Actively Recruiting
Surgery for Limited Spine Metastases Followed by Conventional Radiotherapy or Stereotactic Body Radiation Therapy
Led by National Taiwan University Hospital · Updated on 2024-02-06
111
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating treatment options for patients with limited spine metastases from solid cancers. This trial compares total spondylectomy followed by conventional radiotherapy with debulking surgery followed by either conventional radiotherapy or stereotactic body radiation therapy (SBRT). The main goal is to assess local control of the cancer at one year after surgery. Participants will be randomly assigned to one of three groups: total spondylectomy followed by conventional radiotherapy (20 Gy in 5 fractions), debulking surgery followed by conventional radiotherapy (20 Gy in 5 fractions), or debulking surgery followed by SBRT (24 Gy in 12 fractions). Total spondylectomy involves complete removal of the affected spine segment, while debulking surgery involves partial removal. Radiation treatments are delivered after surgery according to the assigned group. During the study, patients will undergo regular assessments including quality of life evaluations, pain control measurements, and monitoring for treatment-related side effects every three months up to one year after surgery. Researchers will also track overall survival and local control at 12 months. Participants will have preoperative MRI scans and follow-up visits to monitor progress and safety throughout the study period, which started in August 2022 and is expected to continue until July 2027.
CONDITIONS
Brief Title
Post Operative RT for Limited Spine Metastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with confirmed solid cancer and limited spine metastases suitable for spondylectomy or debulking surgery
- Maximum of two continuous spine levels needing surgery; other spine metastases allowed if 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 0-2 (ECOG 3-4 due to cord compression allowed after physician assessment)
- No prior radiotherapy to the spine area being treated
- Women of childbearing potential must use effective contraception
- Ability to comply with study protocol and follow-up schedules
- Provide informed consent
You will not qualify if you...
- Prior radiotherapy to the spine area being treated
- Unable to have gadolinium-enhanced MRI due to pacemaker, metal implants, or impaired kidney function preventing contrast CT
- Diagnosis of blood cancers or primary spine tumors
- Unable to tolerate radiotherapy immobilization
- Severe active medical conditions that interfere with safety or study compliance, including uncontrolled infections requiring IV antibiotics, recent heart attack within 6 months, dangerous heart rhythm problems, liver failure with jaundice or clotting issues, respiratory illness requiring hospitalization, or uncontrolled psychiatric disorders
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to several days post surgery
Participants undergo either spondylectomy or debulking surgery to remove spine metastases followed by immediate post-operative care.
1 surgery visit and immediate post-operative care
Duration - Radiotherapy delivered in 5 to 12 fractions over several days
Participants receive radiation therapy after surgery, either conventional radiotherapy or stereotactic body radiation therapy (SBRT), depending on their assigned group.
5 to 12 visits for radiotherapy sessions
Duration - Up to 12 months post surgery
Participants are followed for up to 12 months after surgery to monitor local control, overall survival, pain control, quality of life, and treatment-related toxicity.
Visits every 3 months for assessments up to 1 year
Trial Site Locations
Total: 1 location
1
National Taiwan University Hospital
Taipei, Taiwan, 100
Actively Recruiting
Research Team
W
Wen Chi Yang
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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