Feasibility Study of Accelerated Partial Breast Irradiation using SAVI (Strut Adjusted Volume Implant)

Not Applicable

• Conditions: breast cancer

• Registration Number: JPRN-UMIN000016032
• Lead Sponsor: ational Cancer Center Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-12-22
• Study Completion: 2021-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: Female
• Target Recruitment: 7

Inclusion Criteria

Not provided

Exclusion Criteria

1. Patients with operation other than lumpectomy. 2. Patients with pure lobular 3. Patient with nonepithelial breast malignancies such as sarcoma or lymphoma. 4. Patients with proven multicentric disease (tumors in different quadrants of the breast, or tumors separated by at least 4 cm) with other clinically or radiographically suspicious lesions in the ipsilateral breast unless confirmed to be negative for malignancy by biopsy. 5. Patients with lumpectomies so extensive that the cosmetic result is fair or poor prior to brachytherapy. 6. Patients whose lumpectomy cavity is not easily delineated by standard breast imaging or contrast injected into the biopsy cavity. 7. Time between final definitive breast procedure to beginning brachytherapy is greater than 8 weeks. 8. Prior non-hormonal therapy for the present breast cancer, including radiation therapy or chemotherapy. 9. Prior Ipsilateral breast or thoracic RT for any condition. 10. Patients who are pregnant or lactating. 11. Patients with collagen vascular diseases, specifically systemic lupus erythematosis, scleroderma, or dermatomyositis with a CPK level above normal or with an active skin rash. 12. Patients with psychiatric or addictive disorders or other conditions which would preclude obtaining informed consent or completing the full series of brachytherapy treatments on an outpatient basis. 13. Other malignancy, except non-melanoma skin cancer or cervical cancer in-situ, < 5 years prior to participation in this study; the disease free interval from any prior carcinoma must be continuous. 14. Patients with a diagnosis of insulin-dependent diabetes.

Study & Design

• Study Type: Interventional
• Study Design: Not specified