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Minimally Invasive Surgery in Treating Patients With Spinal Tumors

Primary Purpose

Adult Spinal Cord Neoplasm, Recurrent Adult Spinal Cord Neoplasm, Spinal Bone Metastases

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

therapeutic conventional surgery

quality-of-life assessment

About this trial

This is an interventional treatment trial for Adult Spinal Cord Neoplasm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

City of Hope Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm I (posterior spinal tumor resection)

Arm II (anterior and posterior spinal tumor resection)

Arm Description

Patients undergo posterior spinal tumor resection on day 0.

Patients undergo anterior and posterior tumor resection on day 0.

Outcomes

Primary Outcome Measures

Estimated blood loss (EBL); in milliliters (ml)

Will be comparing means with the Wilcoxon test.

Length of operation (OR time)

Will be comparing means with the Wilcoxon test.

Complication rate

Neurological preservation

Secondary Outcome Measures

Length of stay

Pain symptoms

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

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.

Full Information

NCT ID

NCT01308489

First Posted

March 1, 2011

Last Updated

June 3, 2015

Sponsor

City of Hope Medical Center

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT01308489

Brief Title

Minimally Invasive Surgery in Treating Patients With Spinal Tumors

Official Title

Comparison of Minimally Invasive Approaches of Spine Tumor Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

June 2015

Overall Recruitment Status

Terminated

Why Stopped

Lack of subject response

Study Start Date

May 2012 (undefined)

Primary Completion Date

June 2014 (Actual)

Study Completion Date

June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

City of Hope Medical Center

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Adult Spinal Cord Neoplasm, Recurrent Adult Spinal Cord Neoplasm, Spinal Bone Metastases, Spinal Cord Metastases

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

7 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm I (posterior spinal tumor resection)

Arm Type

Experimental

Arm Description

Patients undergo posterior spinal tumor resection on day 0.

Arm Title

Arm II (anterior and posterior spinal tumor resection)

Arm Type

Experimental

Arm Description

Patients undergo anterior and posterior tumor resection on day 0.

Intervention Type

Procedure

Intervention Name(s)

therapeutic conventional surgery

Intervention Description

Undergo posterior spinal tumor resection

Intervention Type

Procedure

Intervention Name(s)

therapeutic conventional surgery

Intervention Description

Undergo anterior and posterior spinal tumor resection

Intervention Type

Procedure

Intervention Name(s)

quality-of-life assessment

Other Intervention Name(s)

quality of life assessment

Intervention Description

Ancillary studies

Primary Outcome Measure Information:

Title

Estimated blood loss (EBL); in milliliters (ml)

Description

Will be comparing means with the Wilcoxon test.

Time Frame

Day 0

Title

Length of operation (OR time)

Description

Will be comparing means with the Wilcoxon test.

Time Frame

Day 0

Title

Complication rate

Time Frame

Day 0

Title

Neurological preservation

Time Frame

Post operation day 90

Secondary Outcome Measure Information:

Title

Length of stay

Time Frame

Less than 7 days

Title

Pain symptoms

Time Frame

Pre-operation, post-op day 3, discharge, post-op days 7, 28, 60, and 90

Title

Assessment of neurologic function using the ASIA (American Spinal Injury Association) Impairment Scale

Description

This is an assessment of sensory and motor functions based upon the ASIA Impairment Scale

Time Frame

Pre-operation, post-op day 3, discharge, post-op days 7, 28, 60, and 90

Title

Evaluation of arthrodesis

Description

Time Frame

Post-op day 1, 28, and 90

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rahul Jandial, MD

Organizational Affiliation

City of Hope Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

City of Hope Medical Center

City

Duarte

State/Province

California

ZIP/Postal Code

91010

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Minimally Invasive Surgery in Treating Patients With Spinal Tumors

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