Safety and Efficacy Study of the Xoft® Axxent® eBx™ IORT System
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.
Invasive Ductal Carcinoma
Ductal Carcinoma in Situ
Radiation: Intra-operative Radiation Therapy - IORT
|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|
- Assess the rate of ipsilateral breast tumor recurrence (IBTR) [ Time Frame: Change from baseline reported at 5 and 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 5 and 10 years.
- Assess the rate of regional breast tumor recurrence (RBTR) [ Time Frame: Report at 5 and 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.
|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)|
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
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.
|Contact: Michael A Patz, BS, MBA, RAC||603-882-5200 ext email@example.com|
|Contact: Heidi M Matthews, BA||603-882-5200 ext firstname.lastname@example.org|
|United States, Arizona|
|Cancer Treatment Services Arizona||Recruiting|
|Casa Grande, Arizona, United States, 85122|
|Contact: Rebecca Fisher 520-836-9800 email@example.com|
|Principal Investigator: Ajay Bhatnagar, MD|
|United States, California|
|Long Beach Memorial Medical Center||Recruiting|
|Long Beach, California, United States, 90806|
|Contact: Sylvia Huang 562-933-7866 SHuang@memorialcare.org|
|Principal Investigator: Nisair Syed, MD|
|Tower Outpatient Surgery Center||Recruiting|
|Los Angeles, California, United States, 90048|
|Contact: Dr. Joshua Ellenhorn, MD 310-659-0705 firstname.lastname@example.org|
|Principal Investigator: Joshua D Ellenhorn, MD|
|Orange, California, United States, 92868|
|Contact: Olupero Aiyenimelo, MS 562-981-6101 Olupero.Aiyenimelo@breastlink.com|
|Principal Investigator: Amy Bremner, MD|
|Diablo Valley Oncology Hematology Medical Group||Recruiting|
|Pleasant Hill, California, United States, 94523|
|Contact: Gila Fucanan 925-825-8878 email@example.com|
|Principal Investigator: Sachin Kamath, MD|
|United States, Colorado|
|Western Surgical Care, PC||Recruiting|
|Denver, Colorado, United States, 80220|
|Contact: Wendy Bledsoe 720-261-8240 firstname.lastname@example.org|
|Principal Investigator: Barbara Schwartzberg, MD|
|United States, Florida|
|Florida Hospital Celebration Health||Recruiting|
|Celebration, Florida, United States, 34747|
|Contact: Alexa Williams, RN 407-303-4594 email@example.com|
|Principal Investigator: Olga Ivanov, MD|
|Coral Gables, Florida, United States, 33146|
|Contact: Michelle Lazo 786-308-3517 firstname.lastname@example.org|
|Principal Investigator: Cristina Lopez-Peñalver, MD, FACS|
|United States, Michigan|
|Crittenton Hospital Medical Center||Recruiting|
|Rochester, Michigan, United States, 48307|
|Contact: Pamela Rostek 248-652-5137 email@example.com|
|Principal Investigator: V. Elayne Arterbery, MD|
|United States, New Hampshire|
|Exeter, New Hampshire, United States, 03833|
|Contact: Meredith Thibodeau, RN 603-580-7336 ext 6148 firstname.lastname@example.org|
|Principal Investigator: Gary Proulx, MD|
|United States, Tennessee|
|Parkridge Medical Center||Recruiting|
|Chattanooga, Tennessee, United States, 37404|
|Contact: Kassie Britton, RN, BSN 423-493-1667 email@example.com|
|Principal Investigator: Stephen Golder, MD|
|Vanderbilt-Ingram Cancer Center||Recruiting|
|Nashville, Tennessee, United States, 37212|
|Contact: Julie Scott 615-936-1164 firstname.lastname@example.org|
|Principal Investigator: Anuradha Chakravarthy, MD|
|Principal Investigator:||Helena Chang, MD, PhD||University of California, Los Angeles|
|Principal Investigator:||A.M. Nisar Syed, MD||Long Beach Memorial Medical Center|