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Clinical Trials/JPRN-jRCT1071210107
JPRN-jRCT1071210107
Recruiting
Phase 1

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

Joichi Heianna0 sites52 target enrollmentJanuary 11, 2022

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Bone metastasis from renal cell carcinoma
Sponsor
Joichi Heianna
Enrollment
52
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 11, 2022
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Joichi Heianna

Eligibility Criteria

Inclusion 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.

Exclusion 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.

Outcomes

Primary Outcomes

Not specified

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