Intraoperative Radiotherapy for Early Stage Breast Cancer (IORT)
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|ClinicalTrials.gov Identifier: NCT01189851|
Recruitment Status : Active, not recruiting
First Posted : August 27, 2010
Last Update Posted : February 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Device: Intraoperative Radiotherapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||June 2010|
|Estimated Primary Completion Date :||September 2020|
|Estimated Study Completion Date :||September 2021|
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.
- Proportion of Participants Receiving Additional Surgery Because of Positive or Close Margins as a Measure of the Accuracy of Pre-Operative Assessment [ Time Frame: 10 years ]Invasive cancer margins <1 mm and/or non-invasive cancer margins < 2 mm are considered close or positive. Approximately 15% of patients treated with IORT have close or positive margins on pathologic assessment following IORT therapy and are recommended for additional therapy including re-excision, whole breast radiation or both.
- 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 ]Patients treated with IORT that have high risk features on final pathologic exam, including close/positive margins, tumor size >30 mm, positive lymph nodes and lympho-vascular invasion (LVI) are recommended for additional therapy including re-excision, whole breast radiation or both.
- 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 ]Both tumor size and lymph node status are estimated prior to surgery using mammography, ultrasound and MRI (unless excluded for medical reasons). Patients with estimated tumor spans > 30 mm or positive lymph nodes are excluded from IORT.
- Proportion of Participants with Serious Adverse Events and/or Complications as a Measure of the Safety of the Treatment Algorithm [ Time Frame: 5 years ]We will be monitoring acute side effects attributed directly to IORT. These includ erythemia, hyperpigmentation, fibrosis, seromas, infection and wound breakdown.
- Cosmesis Scores by Physician and Self-Assessment [ Time Frame: 5 years ]The first 213 IORT patients treated will be asked to fill out a yearly cosmesis assessment. Patients filled out these assessments for an average of 2-3 years.
- Progression Free Survival in the First Five Years [ Time Frame: 5 years ]We will follow progression free survival for 5 years
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01189851
|United States, California|
|Hoag Memorial Hospital Presbyterian - Cancer Center|
|Newport Beach, California, United States, 92658|
|Principal Investigator:||Peter V Chen, MD||Hoag Memorial Hospital Presbyterian|