A RAndomized trial comparing COnventional with STereotactic radiotherapy for pain reduction and quality of life in spinal metastases RACOST

Phase 3

Completed

Conditions: spinal metastases
10027476

Registration Number: NL-OMON41242

Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 386

Inclusion Criteria

• Histologically proven solid tumor with radiological diagnosis of spinal metastases
• Pain score minimum 2 on 11-point scale (0=no pain to 10= worst imaginable pain)
• Maximum of 2 consecutive or noncontiguous spinal vertebra involved by tumor
• Gross tumor optimally >3mm from the spinal cord on MRI
• Karnofsky performance status >= 60
• WHO >= 2
• Life expectancy > 6 weeks

Exclusion Criteria

• History of previous radiotherapy to the spine at the current level of interest or overlapping location
• Chemotherapy or targeted systemic therapy within 14 days of radiotherapy
• Spinal instability or neurological deficit resulting from bony compression of neural structures
• Pathologic fracture or impending fracture needing surgical fixation
• Prior surgery to the spine at the current level of interest or overlapping location
• More than 25% spinal canal compromise

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Pain reduction</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• Comparison of the time to response between the randomization arms<br /><br>• Comparison of the time to progression between the randomization arms<br /><br>• Comparison of the quality of life between the randomization arms<br /><br>• Comparison of the toxicity according to CTC-AE 4 criteria between the<br /><br>randomization arms<br /><br>• Comparison of the incidence of radiation induced fracture between the<br /><br>randomization arms<br /><br>• Comparison of the difference in primary endpoint between patients with<br /><br>oligometastases and other patients<br /><br>• Comparison of the difference in primary endpoint between patients surviving<br /><br>more or less than 12 weeks</p><br>