Minimally Invasive Surgery in Treating Patients With Spinal Tumors

Spinal Bone Metastases Clinical Trial

Official title:

Comparison of Minimally Invasive Approaches of Spine Tumor Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01308489
• Other study ID #: 10115
• Secondary ID: NCI-2011-00231
• Status: Terminated
• Phase: N/A
• First received: March 1, 2011
• Last updated: June 3, 2015
• Start date: May 2012
• Est. completion date: June 2014

Study information

• Verified date: June 2015
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adult Spinal Cord Neoplasm
• Neoplasm Metastasis
• Neoplasms
• Recurrent Adult Spinal Cord Neoplasm
• Spinal Bone Metastases
• Spinal Cord Metastases
• Spinal Cord Neoplasms

Intervention

Procedure:
• therapeutic conventional surgery
Undergo posterior spinal tumor resection
• therapeutic conventional surgery
Undergo anterior and posterior spinal tumor resection
• quality-of-life assessment
Ancillary studies

Locations

Country	Name	City	State
United States	City of Hope Medical Center	Duarte	California

Sponsors (2)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimated blood loss (EBL); in milliliters (ml)	Will be comparing means with the Wilcoxon test.	Day 0	No
Primary	Length of operation (OR time)	Will be comparing means with the Wilcoxon test.	Day 0	No
Primary	Complication rate		Day 0	No
Primary	Neurological preservation		Post operation day 90	No
Secondary	Length of stay		Less than 7 days	No
Secondary	Pain symptoms		Pre-operation, post-op day 3, discharge, post-op days 7, 28, 60, and 90	No
Secondary	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	No
Secondary	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	No