An Investigator Initiated Study of Intra-Operative Radiation Therapy (IORT) Using the Xoft Axxent eBx System

  • STATUS
    Recruiting
  • End date
    Aug 1, 2029
  • participants needed
    50
  • sponsor
    MedStar Franklin Square Medical Center
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Updated on 12 September 2021
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Summary

Single arm, prospective, multi-center, non-randomized study of subjects treated with single fraction, intra-operative radiation therapy at the time of lumpectomy for early stage breast cancer.To assess the rate of ipsilateral breast tumor recurrence in subjects treated with the Xoft Axxent Electronic Brachytherapy System when used for single-fraction, intra-operative radiation therapy treatment of early stage breast cancer when compared to whole breast irradiation (WBI) at 5 years of follow-up. The results of this single arm study will be compared to whole breast irradiation (WBI).

Details
Condition Early Stage Breast Cancer
Treatment IORT
Clinical Study IdentifierNCT03561454
SponsorMedStar Franklin Square Medical Center
Last Modified on12 September 2021

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 of the breast
In addition to invasive ductal carcinoma, allowable invasive carcinomas are: i. Adenoid cystic (or adenocystic) carcinoma ii. Low-grade adenosquamous carcinoma iii. Medullary carcinoma iv. Mucinous (or colloid) carcinoma v. Papillary carcinoma vi. Tubular carcinoma vii. Metaplastic carcinoma viii. Micropapillary carcinoma ix. Mixed carcinoma
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
General Exclusion Criteria
Subject is pregnant or nursing
Subject has significant 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
Subject considered by the Investigator to be high-risk for breast conservation surgery and/or intra-operative radiation therapy
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
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