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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-00231 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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Lack of subject response
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (posterior spinal tumor resection) | Experimental | Patients undergo posterior spinal tumor resection on day 0. |
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| Arm II (anterior and posterior spinal tumor resection) | Experimental | Patients undergo anterior and posterior tumor resection on day 0. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| therapeutic conventional surgery | Procedure | Undergo posterior spinal tumor resection |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rahul Jandial, MD | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Medical Center | Duarte | California | 91010 | United States |
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| therapeutic conventional surgery | Procedure | Undergo anterior and posterior spinal tumor resection |
|
| quality-of-life assessment | Procedure | Ancillary studies |
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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 |
| ID | Term |
|---|---|
| D013120 | Spinal Cord Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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