Spinal Cord CompressionPhase 2NCT01826058
Spine Stereotactic Body Radiation Therapy for Metastatic Epidural Spinal Cord Compression
A Phase 2 study testing Stereotactic body radiation therapy in people with Spinal Cord Compression, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Metastatic epidural spinal cord compression (MESCC) is a frequent oncologic emergency that requires to be treated promptly. Although direct decompressive surgery is the most effective treatment, surgery is only used in selected patients because most patients have a poor overall condition and short life expectancy. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Spinal Cord Compression
- What is being tested?
- Stereotactic body radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2012to Aug 2015
- Phase
- Phase 2
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- MESCC is present.
- Localized spine metastases (C1 to L5 level); Maximum 3 separate sites and maximum 2 contiguous vertebral bodies
- Performance state before the occurrence of neurologic symptoms : Eastern Cooperative Oncology Group 0-2
- Age ≥20
- MRI within 2 weeks is mandatory
- Paraspinal mass < 5cm in maximum dimension
- Inoperable patients - refused or medically unfit for decompression surgery
- life expectancy > 3 months
Who cannot join
- Retropulsed bony fragment causing cord compression
- Paraplegia ≥ 48 hours
- Histology preferred to perform the chemotherapy as the first option (e.g. lymphoma, myeloma)
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, 135-710
Doo Ho Choi, MD.PhD., 82-2-3410-2436, doho.choi@samsung.com
Dongryul Oh, MD, 82-2-3410-2615, dongryuloh@gmail.com
About this study
Official title: Spine Stereotactic Body Radiation Therapy for Metastatic Epidural Spinal Cord: Prospective Phase II Study
Metastatic epidural spinal cord compression (MESCC) is a frequent oncologic emergency that requires to be treated promptly. Although direct decompressive surgery is the most effective treatment, surgery is only used in selected patients because most patients have a poor overall condition and short life expectancy. Radiation therapy (RT), therefore, is the most commonly used for patients with MESCC, but conventional RT alone can achieve modest neurologic outcomes.
The hypothesis to use stereotactic body radiation therapy (SBRT) for MESCC is that the rapid decompression of epidural mass, durable local control and subsequently improved neurologic outcomes compared to conventional RT are expected when MESCC is treated with SBRT.
Read the detailed description
The definition of metastatic epidural spinal cord compression (MESCC)
- MESCC is defined as both an evidence of cord compression by radiologic evaluation and a manifestation of clinical feature at the level of cord compression.
- A cord compression by radiologic evaluation is defined as < 3mm gap between epidural mass and true spinal cord or indentation of thecal sac at the level of clinical feature by MRI.
- Clinical features include any or all of the followings: pain (local or radicular) or motor weakness or sensory change or incontinence.
Simulation -A Computed tomography (CT) scan will be acquired with the use of intravenous contrast and planning MRI will be also performed on the same day of simulation.
Spine SBRT
- One to four sessions of SBRT will be performed.
Follow-up
- Patients need to be assessed at 1 week, 1 month and 3 months after the completion of SBRT and will be followed up at 3 month intervals thereafter.
- Pain score, neurologic examination, adverse events and simple X-ray of involved spine should be evaluated at every follow-up visit.
- MRI of involved spine will be performed at 3 months after the completion of SBRT.
Up to 43 patients will be enrolled in this study in Samsung Medical Center, Seoul National University Hospital, and Gachon University Gil Medical Center.
- Conditions
- Spinal Cord Compression
- Being tested
- Stereotactic body radiation therapy
- Keywords
- Stereotactic body radiation therapy, Radiosurgery
- Medical subject headings
- Spinal Cord Compression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic body radiation therapyRadiation
Also called Radiosurgery, SRS, Radiation, Radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Stereotactic body radiation therapy | Experimental | SBRT in one to four fractions
Irradiated total RT dose to gross tumor volume (GTV) according to fraction size
* 1 fx: 16 to 24 Gy
* 2 fx's: 20 to 26 Gy
* 3 fx's: 21 to 30 Gy
* 4 fx's: 24 to 36 Gy Receives: Radiation: Stereotactic body radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurologic response
- Neurologic response is defined as maintaining grade 4 or more motor power after completing SBRT or as an increase of motor power by at least 1 grade from the baseline motor power.
- There should no decrease of motor power after completing SBRT.
- The motor weakness is graded from 0 to 5 by Medical Research Council (MRC) scale.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2013 (estimated)
- Study startOct 2012
- Primary completionJun 2015 (estimated)
- Study completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord CompressionStudies of the same condition, open and under way.
- More trials run by Samsung 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul National University Hospital, Gachon University Gil Medical Center
- Responsible party
- Principal investigator, Doo Ho Choi, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01826058
- Sponsor's protocol ID
- KROG 1316
- Status last verified
- Nov 2014
- First submitted
- 3 Apr 2013
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spine Stereotactic Body Radiation Therapy for Metastatic Epidural Spinal Cord: Prospective Phase II Study
- ClinicalTrials.gov ID
- NCT01826058
- Acronym / sponsor ID
- KROG 1316
- Conditions
- Spinal Cord Compression
- Keywords
- Stereotactic body radiation therapy, Radiosurgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- Seoul National University Hospital, Gachon University Gil Medical Center
- Study start
- Oct 2012
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 8 Apr 2013 (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.
Metastatic epidural spinal cord compression (MESCC) is a frequent oncologic emergency that requires to be treated promptly. Although direct decompressive surgery is the most effective treatment, surgery is only used in selected patients because most patients have a poor overall condition and short life expectancy. Radiation therapy (RT), therefore, is the most commonly used for patients with MESCC, but conventional RT alone can achieve modest neurologic outcomes.
The hypothesis to use stereotactic body radiation therapy (SBRT) for MESCC is that the rapid decompression of epidural mass, durable local control and subsequently improved neurologic outcomes compared to conventional RT are expected when MESCC is treated with SBRT.
Detailed description
The definition of metastatic epidural spinal cord compression (MESCC)
- MESCC is defined as both an evidence of cord compression by radiologic evaluation and a manifestation of clinical feature at the level of cord compression.
- A cord compression by radiologic evaluation is defined as < 3mm gap between epidural mass and true spinal cord or indentation of thecal sac at the level of clinical feature by MRI.
- Clinical features include any or all of the followings: pain (local or radicular) or motor weakness or sensory change or incontinence.
Simulation -A Computed tomography (CT) scan will be acquired with the use of intravenous contrast and planning MRI will be also performed on the same day of simulation.
Spine SBRT
- One to four sessions of SBRT will be performed.
Follow-up
- Patients need to be assessed at 1 week, 1 month and 3 months after the completion of SBRT and will be followed up at 3 month intervals thereafter.
- Pain score, neurologic examination, adverse events and simple X-ray of involved spine should be evaluated at every follow-up visit.
- MRI of involved spine will be performed at 3 months after the completion of SBRT.
Up to 43 patients will be enrolled in this study in Samsung Medical Center, Seoul National University Hospital, and Gachon University Gil Medical Center.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stereotactic body radiation therapy | Experimental | Radiation: Stereotactic body radiation therapySBRT in one to four fractions Irradiated total RT dose to gross tumor volume (GTV) according to fraction size * 1 fx: 16 to 24 Gy * 2 fx's: 20 to 26 Gy * 3 fx's: 21 to 30 Gy * 4 fx's: 24 to 36 Gy |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- MESCC is present.
- Localized spine metastases (C1 to L5 level); Maximum 3 separate sites and maximum 2 contiguous vertebral bodies
- Performance state before the occurrence of neurologic symptoms : Eastern Cooperative Oncology Group 0-2
- Age ≥20
- MRI within 2 weeks is mandatory
Key exclusion criteria (3 listed)
- Retropulsed bony fragment causing cord compression
- Paraplegia ≥ 48 hours
- Histology preferred to perform the chemotherapy as the first option (e.g. lymphoma, myeloma)
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 |
|---|---|---|
| Stereotactic body radiation therapyAlso: Radiosurgery, SRS, Radiation, Radiotherapy | Radiation | Stereotactic body radiation therapy |
Primary outcome
Neurologic response
Time frame: 1 month
* Neurologic response is defined as maintaining grade 4 or more motor power after completing SBRT or as an increase of motor power by at least 1 grade from the baseline motor power. * There should no decrease of motor power after completing SBRT. * The motor weakness is graded from 0 to 5 by Medical Research Council (MRC) scale.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2014.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Stereotactic body radiation therapy in people with Spinal Cord Compression, run by Samsung Medical Center at 1 site in South Korea.
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 8 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 2 Dec 2014. 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 South Korea. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Doo Ho Choi, MD. PhD. (82-2-3410-2436, doho.choi@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurologic response (time frame: 1 month). 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 2 Dec 2014.