A phase I/II clinical trial of radical radiotherapy using carbon-ion beams with standard adjuvant therapy for early breast cancer
Not Applicable
Recruiting
- Conditions
- breast cancer
- Registration Number
- JPRN-UMIN000029478
- Lead Sponsor
- QST Hospital, National Institutes for Quantum and Radiological Sciences and Technology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 30
Inclusion Criteria
Not provided
Exclusion Criteria
1. Severe complication (e.g. uncontroled lung disease, heart disease, infection, or psychiatric disease). 2. Previous treatment history including surgery, chemotherapy, endocrine therapy, molecular-targeted agents for breast cancer in same side. 3. Active other malignancy 4. The distanse between skin surface and tumor (including EIC) <=5 mm. 5. Previous radiation therapy for breast cancer in same side. 6. Eligible patients for "Breast cancer I". 7. Pregnancy, pregnancy potential. 8. Ptinents who are considered inappropriate by the attending physician due to medical, psychological or other factors.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adverse reaction of normal tissue within 90 days after starting of the treatment.
- Secondary Outcome Measures
Name Time Method 1. Adverse reaction of normal tissue in late phase 2. Local effect (CR rate) 3. Local control rate with recommended dose 4. Breast cosmetic outcomes 5. Progression-free survival period 6. Overall survival period