Surgical Versus Nonoperative Treatment of Metastatic Epidural Spinal Cord Compression

NCT00634426 | Completed

• 1 other identifier: 1011
• Study Type: observational
• Target: 163
• Locations: 2 countries
• Sites: 10

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.

Conditions

Metastatic Epidural Spinal Cord Compression

Keywords

Spine; Neoplasm metastasis; Treatment, surgical; Treatment, nonoperative; Quality of life

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (6)

• Survival

  24 months

• SF-36 v2

  24 month

• EQ-5D

  24 months

• Oswestry Disability Index (ODI)

  24 months

• Caregiver Activity Survey

  24 months

Study Arms (3)

1

De novo surgical cohort

Procedure: Surgical excision of the metastatic process

2

Nonoperative treatment cohort

Radiation: Radiotherapy of the metastatic spine process

3

Secondary surgical treatment cohort

Procedure: Surgical excision of the metastatic process

Interventions

Surgical excision of the metastatic process PROCEDURE

Surgical excision of the metastatic process

1; 3

Radiotherapy of the metastatic spine process RADIATION

Standard of care radiotherapy for patients with metastatic epidural spinal cord compression.

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AOSpine North America Research Network: lead
• AOSpine North America: collaborator

Study Sites (10)

University of Kansas Medical Center

Kansas City, Kansas, 66160-0001, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Thomas Jefferson University and The Rothman Institute

Philadelphia, Pennsylvania, 19107-4216, United States

Location

University of Texas Hospital / MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

West Viginia University

Morgantown, West Virginia, 26506, United States

Location

University of British Columbia

Vancouver, British Columbia, V5Z 4E3, Canada

Location

Sunnybrook Health Sciences Center

Toronto, Ontario, M4N 3M5, Canada

Location

University of Toronto

Toronto, Ontario, M5T 2S8, Canada

Location

Related Publications (5)

• 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.

  PMID: 20594024 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.

  PMID: 22505658 BACKGROUND

• 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.

  PMID: 22682804 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.

  PMID: 24594004 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.

  PMID: 25247954 RESULT

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Fehlings, MD FRCSC

  University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2008
• First Posted: March 13, 2008
• Study Start: March 1, 2008
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: May 21, 2015

Record last verified: 2015-03

Locations

US (7); CA (3)