Return to List

Study Summary
No. 2008-0527:.......Spinal......Laurence Rhines......Neurosurgery
.
Study Summary Title
Study Summary
Number:		2008-0527
Study Title:Surgical Versus Nonoperative Treatment of Metastatic Epidural Spinal Cord Compression (MESCC). Quality of Life and Cost-Effectiveness Outcomes.
.
Physician New Patient Referral
Name:Laurence RhinesPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:NeurosurgeryReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-2400
Contact us about clinical trials
.
General Information
Disease Group:SpinalSupported By:AO Spine
Phase of Study:N/AReturn
Visit:		Follow-up visits at 6 weeks, 3, 6, 9 and 12 months
Treatment
Agents:		NoneHome Care:NA
Treatment Loc:Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions
Estimated
Length of Stay
in Houston:		Patients who have surgery to treat MESCC will be hospitalized for a period of 5
to 14 days. Patient who undergo radiation treatment alone will not be
hospitalized.
Description/
Intervention:		The goal of this research study is to compare how patients recover from
surgical and nonsurgical treatment for MESCC. Researchers want to study
participants' quality of life and pain levels throughout their treatment and
recovery. The cost effectiveness of surgical vs. nonsurgical treatments will
also be compared.
.
Study Objectives / Outcomes
    This trial will evaluate efficacy and costs of de novo surgery and radiotherapy for MESCC as opposed to non-operative treatment (radiotherapy alone). The primary objective is to compare change in pain level between baseline and 12 weeks as measured using the Brief Pain Inventory Short Form (BPI) between de novo surgical group and non-operative group.

    Thus, the primary endpoint of this study is change in BPI between baseline and 12 weeks. The primary endpoint will be analyzed on an intention-to-treat basis. For patients without a 12 week BPI re-measurement, the change in BPI will be recorded as 0; that is, for patients with missing data, we will assume no change in BPI.

    Secondary objectives include: 1. Compare neurological outcomes measured by American Spinal Injury Association (ASIA) Motor Scale structured clinical examination between the de novo surgical group and the non-operative group. 2. Compare cost-utility between the de novo surgical group and the non-operative group.

    In addition to the above hypotheses, this study will evaluate differences between de novo surgical and non-operative treatment in the following outcome variables:

    Survival;
    SF-36;
    Quality of life measured through EQ-5D utilities derived QUALY
    Oswestry Disability Index (ODI)
    American Spinal Injury Association Impairment Scale;
    Bladder and bowel function;
    Complications and adverse events;
    Utilization of care;
    Caregiver Activity Survey;
    Zarit Burden Interview

.
Study Status Information
Study Activation / Registration Date:09/03/2009
IRB Review and Approval Date:03/09/2009
Study Type:Observational
Recruitment Status:Closed
Projected Accrual:288
.
Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
Inclusion Criteria:1) Patients with single (solitary) symptomatic (neurologic deficit or pain) metastatic epidural spinal compression at any level confirmed by MRI.

2) Age 18 years and more

3) Able and willing to give written informed consent to participate in the study

4) Able to read and write English on an elementary level
Exclusion Criteria:1) Multiple (greater than or equal to 2) symptomatic spinal metastases

2) Radiosensitive tumors: Lymphoma, Leukemia, Multiple myeloma, Germ-cell tumors

3) Radio resistant tumors: Glandular tumors, Bone and Cartilage tumors, Soft Tissue tumors, very large tumors, slow-growing tumors, inoperable Melanoma

4) Primary cancer site is CNS or spine

5) Poor life expectancy (<3 months)

6) Patients with a tumor that has compressed only the cauda equina or spinal roots

7) Has a recent history of substance abuse (recreational drugs, alcohol) within 12 months prior to screening;

8) Is a prisoner

9) Is currently involved in another study that precludes or complicates participation in this study;

10) Has a disease or condition that would preclude accurate evaluation (e.g., significant psychiatric disease)
.
Links
Registration Number: NCT00634426
Study Information on Clinical Trials Registry (clinicaltrials.gov)
Other Links:
.
Results

Return to Clinical Trials at M.D. Anderson Cancer Center