Neoplasm Metastasis
Conditions
Keywords
First in man, Spinal metastases, Stereotactic bodyradiotherapy, Palliative care, Safety, Surgical stabilisation
Brief summary
The aim of this study is to assess the feasibility and safety of combining stereotactic body radiotherapy (SBRT) and pedicle screw fixation in a 48-hour window for the treatment of painful unstable metastases of the thoracic and/or lumbar spine.
Detailed description
Rationale: Sixty-five percent of cancer patients with terminal illness have bone metastases, with debilitating pain as devastating consequence. The spine is the most common location for bone metastases. Spinal cord compression is present in 10% of patients with vertebral metastases and aggravates pain and performance status even further. Standard treatment of unstable vertebral metastases consists of stabilizing surgery, followed by external beam radiotherapy (8 Gy) after two weeks. Although this approach is effective in 60-70% of patients, it is has several downsides. Firstly, because of the two weeks interval between surgery and external beam radiotherapy, necessary for sufficient wound healing, it takes a long time before radiotherapy induced pain relief is achieved. Scatter artifacts on planning computed tomography images caused by surgical implants prohibit high-resolution imaging and accurate targeting of the lesion. Multiple hospital visits (+/- 10) are needed for administration of external beam irradiation, and in about 30-40% of patients no adequate pain response is achieved. An alternative treatment strategy, which would lead to faster pain relief in a higher proportion of patients with less hospital visits, would be highly desirable from the patient's perspective. Objective: To assess the feasibility and safety of combining stereotactic body radiotherapy (SBRT) and pedicle screw fixation in a 48-hour window for the treatment of painful unstable metastases of the thoracic and/or lumbar spine. Study design: Prospective case series (13), first in man study, Phase I and II a study according to the IDEAL recommendations Study population: All patients, male and female, with impending spinal stability requiring radiation therapy and surgical intervention at the University Medical Center Utrecht Main study parameters/endpoints: The main outcome of this study is safety of the combined procedure, defined as grade 3 or higher treatment-induced toxicity according to common terminology criteria for adverse events (CTC-AE) 4.0 as a result of the procedure within 60 days after the surgery.
Interventions
PROCEDUREBLEND
Stereotactic bodyradiotherapy and surgical stabilization within 48 hours.
Sponsors
UMC Utrecht
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Painful metastases from solid tumors in the thoracic or lumbar spine needing surgical stabilization * Histologic proof of malignancy * Radiographic evidence of spinal metastases * Karnofsky performance status ≤ 50 * Written informed consent
Exclusion criteria
* Multiple spinal metastases necessitating bridging more than five vertebral levels during surgery * Previous surgery or radiotherapy to index lesion * stereotactic body radiotherapy cannot be delivered (Bilsky score 2 and 3) * Neurological deficits (ASIA C, B or A) * Partial neurological deficits (ASIA D) with rapid progression (hours to days) * Inability to lie flat on table for stereotactic body radiotherapy * Non-ambulatory patients * Patient in hospice or with \< 3 months life expectancy * Medically inoperable or patient refused surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of adverse events | first 90 days post treatment | Occurrence of adverse events grade 3/4 according to the common terminology criteria for adverse events (CTCAE) 4.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of pain relief | first 90 days post treatment | Measurement of duration of pain relief |
| Rapidity of pain relief | first 90 days post treatment | Measurement of rapidity of pain relief |
| Hospital stay | first 90 days post treatment | Measurement of length of hospital stay |
| Pain response | first 90 days post treatment | Measurement of pain response to combined therapy according to consensus guidelines |
| Neurological status | First 90 days post treatment | Measurement of neurological deterioration |
| Quality of life | first 90 days post treatment | Evaluation of quality of life |
| Survival | Time from inclusion until date of death from any cause assessed up to 100 months | Overall survival |
| Early mortality | First 30 days post treatment | Measurement of 30 days mortality |
Countries
Netherlands
Outcome results
None listed