A Registry of Intra-Operative Radiation Therapy (IORT) Using the Xoft ® Axxent ® eBx ™ System Pat… (NCT03561454) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
A Registry of Intra-Operative Radiation Therapy (IORT) Using the Xoft ® Axxent ® eBx ™ System Patients
United States100 participantsStarted 2019-01-11
Plain-language 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).
Who can participate
Age range40 Years – 100 Years
SexFEMALE
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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
✓. 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
✕. 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