Multicenter safety trial of hypofractionated radiation therapy after breast-conserving surgery: CONBAT trial (JCOG0906)
Phase 3
- Conditions
- breast cancer after breast-conserving surgery
- Registration Number
- JPRN-UMIN000003200
- Lead Sponsor
- Japan Clinical Oncology Group(JCOG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 310
Inclusion Criteria
Not provided
Exclusion Criteria
1) Simultaneous or metachronous (within 5 years) double cancers. 2) Infection with systemic therapy indicated. 3) Body temperature of 38 or more degrees Celsius. 4) Women during pregnancy, possible pregnancy or breast-feeding. 5) Psychosis. 6) Uncontrollable diabetes mellitus or administration of insulin. 7) Interstitial pneumonia, pulmonary fibrosis, or severe emphysema. 8) Scleroderma, systemic lupus erythematosus, dermatomyositis, or polymyositis. 9) Systemic steroids medication. 10) immunosuppressant for active collagen disease. 11) History of severe heart disease, heart failure, myocardial infarction within 6 months or attack of angina pectoris within 6 months.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of grade 2 or more late adverse reactions at 3 years
- Secondary Outcome Measures
Name Time Method overall survival, disease-free survival, ipsilateral breast recurrence-free survival, proportion of treatment completion in specific term, acute adverse events, proportion of deterioration of breast cosmetic outcomes, proportion of grade 2 or more late adverse reactions at 5 years