Randomized Trial on Same-day SBRT and Surgical Stabilization for Symptomatic Spinal Metastases

NCT05575323 | Recruiting DMC

• 1 other identifier: NL80847.041.22
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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 radiotherapy as soon as the wound healed sufficiently).

Conditions

Spinal Metastases

Keywords

Spinal metastases; SBRT; Surgery; Same-day treatment; RCT

Outcome Measures

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.

  at 4 weeks after the start of treatment

Secondary Outcomes (11)

• Pain response

  at 2, 4, 6 and 8 weeks, and 3 months after the start of treatment

• Duration of pain relief

  up to 3 months

• Duration of hospital stay

  up to 3 months

• Days until return to systemic treatment

  up to 12 months

• Neurological deterioration

  up to 12 months

Other Outcomes (1)

• Cost-effectiveness

  up to 12 months

Study Arms (2)

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.

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.

Other: Standard of care

Interventions

Same-day SBRT and spinal surgery OTHER

SBRT and surgical stabilization with or without decompression within 24 hours

Intervention

Standard of care OTHER

Surgical stabilization with or without decompression followed by cRT or SBRT as soon as the wound is healed sufficiently

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UMC Utrecht: lead
• Radboud University Medical Center: collaborator

Study Sites (1)

University Medical Center Utrecht

Utrecht, Netherlands

RECRUITING

Related Publications (1)

• 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.

  PMID: 37143158 DERIVED

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Helena M. Verkooijen, Prof

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roxanne Gal, PhD

CONTACT

+31 88 75 69624; R.Gal@umcutrecht.nl

Eline Huele, MSc

CONTACT

E.H.Huele-3@umcutrecht.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: According to the TwiCs design, patients allocated to the control group are not informed about their role as a control in the trial.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. H.M. Verkooijen

Study Record Dates

• First Submitted: September 29, 2022
• First Posted: October 12, 2022
• Study Start: October 15, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: April 3, 2025

Record last verified: 2025-03

Locations

NL (1)