A confirmatory trial on concomitant radiotherapy and transcatheter arterial embolization to reduce skeletal-related events (SRE) related to bone metastasis from renal cell carcinoma.
- Conditions
- Bone metastasis from renal cell carcinomarenal cell carcinoma, skeletal-related events
- Registration Number
- JPRN-jRCT1071210107
- Lead Sponsor
- Joichi Heianna
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 52
1. Clinically diagnosed bone metastasis of renal cell carcinoma (with or without biopsy tissue diagnosis).
2. Bone metastases are located in the thoracic spine, lumbar spine, pelvis, or ribs. The number of bone metastases is not required.
3. No spinal cord compression syndrome due to bone metastasis in the vertebral body evident on CT or MRI within one week prior to enrollment (asymptomatic is acceptable).
4. No history of previous radiotherapy in the treated area.
5. Patients must be expected to survive for at least 3 months after radiotherapy followed by TAE (if the prognosis is not promising, there will be no difference in the treatment effect compared to radiotherapy alone).
6. The eGFR of at least 30 ml/min and platelets of at least 50,000/dl within 14 days of enrollment.
7. Age at the time of obtaining consent must be 20 years or older.
8. Written consent has been obtained.
1. Allergy to contrast media.
2. May be pregnant.
3. Has started or will start new chemotherapy or hormonal therapy within 2 weeks of obtaining consent.
4. Performance status 4.
5. The principal investigator or sub-investigator judges that the subject is unsuitable for enrollment in this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Skeletal-related events free rate
- Secondary Outcome Measures
Name Time Method Safety of treatment