Adult Spinal Cord NeoplasmNCT01308489
Minimally Invasive Surgery in Treating Patients With Spinal Tumors
A study testing therapeutic conventional surgery and quality-of-life assessment in people with Adult Spinal Cord Neoplasm and Recurrent Adult Spinal Cord Neoplasm, run by City of Hope Medical Center at 1 site in United States.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult Spinal Cord Neoplasm, Recurrent Adult Spinal Cord Neoplasm, Spinal Bone Metastases
- What is being tested?
- therapeutic conventional surgery and quality-of-life assessment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Medical Center
Duarte, California, 91010
About this study
Official title: Comparison of Minimally Invasive Approaches of Spine Tumor Surgery
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
Read the detailed description
PRIMARY OBJECTIVES:
- Length of operation (operating room [OR] time). II. Estimated blood loss (EBL). III. Complication rate. IV. Neurological preservation.
SECONDARY OBJECTIVES:
- 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
- Being tested
- therapeutic conventional surgery, quality-of-life assessment
- Medical subject headings
- Spinal Cord Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
therapeutic conventional surgeryProcedure or surgery
Undergo posterior spinal tumor resection
therapeutic conventional surgeryProcedure or surgery
Undergo anterior and posterior spinal tumor resection
quality-of-life assessmentProcedure or surgery
Also called quality of life assessment
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (posterior spinal tumor resection) | Experimental | Patients undergo posterior spinal tumor resection on day 0. Receives: Procedure: therapeutic conventional surgery; Procedure: quality-of-life assessment |
| Arm II (anterior and posterior spinal tumor resection) | Experimental | Patients undergo anterior and posterior tumor resection on day 0. Receives: Procedure: therapeutic conventional surgery; Procedure: quality-of-life assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimated blood loss (EBL); in milliliters (ml)
Will be comparing means with the Wilcoxon test.
Measured: Day 0
Length of operation (OR time)
Will be comparing means with the Wilcoxon test.
Measured: Day 0
Complication rate
Measured: Day 0
Neurological preservation
Measured: Post operation day 90
Secondary outcomes (4)
Length of stay
Measured: Less than 7 days
Pain symptoms
Measured: 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
This is an assessment of sensory and motor functions based upon the ASIA Impairment Scale
Measured: 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.
Measured: Post-op day 1, 28, and 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2011 (estimated)
- Study startMay 2012
- Primary completionJun 2014
- Study completionJun 2014
Why it stopped: Lack of subject response
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Spinal Cord NeoplasmStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Rahul Jandial, MD, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01308489
- Sponsor's protocol ID
- 10115
- Other IDs
- NCI-2011-00231
- Status last verified
- Jun 2015
- First submitted
- 1 Mar 2011
- Last updated
- 8 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Minimally Invasive Approaches of Spine Tumor Surgery
- ClinicalTrials.gov ID
- NCT01308489
- Acronym / sponsor ID
- 10115
- Conditions
- Adult Spinal Cord Neoplasm, Recurrent Adult Spinal Cord Neoplasm, Spinal Bone Metastases, Spinal Cord Metastases
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of subject response
- Enrolment
- 7 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 4 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Length of operation (operating room [OR] time). II. Estimated blood loss (EBL). III. Complication rate. IV. Neurological preservation.
SECONDARY OBJECTIVES:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (posterior spinal tumor resection) | Experimental | Procedure: therapeutic conventional surgery, Procedure: quality-of-life assessmentPatients undergo posterior spinal tumor resection on day 0. |
| Arm II (anterior and posterior spinal tumor resection) | Experimental | Procedure: therapeutic conventional surgery, Procedure: quality-of-life assessmentPatients undergo anterior and posterior tumor resection on day 0. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| therapeutic conventional surgeryUndergo posterior spinal tumor resection | Procedure or surgery | Arm I (posterior spinal tumor resection) |
| therapeutic conventional surgeryUndergo anterior and posterior spinal tumor resection | Procedure or surgery | Arm II (anterior and posterior spinal tumor resection) |
| quality-of-life assessmentAlso: quality of life assessmentAncillary studies | Procedure or surgery | Arm I (posterior spinal tumor resection), Arm II (anterior and posterior spinal tumor resection) |
Primary outcome
Estimated blood loss (EBL); in milliliters (ml)
Time frame: Day 0
Will be comparing means with the Wilcoxon test.
Length of operation (OR time)
Time frame: Day 0
Will be comparing means with the Wilcoxon test.
Complication rate
Time frame: Day 0
Neurological preservation
Time frame: Post operation day 90
4 secondary outcomes
Length of stay
Time frame: Less than 7 days
Pain symptoms
Time frame: 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
Time frame: Pre-operation, post-op day 3, discharge, post-op days 7, 28, 60, and 90
Evaluation of arthrodesis
Time frame: Post-op day 1, 28, and 90
Results and safety
The study was stopped early (reason given: Lack of subject response). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rahul Jandial, MD principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing therapeutic conventional surgery and quality-of-life assessment in people with Adult Spinal Cord Neoplasm and Recurrent Adult Spinal Cord Neoplasm, run by City of Hope Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of subject response). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimated blood loss (EBL); in milliliters (ml) (time frame: Day 0). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2015.