RAFAELO study
- Conditions
- Early-stage breast cancer (Tis/T1N0M0 Stage 0/I, the longest diameter <= 1.5 cm)Breast cancer
- Registration Number
- JPRN-jRCTs032180229
- Lead Sponsor
- Takayama Shin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 372
1)Ductal carcinoma (Invasive or non-invasive)diagnosed by core-needle biopsy
2)T<=1.5cm on preoperative examination (mammography, ultrasonography and magnetic resonance imaging)
3)Ages 20 years or more, less than 80 years.
4)Normal organ function and tolerate postoperative radiation therapy
5)No history of cerebral infarction, myocardial infarction and thromboembolism and tolerate general anesthesia
6)No suspicious of axillary lymph node metastasis on preoperative examination (physical examination and imaging)
7)Signed informed consent of the patient for registration
1)Past history of other malignant disease except for the cases who underwent radical operation and had no recurrence more than five 5 years and is low recurrent rate for this disease in the future.
2)Pregnant women or women who are capable of pregnancy
3)Patients who had heart pacemaker or implantable cardioverter defibrillator
4)Local active inflammation and infectious disease
5)Severe complication on heart and brain
6)Patients who could not be attached electrode pads
7)Disorder of blood coagulation: due to the use of antiplatelet drug therapy or anticoagulant therapy
8)Lesions with EIC (extensive intraductal component)or multiple lesions
9)Extensive calcifications on mammography
10)Simulataneous bilateral breast cancer
11)Metachronous ipsilateral breast cancer including IBTR (ipsilateral breast tumor recurrence)
12)Distant metastasis
13)Any other cases who are regarded as inadequate for study enrollment by the attending doctors
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 5 years ipsilateral breast cancer recurrence rate
- Secondary Outcome Measures
Name Time Method OS, DFS, AE, Incomplete ablation rate