Clinical trial NCT00634426: Surgical Versus Nonoperative Treatment of Metastatic Epidural Spinal Cord Compression
Official title: Surgical Versus Nonoperative Treatment of Metastatic Epidural Spinal Cord Compression. Quality of Life and Cost-effectiveness Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Epidural Spinal Cord Compression
Keywords: Spine
Neoplasm metastasis
Treatment, surgical
Treatment, nonoperative
Quality of life
Lead sponsor: AOSpine North America Research Network
Sponsor class: NETWORK
Collaborators: name: AOSpine North America
First posted: 2008-03-13
Enrollment: 163
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who present for the treatment of new (cohorts 1 \& 3) or old (cohort 2) metastatic epidural spinal cord compression at the participating sites.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in spine-associated pain intensity (BPI) measured by Brief Pain Inventory
timeFrame: 6 weeks / 3, 6, 9, 12, 18, 24 months
measure: Neurological outcomes measured by American Spinal Injury Association (ASIA) Motor Scale structured clinical examination
timeFrame: 24 months
Secondary outcomes:
measure: Survival
timeFrame: 24 months
measure: SF-36 v2
timeFrame: 24 month
measure: EQ-5D
timeFrame: 24 months
measure: Oswestry Disability Index (ODI)
timeFrame: 24 months
measure: Caregiver Activity Survey
timeFrame: 24 months
measure: Adverse events
timeFrame: 24 months
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University and The Rothman Institute
state: Pennsylvania
city: Houston
country: United States
facility: University of Texas Hospital / MD Anderson Cancer Center
state: Texas
city: Morgantown
country: United States
facility: West Viginia University
state: West Virginia
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Center
state: Ontario
city: Toronto
country: Canada
facility: University of Toronto
state: Ontario
Study officials:
affiliation: University of Toronto
name: Michael Fehlings, MD FRCSC
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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 Biol Phys. 2012 Oct 1;84(2):e167-72. doi: 10.1016/j.ijrobp.2012.03.057. Epub 2012 Jun 8.
citation: 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.
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 to spinal metastases. AJR Am J Roentgenol. 2014 Oct;203(4):869-74. doi: 10.2214/AJR.13.12269.