A clinical study on the safety and efficacy of accelerated partial breast irradiation in breast-conserving therapy
- Conditions
- Breast cancer
- Registration Number
- JPRN-UMIN000006474
- Lead Sponsor
- Department of Radiation Oncology and Image-applied Therapy, Graduate School of Medicine, Kyoto University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- Female
- Target Recruitment
- 50
Not provided
1) Simultaneous or metachronous (within 5 years) double cancers. 2) Metachronous or simultaneous bilateral breast cancers 3) Infection with systemic therapy indicated. 4) Body temperature of 38 or more degrees Celsius. 5) Psychosis. 6) Uncontrollable diabetes mellitus or administration of insulin. 7) Scleroderma, systemic lupus erythematosus, dermatomyositis, or polymyositis. 8) Systemic steroids medication. 9) Immunosuppressant for active collagen disease. 10) History of severe heart disease, heart failure, myocardial infarction within 6 months or attack of angina pectoris within 6 months. 11) Interstitial pneumonia, pulmonary fibrosis, or severe emphysema. 12) Women during pregnancy, possible pregnancy or breast-feeding.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method proportion of grade 3 or higher acute or late adverse events within 2 years.
- Secondary Outcome Measures
Name Time Method ipsilateral breast recurrence-free survival, proportion of protocol treatment completion, proportion of deterioration of breast cosmetic outcomes, disease-free survival, overall survival