Breast CancerPhase 4EXIBTNCT00742222
Electronic Xoft Intersociety Brachytherapy Trial: Electronic Brachytherapy (EBT) For Treatment of Early Stage Breast Cancer
A Phase 4 study testing Electronic Brachytherapy and Intracavitary accelerated partial breast irradiation in people with Breast Cancer and Carcinoma, run by Xoft, Inc. at 8 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Breast Cancer, Carcinoma, Lumpectomy
- What is being tested?
- Electronic Brachytherapy and Intracavitary accelerated partial breast irradiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 8 sitesUnited States
- Study dates
- May 2008to Jan 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Cancer Institute of Cape Girardeau
Cape Girardeau, Missouri, 63703
Dallas Surgical Group / Northpoint Cancer Center
Dallas, Texas, 75230
AtlantiCare Cancer Care Institute
Galloway, New Jersey, 08205
Beverly Oncology
Montebello, California, 90640
Nazha Cancer Center
Northfield, New Jersey, 08225
Florida Radiation Oncology Group
Orange Park, Florida, 32073
St Elizabeth's and Memorial Cancer Center
Swansea, Illinois, 62226
DCH Cancer Treatment Center
Tuscaloosa, Alabama, 35401
About this study
Official title: Electronic Xoft Intersociety Brachytherapy Trial
PRINCIPAL INVESTIGATORS
- Rakesh Patel, MD- Radiation Oncologist
- Peter Beitsch, MD- Breast Surgeon
Read more
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:
- 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.
- 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
- 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.
- Conditions
- Breast Cancer, Carcinoma, Lumpectomy, Ductal Carcinoma in Situ
- Being tested
- Electronic Brachytherapy, Intracavitary accelerated partial breast irradiation
- Keywords
- Electronic brachytherapy registry, Multi-society registry, Breast cancer registry
- Medical subject headings
- Breast Neoplasms, Carcinoma, Carcinoma, Intraductal, Noninfiltrating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic BrachytherapyRadiation
Also called Radiation therapy, APBI, Intracavitary APBI, Accelerated partial breast irradiation
34 Gy administered over 10 fractions, twice a day times five days. The radiation therapy treatment will be complete upon the 5th day.
Intracavitary accelerated partial breast irradiationRadiation
Also called Xoft Axxent system, electronic brachytherapy
3.4 Gy BID x 5 days
| Study group | Role | What they receive |
|---|---|---|
| single arm, treatment with FDA cleared technology | Other | Patients who have early stage breast cancer, and are candidate for intracavitary accelerated partial breast irradiation may be considered for this study. Receives: Radiation: Electronic Brachytherapy; Radiation: Intracavitary accelerated partial breast irradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Secondary outcomes (1)
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
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2008 (estimated)
- Study startMay 2008
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xoft, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Beitsch, MD, Principal investigator, Dallas Surgical GroupRakesh Patel, MD, Principal investigator, University of Wisconsin Radiation Oncology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00742222
- Sponsor's protocol ID
- TPR-0186
- Acronym
- EXIBT
- Status last verified
- Jul 2015
- First submitted
- 25 Aug 2008
- Last updated
- 17 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Dickler A, Kirk MC, Seif N, Griem K, Dowlatshahi K, Francescatti D, Abrams RA. A dosimetric comparison of MammoSite high-dose-rate brachytherapy and Xoft Axxent electronic brachytherapy. Brachytherapy. 2007 Apr-Jun;6(2):164-8. doi: 10.1016/j.brachy.2007.01.005.
PubMed 17434111Smitt MC, Kirby R. Dose-volume characteristics of a 50-kV electronic brachytherapy source for intracavitary accelerated partial breast irradiation. Brachytherapy. 2007 Jul-Sep;6(3):207-11. doi: 10.1016/j.brachy.2007.03.002.
PubMed 17681242
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electronic Xoft Intersociety Brachytherapy Trial
- ClinicalTrials.gov ID
- NCT00742222
- Acronym / sponsor ID
- EXIBT / TPR-0186
- Conditions
- Breast Cancer, Carcinoma, Lumpectomy, Ductal Carcinoma in Situ
- Keywords
- Electronic brachytherapy registry, Multi-society registry, Breast cancer registry
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Xoft, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 27 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm, treatment with FDA cleared technology | Other | Radiation: Electronic Brachytherapy, Radiation: Intracavitary accelerated partial breast irradiationPatients who have early stage breast cancer, and are candidate for intracavitary accelerated partial breast irradiation may be considered for this study. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient 50 years of age or older
- Estrogen receptor positive
- Tumor size ≤ 3cm
- Tumor histology: invasive carcinoma or DCIS
- Patient is node negative
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electronic BrachytherapyAlso: Radiation therapy, APBI, Intracavitary APBI, Accelerated partial breast irradiation34 Gy administered over 10 fractions, twice a day times five days. The radiation therapy treatment will be complete upon the 5th day. | Radiation | single arm, treatment with FDA cleared technology |
| Intracavitary accelerated partial breast irradiationAlso: Xoft Axxent system, electronic brachytherapy3.4 Gy BID x 5 days | Radiation | single arm, treatment with FDA cleared technology |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2016.
- Background: PubMed 17434111Dickler A, Kirk MC, Seif N, Griem K, Dowlatshahi K, Francescatti D, Abrams RA. A dosimetric comparison of MammoSite high-dose-rate brachytherapy and Xoft Axxent electronic brachytherapy. Brachytherapy. 2007 Apr-Jun;6(2):164-8. doi: 10.1016/j.brachy.2007.01.005.
- Background: PubMed 17681242Smitt MC, Kirby R. Dose-volume characteristics of a 50-kV electronic brachytherapy source for intracavitary accelerated partial breast irradiation. Brachytherapy. 2007 Jul-Sep;6(3):207-11. doi: 10.1016/j.brachy.2007.03.002.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Beitsch, MD principal investigator
Dallas Surgical Group
Rakesh Patel, MD principal investigator
University of Wisconsin Radiation Oncology Department
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Electronic Brachytherapy and Intracavitary accelerated partial breast irradiation in people with Breast Cancer and Carcinoma, run by Xoft, Inc. at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00742222, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2016.