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Intraoperative Radiotherapy for Early Stage Breast Cancer (IORT)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Hoag Memorial Hospital Presbyterian Identifier:
First received: June 21, 2010
Last updated: July 13, 2016
Last verified: July 2016
Up to 200 patients with biopsy proven early stage breast cancer selecting Wide Local Excision (WLE) will undergo mammography, ultrasound (of affected breast and ipsilateral axilla) and contrast enhanced-magnetic resonance imaging (CE-MRI) of the affected breast to evaluate the extent of disease.

Condition Intervention
Breast Cancer
Device: Intraoperative Radiotherapy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intraoperative Radiotherapy (IORT) for the Management of Carcinoma of the Breast: Use of Mammography, Ultrasonography,and Contrast-Enhanced Magnetic Resonance Imaging (CE-MRI) to Identify Candidates for IORT

Resource links provided by NLM:

Further study details as provided by Hoag Memorial Hospital Presbyterian:

Primary Outcome Measures:
  • Proportion of Participants Receiving Additional Surgery Because of Positive or Close Margins as a Measure of the Accuracy of Pre-Operative Assessment [ Time Frame: 5 years ]

Secondary Outcome Measures:
  • Proportion of Participants Recommended to Have Additional Whole Breast Radiation Therapy (WBRT) Because of High Risk Features Found on Final Pathology as a Measure of the Accuracy of Pre-Operative Assessment [ Time Frame: 5 years ]
  • Proportion of Participants with Tumor Size Larger than the Entry Criteria Size and/or Positive Lymph Nodes as a Measure of the Accuracy of Pre-Operative Assessment [ Time Frame: 5 years ]
  • Proportion of Participants with Serious Adverse Events and/or Complications as a Measure of the Safety of the Treatment Algorithm [ Time Frame: 5 years ]
  • Cosmesis Scores by Physician and Self-Assessment [ Time Frame: 5 years ]
  • Progression Free Survival in the First Five Years [ Time Frame: 5 years ]

Estimated Enrollment: 200
Study Start Date: June 2010
Estimated Study Completion Date: September 2018
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Treated with Intraoperative Radiation Therapy
Device: Intraoperative Radiotherapy
The Axxent eBx™ System utilizes a miniaturized high dose rate (HDR) X-ray source to apply radiation directly to the cancerous tumor bed and provides brachytherapy when the physician chooses to deliver intracavitary or interstitial radiation to the surgical margins following lumpectomy for breast cancer.
Other Names:
  • 510(k) Number K050843
  • Axxent™ Electronic Brachytherapy System

Detailed Description:
Patients will be deemed eligible for immediate IORT if the invasive cancer lesion is estimated to measure ≤ 3.0 centimeters maximum dimension by mammogram, ultrasound, and CE-MRI and is thought to be resectable with WLE and clear surgical margins, with clinically staged N0M0 disease, minimum age of 48, and histology of invasive ductal or lobular carcinoma of the breast. The lesion size determined by imaging will be compared with lesion size and surgical margin status obtained from the surgical pathology specimen to evaluate the ability of mammography combined with ultrasound and CE-MRI to identify suitable candidates for immediate IORT.

Ages Eligible for Study:   48 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Informed Consent. Each eligible patient must willingly give written consent after being informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential benefits, side effects, risks, and discomforts.
  2. Histology. Patients must have biopsy-proven invasive ductal or lobular carcinoma of the breast.
  3. Female, age ≥ 48 years.
  4. Clinically and/or histologically negative axillary lymph nodes.
  5. No imaging or clinical findings that indicate metastatic disease.
  6. Procedure deemed appropriate based upon factors such as breast size by the treating surgeon and radiation oncologist.

Exclusion Criteria:

  1. Male sex
  2. Age < 48
  3. Non-epithelial breast malignancies such as sarcoma, lymphoma, or metastatic breast cancer
  4. Pregnancy or lactation
  5. Serious psychiatric or addictive disorders
  6. More than one obvious cancer in the same breast as diagnosed by clinical examination, mammography, ultrasonography, and/or CE-MRI.
  7. Bilateral breast cancer at the time of diagnosis, unless agreed upon by the surgeon and radiation oncologist.
  8. Ipsilateral breast with a previous cancer and/or irradiation.
  9. Extensive Intraductal Component (DCIS ≥ 25% of the tumor).
  10. Patients presenting with gross nodal disease considered to be clinically malignant by scanning or proven cytologically or by sentinel node biopsy will be cancelled.
  11. Previous history of malignant disease does not preclude entry if the expectation of relapse-free survival at 10 years is 90% or greater.
  12. Lymphovascular invasion on needle biopsy.
  13. Patients undergoing primary medical treatment (hormones or chemotherapy) as initial treatment with intent to reduce tumor size.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01189851

United States, California
Hoag Memorial Hospital Presbyterian - Cancer Center
Newport Beach, California, United States, 92658
Sponsors and Collaborators
Hoag Memorial Hospital Presbyterian
Principal Investigator: Peter V Chen, MD Hoag Memorial Hospital Presbyterian
  More Information

Responsible Party: Hoag Memorial Hospital Presbyterian Identifier: NCT01189851     History of Changes
Other Study ID Numbers: IORT
Study First Received: June 21, 2010
Last Updated: July 13, 2016

Keywords provided by Hoag Memorial Hospital Presbyterian:
electronic brachytherapy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases processed this record on March 29, 2017