Lumpectomy Followed By Intraoperative Electron Radiation Therapy (IOERT)
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|ClinicalTrials.gov Identifier: NCT01960803|
Recruitment Status : Completed
First Posted : October 11, 2013
Last Update Posted : July 24, 2019
|Condition or disease||Intervention/treatment||Phase|
|Invasive Ductal Breast Cancer Carcinoma Breast Stage I||Radiation: Intraoperative Electron Radiotherapy||Not Applicable|
Evaluate local and distant recurrence rates and cosmetic outcomes. Both clinical evaluation of cosmetic outcome by the Surgeon, and subjective impression of cosmetic outcome by the patient, are evaluated using questionnaire.
Local recurrence is evaluated under the same imaging protocol used for Whole breast radiation.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Lumpectomy Followed By Intraoperative Electron Radiation Therapy (IOERT) As A Single, Full Dose Partial Breast Irradiation For Early Stage, Node Negative, Invasive Breast Cancer|
|Study Start Date :||May 1, 2013|
|Actual Primary Completion Date :||July 1, 2019|
|Actual Study Completion Date :||July 1, 2019|
Experimental: IOERT arm
Intraoperative electron radiotherapy (IOERT) is delivered after completion of the lumpectomy and sentinel node procedure. IOERT is performed on a mobile self-shielded magnetron-driven X-band linear accelerator specifically developed for use in the operating room. This machine produces megavoltage electron beams of energy ranging between 4 and 12 MeV. The radiation is delivered from the device to the tumor bed through an attached applicator. A single dose of 21 Gy calculated to the 90% depth posterior to the tumor bed will be administered and will last approximately 2.5 minutes.
Radiation: Intraoperative Electron Radiotherapy
Intraoperative Electron Radiotherapy (IOERT) is delivered after completion of the lumpectomy and sentinel node procedure.
- To evaluate change over time on the incidence of local and distance recurrence rates. [ Time Frame: 1 month, 3 months, 6 months, 12 months, and then annually for 10 years. ]Subjects will be followed for recurrence rates at one month, three months, six months, twelve months, and then annually for up to 10 years. This will include: history and physical exam, as well as radiographic images at physician discretion and per study protocol.
- To evaluate changes in the short-term and long-term side effects related to IOERT [ Time Frame: 1 month, 3 months, 6 months, 12 months, and then annually for 10 years. ]Assessment of the overall patient satisfaction related to the therapy and cosmetic outcome. Cosmesis will be scored by both the physician and patient using the RTOG cosmesis rating system at one month, three months, six months, twelve months, and 24 months. The secondary outcome measure will only take place in the first two years of the 10 year time frame for patient follow up. After 24 month evaluations, patients will only be followed for incidence of local and distance recurrence rates.
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): NCT01960803
|United States, Illinois|
|Advocate Christ Medical Center|
|Oak Lawn, Illinois, United States, 60453|
|Principal Investigator:||Barbara Krueger, MD FACS||Advocate Health Care - Advocate Christ Medical Center|