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Minimally Invasive Surgery in Treating Patients With Spinal Tumors

This study has been terminated.
(Lack of subject response)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01308489
First Posted: March 4, 2011
Last Update Posted: June 8, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
City of Hope Medical Center
March 1, 2011
March 4, 2011
June 8, 2015
May 2012
June 2014   (Final data collection date for primary outcome measure)
  • Estimated blood loss (EBL); in milliliters (ml) [ Time Frame: Day 0 ]
    Will be comparing means with the Wilcoxon test.
  • Length of operation (OR time) [ Time Frame: Day 0 ]
    Will be comparing means with the Wilcoxon test.
  • Complication rate [ Time Frame: Day 0 ]
  • Neurological preservation [ Time Frame: Post operation day 90 ]
  • Estimated blood loss (EBL); in milliliters (ml) [ Time Frame: Day 0 ]
  • Length of operation (OR time) [ Time Frame: Day 0 ]
Complete list of historical versions of study NCT01308489 on ClinicalTrials.gov Archive Site
  • Length of stay [ Time Frame: Less than 7 days ]
  • Pain symptoms [ Time Frame: Pre-operation, post-op day 3, discharge, post-op days 7, 28, 60, and 90 ]
  • Assessment of neurologic function using the ASIA (American Spinal Injury Association) Impairment Scale [ Time Frame: Pre-operation, post-op day 3, discharge, post-op days 7, 28, 60, and 90 ]
    This is an assessment of sensory and motor functions based upon the ASIA Impairment Scale
  • Evaluation of arthrodesis [ Time Frame: Post-op day 1, 28, and 90 ]
    Plain x-ray films and CT scans are used to determine the success of arthrodesis (spinal fusion in this case) which is the artificial induction of joint ossification between two bones via surgery. This is done to relieve intractable pain in a joint which cannot be managed by pain medication.
  • Length of stay [ Time Frame: Less than 7 days ]
  • Pain symptoms [ Time Frame: Pre-operation, post-op day 3, discharge, post-op days 7, 28, 60, and 90 ]
  • Assessment of neurologic function using the ASIA (American Spinal Injury Association) Impairment Scale [ Time Frame: Pre-operation, post-op day 3, discharge, post-op days 7, 28, 60, and 90 ]
    This is an assessment of sensory and motor functions based upon the ASIA Impairment Scale
  • Evaluation of arthrodesis [ Time Frame: Post-op day 1, 28, and 90 ]
    Plain x-ray films and CT scans are used to determine the success of arthrodesis (spinal fusion in this case) which is the artifical induction of joint ossification between two bones via surgery. This is done to relieve intractable pain in a joint which cannot be managed by pain medication.
Not Provided
Not Provided
 
Minimally Invasive Surgery in Treating Patients With Spinal Tumors
Comparison of Minimally Invasive Approaches of Spine Tumor Surgery
This randomized clinical trial studies minimally invasive surgery in treating patients with spinal tumors. Posterior spinal tumor resection and anterior and posterior spinal tumor resection are less invasive types of surgery for spinal tumors and may have fewer side effects and improve recovery

PRIMARY OBJECTIVES:

I. Length of operation (operating room [OR] time). II. Estimated blood loss (EBL). III. Complication rate. IV. Neurological preservation.

SECONDARY OBJECTIVES:

I. Motor strength and sensory level (neurological outcome). II. Bladder and bowel function. III. Post-operative pain. IV. Hospital length of stay (recovery time). V. Arthrodesis.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients undergo posterior spinal tumor resection on day 0.

ARM II: Patients undergo anterior and posterior spinal tumor resection on day 0.

After completion of study treatment, patients are followed up for 6 months.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Adult Spinal Cord Neoplasm
  • Recurrent Adult Spinal Cord Neoplasm
  • Spinal Bone Metastases
  • Spinal Cord Metastases
  • Procedure: therapeutic conventional surgery
    Undergo posterior spinal tumor resection
  • Procedure: therapeutic conventional surgery
    Undergo anterior and posterior spinal tumor resection
  • Procedure: quality-of-life assessment
    Ancillary studies
    Other Name: quality of life assessment
  • Experimental: Arm I (posterior spinal tumor resection)
    Patients undergo posterior spinal tumor resection on day 0.
    Interventions:
    • Procedure: therapeutic conventional surgery
    • Procedure: quality-of-life assessment
  • Experimental: Arm II (anterior and posterior spinal tumor resection)
    Patients undergo anterior and posterior tumor resection on day 0.
    Interventions:
    • Procedure: therapeutic conventional surgery
    • Procedure: quality-of-life assessment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
7
June 2014
June 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients must have a diagnosis of primary, secondary or metastatic spine tumor and be undergoing any posterior spinal fusion with or without anterior fusion anywhere from occiput to sacrum
  • Greater than 3 month life expectancy
  • Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately
  • All subjects must have the ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

  • Patients who are not surgical candidates for spine tumor removal, determined by the surgical team
  • Patients who have undergone previous spine surgery for tumor removal will be excluded
  • Patients with renal cell carcinoma
  • As there is an emphasis on blood loss and length of surgery, the critical variable for homogeneity is the vascularity of the tumor; hypervascular spine tumors are regarded by surgeons as amongst the most challenging of cases; by far the three most common hypervascular metastatic tumors are those arising from renal cell carcinoma, thyroid carcinoma and melanoma; these pathologies are usually regarded as a distinct subset for this reason in the majority of studies; because we rarely encounter the later two pathologies in our practice, we chose to include only the former; however, to further homogenize our study population we will exclude all three of the known hypervascular metastatic spine tumors
  • Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01308489
10115
NCI-2011-00231 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
Yes
Not Provided
Not Provided
City of Hope Medical Center
City of Hope Medical Center
National Cancer Institute (NCI)
Principal Investigator: Rahul Jandial, MD City of Hope Medical Center
City of Hope Medical Center
June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP