To evaluate the (cost-)effectiveness of SBRT (with active dose-sparing of the surgical site) followed by surgical stabilization with or without decompression within 24 hours for the treatment of symptomatic, unstable metastases of the cervical,…
ID
Source
Brief title
Condition
- Metastases
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Physical functioning, four weeks after the start of the treatment, which is a
functional scale from the EORTC QLQ-C15-PAL questionnaire.
Secondary outcome
Secondary goals are to compare the 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 between intervention and control. In addition, we will study the
cost-effectiveness.
Background summary
With improved survival rates, more patients will develop bone metastases, with
the spine as the most common site for metastases. Spinal metastases can lead to
devastating consequences including progressive, unremitting pain, and
paralysis, and significantly impairs the patients* daily functioning and health
related quality of life (HRQOL). Currently, patients with unstable spinal
metastases receive surgical stabilization with or without decompression
followed by CRT or SBRT after a time interval of 7 to 14 days (as soon as the
wound is healed sufficiently) to prevent wound complications. However, this
approach delays radiotherapy-induced pain relief and return to systemic
therapy. In addition, surgical implants may cause imaging artefacts and may
limit the dose behind the implants. Advancements in radiotherapy techniques
makes stereotactic body radiation therapy (SBRT) possible. SBRT enables the
delivery of high-dose radiation precisely to the spinal metastasis while
keeping the dose to the spinal cord and surrounding tissues, including the
surgical area, low. As a result, the risk of wound complications is reduced and
both treatments can be performed within a single hospital visit. This will
result in earlier pain relief from irradiation and faster return to systemic
therapy. The benefits are substantial, considering the relatively short life
expectancy of these patients.
Study objective
To evaluate the (cost-)effectiveness of SBRT (with active dose-sparing of the
surgical site) followed by surgical stabilization with or without decompression
within 24 hours for the treatment of symptomatic, unstable metastases of the
cervical, thoracic and/or lumbar spine on physical functioning after four
weeks, compared with the standard of care (control arm; surgical stabilization
with or without decompression followed by radiotherapy, i.e., CRT or SBRT).
Study design
This randomized controlled trial will be performed 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. From patients who meet the pre-specified in- and exclusion
criteria for the current study and who have provided informed consent for
PRESENT, including randomization into future intervention studies, we randomly
select patients on a 1:1 basis for the intervention arm. These patients will
receive detailed information about the experimental treatment procedure, which
they can accept or refuse to undergo. Informed consent is obtained from those
patients accepting the intervention. Patients who were eligible but not
selected for the intervention arm (i.e., control arm), will not be notified
about the trial and their cohort data will be used comparatively. They are,
however, aware of the fact that their clinical data and patient reported
outcomes will be used for (comparative) research and they have given informed
consent for that. These patients, as well as patients who refused to undergo
the intervention, will receive the standard of care.
Intervention
Same-day SBRT and surgical stabilization with or without decompression.
Study burden and risks
Both irradiation and surgical techniques are the current standard of care for
patients with unstable spinal metastases and have been proven to be safe and
effective in isolation. Both treatments are commonly practiced in our hospital.
The preceding First-In-Man study demonstrated that delivery of single fraction
SBRT followed by surgical stabilization with or without decompression within 24
hours is safe and feasible for the treatment of unstable spinal metastases.
Also, no wound complications were observed.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
• Symptomatic (cervical, thoracic and/or lumbar) spinal metastases and
impending spinal instability requiring radiotherapy and surgical 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
• Surgery cannot be performed, e.g., multiple spinal metastases requiring
surgical bridging of more than five vertebral levels
• Prior surgery or radiotherapy to the index levels
• Neurological deficits (ASIA C, B or A), or partial neurological deficits
(ASIA D) with rapid progression (hours to days)
• Life expectancy of less than 3 months
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL80847.041.22 |