NCT01308489

Brief Summary

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

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 4, 2011

Completed
1.2 years until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

June 8, 2015

Status Verified

June 1, 2015

Enrollment Period

2.1 years

First QC Date

March 1, 2011

Last Update Submit

June 3, 2015

Conditions

Adult Spinal Cord NeoplasmRecurrent Adult Spinal Cord NeoplasmSpinal Bone MetastasesSpinal Cord Metastases

Outcome Measures

Primary Outcomes (4)

  • Estimated blood loss (EBL); in milliliters (ml)

    Will be comparing means with the Wilcoxon test.

    Day 0

  • Length of operation (OR time)

    Will be comparing means with the Wilcoxon test.

    Day 0

  • Complication rate

    Day 0

  • Neurological preservation

    Post operation day 90

Secondary Outcomes (4)

  • Length of stay

    Less than 7 days

  • Pain symptoms

    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

    Pre-operation, post-op day 3, discharge, post-op days 7, 28, 60, and 90

  • Evaluation of arthrodesis

    Post-op day 1, 28, and 90

Study Arms (2)

Arm I (posterior spinal tumor resection)

EXPERIMENTAL

Patients undergo posterior spinal tumor resection on day 0.

Procedure: therapeutic conventional surgeryProcedure: quality-of-life assessment

Arm II (anterior and posterior spinal tumor resection)

EXPERIMENTAL

Patients undergo anterior and posterior tumor resection on day 0.

Procedure: therapeutic conventional surgeryProcedure: quality-of-life assessment

Interventions

therapeutic conventional surgeryPROCEDURE

Undergo posterior spinal tumor resection

Arm I (posterior spinal tumor resection)
quality-of-life assessmentPROCEDURE

Ancillary studies

Also known as: quality of life assessment
Arm I (posterior spinal tumor resection)Arm II (anterior and posterior spinal tumor resection)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

MeSH Terms

Conditions

Spinal Cord Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsSpinal Cord DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Rahul Jandial, MD

    City of Hope Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2011

First Posted

March 4, 2011

Study Start

May 1, 2012

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

June 8, 2015

Record last verified: 2015-06

Locations

US(1)