Electronic Xoft Intersociety Brachytherapy Trial: Electronic Brachytherapy (EBT) For Treatment of Early Stage Breast Cancer (EXIBT)
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|ClinicalTrials.gov Identifier: NCT00742222|
Recruitment Status : Completed
First Posted : August 27, 2008
Last Update Posted : May 17, 2016
- Rakesh Patel, MD- Radiation Oncologist
- Peter Beitsch, MD- Breast Surgeon
- Multicenter, non-randomized, post market registry of intracavitary accelerated partial breast irradiation in appropriately selected patients.
SAMPLE SIZE AND SITES:
- Approximately 400 patients may be enrolled.
- Up to 100 qualified U.S. sites may participate in this registry.
- Subcutaneous Toxicities - The incidence of signs and symptoms of subcutaneous toxicities will be recorded at the following follow-up visits; at six (6) month, one (1) year, two (2) year, three (3) year, four (4) year, and five (5) year.
- Skin Toxicities - Specific toxicities that can result from radiation therapy will be recorded at each follow-up visit. The Common Terminology Criteria for Adverse Events will be used and to be recorded at each follow-up visits; at one (1) month, six (6) month, one (1) year, two (2) year, three (3) year, four (4) year, and five (5) year.
- Cosmetic Outcome - Cosmetic outcome will be recorded at the following follow-up visits; at one (1) month, six (6) month, one (1) year, two (2) year, three (3) year, four (4) year, and five (5) year. Cosmetic outcome will be assessed and graded in two ways:
- Patient Quality of Life Questionnaire - A Quality of Life Questionnaire (QOL) will be completed at the following visits; at one (1) month, six (6) month, one (1) year, two (2) year, three (3) year, four (4) year, and five (5) year.
- Local-regional Breast Failure - The secondary efficacy endpoint is ipsilateral breast failure at five (5) years.
- Ipsilateral recurrence within the initially treated volume. (Within the tumor bed)
- Ipsilateral recurrence of cancer outside of the initially treated volume. (Elsewhere Failure)
Axillary nodal recurrence
- Survival - to be recorded at each follow-up visit
- Overall Survival
Disease Free Survival
- Device Performance - to be recorded during the balloon applicator placement and during the course of the radiation treatments:
- Ability to deliver treatment
- Axxent System / Balloon Applicator performance
- TREATMENT DEVICE
The device to be used is the electronic brachytherapy system for the treatment of early stage breast cancer with intracavitary accelerated partial breast irradiation. The device manufacturer is Xoft, Incorporated. All Xoft technology cleared by the FDA for the treatment of early stage breast cancer can be used in this post market data collection registry.
Representatives from American Brachytherapy Society (ABS), American Society of Breast Surgeons (ASBS), and American College of Radiation Oncology (ACRO)will oversee study management.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Carcinoma Lumpectomy Ductal Carcinoma in Situ||Radiation: Electronic Brachytherapy Radiation: Intracavitary accelerated partial breast irradiation||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||63 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Electronic Xoft Intersociety Brachytherapy Trial|
|Study Start Date :||May 2008|
|Actual Primary Completion Date :||January 2015|
|Actual Study Completion Date :||January 2015|
single arm, treatment with FDA cleared technology
Patients who have early stage breast cancer, and are candidate for intracavitary accelerated partial breast irradiation may be considered for this study.
Radiation: Electronic Brachytherapy
34 Gy administered over 10 fractions, twice a day times five days. The radiation therapy treatment will be complete upon the 5th day.
Radiation: Intracavitary accelerated partial breast irradiation
3.4 Gy BID x 5 days
- The incidence of signs and symptoms of subcutaneous toxicities will be recorded at the following follow-up visits; six month, one year, two year, three year, four year, and five year. [ Time Frame: 5 years ]
- Local-regional Breast Failure - Ipsilateral breast failure at five years, Including: Ipsilateral recurrence within the initially treated volume, Ipsilateral recurrence of cancer outside of the initially treated volume, and axillary nodal recurrence [ Time Frame: 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): NCT00742222
|United States, Alabama|
|DCH Cancer Treatment Center|
|Tuscaloosa, Alabama, United States, 35401|
|United States, California|
|Montebello, California, United States, 90640|
|United States, Florida|
|Florida Radiation Oncology Group|
|Orange Park, Florida, United States, 32073|
|United States, Illinois|
|St Elizabeth's and Memorial Cancer Center|
|Swansea, Illinois, United States, 62226|
|United States, Missouri|
|Cancer Institute of Cape Girardeau|
|Cape Girardeau, Missouri, United States, 63703|
|United States, New Jersey|
|AtlantiCare Cancer Care Institute|
|Galloway, New Jersey, United States, 08205|
|Nazha Cancer Center|
|Northfield, New Jersey, United States, 08225|
|United States, Texas|
|Dallas Surgical Group / Northpoint Cancer Center|
|Dallas, Texas, United States, 75230|
|Principal Investigator:||Peter Beitsch, MD||Dallas Surgical Group|
|Principal Investigator:||Rakesh Patel, MD||University of Wisconsin Radiation Oncology Department|