Spinal Metastases Clinical Trial
— BLENDOfficial 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).
Status | Recruiting |
Enrollment | 100 |
Est. completion date | June 30, 2027 |
Est. primary completion date | June 30, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Netherlands | University Medical Center Utrecht | Utrecht |
Lead Sponsor | Collaborator |
---|---|
UMC Utrecht | Radboud University Medical Center |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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. | up to 12 months | |
Primary | 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 | 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. | at 2, 4, 6 and 8 weeks, and 3 months after the start of treatment | |
Secondary | Duration of pain relief | Duration of pain relief as measured by the Brief Pain Inventory (BPI). | up to 3 months | |
Secondary | Duration of hospital stay | Duration of hospital stay in days | up to 3 months | |
Secondary | Days until return to systemic treatment | Days until return to systemic treatment | up to 12 months | |
Secondary | 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. | up to 12 months | |
Secondary | 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. | at 4 and 8 weeks, and 3 and 6 months after the start of treatment | |
Secondary | 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. | at 4 and 8 weeks, and 3 and 6 months after the start of treatment | |
Secondary | Local control | Local control according to routine imaging and electronic patient chart | up to 12 months | |
Secondary | 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. | up to 3 months | |
Secondary | Progression free survival | Progression free survival is defined as time between treatment and first sign of progression of disease. | up to 12 months | |
Secondary | Overall survival | Overall survival is defined as time between treatment and death from any cause. | up to 12 months |
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