A phase I/II study of proton beam therapy for early breast cancer evaluating safety and effectiveness
Phase 1
Recruiting
- Conditions
- Breast cancer
- Registration Number
- JPRN-UMIN000017579
- Lead Sponsor
- Medipolis Proton Therapy and Research Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 24
Inclusion Criteria
Not provided
Exclusion Criteria
1) History of previous radiotherapy to the breast. 2) History of previous surgery/chemotherapy to the breast. 3) DCIS/LCIS 4) Massive intra-ductal spread. 5) Having infectious disease. 6) Having collagen disease or infectios skin disease. 7) Diabetes. 8) Pregnancy. 9) Other malignant disease. 10) Medically, psycholgicaliy or other reason who are not suitable for candidate by the physician.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adverse events of normal tissue
- Secondary Outcome Measures
Name Time Method location of local recurrence, duration of extra-breast recurrence, survival duration, cosmesis