breast cancer
Conditions
Interventions
accelerated partial breast irradiation using SAVI
Sponsors
National Cancer Center Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Clinically tumor diameter is less than or equal to 3 cm, and planed to be treated with lumpectomy. 2. Clinically negative nodes and negative metastases. 3. Negative multicentric disease(excluding tumors in different quadrants of the breast, or tumors separated by at least 4 cm) 4. Histologically ductal carcinoma 5. Negative,inked histologic margins of lumpectomy or reexcision specimen to be confirmed prior to introducing the radiation sources. Margins are positive if there is invasive or noninvasive tumor at the inked resection margin. 6. Negative axillary nodes and/or a negative sentinel node. No axillary dissection is needed if pure DCIS. 7. Hormonal manipulation therapy is allowed. Chemotherapy planned for 2 weeks after removal of brachytherapy catheters is permitted. 8. Female 9. Age 45 years or older 10. Written Informed Consent obtained
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the rate for completion of protocol treatment | — |
Countries
Japan
Contacts
Public ContactKana Takahashi
National Cancer Center Hospital Department of Radiation Oncology
Outcome results
None listed