Spinal MetastasesBLENDNCT05575323
Randomized Trial on Same-day SBRT and Surgical Stabilization for Symptomatic Spinal Metastases
A study testing Same-day SBRT and spinal surgery in people with Spinal Metastases, run by UMC Utrecht at 1 site in Netherlands.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Metastases
- What is being tested?
- Same-day SBRT and spinal surgery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteNetherlands
- Study dates
- 15 Oct 2022to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Fit for (radio)surgery
- Age >18 years
- Written informed consent
Who cannot join
- 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
- Neurological deficits (ASIA C, B or A), or partial neurological deficits (ASIA D) with rapid progression (hours to days)
- Treated with Bevacizumab and other medication with long half-life that interferes with radiotherapy
- Life expectancy of less than 3 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Eline Huele, MSc contact
Netherlands1 site, 1 recruiting
- Recruiting
University Medical Center Utrecht
Utrecht
Helena M. Verkooijen, MD, PhD, H.M.Verkooijen@umcutrecht.nl
Roxanne Gal, PhD
About this study
Official title: Stereotactic Body Radiotherapy and pedicLE Screw fixatioN During One Hospital Visit for Patients With Painful Unstable Spinal Metastases: A Randomized Trial (BLEND)
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).
Read the detailed description
Rationale: Currently, patients with unstable spinal metastases receive surgical stabilization with/without decompression followed by conventional radiotherapy (cRT) or stereotactic body radiotherapy (SBRT) as soon as wound healing allows (at least 1 week). Advancements in radiotherapy techniques makes preoperative radiotherapy possible with sparing of the soft tissues overlying the surgical field. This makes it possible to shorten or even eliminate the time interval between surgery and radiotherapy. This will result in shorter and less hospital visits, earlier pain relief from irradiation, and faster return to systemic therapy without an increase in wound complications due to the short interval between surgery and radiotherapy.
Objective: The BLEND RCT aims to evaluate the (cost-)effectiveness of same-day SBRT and surgery for the treatment of symptomatic, unstable spinal metastases on physical functioning four weeks after the start of the treatment, compared with the standard of care (surgery followed by radiotherapy, i.e., CRT or SBRT).
Study design: A phase II randomized controlled trial within the PRospective Evaluation of interventional StudiEs on boNe metastases (PRESENT) cohort including patients with bone metastases, according to the Trials within Cohorts (TwiCs) design.
Study population: Patients with symptomatic (cervical, thoracic and/or lumbar) spinal metastases and impending spinal instability requiring radiotherapy and surgical stabilization with or without decompression.
Intervention: SBRT (with active dose-sparing of the surgical site) and surgical stabilization with or without decompression within 24 hours. The control group will receive the standard of care, which is surgical stabilization with or without decompression followed by cRT or SBRT as soon as the wound is healed sufficiently.
Main study endpoints: The primary endpoint is physical functioning at four weeks after the start of the treatment. Secondary endpoints are pain response, duration of pain relief, length of hospital stay, time to return to systemic therapy, neurological deterioration, adverse events (e.g. wound complications), quality of life and survival. In addition, we will study the cost-effectiveness.
- Conditions
- Spinal Metastases
- Being tested
- Same-day SBRT and spinal surgery, Standard of care
- Keywords
- Spinal metastases, SBRT, Surgery, Same-day treatment, RCT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Same-day SBRT and spinal surgeryOther
SBRT and surgical stabilization with or without decompression within 24 hours
Standard of careOther
Surgical stabilization with or without decompression followed by cRT or SBRT as soon as the wound is healed sufficiently
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Patients will receive high dose, single fraction stereotactic body radiotherapy (SBRT) using differential dosing: 18 or 21 Gy on the metastasis. Within 24 hours after SBRT, patients will have surgical stabilization with or without decompression. Receives: Other: Same-day SBRT and spinal surgery |
| Control | Active comparator | Patients will undergo the standard of care, which is surgical stabilization with or without decompression, followed by conventional radiotherapy (cRT) or SBRT as soon as the wound is healed sufficiently. Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 4 weeks after the start of treatment
Secondary outcomes (11)
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.
Measured: at 2, 4, 6 and 8 weeks, and 3 months after the start of treatment
Duration of pain relief
Duration of pain relief as measured by the Brief Pain Inventory (BPI).
Measured: up to 3 months
Duration of hospital stay
Duration of hospital stay in days
Measured: up to 3 months
Days until return to systemic treatment
Days until return to systemic treatment
Measured: up to 12 months
Neurological deterioration
Occurrence of neurological deterioration is defined as deterioration of more than one grade on the American Spinal Cord Injury Association (ASIA) scale as measured by physical examination by a neurologists or trained ASIA physician.
Measured: up to 12 months
Change in health-related quality of life
Change in patient-reported health-related quality of life is measured by the EORTC QLQ-C15-PAL at predefined time intervals.
Measured: at 4 and 8 weeks, and 3 and 6 months after the start of treatment
Change in health-related quality of life
Change in patient-reported health-related quality of life is measured by the EORTC QLQ-BM22 at predefined time intervals.
Measured: at 4 and 8 weeks, and 3 and 6 months after the start of treatment
Local control
Local control according to routine imaging and electronic patient chart
Measured: up to 12 months
Adverse events
Adverse events are defined as any undesirable experience occurring to a patient during the study, (likely) related to the experimental treatment procedure. All adverse events during hospital stay will be evaluated using the most recent version of the National Cancer Institute Common Toxicity Criteria of Adverse Events (CTCAE; version 5.0, version 6.0 when available at the start of the study) for acute and late toxicity. All adverse events after hospital discharge reported spontaneously by the patient or observed by the investigator or research team will be recorded up to three months after the treatments.
Measured: up to 3 months
Progression free survival
Progression free survival is defined as time between treatment and first sign of progression of disease.
Measured: up to 12 months
Overall survival
Overall survival is defined as time between treatment and death from any cause.
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2022
- Study start15 Oct 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal MetastasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- Radboud University Medical Center
- Responsible party
- Principal investigator, Helena M Verkooijen, UMC Utrecht
- Investigators
- Helena M. Verkooijen, Prof, Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05575323
- Sponsor's protocol ID
- NL80847.041.22
- Acronym
- BLEND
- Status last verified
- May 2026
- First submitted
- 29 Sep 2022
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Huele EH, van der Velden JM, Kasperts N, Eppinga WSC, Grutters JPC, Suelmann BBM, Weening AA, Delawi D, Teunissen SCCM, Verkooijen HM, Verlaan JJ, Gal R. Stereotactic Body radiotherapy and pedicLE screw fixatioN During one hospital visit for patients with symptomatic unstable spinal metastases: a randomized trial (BLEND RCT) using the Trials within Cohorts (TwiCs) design. Trials. 2023 May 4;24(1):307. doi: 10.1186/s13063-023-07315-y.
PubMed 37143158
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stereotactic Body Radiotherapy and pedicLE Screw fixatioN During One Hospital Visit for Patients With Painful Unstable Spinal Metastases: A Randomized Trial (BLEND)
- ClinicalTrials.gov ID
- NCT05575323
- Acronym / sponsor ID
- BLEND / NL80847.041.22
- Conditions
- Spinal Metastases
- Keywords
- Spinal metastases, SBRT, Surgery, Same-day treatment, RCT
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- Radboud University Medical Center
- Study start
- 15 Oct 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 12 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Rationale: Currently, patients with unstable spinal metastases receive surgical stabilization with/without decompression followed by conventional radiotherapy (cRT) or stereotactic body radiotherapy (SBRT) as soon as wound healing allows (at least 1 week). Advancements in radiotherapy techniques makes preoperative radiotherapy possible with sparing of the soft tissues overlying the surgical field. This makes it possible to shorten or even eliminate the time interval between surgery and radiotherapy. This will result in shorter and less hospital visits, earlier pain relief from irradiation, and faster return to systemic therapy without an increase in wound complications due to the short interval between surgery and radiotherapy.
Objective: The BLEND RCT aims to evaluate the (cost-)effectiveness of same-day SBRT and surgery for the treatment of symptomatic, unstable spinal metastases on physical functioning four weeks after the start of the treatment, compared with the standard of care (surgery followed by radiotherapy, i.e., CRT or SBRT).
Study design: A phase II randomized controlled trial within the PRospective Evaluation of interventional StudiEs on boNe metastases (PRESENT) cohort including patients with bone metastases, according to the Trials within Cohorts (TwiCs) design.
Study population: Patients with symptomatic (cervical, thoracic and/or lumbar) spinal metastases and impending spinal instability requiring radiotherapy and surgical stabilization with or without decompression.
Intervention: SBRT (with active dose-sparing of the surgical site) and surgical stabilization with or without decompression within 24 hours. The control group will receive the standard of care, which is surgical stabilization with or without decompression followed by cRT or SBRT as soon as the wound is healed sufficiently.
Main study endpoints: The primary endpoint is physical functioning at four weeks after the start of the treatment. Secondary endpoints are pain response, duration of pain relief, length of hospital stay, time to return to systemic therapy, neurological deterioration, adverse events (e.g. wound complications), quality of life and survival. In addition, we will study the cost-effectiveness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Same-day SBRT and spinal surgeryPatients will receive high dose, single fraction stereotactic body radiotherapy (SBRT) using differential dosing: 18 or 21 Gy on the metastasis. Within 24 hours after SBRT, patients will have surgical stabilization with or without decompression. |
| Control | Active comparator | Other: Standard of carePatients will undergo the standard of care, which is surgical stabilization with or without decompression, followed by conventional radiotherapy (cRT) or SBRT as soon as the wound is healed sufficiently. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
- Fit for (radio)surgery
Key exclusion criteria (7 listed)
- 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
- Neurological deficits (ASIA C, B or A), or partial neurological deficits (ASIA D) with rapid progression (hours to days)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Same-day SBRT and spinal surgerySBRT and surgical stabilization with or without decompression within 24 hours | Other | Intervention |
| Standard of careSurgical stabilization with or without decompression followed by cRT or SBRT as soon as the wound is healed sufficiently | Other | Control |
Primary outcome
Physical functioning
Time frame: at 4 weeks after the start of treatment
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.
11 secondary outcomes
Pain response
Time frame: at 2, 4, 6 and 8 weeks, and 3 months after the start of treatment
Duration of pain relief
Time frame: up to 3 months
Duration of hospital stay
Time frame: up to 3 months
Days until return to systemic treatment
Time frame: up to 12 months
Neurological deterioration
Time frame: up to 12 months
Change in health-related quality of life
Time frame: at 4 and 8 weeks, and 3 and 6 months after the start of treatment
Change in health-related quality of life
Time frame: at 4 and 8 weeks, and 3 and 6 months after the start of treatment
Local control
Time frame: up to 12 months
Adverse events
Time frame: up to 3 months
Progression free survival
Time frame: up to 12 months
Overall survival
Time frame: up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Derived from this study: PubMed 37143158Huele EH, van der Velden JM, Kasperts N, Eppinga WSC, Grutters JPC, Suelmann BBM, Weening AA, Delawi D, Teunissen SCCM, Verkooijen HM, Verlaan JJ, Gal R. Stereotactic Body radiotherapy and pedicLE screw fixatioN During one hospital visit for patients with symptomatic unstable spinal metastases: a randomized trial (BLEND RCT) using the Trials within Cohorts (TwiCs) design. Trials. 2023 May 4;24(1):307. doi: 10.1186/s13063-023-07315-y.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eline Huele, MSc contact
Helena M. Verkooijen, Prof principal investigator
UMC Utrecht
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Same-day SBRT and spinal surgery in people with Spinal Metastases, run by UMC Utrecht at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Roxanne Gal, PhD (+31 88 75 69624, R.Gal@umcutrecht.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical functioning (time frame: at 4 weeks after the start of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05575323, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.