Stereotactic Body radiotherapy and pedicLE screw fixatioN During one hospital visit for patients with symptomatic unstable spinal metastases: A randomized trial (BLEND RCT)

Recruiting

Conditions: Spinal metastases
10027476

Registration Number: NL-OMON51812

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 100

Inclusion Criteria

• Symptomatic (cervical, thoracic and/or lumbar) spinal metastases and
impending spinal instability requiring radiotherapy and surgical stabilization
• Histologic proof of malignancy or radiographic/clinical characteristics
indicating malignancy beyond reasonable doubt
• Radiographic evidence of spinal metastases
• Participation in PRESENT cohort, including consent for randomization into
future trials
• Fit for (radio)surgery
• Age >18 years
• Written informed consent

Exclusion Criteria

• SBRT cannot be delivered, e.g. in patients who cannot lie on the treatment
table because of pain
• Surgery cannot be performed, e.g., multiple spinal metastases requiring
surgical bridging of more than five vertebral levels
• Prior surgery or radiotherapy to the index levels
• Neurological deficits (ASIA C, B or A), or partial neurological deficits
(ASIA D) with rapid progression (hours to days)
• Life expectancy of less than 3 months

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Physical functioning, four weeks after the start of the treatment, which is a<br /><br>functional scale from the EORTC QLQ-C15-PAL questionnaire.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary goals are to compare the pain response, duration of pain relief,<br /><br>length of hospital stay, time to return to systemic therapy, neurological<br /><br>deterioration, adverse events (e.g. wound complications), quality of life and<br /><br>survival between intervention and control. In addition, we will study the<br /><br>cost-effectiveness.</p><br>