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| Name | Class |
|---|---|
| AOSpine North America | INDUSTRY |
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The aim of this trial is to evaluate the differences in pain relief, neurological function, quality of life and survival in patients with metastatic epidural spinal cord compression (MESCC) who are managed with a combination of surgery and radiotherapy versus radiotherapy alone.
Further we shall evaluate cost-effectiveness of the two treatment approaches.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | De novo surgical cohort |
| |
| 2 | Nonoperative treatment cohort |
| |
| 3 | Secondary surgical treatment cohort |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgical excision of the metastatic process | Procedure | Surgical excision of the metastatic process |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in spine-associated pain intensity (BPI) measured by Brief Pain Inventory | 6 weeks / 3, 6, 9, 12, 18, 24 months | |
| Neurological outcomes measured by American Spinal Injury Association (ASIA) Motor Scale structured clinical examination | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Survival | 24 months | |
| SF-36 v2 | 24 month | |
| EQ-5D |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who present for the treatment of new (cohorts 1 & 3) or old (cohort 2) metastatic epidural spinal cord compression at the participating sites.
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| Name | Affiliation | Role |
|---|---|---|
| Michael Fehlings, MD FRCSC | University of Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Kansas | 66160-0001 | United States | ||
| Johns Hopkins University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20594024 | Background | Sciubba DM, Petteys RJ, Dekutoski MB, Fisher CG, Fehlings MG, Ondra SL, Rhines LD, Gokaslan ZL. Diagnosis and management of metastatic spine disease. A review. J Neurosurg Spine. 2010 Jul;13(1):94-108. doi: 10.3171/2010.3.SPINE09202. | |
| 22505658 | Background | Furlan JC, Chan KK, Sandoval GA, Lam KC, Klinger CA, Patchell RA, Laporte A, Fehlings MG. The combined use of surgery and radiotherapy to treat patients with epidural cord compression due to metastatic disease: a cost-utility analysis. Neuro Oncol. 2012 May;14(5):631-40. doi: 10.1093/neuonc/nos062. Epub 2012 Apr 14. |
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| Radiotherapy of the metastatic spine process | Radiation | Standard of care radiotherapy for patients with metastatic epidural spinal cord compression. |
|
| 24 months |
| Oswestry Disability Index (ODI) | 24 months |
| Caregiver Activity Survey | 24 months |
| Adverse events | 24 months |
| Baltimore |
| Maryland |
| 21287 |
| United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Thomas Jefferson University and The Rothman Institute | Philadelphia | Pennsylvania | 19107-4216 | United States |
| University of Texas Hospital / MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| West Viginia University | Morgantown | West Virginia | 26506 | United States |
| University of British Columbia | Vancouver | British Columbia | V5Z 4E3 | Canada |
| Sunnybrook Health Sciences Center | Toronto | Ontario | M4N 3M5 | Canada |
| University of Toronto | Toronto | Ontario | M5T 2S8 | Canada |
| 22682804 | Result | Fitzpatrick D, Grabarz D, Wang L, Bezjak A, Fehlings MG, Fosker C, Rampersaud R, Wong RK. How effective is a virtual consultation process in facilitating multidisciplinary decision-making for malignant epidural spinal cord compression? Int J Radiat Oncol Biol Phys. 2012 Oct 1;84(2):e167-72. doi: 10.1016/j.ijrobp.2012.03.057. Epub 2012 Jun 8. |
| 24594004 | Result | Fisher CG, Schouten R, Versteeg AL, Boriani S, Varga PP, Rhines LD, Kawahara N, Fourney D, Weir L, Reynolds JJ, Sahgal A, Fehlings MG, Gokaslan ZL. Reliability of the Spinal Instability Neoplastic Score (SINS) among radiation oncologists: an assessment of instability secondary to spinal metastases. Radiat Oncol. 2014 Mar 4;9:69. doi: 10.1186/1748-717X-9-69. |
| 25247954 | Result | Fisher CG, Versteeg AL, Schouten R, Boriani S, Varga PP, Rhines LD, Heran MK, Kawahara N, Fourney D, Reynolds JJ, Fehlings MG, Gokaslan ZL. Reliability of the spinal instability neoplastic scale among radiologists: an assessment of instability secondary to spinal metastases. AJR Am J Roentgenol. 2014 Oct;203(4):869-74. doi: 10.2214/AJR.13.12269. |
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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