Spine Metastases
Conditions
Keywords
Stereotactic body radiotherapy, Spondylectomy, Separation surgery
Brief summary
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.
Interventions
PROCEDURESpondylectomy
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.
RADIATIONSBRT
Patient received debulking surgery will be randomized to receive SBRT or conventional RT. SBRT means high dose per fraction compared to conventional RT.
Sponsors
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients who had pathologically proved solid cancer, with radiographic evident limited spine metastases indicative and feasible for spondylectomy or debulking surgery. 2. Patients with maximum two continuous level of spine metastases need for surgery are eligible. Patients who have other spine metastases but not necessary for surgery are allowed. 3. A preoperative gadolinium enhance MRI should be obtained up to 8 weeks before enrollment. 4. Patients aged at least 20 years old are eligible. 5. Life expectancy of ≥ 6 months. 6. ECOG performance status 0-2 (ECOG 3-4 related to cord compression can be enrolled after physician assessment) 7. No prior RT to the index spine level(s) 8. Women of childbearing potential must practice adequate contraception 9. Patients must be able to comply with the study protocol and follow-up schedules and provide study-specific informed consent.
Exclusion criteria
1. Patients received prior radiotherapy to the index spine level. 2. 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. 3. Patients who have hematological cancer or primary spine tumor will be excluded for enrolment. 4. Patients who cannot tolerate radiotherapy immobilization. 5. 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: 1. Uncontrolled active infection requiring intravenous antibiotics at the time of registration 2. Transmural myocardial infarction ≤ 6 months prior to registration. 3. Life-threatening uncontrolled clinically significant cardiac arrhythmias. 4. Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects. 5. Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration. 6. Uncontrolled psychiatric disorder. 6. Pregnant or breast-feeding women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Local control | 12 months post surgery | Number of patients with locally controlled disease of index spine after intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 12 months post surgery | Survival from treatment to death |
| pain control | Every 3 months up to 1 year post surgery | using numerical pain score to assess pain |
| Quality of life assessment | Every 3 months up to 1 year post surgery | EORTC QLQ-C15 PAL |
| Treatment related toxicity | Every 3 months up to 1 year post surgery | Using Common Terminology Criteria for Adverse Events |
Countries
Taiwan
Contacts
Primary ContactWen Chi Yang
Outcome results
None listed