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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spondylectomy with Conventional RT | Experimental | Spondylectomy for involved spine level followed by conventional RT 20Gy in 5 fractions |
|
| Debulking surgery with Conventional RT | Active Comparator | Debulking surgery for involved spine level followed by conventional RT 20Gy in 5 fractions |
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| Debulking surgery with SBRT | Experimental | Debulking surgery for involved spine level followed by SBRT 24Gy in 12 fractions |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spondylectomy | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Local control | Number of patients with locally controlled disease of index spine after intervention | 12 months post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Survival from treatment to death | 12 months post surgery |
| pain control | using numerical pain score to assess pain | Every 3 months up to 1 year post surgery |
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Inclusion Criteria:
Exclusion Criteria:
Patients received prior radiotherapy to the index spine level.
Patients who cannot receive Gadolinium enhanced MRI due to pacemaker or metal implant or who cannot receive contrast enhanced CT scan due to impaired renal function.
Patients who have hematological cancer or primary spine tumor will be excluded for enrolment.
Patients who cannot tolerate radiotherapy immobilization.
Severe, active comorbidities which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and adverse events of the protocol, or limit compliance with study requirements, defined as follows:
Pregnant or breast-feeding women
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wen Chi Yang | Contact | +886223123456 | claireds23@ntuh.gov.tw |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Recruiting | Taipei | 100 | Taiwan |
IPD sharing required by other researchers will be discussed in institution
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| SBRT | Radiation | Patient received debulking surgery will be randomized to receive SBRT or conventional RT. SBRT means high dose per fraction compared to conventional RT. |
|
| Quality of life assessment | EORTC QLQ-C15 PAL | Every 3 months up to 1 year post surgery |
| Quality of life assessment | Spine Oncology Study Group Outcomes Questionnaire 2.0 (SOSGOQ 2.0) | pre surgery and 1 month after surgery |
| Quality of life assessment | EORTC QLQ-BM22 | Every 3 months up to 1 year post surgery |
| Treatment related toxicity | Using Common Terminology Criteria for Adverse Events | Every 3 months up to 1 year post surgery |