Intraoperative Radiation Therapy in Early Stage Breast Cancer (IORTBreast)
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|ClinicalTrials.gov Identifier: NCT02266602|
Recruitment Status : Completed
First Posted : October 17, 2014
Last Update Posted : March 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Radiation: Intraoperative Radiation Therapy||Not Applicable|
The purpose of this clinical study is to assess the effectiveness of IORT, using an electronic brachytherapy system, in patients with limited-volume in situ and early stage breast cancer, with endpoints of:
- Local recurrence in early stage breast cancer patients treated with IORT.
- Toxicity associated with IORT.
- Long-term disease-specific and overall survival
- Cosmetic results using the Harvard Scale at start and follow-up periods in patients treated with IORT.
- Quality of life in patients treated with IORT.
- Health care costs associated with IORT.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||500 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Intra-Operative Radiotherapy After Breast Conserving Therapy in the Treatment of in Situ and Early Stage Breast Cancer|
|Study Start Date :||February 2012|
|Actual Primary Completion Date :||July 30, 2018|
|Actual Study Completion Date :||July 31, 2018|
Patients treated with intraoperative radiation therapy at the time of partial mastectomy.
Radiation: Intraoperative Radiation Therapy
Intraoperative radiation therapy at the time of partial mastectomy in early stage breast cancer
Other Name: IORT
- Local Disease Relapse [ Time Frame: 10 years ]Patients are evaluated clinically at 3 months, 6 months, 9 months, 1 year and every six months for 10 years for disease recurrence. In addition to clinical exams, yearly mammograms and other imaging studies as deemed appropriate will be obtained to rule out recurrent disease. Recurrent disease will be defined as cancer recurrence within 2cm of site of original tumor bed (marked by surgical clips).
- Disease specific and overall survival [ Time Frame: 10 years ]Disease specific and overall survival will be obtained for all patients in the study.
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): NCT02266602
|United States, Washington|
|Virginia Mason Medical Center|
|Seattle, Washington, United States, 98101|
|Principal Investigator:||Janie Grumley, MD||Virginia Mason Medical Center|