Post Operative RT for Limited Spine Metastases

Study Overview
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Brief Summary
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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.

Official Title
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Surgery for Limited Spine Metastases Followed by Conventional Radiotherapy or Stereotactic Body Radiation Therapy

Conditions
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Spine Metastases

Intervention / Treatment
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* Procedure: Spondylectomy
* Radiation: SBRT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who had pathologically proved solid cancer, with radiographic evident limited spine metastases indicative and feasible for spondylectomy or debulking surgery. 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. A preoperative gadolinium enhance MRI should be obtained up to 8 weeks before enrollment. Patients aged at least 20 years old are eligible. Life expectancy of ≥ 6 months. ECOG performance status 0-2 (ECOG 3-4 related to cord compression can be enrolled after physician assessment) No prior RT to the index spine level(s) Women of childbearing potential must practice adequate contraception Patients must be able to comply with the study protocol and follow-up schedules and provide study-specific informed consent. 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: Uncontrolled active infection requiring intravenous antibiotics at the time of registration Transmural myocardial infarction ≤ 6 months prior to registration. Life-threatening uncontrolled clinically significant cardiac arrhythmias. Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects. Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration. Uncontrolled psychiatric disorder. Pregnant or breast-feeding women

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spondylectomy with Conventional RT<br>Spondylectomy for involved spine level followed by conventional RT 20Gy in 5 fractions | Procedure: Spondylectomy<br>* 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.<br>|
| Active Comparator: Debulking surgery with Conventional RT<br>Debulking surgery for involved spine level followed by conventional RT 20Gy in 5 fractions | Procedure: Spondylectomy<br>* 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.<br>Radiation: SBRT<br>* Patient received debulking surgery will be randomized to receive SBRT or conventional RT. SBRT means high dose per fraction compared to conventional RT.<br>|
| Experimental: Debulking surgery with SBRT<br>Debulking surgery for involved spine level followed by SBRT 24Gy in 12 fractions | Radiation: SBRT<br>* Patient received debulking surgery will be randomized to receive SBRT or conventional RT. SBRT means high dose per fraction compared to conventional RT.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local control | Number of patients with locally controlled disease of index spine after intervention | 12 months post surgery | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stereotactic body radiotherapy, Spondylectomy, Separation surgery