Clinical trial NCT01988870: IORT (Intra-operative Radiation Therapy) in Early Stage Breast Cancer
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2013-11-20
Enrollment: 28
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: IORT (Intra-operative Radiation Therapy) treatment interval
timeFrame: 90 minutes or less
measure: Overall incidence of adverse events and major toxicities
timeFrame: Up to 6 months following treatment
Secondary outcomes:
measure: IORT treatment parameters
timeFrame: up to 6 hours
measure: Cosmetic Outcome
timeFrame: Up to 6 months following treatment
measure: Quality of life assessment
timeFrame: Up to 6 months following treatment
measure: IORT treatment parameters
timeFrame: upto 6 hours
measure: IORT treatment parameters
timeFrame: upto 6 hours
measure: IORT treatment parameters
timeFrame: upto 6 hours
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
Study officials:
affiliation: University of Virginia
name: Shayna Showalter, MD
role: PRINCIPAL_INVESTIGATOR
References: