Intraoperative Radiotherapy for Early Stage Breast Cancer (IORT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Hoag Memorial Hospital Presbyterian
Sponsor:
Information provided by (Responsible Party):
Hoag Memorial Hospital Presbyterian
ClinicalTrials.gov Identifier:
NCT01189851
First received: June 21, 2010
Last updated: March 22, 2013
Last verified: March 2013
  Purpose

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: Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Proportion of Participants with Serious Adverse Events and/or Complications as a Measure of the Safety of the Treatment Algorithm [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Cosmesis Scores by Physician and Self-Assessment [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Progression Free Survival in the First Five Years [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: June 2010
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    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.

  Eligibility

Ages Eligible for Study:   48 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01189851

Contacts
Contact: Peter V Chen, MD 949-764-5528 peter.chen@hoag.org

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

No publications provided

Responsible Party: Hoag Memorial Hospital Presbyterian
ClinicalTrials.gov Identifier: NCT01189851     History of Changes
Other Study ID Numbers: IORT
Study First Received: June 21, 2010
Last Updated: March 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Hoag Memorial Hospital Presbyterian:
breast
IORT
electronic brachytherapy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 28, 2014