Surgical Versus Nonoperative Treatment of Metastatic Epidural Spinal Cord Compression

Metastatic Epidural Spinal Cord Compression Clinical Trial

— MESCC  

Official title:

Surgical Versus Nonoperative Treatment of Metastatic Epidural Spinal Cord Compression. Quality of Life and Cost-effectiveness Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00634426
• Other study ID #: 1011
• Status: Completed
• Phase: Phase 4
• First received: March 3, 2008
• Last updated: May 19, 2015
• Start date: March 2008
• Est. completion date: March 2013

Study information

• Verified date: March 2015
• Source: AOSpine North America Research Network
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Metastatic Epidural Spinal Cord Compression
• Spinal Cord Compression

Intervention

Procedure:
• Surgical excision of the metastatic process
Surgical excision of the metastatic process

Radiation:
• Radiotherapy of the metastatic spine process
Standard of care radiotherapy for patients with metastatic epidural spinal cord compression.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
AOSpine North America Research Network	AOSpine North America

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (5)

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

Outcome

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