Minimally Invasive Surgery in Treating Patients With Spinal Tumors

NCT ID: NCT01308489

Last Updated: 2015-06-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2014-06-30

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.

Conditions

Adult Spinal Cord Neoplasm; Recurrent Adult Spinal Cord Neoplasm; Spinal Bone Metastases; Spinal Cord Metastases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm I (posterior spinal tumor resection)

Patients undergo posterior spinal tumor resection on day 0.

Group Type: EXPERIMENTAL

therapeutic conventional surgery

Intervention Type: PROCEDURE

Undergo posterior spinal tumor resection

quality-of-life assessment

Intervention Type: PROCEDURE

Ancillary studies

Arm II (anterior and posterior spinal tumor resection)

Patients undergo anterior and posterior tumor resection on day 0.

Group Type: EXPERIMENTAL

therapeutic conventional surgery

Intervention Type: PROCEDURE

Undergo anterior and posterior spinal tumor resection

quality-of-life assessment

Intervention Type: PROCEDURE

Ancillary studies

Interventions

therapeutic conventional surgery

Undergo posterior spinal tumor resection

Intervention Type: PROCEDURE

therapeutic conventional surgery

Undergo anterior and posterior spinal tumor resection

Intervention Type: PROCEDURE

quality-of-life assessment

Ancillary studies

Intervention Type: PROCEDURE

Other Intervention Names

quality of life assessment

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

City of Hope Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rahul Jandial, MD

Role: PRINCIPAL_INVESTIGATOR

City of Hope Medical Center

Locations

City of Hope Medical Center

Duarte, California, United States

Countries

United States

Other Identifiers

NCI-2011-00231

Identifier Type: REGISTRY

Identifier Source: secondary_id

10115

Identifier Type: -

Identifier Source: org_study_id