Electronic Xoft Intersociety Brachytherapy Trial: Electronic Brachytherapy (EBT) For Treatment of Early Stage Breast Cancer
- Conditions
- CarcinomaBreast CancerDuctal Carcinoma in SituLumpectomy
- Interventions
- Radiation: Electronic BrachytherapyRadiation: Intracavitary accelerated partial breast irradiation
- Registration Number
- NCT00742222
- Lead Sponsor
- Xoft, Inc.
- Brief Summary
PRINCIPAL INVESTIGATORS
* Rakesh Patel, MD- Radiation Oncologist
* Peter Beitsch, MD- Breast Surgeon
REGISTRY DESIGN
* 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.
ENDPOINTS:
1. PRIMARY ENDPOINTS
* 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.
2. SECONDARY ENDPOINTS
* Local-regional Breast Failure - The secondary efficacy endpoint is ipsilateral breast failure at five (5) years.
This includes:
* 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
3. 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.
OVERSIGHT COMMITTEE
Representatives from American Brachytherapy Society (ABS), American Society of Breast Surgeons (ASBS), and American College of Radiation Oncology (ACRO)will oversee study management.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 63
- Patient 50 years of age or older
- Estrogen receptor positive
- Tumor size ≤ 3cm
- Tumor histology: invasive carcinoma or DCIS
- Patient is node negative
- Patient has negative surgical margins (NSABP definition, no tumor on ink) after final surgery
- Life expectancy > 5 years
- Pregnancy or breast-feeding. (If appropriate, patient must use birth control during the registry.) The need for a pregnancy test is based on the physician's standard practice and will be performed according to the physician's standard of care.
- Collagen Vascular Disease
- Scleroderma
- Systemic sclerosis
- Active lupus
- Infiltrating lobular histology
- Previous ipsilateral radiation to the thorax or breast
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description single arm, treatment with FDA cleared technology Electronic Brachytherapy Patients who have early stage breast cancer, and are candidate for intracavitary accelerated partial breast irradiation may be considered for this study. single arm, treatment with FDA cleared technology Intracavitary accelerated partial breast irradiation Patients who have early stage breast cancer, and are candidate for intracavitary accelerated partial breast irradiation may be considered for this study.
- Primary Outcome Measures
Name Time Method 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. 5 years
- Secondary Outcome Measures
Name Time Method 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 5 years
Trial Locations
- Locations (8)
Florida Radiation Oncology Group
🇺🇸Orange Park, Florida, United States
Nazha Cancer Center
🇺🇸Northfield, New Jersey, United States
DCH Cancer Treatment Center
🇺🇸Tuscaloosa, Alabama, United States
Beverly Oncology
🇺🇸Montebello, California, United States
St Elizabeth's and Memorial Cancer Center
🇺🇸Swansea, Illinois, United States
Cancer Institute of Cape Girardeau
🇺🇸Cape Girardeau, Missouri, United States
AtlantiCare Cancer Care Institute
🇺🇸Galloway, New Jersey, United States
Dallas Surgical Group / Northpoint Cancer Center
🇺🇸Dallas, Texas, United States