Radiation treatment prior to surgery for local spine metastasis
A Phase II Study for the Treatment of Localised Spine Metastasis: Assessing the Safety and Efficacy of Image Guided Radiosurgery prior to Surgical Stabilisation.
Epworth HealthCare
20 participants
Jul 3, 2017
Interventional
Conditions
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.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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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 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.
Locations(2)
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ACTRN12615001031550