500 Boylston Street, Boston, MA 02116 617-419-4700
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- 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.
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.
- Ipsilateral recurrence within the initially treated volume. (Within the tumor
- Ipsilateral recurrence of cancer outside of the initially treated volume.
- 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
Representatives from American Brachytherapy Society (ABS), American Society of Breast
Surgeons (ASBS), and American College of Radiation Oncology (ACRO)will oversee study
Active, not recruiting
Ages:50 and older
Inclusion Criteria: - 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 Exclusion Criteria: - 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
Sponsor: Xoft, Inc.
Phase: Phase 4
Trial ID: NCT00742222
Not Accepting Healthy Volunteers