Clinical trial NCT01308489: Minimally Invasive Surgery in Treating Patients With Spinal Tumors
Official title: Comparison of Minimally Invasive Approaches of Spine Tumor Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Adult Spinal Cord Neoplasm
Recurrent Adult Spinal Cord Neoplasm
Spinal Bone Metastases
Spinal Cord Metastases
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-03-04
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
measure: Estimated blood loss (EBL); in milliliters (ml)
timeFrame: Day 0
measure: Length of operation (OR time)
timeFrame: Day 0
measure: Complication rate
timeFrame: Day 0
measure: Neurological preservation
timeFrame: Post operation day 90
Secondary outcomes:
measure: Length of stay
timeFrame: Less than 7 days
measure: Pain symptoms
timeFrame: Pre-operation, post-op day 3, discharge, post-op days 7, 28, 60, and 90
measure: Assessment of neurologic function using the ASIA (American Spinal Injury Association) Impairment Scale
timeFrame: Pre-operation, post-op day 3, discharge, post-op days 7, 28, 60, and 90
measure: Evaluation of arthrodesis
timeFrame: Post-op day 1, 28, and 90
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
Study officials:
affiliation: City of Hope Medical Center
name: Rahul Jandial, MD
role: PRINCIPAL_INVESTIGATOR
References: