A confirmatory trial on concomitant radiotherapy and transcatheter arterial embolization to reduce skeletal-related events (SRE) related to bone metastasis from renal cell carcinoma.

JRCT ID: jRCT1071210107

Registered date:11/01/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Bone metastasis from renal cell carcinoma
• Date of first enrollment: 18/02/2022
• Target sample size: 52
• Study type: Interventional
• Intervention(s): radiotheraphy followed by arterial embolization

Outcome(s)

• Primary Outcome: Skeletal-related events free rate
• Secondary Outcome: Safety of treatment

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

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.

Exclude criteria

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.

Related Information

• Primary Sponsor: Joichi Heianna