Safety and Efficacy Study of the Xoft® Axxent® eBx® IORT System®
NCT ID: NCT01644669
Last Updated: 2025-01-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
NA
1200 participants
INTERVENTIONAL
2012-05-08
2029-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Intra-Operative Radiation Therapy Immediately Following Resection of Early Stage Breast Cancer
NCT02040493
IORT-Breast at Medical Center Navicent Health
NCT04595435
IORT (Intra-operative Radiation Therapy) in Early Stage Breast Cancer
NCT01988870
Lumpectomy Followed By Intraoperative Electron Radiation Therapy (IOERT)
NCT01960803
Intra-Operative Radiation Registry
NCT04994067
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Favorable preliminary results in feasibility, safety and efficacy outcomes: Accelerated Partial Breast Irradiation (APBI) is an accepted alternative to whole breast irradiation following breast-conserving surgery for early stage breast cancer. Intra-Operative Radiation Therapy (IORT) is a form of APBI that allows radiation to be delivered directly to the open tumor bed following Breast Conservation Surgery (BCS). After 4 years of follow-up, IORT has shown equivalent disease control rates as whole breast irradiation.
Direct and timely radiation to the tumor bed: Radiation is delivered at to the target tissue (adjacent to the resection margins at the time of lumpectomy). It avoids treatment delays and eliminates weeks or months of post-surgical radiation therapy during which residual cancer cells might proliferate. An in vitro study showed that un-irradiated wound fluid stimulated the growth of breast cancer cells while irradiated wound fluid did not. Each month of delay in radiation treatment is associated with a 1% increase in the recurrence rate. Huang, et al., found a 5.8% recurrence rate in patients who received WBRT within 8 weeks of BCS compared with a 9.1% recurrence rate in patients who started radiotherapy 9-16 weeks after BCS.
Increased patient treatment compliance compared to conventional radiation therapy: Suitable early stage breast cancer patients are able to complete their breast cancer radiotherapy treatment at the time of BCS, which offers a convenient and potentially life-saving benefit to patients who might otherwise omit radiation therapy if it required lengthy travel or time commitments. In addition, healthcare resources, including both personnel and facilities, will be conserved by eliminating the overhead cost of multiple patient visits, eliminating waiting time for patients, and consolidating therapy to one visit combined with the surgical procedure.
Available Technology: The Xoft Axxent controller, x-ray source, and balloon applicator are cleared by the United States Food and Drug Administration (FDA) to deliver brachytherapy treatments using high dose rate x-ray radiation. The Xoft Axxent System has been used to treat breast cancer subjects using a multi-fraction APBI technique on an outpatient basis as part of two multi-center studies. The Xoft Axxent System enables the Radiation Oncologist to administer electronic brachytherapy without the use of a radioactive isotope in minimally shielded rooms. Characteristics of the Xoft System that make it well-suited for IORT include its portability and low energy photons, allowing for minimal shielding during the radiation therapy.
This protocol has been developed to further study the use of the Xoft Axxent eBx System in the delivery of IORT for subjects with early-stage breast cancer. The Xoft Axxent eBx System will be used according to the United States Food and Drug Administration (FDA) 510(k) cleared labeling; therefore, the use of the technology in this study is considered on-label and within the scope of the FDA cleared indication.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Intra-operative Radiation Therapy - IORT
Intra-operative Radiation Therapy
Intra-operative Radiation Therapy - IORT
Single dose of 20 Gy
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Intra-operative Radiation Therapy - IORT
Single dose of 20 Gy
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Subject must have biopsy-proven invasive ductal carcinoma or ductal carcinoma in situ of the breast
3. Subject must be female ≥ 40 years of age
4. Subject's tumor(s) must be \< 3.0 cm in greatest diameter by pre-operative assessment
5. Subject's tumor(s) must meet AJCC Tumor Classification: Tis, T1 or T2 (\< 3 cm), N0, M0
Exclusion Criteria
8. Women of child-bearing potential must agree to use adequate contraceptive precautions (defined as oral contraceptives, intrauterine devices, surgical contraceptives or a combination of condom and spermicide) from the time of negative pregnancy test through completion of the radiation treatment period
1. Subject is pregnant or nursing
2. Subject has significant auto-immune disease
3. Subject has a pacemaker present in the field of radiation or quadrant of the breast cancer
4. Subject has biopsy-proven multifocal breast cancer
5. Subject has multi-centric breast cancer
6. Subject has known lympho-vascular invasion
7. Subject has invasive lobular cancer
8. Subject has undergone neo-adjuvant chemotherapy or neo-adjuvant endocrine therapy for current breast cancer
9. Subject has a history of recurrent breast cancer in the ipsilateral breast
10. Subject has had previous radiation exposure of the involved breast
11. Subject has BRCA 1 or 2 mutations. Note: Testing will only be required for Subjects presenting with bilateral breast cancer; testing is not required for unilateral cancers
12. Subject has contraindications for radiation
13. Subject considered by the Investigator to be high-risk for breast conservation surgery and/or intra-operative radiation therapy
14. Subject has participated in any other clinical investigation that is likely to confound study results or affect study outcome either at the time of IORT or for 3 months prior to IORT.
40 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Icad, Inc.
INDUSTRY
Xoft, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
A.M. Nisar Syed, MD
Role: PRINCIPAL_INVESTIGATOR
Long Beach Memorial Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Arizona
Tucson, Arizona, United States
City of Hope
Duarte, California, United States
Long Beach Memorial Medical Center
Long Beach, California, United States
UCLA
Los Angeles, California, United States
Tri-City Medical Center
Oceanside, California, United States
Diablo Valley Oncology Hematology Medical Group
Pleasant Hill, California, United States
Western Surgical Care, PC
Denver, Colorado, United States
Swedish Medical Center
Englewood, Colorado, United States
Florida Hospital Celebration Health
Celebration, Florida, United States
Doctors Hospital
Coral Gables, Florida, United States
Martin Health System Center for Clinical Research
Stuart, Florida, United States
Rush University
Chicago, Illinois, United States
Lutheran Hospital of Indiana
Fort Wayne, Indiana, United States
Greater Baltimore Medical Center
Baltimore, Maryland, United States
MedStar Oncology Network - Good Samaritan Hospital
Baltimore, Maryland, United States
MedStar Oncology Network - Franklin Square
Baltimore, Maryland, United States
Exeter Hospital
Exeter, New Hampshire, United States
Staten Island University Hospital
Staten Island, New York, United States
University of Oklahoma
Oklahoma City, Oklahoma, United States
Parkridge Medical Center
Chattanooga, Tennessee, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Sentara Northern Virginia Medical Center
Woodbridge, Virginia, United States
Monash Health / Peter MacCallum Cancer Centre
Clayton, Victoria, Australia
Hospital CUF Porto
Porto, , Portugal
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Ivanov O, Dickler A, Lum BY, Pellicane JV, Francescatti DS. Twelve-month follow-up results of a trial utilizing Axxent electronic brachytherapy to deliver intraoperative radiation therapy for early-stage breast cancer. Ann Surg Oncol. 2011 Feb;18(2):453-8. doi: 10.1245/s10434-010-1283-x. Epub 2010 Aug 25.
Dickler A, Ivanov O, Francescatti D. Intraoperative radiation therapy in the treatment of early-stage breast cancer utilizing xoft axxent electronic brachytherapy. World J Surg Oncol. 2009 Mar 2;7:24. doi: 10.1186/1477-7819-7-24.
Related Links
Access external resources that provide additional context or updates about the study.
National Cancer Institute Factsheet - Radiation Therapy for Cancer
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CTPR-0009
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.