Radiation treatment prior to surgery for local spine metastasis
- Conditions
- Metastatic solid (non-haematological) cancerous malignancies of the spine.Cancer - Any cancer
- Registration Number
- ACTRN12615001031550
- Lead Sponsor
- Epworth HealthCare
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 20
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Tolerability: The intervention will be deemed tolerable if <15% of the participants experience Grade 4 or higher toxicities (CTCAE V4.0)<br>[Toxicities will be assessed immediately after each treatment fraction, and at one month post SBRT and then every 3 months up to 24 months.];Feasibility: The intervention will be deemed a feasible approach if at least 75% of participants fulfil 3 of the 4 following criteria:<br><br>1. Able to undergo preoperative Stereotactic Body Radiotherapy (SBRT) within 36 hours of obtaining consent.<br>2. Able to undergo surgery a minimum of 7 days after SBRT.<br>3. Able to lie flat for the duration of treatment (immobilisation)<br>4. Able to achieve a SBRT plan that meets the pre defined requirement in terms of target coverage and spinal cord tolerance.[SBRT will be delivered to the affected spinal segment within 36 hours of obtaining patient consent. Patients will proceed to surgery a minimum of 7 days after the last day of SBRT treatment.]
- Secondary Outcome Measures
Name Time Method Change in pain from baseline (Numerical Rating Pain Scale)[1, 3, 6, 12, 15, 18, 21 and 24 months following SBRT];Change in neurological status from baseline (RTOG 0631)[1, 3, 6, 12, 15, 18, 21 and 24 months following SBRT]