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

Study Overview

• Status: Terminated
• Conditions: Adult Spinal Cord Neoplasm; Spinal Bone Metastases; Spinal Cord Metastases; Recurrent Adult Spinal Cord Neoplasm
• Intervention / Treatment: Procedure: quality-of-life assessment; Procedure: therapeutic conventional surgery; Procedure: therapeutic conventional surgery

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.

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Duarte, California, United States, 91010
      • City of Hope Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I (posterior spinal tumor resection); Patients undergo posterior spinal tumor resection on day 0.	Procedure: quality-of-life assessment; Ancillary studies; Other Names: quality of life assessment; Procedure: therapeutic conventional surgery; Undergo posterior spinal tumor resection; Procedure: therapeutic conventional surgery; Undergo anterior and posterior spinal tumor resection
Experimental: Arm II (anterior and posterior spinal tumor resection); Patients undergo anterior and posterior tumor resection on day 0.	Procedure: quality-of-life assessment; Ancillary studies; Other Names: quality of life assessment; Procedure: therapeutic conventional surgery; Undergo posterior spinal tumor resection; Procedure: therapeutic conventional surgery; Undergo anterior and posterior spinal tumor resection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	This is an assessment of sensory and motor functions based upon the ASIA Impairment Scale	Pre-operation, post-op day 3, discharge, post-op days 7, 28, 60, and 90
Evaluation of arthrodesis	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.	Post-op day 1, 28, and 90

Collaborators and Investigators

• Sponsor: City of Hope Medical Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Rahul Jandial, MD, City of Hope Medical Center

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: March 1, 2011
• First Submitted That Met QC Criteria: March 2, 2011
• First Posted (Estimate): March 4, 2011

Study Record Updates

• Last Update Posted (Estimate): June 8, 2015
• Last Update Submitted That Met QC Criteria: June 3, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Site; Neoplastic Processes; Spinal Cord Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms; Neoplasm Metastasis; Spinal Cord Neoplasms
• Other Study ID Numbers: 10115 (DAIDS-ES); NCI-2011-00231 (Registry Identifier: CTRP (Clinical Trial Reporting Program))