Our aim is to study whether the pain response after three months in patients with bone metastatic disease increases after SBRT in comparison to low dose EBRT.
ID
Source
Brief title
Condition
- Bone disorders (excl congenital and fractures)
- Metastases
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is pain control at three months after radiotherapy.
Secondary outcome
Secondary outcomes are the occurence of vertebral compression fracture (VCF)
and radiation induced myelopathy in spinal metastases, evaluation of local
tumour control and toxicity after SBRT, measurement of duration and rapidity of
pain relief, evaluation of quality of life, and evaluation of progression free
and overall survival.
Background summary
Bone metastases are a frequent distant manifestation of solid tumours, the most
common areas include spine, pelvis, ribs and long bones of the upper and lower
extremities. Patients with bone metastases mostly present with severe pain
which reduces quality of life. The primary treatment for pain management is a
single-fraction low dose external beam radiation therapy (EBRT), effective in
achieving pain reduction in around 60% of patients, of whom 0-23% experience
complete pain response. Recently, there is growing evidence that Stereotactic
Body Radiotherapy (SBRT) achieves a much higher pain response due to the higher
dose administered. In retrospective and a few prospective case series, SBRT for
bone metastases has been demonstrated to be safe, and efficacious. However, no
randomized controlled trials have been performed.
Study objective
Our aim is to study whether the pain response after three months in patients
with bone metastatic disease increases after SBRT in comparison to low dose
EBRT.
Study design
We set up a randomized controlled trial, nested within the PRESENT cohort.
Intervention
Patients will undergo MRI-based, cone beam CT-guided SBRT and will receive a
single dose of 18 Gray (Gy) on the visible metastasis, and 8 Gy on the bony
compartment containing the metastasis (e.g. the affected vertebra or pedicle),
or an equivalent fractionation schedule.
Study burden and risks
Patients who undergo SBRT may benefit from a more substantial pain response
after SBRT. However, SBRT treatment time is longer than EBRT treatment time and
in this study SBRT patients have to undergo 2 additional MRI scans which will
last 15 minutes. There are no severe compications described for non-spine bone
metastases. Furthermore, the two complications secondary to spine SBRT that
must be discussed with the patient in order to ensure informed consent are VCF
and radiation myelopathy. Since these patients are participants in the PRESENT
cohort, and have already provided informed consent to fill out questionnaires
on Patients Reported Outcomes, filling out questionnaires is not an additional
burden to the patient.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
Radiographic evidence of bone metastases;
Per spinal lesion no more than 3 consecutive spine segments involved with one unaffected vertebral body above and below;
No more than 2 painful lesions needing treatment;
Histologic proof of malignancy;
No compression of spinal cord;
No or mild neurological signs (i.e. radiculopathy, dermatomal sensory change, and muscle strength of involved extremity is Medical Research Counsil (MRC) 4/5);
Medically inoperable or patient refused surgery;
Karnofsky performance score (KPS) * 50;
Numeric rating scale (NRS) * 3;
Age * 18 years;
Written informed consent;
Filling out PRESENT-questionnaires.
Exclusion criteria
General exclusion criteria:
Radiosensitive histology such as multiple myeloma, lymphoma, small cell and germ cell;
MRI cannot be completed for any reason (in according with the MRI protocol of the Department of Radiology);
Impossible to delineate metastasis and organs at risk (OAR) due to artefacts on CT or MRI from previous surgical stabilisation;
Unable to undergo SBRT treatment, according to treating doctor*s opinion;
Severe, worsening or progressive neurological deficit;
Unstable bone requiring surgical stabilization;
Patient with < 3 months life expectancy;
Previous EBRT or SBRT to same location with bone metastases as target volume;
Chemotherapy or systemic radionuclide delivery within 24 hours before and after SBRT;
Patients with oligometastases who are selected for SBRT after multidisciplinary consultation;
Maximum diameter of target volume > 10 cm;
Extension of the tumour to the skin. ;Spinal metastases specific exclusion criteria:
Lesion in C1 and C2;
Epidural disease.;Specific exclusion criteria for bone metastases in the extremities:
Fixation material in target volume;
Impending fracture (if surgery or stabilisation is an option).
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 |
|---|---|
| ClinicalTrials.gov | NCT02364115 |
| CCMO | NL49316.041.14 |