Metastatic Epidural Spinal Cord Compression Clinical Trial
— MESCCOfficial title:
Surgical Versus Nonoperative Treatment of Metastatic Epidural Spinal Cord Compression. Quality of Life and Cost-effectiveness Outcomes
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.
Status | Completed |
Enrollment | 163 |
Est. completion date | March 2013 |
Est. primary completion date | March 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Single symptomatic metastatic epidural spinal compression at any level confirmed by MRI - Age 18 and more - Able and willing to give written informed consent to participate in the study - Able to read and write English on an elementary level Exclusion Criteria: - Multiple symptomatic spinal metastases - Radiosensitive tumors - Radioresistant tumors - Primary cancer site in CNS or spine - Poor life expectancy (< 3 months) - Patients with a tumor that has compressed only the cauda equina or spinal roots - Has a recent history of substance abuse - Is a prisoner - Currently involved in another study - has a disease or condition that would preclude accurate evaluation |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Canada | Sunnybrook Health Sciences Center | Toronto | Ontario |
Canada | University of Toronto | Toronto | Ontario |
Canada | University of British Columbia | Vancouver | British Columbia |
United States | Johns Hopkins University | Baltimore | Maryland |
United States | University of Texas Hospital / MD Anderson Cancer Center | Houston | Texas |
United States | University of Kansas Medical Center | Kansas City | Kansas |
United States | West Viginia University | Morgantown | West Virginia |
United States | Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania |
United States | Thomas Jefferson University and The Rothman Institute | Philadelphia | Pennsylvania |
United States | Mayo Clinic | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
AOSpine North America Research Network | AOSpine North America |
United States, Canada,
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 — View Citation
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 t — View Citation
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 — View Citation
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. — View Citation
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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in spine-associated pain intensity (BPI) measured by Brief Pain Inventory | 6 weeks / 3, 6, 9, 12, 18, 24 months | No | |
Primary | Neurological outcomes measured by American Spinal Injury Association (ASIA) Motor Scale structured clinical examination | 24 months | No | |
Secondary | Survival | 24 months | No | |
Secondary | SF-36 v2 | 24 month | No | |
Secondary | EQ-5D | 24 months | No | |
Secondary | Oswestry Disability Index (ODI) | 24 months | No | |
Secondary | Caregiver Activity Survey | 24 months | No | |
Secondary | Adverse events | 24 months | Yes |
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