Surgical Versus Nonoperative Treatment of Metastatic Epidural Spinal Cord Compression - Full Text View

Purpose

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.

Condition	Intervention	Phase
Metastatic Epidural Spinal Cord Compression	Procedure: Surgical excision of the metastatic process Radiation: Radiotherapy of the metastatic spine process	Phase IV

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective

Official Title:	Surgical Versus Nonoperative Treatment of Metastatic Epidural Spinal Cord Compression. Quality of Life and Cost-Effectiveness Outcomes

Further study details as provided by AO Clinical Investigation and Documentation:

Primary Outcome Measures:

Change in spine-associated pain intensity (BPI) measured by Brief Pain Inventory [ Time Frame: 6 weeks / 3, 6, 9, 12, 18, 24 months ] [ Designated as safety issue: No ]
Neurological outcomes measured by American Spinal Injury Association (ASIA) Motor Scale structured clinical examination [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Survival [ Time Frame: 24 months ] [ Designated as safety issue: No ]
SF-36 v2 [ Time Frame: 24 month ] [ Designated as safety issue: No ]
EQ-5D [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Oswestry Disability Index (ODI) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Caregiver Activity Survey [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Adverse events [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	432
Study Start Date:	March 2008
Estimated Study Completion Date:	March 2012
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 De novo surgical cohort	Procedure: Surgical excision of the metastatic process Surgical excision of the metastatic process
2 Nonoperative treatment cohort	Radiation: Radiotherapy of the metastatic spine process Standard of care radiotherapy for patients with metastatic epidural spinal cord compression.
3 Secondary surgical treatment cohort	Procedure: Surgical excision of the metastatic process Surgical excision of the metastatic process

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
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.

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00634426

Contacts


Contact: Elinor Cappuccio, RN CCRC	+1 609 452 8613	elinor.cappuccio@aofoundation.org

Locations


United States, Kansas
	University of Kansas Medical Center	Recruiting
	Kansas City, Kansas, United States, 66160-0001
	Contact: Joan K. McMahon, MSA, BSN 913-588-7815 jmcmahon@kumc.edu
	Contact: Paul M. Arnold, MD 913-588-7587 parnold@kumc.edu
	Principal Investigator: Paul M. Arnold, MD

United States, Maryland
	Johns Hopkins University	Not yet recruiting
	Baltimore, Maryland, United States, 21287
	Contact: Eunice Aikins-Afful, MA, MS, CCRP 443-287-4934 eaikins@jhmi.edu
	Contact: Ziya L. Gokaslan, MD +1 410 955 4424 zgokasl1@jhmi.edu
	Principal Investigator: Ziya Gokaslan, MD

United States, Massachusetts
	Brigham & Women's Hospital	Recruiting
	Boston, Massachusetts, United States, 02115
	Contact: Natalie Warholic 617-525-8761 nwarholic@partners.org
	Principal Investigator: Christopher M. Bono, MD

United States, Minnesota
	Mayo Clinic	Recruiting
	Rochester, Minnesota, United States, 55905
	Contact: Kimberly Timm 507-538-3561 Timm.Kimberly@mayo.edu
	Contact: Steve Thalacker thals@mayo.edu
	Principal Investigator: Mark B. Dekutoski, MD

United States, Pennsylvania
	Thomas Jefferson University and The Rothman Institute	Recruiting
	Philadelphia, Pennsylvania, United States, 19107-4216
	Contact: Lindsey Marshall 267-339-3678 Lindsey.Marshall@rothmaninstitute.com
	Contact: Alexander Vaccaro, MD +1 267 339 3623
	Principal Investigator: Alexander R. Vaccaro, MD
	Hospital of the University of Pennsylvania	Not yet recruiting
	Philadelphia, Pennsylvania, United States, 19104
	Contact: Joanna Lopinto, BSN, RN 215-615-4590 jlopinto@uphs.upenn.edu
	Contact: James Schuster, MD 215-615-4587 James.Schuster@uphs.upenn.edu
	Principal Investigator: James Schuster, MD

United States, Texas
	University of Texas Hospital/ MD Anderson Cancer Center	Not yet recruiting
	Houston, Texas, United States, 77030
	Contact: Susan Graham, RN, BSN 713-563-8747 sograham@mdanderson.org
	Principal Investigator: Larry Rhines, MD

Canada, British Columbia
	University of British Columbia	Not yet recruiting
	Vancouver, British Columbia, Canada, V5Z 4E3
	Contact: Charles G. Fisher, MD FRCSC +1 604 875 4746 charles.fisher@vch.ca
	Contact: Amy LaFrance, BASc MASc 604-877-6000 ext 2587 alafrance@bccancer.bc.ca
	Principal Investigator: Charles Fisher, MD FRCSC

Canada, Ontario
	University of Toronto	Recruiting
	Toronto, Ontario, Canada, M5T 2S8
	Contact: Yuliya Petrenko 416-603-5285 yuliya.petrenko@uhn.on.ca
	Principal Investigator: Michael Fehlings, MD FRCSC
	Sunnybrook Health Sciences Center	Recruiting
	Toronto, Ontario, Canada, M4N 3M5
	Contact: Aimee Gallant 416-480-4285 aimee.gallant@sunnybrook.ca
	Principal Investigator: Joel Finkelstein, MD

Sponsors and Collaborators

AO Clinical Investigation and Documentation

AOSpine North America

Investigators


Principal Investigator:	Michael Fehlings, MD FRCSC	University of Toronto

More Information

Responsible Party:	University of Washington ( Branko Kopjar / Coordinating Investigator )
Study ID Numbers:	1011
First Received:	March 3, 2008
Last Updated:	August 26, 2008
ClinicalTrials.gov Identifier:	NCT00634426
Health Authority:	United States: Institutional Review Board

Keywords provided by AO Clinical Investigation and Documentation:

Spine

Neoplasm metastasis

Treatment, surgical

Treatment, nonoperative

Quality of life

Study placed in the following topic categories:

Spinal Cord Injuries

Spinal Cord Diseases

Spinal Cord Compression

Wounds and Injuries

Neoplasm Metastasis

Quality of Life

Disorders of Environmental Origin

Central Nervous System Diseases

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on September 23, 2008

Sponsors and Collaborators:	AO Clinical Investigation and Documentation AOSpine North America
Information provided by:	AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier:	NCT00634426