Actively Recruiting
Post Operative RT for Limited Spine Metastases
Led by National Taiwan University Hospital · Updated on 2024-02-06
111
Participants Needed
1
Research Sites
256 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Post Operative RT for Limited Spine Metastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with pathologically confirmed solid cancer and limited spine metastases suitable for spondylectomy or debulking surgery
- Maximum of two continuous spine levels requiring surgery, with allowance for other spine metastases not needing surgery
- Preoperative gadolinium-enhanced MRI obtained within 8 weeks before enrollment
- Age 20 years or older
- Life expectancy of at least 6 months
- ECOG performance status between 0 and 2, or ECOG 3-4 related to cord compression after physician assessment
- No prior radiotherapy to the index spine levels
- Women of childbearing potential must use adequate contraception
- Ability to comply with study procedures and provide informed consent
You will not qualify if you...
- Prior radiotherapy to the index spine levels
- Inability to undergo gadolinium-enhanced MRI or contrast-enhanced CT due to pacemaker, metal implants, or impaired kidney function
- Diagnosis of hematological cancer or primary spine tumor
- Inability to tolerate radiotherapy immobilization
- Severe active comorbidities such as uncontrolled infection, recent myocardial infarction within 6 months, life-threatening arrhythmias, hepatic insufficiency with jaundice or coagulation defects, severe respiratory illness needing hospitalization, or uncontrolled psychiatric disorders
- Pregnant or breastfeeding women
AI-Screening
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Trial Site Locations
Total: 1 location
1
National Taiwan University Hospital
Taipei, Taiwan, 100
Actively Recruiting
Research Team
W
Wen Chi Yang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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