A Registry of Intra-Operative Radiation Therapy (IORT) Using the Xoft ® Axxent ® eBx ™ System Patients

A Registry of Intra-Operative Radiation Therapy (IORT) Using the Xoft ® Axxent ® eBx™ System Patients

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03561454

Enrollment

100

Registered

2018-06-19

Start date

2019-01-11

Completion date

2029-08-01

Last updated

2023-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early Stage Breast Cancer

Brief 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).

Interventions

DEVICEIORT

Intra-Operative Radiation Therapy

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

40 Years to 100 Years

Healthy volunteers

Inclusion criteria

General Inclusion Criteria 1. Subject must have provided written Informed Consent 2. Subject must have biopsy-proven ductal carcinoma in situ (DCIS) or invasive ductal carcinoma of the breast a. 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 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. Clinical staging of 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 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

Design outcomes

Primary

Measure	Time frame
tumor recurrence	5 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026