Breast CancerNCT02040493
Intra-Operative Radiation Therapy Immediately Following Resection of Early Stage Breast Cancer
A study testing Intra-operative radiation therapy (IORT) in people with Breast Cancer, run by Xoft, Inc. at 7 sites in United States.
Trial summary
This is a physician sponsored multi-center, non-randomized, prospectively enrolling data collection study of patients with early stage breast cancer treated with electronic brachytherapy at the time of surgical resection of the cancer in the operating room. Read more about this study
- Who is it for?
- Ages 45 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Intra-operative radiation therapy (IORT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 7 sitesUnited States
- Study dates
- Sep 2008to 4 Oct 2016
- Phase
- Interventional
- 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 45 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
General Inclusion Criteria
- Age > 45 years
- Tumor with Tis, T1, T2 (≤ 3cm), N0, M0 - (AJC Classification)
- Invasive ductal carcinoma and / or DCIS
Intra-operative Inclusion Criteria
- Negative sentinel node assessment
- Balloon surface to skin distance of at least 1-cm and adequate conformance via Intra-operative ultrasound
Post procedure Inclusion Criteria 1. Negative microscopic surgical margins**
**If positive margins patient my undergo re-excision and/or additional radiation at the treating physician's discretion but the patient will be excluded from the protocol data analysis.
General Exclusion Criteria
- Scleroderma, systemic sclerosis and active lupus
- Participation in an investigational drug or device study
- Previous ipsilateral radiation to the thorax or breast
Intra-operative Exclusion Criteria
- Intra-operative positive sentinel lymph node biopsy
- Inadequate conformance (greater than 10% of PTV encompassed by fluid or air on physician assessment of intraOp ultrasound image)
- Skin spacing less than 1-cm via intraOp ultrasound.
- A cavity size that is not appropriate for a 40 -70 cc balloon.
- Patient becomes unstable and physician determines patient is not a good candidate at time of lumpectomy.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Cancer Treatment Services Arizona
Casa Grande, Arizona, 85122
Parkridge
Chattanooga, Tennessee, 37404
Little Company of Mary Hospital
Evergreen Park, Illinois, 60805
Exeter Hospital
Exeter, New Hampshire, 03833
Long Beach Memorial Medical Center
Long Beach, California, 90806
Diablo Valley Oncology Hematology
Pleasant Hill, California, 94523
Rockford Memorial Hospital
Rockford, Illinois, 61103
About this study
Official title: Intra-Operative Radiation Therapy (IORT) Treatment Immediately Following Resection of Early Stage Breast Cancer
This is a physician sponsored multi-center, non-randomized, prospectively enrolling data collection study of patients with early stage breast cancer treated with electronic brachytherapy at the time of surgical resection of the cancer in the operating room. The radiation therapy treatments will be administered with electronic brachytherapy using the FDA cleared Xoft Axxent System.
Read the detailed description
Breast Conserving Therapy (BCT) is a standard treatment option for patients with stage I or II breast cancer. Breast conserving therapy consists of surgical removal of the tumor with negative margins, axillary lymph node dissection or sentinel node biopsy and radiation therapy. Several studies have shown BCT to be comparable to mastectomy in terms of overall and disease free survival for patients. The major advantage to BCT over mastectomy is breast preservation and reduced psychological trauma to the patient. The major disadvantage to BCT is prolonged time of treatment. The whole breast radiation portion of BCT can add 7 weeks to the treatment time. This additional treatment time can be a detriment to women who logistically may not be able to meet the demands of daily irradiation for 6-7 weeks. A new form of treatment, breast brachytherapy, was developed to decrease the treatment time required for breast irradiation. This treatment uses the Xoft Axxent system to administer intra-operative breast brachytherapy in one treatment, at the time of lumpectomy in the operating room.
This study has been designed to assess local recurrence, serious adverse events, adverse events and their severity, and cosmesis following intra-operative radiation therapy (IORT) using the Xoft Axxent System and balloon applicators. The study device is FDA cleared. The purpose of this clinical study is to compile data on the treatment of patients using the Xoft Axxent System for the delivery of radiation therapy in the intra-operative setting as part of breast conserving therapy in women with resected, early stage breast cancer.
- Conditions
- Breast Cancer
- Being tested
- Intra-operative radiation therapy (IORT)
- Keywords
- breast cancer, IORT, brachytherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-operative radiation therapy (IORT)Radiation
All subjects will receive IORT at the time of lumpectomy.
| Study group | Role | What they receive |
|---|---|---|
| Intra-operative radiation therapy (IORT) | Experimental | IORT Receives: Radiation: Intra-operative radiation therapy (IORT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local recurrence in patients treated with intra-operative electronic brachytherapy for early stage breast cancer.
Local recurrence will be assessed at one (1) month, six (6) months, one (1) year, two (2) years, three (3) years, four (4) years, and five (5) years post IORT.
Measured: 5 Years
Occurence of serious adverse events during and following IORT treatment.
Serious adverse events are defined as a serious injury or illness that:
- is life threatening, even if temporary in nature;
- results in permanent impairment of a body function or permanent damage to a body structure; or
- necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.
Measured: 5 Years
Secondary outcomes (1)
Cosmesis
Cosmesis will be evaluated with the Harvard scale at one (1) month, six (6) months, and at one (1) year, two (2) years, three (3) years, four (4) years, and five (5) years post IORT.
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 posted20 Jan 2014 (estimated)
- Study startSep 2008
- Primary completion4 Oct 2016
- Study completion4 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xoft, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Adam Dickler, MD, Principal investigator, Little Company of Mary Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02040493
- Sponsor's protocol ID
- LCMH-001
- Status last verified
- Jul 2017
- First submitted
- 16 Jan 2014
- Last updated
- 25 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-Operative Radiation Therapy (IORT) Treatment Immediately Following Resection of Early Stage Breast Cancer
- ClinicalTrials.gov ID
- NCT02040493
- Acronym / sponsor ID
- LCMH-001
- Conditions
- Breast Cancer
- Keywords
- breast cancer, IORT, brachytherapy
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Xoft, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- 4 Oct 2016 (actual)
- Study completion
- 4 Oct 2016 (actual)
- First posted
- 20 Jan 2014 (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.
This is a physician sponsored multi-center, non-randomized, prospectively enrolling data collection study of patients with early stage breast cancer treated with electronic brachytherapy at the time of surgical resection of the cancer in the operating room. The radiation therapy treatments will be administered with electronic brachytherapy using the FDA cleared Xoft Axxent System.
Detailed description
Breast Conserving Therapy (BCT) is a standard treatment option for patients with stage I or II breast cancer. Breast conserving therapy consists of surgical removal of the tumor with negative margins, axillary lymph node dissection or sentinel node biopsy and radiation therapy. Several studies have shown BCT to be comparable to mastectomy in terms of overall and disease free survival for patients. The major advantage to BCT over mastectomy is breast preservation and reduced psychological trauma to the patient. The major disadvantage to BCT is prolonged time of treatment. The whole breast radiation portion of BCT can add 7 weeks to the treatment time. This additional treatment time can be a detriment to women who logistically may not be able to meet the demands of daily irradiation for 6-7 weeks. A new form of treatment, breast brachytherapy, was developed to decrease the treatment time required for breast irradiation. This treatment uses the Xoft Axxent system to administer intra-operative breast brachytherapy in one treatment, at the time of lumpectomy in the operating room.
This study has been designed to assess local recurrence, serious adverse events, adverse events and their severity, and cosmesis following intra-operative radiation therapy (IORT) using the Xoft Axxent System and balloon applicators. The study device is FDA cleared. The purpose of this clinical study is to compile data on the treatment of patients using the Xoft Axxent System for the delivery of radiation therapy in the intra-operative setting as part of breast conserving therapy in women with resected, early stage breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intra-operative radiation therapy (IORT) | Experimental | Radiation: Intra-operative radiation therapy (IORT)IORT |
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Intra-operative radiation therapy (IORT)All subjects will receive IORT at the time of lumpectomy. | Radiation | Intra-operative radiation therapy (IORT) |
Primary outcome
Local recurrence in patients treated with intra-operative electronic brachytherapy for early stage breast cancer.
Time frame: 5 Years
Local recurrence will be assessed at one (1) month, six (6) months, one (1) year, two (2) years, three (3) years, four (4) years, and five (5) years post IORT.
Occurence of serious adverse events during and following IORT treatment.
Time frame: 5 Years
Serious adverse events are defined as a serious injury or illness that: 1. is life threatening, even if temporary in nature; 2. results in permanent impairment of a body function or permanent damage to a body structure; or 3. necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.
1 secondary outcome
Cosmesis
Time frame: 5 Years
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2017.
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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.
Adam Dickler, MD principal investigator
Little Company of Mary Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intra-operative radiation therapy (IORT) in people with Breast Cancer, run by Xoft, Inc. at 7 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?
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: stopped early, as of the sponsor's last update on 25 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
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?
Local recurrence in patients treated with intra-operative electronic brachytherapy for early stage breast cancer. (time frame: 5 Years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jul 2017.