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

NCT01988870 | Completed DMC

• 1 other identifier: 17091
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

• IORT (Intra-operative Radiation Therapy) treatment interval

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

  90 minutes or less

• Overall incidence of adverse events and major toxicities

  Up to 6 months following treatment

Secondary Outcomes (6)

• IORT treatment parameters

  up to 6 hours

• Cosmetic Outcome

  Up to 6 months following treatment

• Quality of life assessment

  Up to 6 months following treatment

• IORT treatment parameters

  upto 6 hours

• IORT treatment parameters

  upto 6 hours

Study Arms (1)

Intra-operative Radiation Therapy (IORT)

EXPERIMENTAL

Following breast conserving surgery, a CT-based plan will be prepared to deliver highly conformal IORT and the treatment will be administered.

Radiation: Intra-operative Radiation Therapy (IORT)

Interventions

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.

Intra-operative Radiation Therapy (IORT)

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shayna Showalter, MD: lead

Study Sites (1)

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Shayna Showalter, MD

  University of Virginia

  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 INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 13, 2013
• First Posted: November 20, 2013
• Study Start: December 1, 2013
• Primary Completion: April 1, 2015
• Study Completion: November 1, 2015
• Last Updated: November 22, 2016

Record last verified: 2016-11

Locations

US (1)