Minimally Invasive Surgery in Treating Patients With Spinal Tumors

This study has been terminated.
(Lack of subject response)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT01308489
First received: March 1, 2011
Last updated: July 2, 2014
Last verified: July 2014
  Purpose

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


Condition Intervention
Adult Spinal Cord Neoplasm
Recurrent Adult Spinal Cord Neoplasm
Spinal Bone Metastases
Spinal Cord Metastases
Procedure: therapeutic conventional surgery
Procedure: quality-of-life assessment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Minimally Invasive Approaches of Spine Tumor Surgery

Resource links provided by NLM:


Further study details as provided by City of Hope Medical Center:

Primary Outcome Measures:
  • Estimated blood loss (EBL); in milliliters (ml) [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
    Will be comparing means with the Wilcoxon test.

  • Length of operation (OR time) [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
    Will be comparing means with the Wilcoxon test.

  • Complication rate [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
  • Neurological preservation [ Time Frame: Post operation day 90 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Length of stay [ Time Frame: Less than 7 days ] [ Designated as safety issue: No ]
  • Pain symptoms [ Time Frame: Pre-operation, post-op day 3, discharge, post-op days 7, 28, 60, and 90 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 7
Study Start Date: May 2012
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (posterior spinal tumor resection)
Patients undergo posterior spinal tumor resection on day 0.
Procedure: therapeutic conventional surgery
Undergo posterior spinal tumor resection
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Experimental: Arm II (anterior and posterior spinal tumor resection)
Patients undergo anterior and posterior tumor resection on day 0.
Procedure: therapeutic conventional surgery
Undergo anterior and posterior spinal tumor resection
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment

Detailed Description:

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.

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01308489

Locations
United States, California
City of Hope Medical Center
Duarte, California, United States, 91010
Sponsors and Collaborators
City of Hope Medical Center
Investigators
Principal Investigator: Rahul Jandial, MD City of Hope Medical Center
  More Information

No publications provided

Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT01308489     History of Changes
Other Study ID Numbers: 10115, NCI-2011-00231
Study First Received: March 1, 2011
Last Updated: July 2, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms
Spinal Cord Neoplasms
Central Nervous System Diseases
Central Nervous System Neoplasms
Neoplasms by Site
Neoplastic Processes
Nervous System Diseases
Nervous System Neoplasms
Pathologic Processes
Spinal Cord Diseases

ClinicalTrials.gov processed this record on October 22, 2014