An Efficacy Study of the Xoft® Axxent® eBx® IORT System® "Lite"

  • STATUS
    Recruiting
  • End date
    Jun 30, 2034
  • participants needed
    2000
  • sponsor
    Xoft, Inc.
Updated on 13 June 2022
cancer
breast cancer
carcinoma in situ
ductal carcinoma in situ
breast cancer staging
ductal carcinoma
breast irradiation
intraoperative radiation therapy
stage breast cancer

Summary

The purpose of this trial is to assess the efficacy of the Xoft Axxent eBx System when used for single-fraction IORT in early stage breast cancer. A comparison will be made to the current standard of care, whole breast irradiation (WBI), in women with early stage breast cancer.

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.

Details
Condition Invasive Ductal Carcinoma, Ductal Carcinoma In Situ
Treatment Intra-operative Radiation Therapy - IORT
Clinical Study IdentifierNCT04349111
SponsorXoft, Inc.
Last Modified on13 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Subject must have provided written Informed Consent
Subject must have biopsy-proven ductal carcinoma in situ (DCIS) or invasive ductal carcinoma (IDC) of the breast
Subject must be female ≥ 40 years of age
Subject's tumor(s) must be < 3.0 cm in greatest diameter by pre-operative assessment
Clinical staging of Subject's tumor(s) must meet AJCC Tumor Classification: Tis, T1 or T2 (< 3 cm), N0, M0

Exclusion Criteria

Women of child-bearing potential must have a negative pregnancy test within one week of IORT treatment
Women of child-bearing potential must agree to use adequate contraceptive precautions (defined as 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
Subject is pregnant or nursing
Subject has active auto-immune disease
Subject has a pacemaker present in the field of radiation or quadrant of the breast cancer
Subject has multi-focal breast cancer where the sum of the individual tumor sizes (greatest diameters) are > 3 cm
Subject has multi-centric breast cancer
Subject has known lympho-vascular invasion
Subject has invasive lobular cancer
Subject has undergone neo-adjuvant chemotherapy or neo-adjuvant endocrine therapy for current breast cancer
Subject has a history of recurrent breast cancer in the ipsilateral breast
Subject has had previous radiation exposure of the involved breast
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
Subject has contraindications for radiation
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