Randomized controlled trial comparing conVEntional RadioTherapy with stereotactIC body radiotherapy in patients with spinAL metastases

Completed

• Conditions: bone metastases; metastatic bone disease; 10005959; 10027476

• Registration Number: NL-OMON44250
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 110

Inclusion Criteria

Radiographic evidence of bone metastases;
Per spinal lesion no more than 3 consecutive spine segments involved with one unaffected vertebral body above and below;
No more than 2 painful lesions needing treatment;
Histologic proof of malignancy;
No compression of spinal cord;
No or mild neurological signs (i.e. radiculopathy, dermatomal sensory change, and muscle strength of involved extremity is Medical Research Counsil (MRC) 4/5);
Medically inoperable or patient refused surgery;
Karnofsky performance score (KPS) * 50;
Numeric rating scale (NRS) * 3;
Age * 18 years;
Written informed consent;
Filling out PRESENT-questionnaires.

Exclusion Criteria

General exclusion criteria:
Radiosensitive histology such as multiple myeloma, lymphoma, small cell and germ cell;
MRI cannot be completed for any reason (in according with the MRI protocol of the Department of Radiology);
Impossible to delineate metastasis and organs at risk (OAR) due to artefacts on CT or MRI from previous surgical stabilisation;
Unable to undergo SBRT treatment, according to treating doctor*s opinion;
Severe, worsening or progressive neurological deficit;
Unstable bone requiring surgical stabilization;
Patient with < 3 months life expectancy;
Previous EBRT or SBRT to same location with bone metastases as target volume;
Chemotherapy or systemic radionuclide delivery within 24 hours before and after SBRT;
Patients with oligometastases who are selected for SBRT after multidisciplinary consultation;
Maximum diameter of target volume > 10 cm;
Extension of the tumour to the skin. ;Spinal metastases specific exclusion criteria:
Lesion in C1 and C2;
Epidural disease.;Specific exclusion criteria for bone metastases in the extremities:
Fixation material in target volume;
Impending fracture (if surgery or stabilisation is an option).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is pain control at three months after radiotherapy. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes are the occurence of vertebral compression fracture (VCF)<br /><br>and radiation induced myelopathy in spinal metastases, evaluation of local<br /><br>tumour control and toxicity after SBRT, measurement of duration and rapidity of<br /><br>pain relief, evaluation of quality of life, and evaluation of progression free<br /><br>and overall survival.</p><br>