Spinal MetastasesNCT01347307

Stereotactic Body Radiotherapy for Spine Tumors

A study testing SBRT for Benign Extradural Spine Tumors and SBRT for Vertebral/Paraspinal Metastases in people with Spinal Metastases and Vertebral Metastases, run by Mercy Research at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will evaluate the local control rate as well as acute and late toxicity rates of stereotactic body radiotherapy (SBRT) for the treatment of spine metastases and benign spine tumors. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Spinal Metastases, Vertebral Metastases, Benign Spinal Tumors
What is being tested?: SBRT for Benign Extradural Spine Tumors and SBRT for Vertebral/Paraspinal Metastases
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 38 participants
Where: 1 siteUnited States
Study dates: Sep 2008to Sep 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

None listed.

Who cannot join

Lesion involving > 3 adjacent vertebral levels
Overt spinal instability
Neurologic deficit due to bony fragments/bony compression of neural structures
Prior radiotherapy at the involved level(s) within 3 months of radiosurgery, more than one prior course of radiotherapy at the involved level(s), or more than 45 Gy previous radiation exposure at the involved level(s)
Rapidly progressive spinal cord compromise or neurological deficit
Paralysis, or otherwise compromised motor function due to radiographically confirmed cord compression

Show all 9Show fewer

Patient unable to undergo an MRI
Pregnant or lactating women, due to potential exposure of the fetus to RT and unknown effects of RT on lactating females
Patients with psychiatric or addictive disorder that would preclude obtaining informed consent

Trial locations and contacts

1 site in 1 country.

United States1 site

Mercy Medical Center, St. Louis
St Louis, Missouri, 63141

Other trials in United States

About this study

Official title: Phase IV Trial Evaluating the Use of Stereotactic Body Radiotherapy for the Treatment of Spine Metastases and Primary Spine Tumors

This study will evaluate the local control rate as well as acute and late toxicity rates of stereotactic body radiotherapy (SBRT) for the treatment of spine metastases and benign spine tumors.

Read the detailed description

This study is a single site, non-randomized, prospective, phase IV trial. Patients are composed of 2 groups:Spine Metastases OR Benign Spine Tumors. Data collected will include patient demographics, pathology data, tumor stage, SBRT dose fractionation scheme, dose received by adjacent critical normal tissues, tumor recurrence data, and acute and late toxicities.

Follow up data will be collected during the patient's standard office visits. The anticipated duration of this study is 5 years

Conditions: Spinal Metastases, Vertebral Metastases, Benign Spinal Tumors, Chordoma, Meningioma, Schwannoma
Being tested: SBRT for Benign Extradural Spine Tumors, SBRT for Vertebral/Paraspinal Metastases
Keywords: stereotactic radiotherapy, spinal metastases, vertebral metastases, benign spinal tumors
Medical subject headings: Chordoma, Meningioma, Neurilemmoma, Neurofibroma, Paraganglioma, Arteriovenous Malformations

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SBRT for Benign Extradural Spine TumorsRadiation
Also called Stereotactic Body Radiotherapy (SBRT)
14-25 Gy / 1 fraction OR 21-27 Gy / 3 fractions (7-9 Gy per fraction) OR 25-30 Gy / 5 fractions (5-6 Gy per fraction)
SBRT for Vertebral/Paraspinal MetastasesRadiation
Also called Stereotactic Body Radiotherapy (SBRT)
12-16 Gy / 1 fraction OR 21-27 Gy / 3 fractions (7-9 Gy per fraction) OR 25-30 Gy / 5 fractions (5-6 Gy per fraction)

Study groups in NCT01347307
Study group	Role	What they receive
SBRT for Benign Extradural Spine Tumors	Other	Benign extradural spine tumors such as chordomas, meningiomas, schwannomas, neurofibromas, paragangliomas, and arteriovenous malformations (AVMs). Receives: Radiation: SBRT for Benign Extradural Spine Tumors
SBRT for Vertebral/Paraspinal Metastases	Other	Vertebral and/or paraspinal metastases, with or without prior surgery and/or fractionated radiotherapy Receives: Radiation: SBRT for Vertebral/Paraspinal Metastases

What is being measured

The primary outcome is the main question the study is designed to answer.

Initial Symptom Control
Evaluation of pain relief per patient report
Measured: 6 weeks post-SBRT (or at first post-treatment follow-up)
Local Tumor Recurrence Rate
Local recurrence is defined as tumor recurrence or progression within the planning target volume.
Local control rate will be evaluated by imaging techniques and/or clinical symptoms (worsening or no improvement in pain or neurologic compromise). If follow-up imaging is available, a local recurrence will be defined as an increase of > 20% in tumor size.
Measured: (1) At 1 year post-SBRT, (2) At patient's last follow-up or time of death

Secondary outcomes (1)

Late Toxicity Rate
Toxicity will be assessed using CTCAE grading criteria at specified timepoints.
Measured: at patient's last follow-up (at least 3 months from treatment) or time of death

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2008Sep 2017

First posted4 May 2011 (estimated)
Study startSep 2008
Primary completionSep 2017
Study completionSep 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Spinal MetastasesStudies of the same condition, open and under way.
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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 38 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01347307
Sponsor's protocol ID: 08-044
Status last verified: Jun 2020
First submitted: 2 May 2011
Last updated: 18 Jun 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 18 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase IV Trial Evaluating the Use of Stereotactic Body Radiotherapy for the Treatment of Spine Metastases and Primary Spine Tumors
ClinicalTrials.gov ID: NCT01347307
Acronym / sponsor ID: 08-044
Conditions: Spinal Metastases, Vertebral Metastases, Benign Spinal Tumors, Chordoma, Meningioma, Schwannoma
Keywords: stereotactic radiotherapy, spinal metastases, vertebral metastases, benign spinal tumors
Study type: Interventional
Recruitment status: Completed
Enrolment: 38 participants (actual)
Lead sponsor: Mercy ResearchUniversity, hospital or other
Study start: Sep 2008 (actual)
Primary completion: Sep 2017 (actual)
Study completion: Sep 2017 (actual)
First posted: 4 May 2011 (estimated)
Results: Posted 18 Jun 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study will evaluate the local control rate as well as acute and late toxicity rates of stereotactic body radiotherapy (SBRT) for the treatment of spine metastases and benign spine tumors.

Detailed description

Follow up data will be collected during the patient's standard office visits. The anticipated duration of this study is 5 years

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
SBRT for Benign Extradural Spine Tumors	Other	Radiation: SBRT for Benign Extradural Spine TumorsBenign extradural spine tumors such as chordomas, meningiomas, schwannomas, neurofibromas, paragangliomas, and arteriovenous malformations (AVMs).
SBRT for Vertebral/Paraspinal Metastases	Other	Radiation: SBRT for Vertebral/Paraspinal MetastasesVertebral and/or paraspinal metastases, with or without prior surgery and/or fractionated radiotherapy

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (0 listed)

Key exclusion criteria (9 listed)

Lesion involving > 3 adjacent vertebral levels
Overt spinal instability
Neurologic deficit due to bony fragments/bony compression of neural structures
Prior radiotherapy at the involved level(s) within 3 months of radiosurgery, more than one prior course of radiotherapy at the involved level(s), or more than 45 Gy previous radiation exposure at the involved level(s)
Rapidly progressive spinal cord compromise or neurological deficit

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
SBRT for Benign Extradural Spine TumorsAlso: Stereotactic Body Radiotherapy (SBRT)14-25 Gy / 1 fraction OR 21-27 Gy / 3 fractions (7-9 Gy per fraction) OR 25-30 Gy / 5 fractions (5-6 Gy per fraction)	Radiation	SBRT for Benign Extradural Spine Tumors
SBRT for Vertebral/Paraspinal MetastasesAlso: Stereotactic Body Radiotherapy (SBRT)12-16 Gy / 1 fraction OR 21-27 Gy / 3 fractions (7-9 Gy per fraction) OR 25-30 Gy / 5 fractions (5-6 Gy per fraction)	Radiation	SBRT for Vertebral/Paraspinal Metastases

Primary outcome

Initial Symptom Control
Time frame: 6 weeks post-SBRT (or at first post-treatment follow-up)
Evaluation of pain relief per patient report
Local Tumor Recurrence Rate
Time frame: (1) At 1 year post-SBRT, (2) At patient's last follow-up or time of death
Local recurrence is defined as tumor recurrence or progression within the planning target volume. Local control rate will be evaluated by imaging techniques and/or clinical symptoms (worsening or no improvement in pain or neurologic compromise). If follow-up imaging is available, a local recurrence will be defined as an increase of > 20% in tumor size.

1 secondary outcome

Late Toxicity Rate
Time frame: at patient's last follow-up (at least 3 months from treatment) or time of death

Results and safety

Results posted to the registry on 18 Jun 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SBRT for Benign Extradural Spine Tumors	3	3
SBRT for Vertebral/Paraspinal Metastases	33	28

Primary outcome: Initial Symptom Control

Time frame: 6 weeks post-SBRT (or at first post-treatment follow-up). Count of participants. Unit: Participants

Measure	SBRT for Benign Extradural Spine Tumors n = 3	SBRT for Vertebral/Paraspinal Metastases n = 28
Number with Follow-up Data	3	28
Number with Initial Symptom Control	3	27
Number without Symptom Control	0	1

Population analysed: 2 enrolled pts were not treated. 35 pts completed 36 SBRT courses. 5 pts either died prior to any follow-up appointment or imaging (4 pts) or did not follow-up due to loss of insurance (1 pt). 3 pts with benign spine tumors and 28 pts with vertebral metastases who underwent a total of 32 courses of SBRT had follow-up data available for analysis.

Primary outcome: Local Tumor Recurrence Rate

Time frame: (1) At 1 year post-SBRT, (2) At patient's last follow-up or time of death. Count of participants. Unit: Participants

Measure	SBRT for Benign Extradural Spine Tumors n = 3	SBRT for Vertebral/Paraspinal Metastases n = 28
Local Control at last Follow-up	3	25
No Response to Treatment	0	1
Local Recurrence after Initial Response	0	2
Number with at least 1 year Follow-up	3	18
Local Control at 1 year Follow-up	3	17
Local Recurrence within 1st year of Follow-up	0	1

Population analysed: 35 pts completed 36 SBRT courses. All 3 benign tumor pts are still alive. 15 pts with metastatic disease died prior to first post-SBRT follow-up appointment or imaging (4 pts), did not follow-up due to loss of insurance (1 pt), or had initial follow-up but then died prior to 1 year from treatment completion (10 pts).

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Patients were followed until time of death or until lost to follow-up.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SBRT for Benign Extradural Spine Tumors	0 of 3 (0%)	1 of 3 (33.3%)	0 of 3
SBRT for Vertebral/Paraspinal Metastases	1 of 28 (3.6%)	7 of 28 (25%)	27 of 28

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Bethany Sleckman, MD study chair

Mercy Research

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 0 inclusion and 9 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: finished, as of the sponsor's last update on 18 Jun 2020. 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?

Yes. Results are posted in the registry (first posted 18 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Initial Symptom Control (time frame: 6 weeks post-SBRT (or at first post-treatment follow-up)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01347307.

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 18 Jun 2020.