Randomized Trial on Same-day SBRT and Surgical Stabilization for Symptomatic Spinal Metastases
ConditionSpinal Metastases
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUMC Utrecht
About this trial
The BLEND RCT aims to evaluate the (cost-)effectiveness of same-day SBRT and surgical stabilization with or without decompression for the treatment of symptomatic, unstable spinal metastases on physical functioning four weeks after the start of treatment, compared with the standard of care (surgery followed by radiotherapy as soon as the wound healed sufficiently).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Symptomatic (cervical, thoracic and/or lumbar) spinal metastases from solid tumors and (impending) spinal instability requiring radiotherapy and surgical decompression and/or 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
Disqualifiers
SBRT cannot be delivered, e.g. in patients who cannot lie on the treatment table because of pain
Routine surgical decompression and/or stabilization and radiotherapy cannot be performed, e.g., multiple spinal metastases requiring surgical bridging of more than five vertebral levels and/or requiring radiotherapy on more than one location
Prior surgery or radiotherapy to the index level(s)
Multiple myeloma
Trial design
Design model
Parallel
Treatments tested in this trial
Same-day SBRT and spinal surgery
Other interventionSBRT and surgical stabilization with or without decompression within 24 hours
Standard of care
Other interventionSurgical stabilization with or without decompression followed by cRT or SBRT as soon as the wound is healed sufficiently
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: InterventionExperimental treatment 1 intervention
Group B: ControlActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Physical functioning
Physical functioning is a functional scale from the EORTC QLQ-C15-PAL questionnaire. Patients rate each item on a 4-point Likert scale ranging from 1 (not at all) to 4 (very much), and scale scores were linearly transformed to a 0-100 scale. A higher score on the functional scale indicates better functioning.
Time frame
at 4 weeks after the start of treatmentSecondary outcomes
1
Pain response
Pain response is defined as 1) a decline in worst pain score of at least two points on an NRS of ten at the treated site without increase in analgesic use, or 2) an analgesic decrease of at least 25% without an increase in pain score. Worst pain score will be measured with the Brief Pain Inventory.
Time frame
at 2, 4, 6 and 8 weeks, and 3 months after the start of treatment2
Duration of pain relief
Duration of pain relief as measured by the Brief Pain Inventory (BPI).
Time frame
up to 3 months3
Duration of hospital stay
Duration of hospital stay in days
Time frame
up to 3 months4
Days until return to systemic treatment
Days until return to systemic treatment
Time frame
up to 12 monthsOther outcomes
1
Cost-effectiveness
If same-day SBRT and surgery is more costly and more effective than the standard of care, an incremental cost-effectiveness ratio (ICER) will be calculated by dividing the extra QALYs by the extra effects. This will give an estimation of the extra costs that are needed to gain one QALY. If this is below the cost-effectiveness threshold, same-day SBRT and surgery is deemed cost-effective. If either same-day SBRT and surgery or the standard of care is less costly and more effective than its alternative, it dominates this alternative and no ICER is necessary to determine cost-effectiveness.
Time frame
up to 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
UMC Utrecht
Lead sponsor
Radboud University Medical Center
Collaborator
Source ClinicalTrials.gov