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).
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
SBRT and surgical stabilization with or without decompression within 24 hours
Surgical stabilization with or without decompression followed by cRT or SBRT as soon as the wound is healed sufficiently
University Medical Center Utrecht
Utrecht, Netherlands
RECRUITINGPhysical 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 treatment
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 treatment
Duration of pain relief
Duration of pain relief as measured by the Brief Pain Inventory (BPI).
Time frame: up to 3 months
Duration of hospital stay
Duration of hospital stay in days
Time frame: up to 3 months
Days until return to systemic treatment
Days until return to systemic treatment
Time frame: 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.
Time frame: up to 12 months
Change in health-related quality of life
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Change in patient-reported health-related quality of life is measured by the EORTC QLQ-C15-PAL at predefined time intervals.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: up to 3 months
Progression free survival
Progression free survival is defined as time between treatment and first sign of progression of disease.
Time frame: up to 12 months
Overall survival
Overall survival is defined as time between treatment and death from any cause.
Time frame: up to 12 months