To evaluate patients with limited spine metastases treated with total spondylectomy followed by conventional radiotherapy or debulking surgery followed by SBRT or conventional RT. The study primary endpoint is one year local control.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
111
Patient will be randomized to treated by spondylectomy or debulking surgery. Spondylectomy implied total resection of involved spine; while debulking surgery means partial resection of involved spine.
Patient received debulking surgery will be randomized to receive SBRT or conventional RT. SBRT means high dose per fraction compared to conventional RT.
National Taiwan University Hospital
Taipei, Taiwan
RECRUITINGLocal control
Number of patients with locally controlled disease of index spine after intervention
Time frame: 12 months post surgery
Overall survival
Survival from treatment to death
Time frame: 12 months post surgery
pain control
using numerical pain score to assess pain
Time frame: Every 3 months up to 1 year post surgery
Quality of life assessment
EORTC QLQ-C15 PAL
Time frame: Every 3 months up to 1 year post surgery
Quality of life assessment
Spine Oncology Study Group Outcomes Questionnaire 2.0 (SOSGOQ 2.0)
Time frame: pre surgery and 1 month after surgery
Quality of life assessment
EORTC QLQ-BM22
Time frame: Every 3 months up to 1 year post surgery
Treatment related toxicity
Using Common Terminology Criteria for Adverse Events
Time frame: Every 3 months up to 1 year post surgery
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