None listed
Conditions
Brief summary
The primary purpose of this study is to determine whether Stereotactic Body Radiotherapy (SBRT) given prior to surgery is technically feasible and clinically safe for the treatment of patients with localised spine metastases. Who is it for? You may be eligible to join this study if you are aged 18 to 85 years, have any non-haematological cancer type, and have been diagnosed with spinal metastases in the past 4 weeks for which spinal surgery has been prescribed. Study details: SBRT is a type of radiation therapy in which a few, very high, doses of radiation are very accurately delivered to a small, well-defined target area. It is normally delivered after surgery in the treatment of spinal metastases however this approach has a number of drawbacks. In this study, all participants will receive radiation treatment at least 7 days before surgery, with doses ranging between 16 – 24 Gy over 1-2 days. Patients will be assessed for signs of toxicity and pain at 1 then 3 monthly intervals for 2 years following the SBRT treatment. It is hoped that the findings of this trial will aid understanding of whether it is technically possible, and safe, to deliver SBRT prior to surgery for spinal metastases, in place of the current standard care in which SBRT is delivered following surgery.
Interventions
Participants will undergo stereotactic body radiotherapy (SBRT) within 36 hours of being consented for the study. Participants will proceed to spinal surgery at least 7 days following the last SBRT treatment fraction.
Participants will receive either:
1) 16 Gy in a single fraction (radiosensitive histology);
2) 18 Gy in a single fraction (radioresistant histology); or
3) 24 Gy in two fractions, at one fraction per day, over two consecutive days in the same week (Mon to Fri) when spinal cord co
Participants will undergo stereotactic body radiotherapy (SBRT) within 36 hours of being consented for the study. Participants will proceed to spinal surgery at least 7 days following the last SBRT treatment fraction. Participants will receive either: 1) 16 Gy in a single fraction (radiosensitive histology); 2) 18 Gy in a single fraction (radioresistant histology); or 3) 24 Gy in two fractions, at one fraction per day, over two consecutive days in the same week (Mon to Fri) when spinal cord constraints cannot be met for 16 or 18 Gy plans. The dose prescription and fractionation will be decided by the referring radiation oncologist based on cancer histology, tumour location and other factors. All treatments will be planned off a single simulation CT scan, and treatment will be delivered using daily kV orthogonal imaging with 6D correction and cone-beam computed tomography. Participant adherence will be monitored through the departmental record and verify system.
Sponsors
Epworth HealthCare
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
Males or females aged 18 to 85 (inclusive). Histological diagnosis of a non-haematological malignancy. Radiological (MRI or CT within 4 weeks) diagnosis of spinal metastases (C1-L5) who require surgery. TOKUHASHI score of 9 or above. Karnovsky performance score (KPS) > 70%. Maximum involvement of two contiguous spinal levels. Muscle power greater than 3/5. Baseline NRPS greater or equal to 4 assessed within 36 hours prior to registration. Ability to lie supine. Women with child-bearing potential must have a negative serum pregnancy test and practice adequate contraception.
Exclusion criteria
Participants with rapidly progressive neurological symptoms. Previous irradiation to the same spinal level. Non-ambulatory status. > 2 contiguous vertebral bodies involved. > 2 treatment sites. Predefined spinal cord tolerances cannot be met. Chemotherapy or other systemic treatment <3 weeks prior to SBRT. Taxane or Anthracycline containing chemotherapy < 4 weeks prior to, or concurrent with, SBRT. Contraindications to radiological imaging and surgical intervention.
Outcome results
None listed