therapy) treatment interval

    Time frame: 90 minutes or less

    Evaluation of the time from the acquisition of the initial CT-on-rails until the time at which IORT is complete

  2. Overall incidence of adverse events and major toxicities

    Time frame: Up to 6 months following treatment

Secondary outcomes

  1. IORT treatment parameters

    Time frame: up to 6 hours

    Gather preliminary data on planning time

  2. Cosmetic Outcome

    Time frame: Up to 6 months following treatment

    Digital photographs will be taken and used to assess breast characteristics (i.e. color/pigmentation, size, shape) and evaluated for cosmetic outcomes

  3. Quality of life assessment

    Time frame: Up to 6 months following treatment

    Patients will complete a breast cancer specific quality of life survey

  4. IORT treatment parameters

    Time frame: upto 6 hours

    gather preliminary data on total radiation delivery time

  5. IORT treatment parameters

    Time frame: upto 6 hours

    Gather preliminary data on total procedure time

  6. IORT treatment parameters

    Time frame: upto 6 hours

    Gather preliminary data on dosimetry

Sponsors and collaborators

Lead sponsor

Shayna Showalter, MD

Other

Registry information

Official study title

A Pilot, Single Arm, Study of the Safety and Feasibility of Single-Fraction Intraoperative Radiation Treatment (IORT) With CT-On-Rails-Guided HDR Brachytherapy for the Treatment of Early-Stage Breast Cancer

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Nov 20, 2013
Registry last updated
Nov 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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