National Taiwan University Hospital
Taipei, 100, Taiwan
Location status: Recruiting
NCT Number: NCT05495399
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.
Interested in participating?
Request Info20 year and older
All sexes
Interventional
Not applicable
Taipei, 100, Taiwan
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 12 months post surgery
Number of patients with locally controlled disease of index spine after intervention
Time frame: 12 months post surgery
Survival from treatment to death
Time frame: Every 3 months up to 1 year post surgery
using numerical pain score to assess pain
Time frame: Every 3 months up to 1 year post surgery
EORTC QLQ-C15 PAL
Time frame: pre surgery and 1 month after surgery
Spine Oncology Study Group Outcomes Questionnaire 2.0 (SOSGOQ 2.0)
Time frame: Every 3 months up to 1 year post surgery
EORTC QLQ-BM22
Time frame: Every 3 months up to 1 year post surgery
Using Common Terminology Criteria for Adverse Events
Contact information is provided by the study sponsor or research team.
National Taiwan University Hospital
Other
Surgery for Limited Spine Metastases Followed by Conventional Radiotherapy or Stereotactic Body Radiation Therapy
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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