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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 by Xoft, Inc.
Sponsor:
Collaborator:
Icad, Inc.
Information provided by (Responsible Party):
Xoft, Inc.
ClinicalTrials.gov Identifier:
NCT01644669
First received: June 28, 2012
Last updated: August 1, 2016
Last verified: July 2016
  Purpose
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 Intervention Phase
Invasive Ductal Carcinoma
Ductal Carcinoma in Situ
Radiation: Intra-operative Radiation Therapy - IORT
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Xoft, Inc.:

Primary Outcome Measures:
  • Assess the rate of ipsilateral breast tumor recurrence (IBTR) at 5 years [ Time Frame: Change from baseline reported at 5 years ] [ Designated as safety issue: No ]
    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:
  • Assess the rate of regional breast tumor recurrence (RBTR) [ Time Frame: Report at 10 yrs ] [ Designated as safety issue: No ]
    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.

  • Disease Free Survival Rate (DFSR) and Overall Survival rate [ Time Frame: Report at 5 and 10 years ] [ Designated as safety issue: No ]
    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.

  • Cosmetic Outcome [ Time Frame: Report at 5 and 10 yrs ] [ Designated as safety issue: No ]
    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.

  • Quality of Life (QOL) [ Time Frame: Reported at 5 and 10 yrs ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: Yes ]
    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.

  • Assess the rate of ipsilateral breast tumor recurrence (IBTR) at 10 years [ Time Frame: Change from baseline reported at 10 years ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 1200
Study Start Date: May 2012
Estimated Study Completion Date: December 2024
Estimated Primary Completion Date: May 2024 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Genders 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01644669

Contacts
Contact: Joyce B Musacchio, BS 603-882-5200 ext 7308 jmusacchio@icadmed.com
Contact: Crystal A Leonard 603-882-5200 ext 7284 cleonard@icadmed.com

  Show 27 Study Locations
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
  More Information

Additional Information:
Publications:
Responsible Party: Xoft, Inc.
ClinicalTrials.gov Identifier: NCT01644669     History of Changes
Other Study ID Numbers: CTPR-0009 
Study First Received: June 28, 2012
Last Updated: August 1, 2016
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
Individual Participant Data  
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

ClinicalTrials.gov processed this record on September 23, 2016