The purpose of this study is to find out if SBRT is better than CRT at controlling pain in the spine 3 months after receiving treatment.
This research is being done because while there is some evidence suggesting that SBRT may improve treatment for patients with spine metastases, more research is needed to determine if it is better than CRT. The first part of the randomized trial (phase II) looked at whether it was possible (feasible) to provide these treatments in cancer centres across Canada, by aiming to recruit 54 participants within 18 months. This part of the study was successfully completed in early 2017. The second component of this study, called a randomized phase III trial, is now underway. It involves recruiting another 124 participants to receive either CRT or SBRT, using the same study procedure as in the feasibility study. We will continue to obtain information about whether SBRT is better than CRT at controlling pain.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
229
Auckland City Hospital
Grafton, Aucklund, Australia
Phase III: Complete Pain Response at 3 Months Post-radiation
A Complete Pain Response is defined as a pain score of zero (0) at the treated site with no concomitant increase in analgesic intake (stable or reducing analgesics in daily oral morphine equivalent) .
Time frame: 3 months
Complete Pain Response at 6 Months Post Radiation Based on the International Bone Metastases Consensus Working Party Criteria
A Complete Pain Response is defined as a pain score of zero (0) at the treated site with no concomitant increase in analgesic intake (stable or reducing analgesics in daily oral morphine equivalent) .
Time frame: 6 months post radiation
Radiation Site Progression-free Survival Rate at 6 Months Using MRI Imaging
Radiation site progression was defined as: * Gross unequivocal increase in tumor volume or linear dimension \> 20%. * Any new or progressive tumor within the epidural space. * Neurologic deterioration attributable to pre-existing epidural disease with equivocal increased epidural disease dimensions on MRI.
Time frame: 6 months.
Overall Survival Rate at 6 Months
Proportion of participants who were alive at 6 months in study.
Time frame: 6 months post radiation
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