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

NCT ID: NCT03561454

Last Updated: 2023-10-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-01-11
• Study Completion Date: 2029-08-01

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).

Conditions

Early Stage Breast Cancer

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

IORT

Intra-Operative Radiation Therapy

Intervention Type: DEVICE

Eligibility Criteria

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

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

1. Subject is pregnant or nursing

2. Subject has significant auto-immune disease

3. Subject has a pacemaker present in the field of radiation or quadrant of the breast cancer

4. 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

5. Subject has known lympho-vascular invasion

6. Subject has invasive lobular cancer

7. Subject has undergone neo-adjuvant chemotherapy or neo-adjuvant endocrine therapy for current breast cancer

8. Subject has a history of recurrent breast cancer in the ipsilateral breast

9. Subject has had previous radiation exposure of the involved breast

10. 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

11. Subject has contraindications for radiation

12. Subject considered by the Investigator to be high-risk for breast conservation surgery and/or intra-operative radiation therapy

13. 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Medstar Health Research Institute

OTHER

Sponsor Role: collaborator

MedStar Franklin Square Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maen Farha, MD

Role: PRINCIPAL_INVESTIGATOR

Medstar Health Research Institute

Locations

MedStar Good Samaritan Hospital

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

20180335

Identifier Type: -

Identifier Source: org_study_id