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Safety and Efficacy Study of the Xoft® Axxent® eBx™ IORT System

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ClinicalTrials.gov Identifier: NCT01644669
Recruitment Status : Active, not recruiting
First Posted : July 19, 2012
Last Update Posted : August 8, 2018
Sponsor:
Collaborator:
Icad, Inc.
Information provided by (Responsible Party):
Xoft, Inc.

Brief Summary:
The purpose of this trial is to assess the safety and efficacy of the Xoft Axxent eBx System when used for single-fraction IORT in early stage breast cancer. Hypothesis: IORT using the Xoft Axxent eBx System is no worse (non-inferior) than whole breast irradiation (WBI) when used as stand-alone radiation treatment in breast conserving therapy in women with early stage breast cancer.

Condition or disease Intervention/treatment Phase
Invasive Ductal Carcinoma Ductal Carcinoma in Situ Radiation: Intra-operative Radiation Therapy - IORT Not Applicable

Detailed Description:

The rationale for IORT as the sole radiation therapy is:

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1200 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Single 20Gy dose of electronic brachytherapy (IORT)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Safety and Efficacy Study of Intra-Operative Radiation Therapy (IORT) Using the Xoft® Axxent® eBx™ System at the Time of Breast Conservation Surgery for Early Stage Breast Cancer
Actual Study Start Date : May 2012
Estimated Primary Completion Date : February 2023
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intra-operative Radiation Therapy - IORT
Intra-operative Radiation Therapy
Radiation: Intra-operative Radiation Therapy - IORT
Single dose of 20 Gy
Other Name: Electronic Brachytherapy




Primary Outcome Measures :
  1. Assess the rate of ipsilateral breast tumor recurrence (IBTR) at 5 years [ Time Frame: Change from baseline reported at 5 years ]
    IBTR is defined as biopsy-proven reappearance of cancer in the treated breast. IBTR will be assessed at Month 6, Month 12, Month 18, Year 2, and then annually through ten (10) year follow-up. A non-inferiority comparison to whole breast irradiation will be made at 5 years.


Secondary Outcome Measures :
  1. Assess the rate of regional breast tumor recurrence (RBTR) [ Time Frame: Report at 10 yrs ]
    Regional breast tumor recurrence is defined as biopsy-proven reappearance of cancer in the axilla. Regional recurrence will be assessed at Month 6, Month 12, Month 18, Year 2, and then annually through ten (10) year follow-up. Regional recurrence rates will be compared to the historical control of WBI at 5 and 10 years.

  2. Disease Free Survival Rate (DFSR) and Overall Survival rate [ Time Frame: Report at 5 and 10 years ]
    Disease free survival (DFS) is defined as the length of time from IORT to any first recurrence. The incidence of disease free survival will be assessed at Month 1, Month 6, Month 12, Month 18, Year 2, and then annually through ten (10) year follow-up. DFS will be compared to the historical control at 5 and 10 years.

  3. Cosmetic Outcome [ Time Frame: Report at 5 and 10 yrs ]
    Cosmetic outcome will be recorded at baseline, Month 12, Month 18, Year 2, and then annually through ten (10) year follow-up. a. Physician evaluation will be done using the Harvard Scale.

  4. Quality of Life (QOL) [ Time Frame: Reported at 5 and 10 yrs ]
    Quality of Life will be assessed at baseline and at each follow-up visit: Month 1, Month 6, Month 12, Month 18, Year 2, and then annually through ten (10) year follow-up. QOL will be measured using the FACT-B self-reporting questionnaires.

  5. Assess the safety of single fraction IORT at the time of breast conserving surgery for early stage breast cancer [ Time Frame: On-going monitoring, report at 5 and 10 years ]
    The rates and severity of Adverse Events (AEs), Adverse Device Effects (ADEs), and Unanticipated Adverse Device Effects (UADEs) during and following IORT will be assessed at each follow-up visit. Safety events will be compared to the historical control of WBI at 5 and 10 years. Each event will be classified according to the following: Device Related, Procedure Related or Radiation Related.

  6. Assess the rate of ipsilateral breast tumor recurrence (IBTR) at 10 years [ Time Frame: Change from baseline reported at 10 years ]
    IBTR is defined as biopsy-proven reappearance of cancer in the treated breast. IBTR will be assessed at Month 6, Month 12, Month 18, Year 2, and then annually through ten (10) year follow-up. A non-inferiority comparison to whole breast irradiation will be made at 10 years.



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject must have provided written Informed Consent
  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
  6. Subject presenting with bilateral breast cancer may be enrolled if BOTH cancers meet all of the inclusion and none of the exclusion criteria
  7. Women of child-bearing potential must have a negative pregnancy test within one week of IORT treatment
  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

Exclusion Criteria:

  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01644669


  Hide Study Locations
Locations
United States, Arizona
Cancer Treatment Services Arizona
Casa Grande, Arizona, United States, 85122
Phoenix Baptist Hospital
Phoenix, Arizona, United States, 85015
University of Arizona
Tucson, Arizona, United States, 85704
United States, California
Kern Medical Center
Bakersfield, California, United States, 93306
City of Hope
Duarte, California, United States, 91010
Long Beach Memorial Medical Center
Long Beach, California, United States, 90806
UCLA
Los Angeles, California, United States, 90095
Tri-City Medical Center
Oceanside, California, United States, 92056
Breastlink
Orange, California, United States, 92868
Diablo Valley Oncology Hematology Medical Group
Pleasant Hill, California, United States, 94523
United States, Colorado
Western Surgical Care, PC
Denver, Colorado, United States, 80220
Swedish Medical Center
Englewood, Colorado, United States, 80113
United States, Florida
Florida Hospital Celebration Health
Celebration, Florida, United States, 34747
Doctors Hospital
Coral Gables, Florida, United States, 33146
Martin Health System Center for Clinical Research
Stuart, Florida, United States, 34994
United States, Illinois
Rush University
Chicago, Illinois, United States, 60612
United States, Indiana
Lutheran Hospital of Indiana
Fort Wayne, Indiana, United States, 46804
United States, Maryland
Greater Baltimore Medical Center
Baltimore, Maryland, United States, 21204
MedStar Oncology Network - Union Memorial Hospital
Baltimore, Maryland, United States, 21218
MedStar Oncology Network - Franklin Square
Baltimore, Maryland, United States, 21237
United States, New Hampshire
Exeter Hospital
Exeter, New Hampshire, United States, 03833
United States, New York
Staten Island University Hospital
Staten Island, New York, United States, 10305
United States, Oklahoma
University of Oklahoma
Oklahoma City, Oklahoma, United States, 73104
United States, Tennessee
Parkridge Medical Center
Chattanooga, Tennessee, United States, 37404
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37212
United States, Virginia
Sentara Northern Virginia Medical Center
Woodbridge, Virginia, United States, 22191
Australia, Victoria
Monash Health / Peter MacCallum Cancer Centre
Clayton, Victoria, Australia, 3165
Portugal
Hospital CUF Porto
Porto, Portugal
Sponsors and Collaborators
Xoft, Inc.
Icad, Inc.
Investigators
Principal Investigator: Helena Chang, MD, PhD University of California, Los Angeles
Principal Investigator: A.M. Nisar Syed, MD Long Beach Memorial Medical Center

Additional Information:
Publications:
Responsible Party: Xoft, Inc.
ClinicalTrials.gov Identifier: NCT01644669     History of Changes
Other Study ID Numbers: CTPR-0009
First Posted: July 19, 2012    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Carcinoma
Carcinoma in Situ
Carcinoma, Ductal
Carcinoma, Intraductal, Noninfiltrating
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary
Breast Carcinoma In Situ