Clinical trial NCT05575323: Randomized Trial on Same-day SBRT and Surgical Stabilization for Symptomatic Spinal Metastases
Official title: Stereotactic Body Radiotherapy and pedicLE Screw fixatioN During One Hospital Visit for Patients With Painful Unstable Spinal Metastases: A Randomized Trial (BLEND)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Metastases
Keywords: Spinal metastases
SBRT
Surgery
Same-day treatment
RCT
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
Collaborators: name: Radboud University Medical Center
First posted: 2022-10-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Physical functioning
timeFrame: at 4 weeks after the start of treatment
Secondary outcomes:
measure: Pain response
timeFrame: at 2, 4, 6 and 8 weeks, and 3 months after the start of treatment
measure: Duration of pain relief
timeFrame: up to 3 months
measure: Duration of hospital stay
timeFrame: up to 3 months
measure: Days until return to systemic treatment
timeFrame: up to 12 months
measure: Neurological deterioration
timeFrame: up to 12 months
measure: Change in health-related quality of life
timeFrame: at 4 and 8 weeks, and 3 and 6 months after the start of treatment
measure: Change in health-related quality of life
timeFrame: at 4 and 8 weeks, and 3 and 6 months after the start of treatment
measure: Local control
timeFrame: up to 12 months
measure: Adverse events
timeFrame: up to 3 months
measure: Progression free survival
timeFrame: up to 12 months
measure: Overall survival
timeFrame: up to 12 months
Other outcomes:
measure: Cost-effectiveness
timeFrame: up to 12 months
Locations:
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
Study officials:
affiliation: UMC Utrecht
name: Helena M. Verkooijen, Prof
role: PRINCIPAL_INVESTIGATOR
References: