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Clinical Trials/NL-OMON42087
NL-OMON42087
Completed
Phase 2

Stereotactic body radiotherapy followed by surgical stabilization for patients with painful unstable spinal metastases: First-in-man study according to the IDEAL recommendations - BLEND study

niversitair Medisch Centrum Utrecht0 sites13 target enrollmentTBD
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Conditionsmetastatic spine tumorspinal metastases100059591002747610005944

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
metastatic spine tumor
Sponsor
niversitair Medisch Centrum Utrecht
Enrollment
13
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
niversitair Medisch Centrum Utrecht

Eligibility Criteria

Inclusion Criteria

  • •\* Painful radiosensitive metastases from solid tumors in the thoracic or lumbar spine needing surgical stabilization
  • •\* Histologic proof of malignancy
  • •\* Radiographic evidence of spinal metastases
  • •\* Karnofsky performance status \> 50
  • •\* Age \> 18 years
  • •\* Written informed consent

Exclusion Criteria

  • •\* Multiple spinal metastases necessitating bridging more than five vertebral levels during surgery
  • •\* Previous surgery or radiotherapy to index lesion
  • •\* SBRT cannot be delivered (Bilsky score 2 and 3 \[Bilsky 2010])
  • •\* Neurological deficits (ASIA C, B or A)
  • •\* Partial neurological deficits (ASIA D) with rapid progression (hours to days)
  • •\* Inability to lie flat on table for SBRT
  • •\* Non\-ambulatory patients
  • •\* Patient in hospice or with \< 3 months life expectancy
  • •\* Medically inoperable or patient refused surgery

Outcomes

Primary Outcomes

Not specified

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