Spinal Cord CompressionCRUSSHNCT03529708
Stereotactic Body Radiotherapy Boost After Palliative Radiotherapy for Spinal Cord Compression
A study testing 3D CRT plus SBRT boost in people with Spinal Cord Compression and Cauda Equina Syndrome, run by Juravinski Cancer Center at 1 site in Canada.
Trial summary
Spinal cord compression (SCC) is a devastating complication of advanced malignancy, and can cause significant deterioration in function and quality of life (QoL). The goal of treatment is to improve functional status and symptoms, but the optimal treatment regimen for these patients has not been thoroughly… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Compression, Cauda Equina Syndrome, Stereotactic Body Radiotherapy
- What is being tested?
- 3D CRT plus SBRT boost
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2018to 1 Dec 2020
- 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
- Diagnosis of metastatic malignancy (radiologic or pathologic)
- Evidence of disease in vertebral body with epidural component such that Bilsky radiologic score is 1c-2 on MRI (abuts spinal cord without cord compression (1c), or spinal cord compression but with visible CSF (2)
- Motor function (MF) of 3 or greater
Who cannot join
- Surgical candidate
- Instability of vertebral bodies with or without bony retropulsion requiring surgical intervention or hardware placement
- Previous radiotherapy course to same region of spine with overlapping fields (prior to phase I course) at discretion of treating radiation oncologist
- No CT or MRI within previous 3 months
- Life expectancy estimated <3 months
- Performance status KPS<40
Show all 11Show fewer
- On active chemotherapy or targeted therapy or immunotherapy (must be stopped for at least one week prior to and following)
- Pregnant or lactating
- Contraindications to radiotherapy (eg. active autoimmune disease requiring medication)
- Inability to lie flat comfortably for at least 20 minutes
- Age < 18
Trial locations and contacts
1 site in 1 country.
Shelley Chambers, MA contact
Canada1 site, 1 recruiting
- Recruiting
Juravinski Cancer Center
Hamilton, Ontario, L8V1C5
Kara L Schnarr
About this study
Official title: Stereotactic Body Radiotherapy (SBRT) Boost Following Urgent 3D Conformal Radiotherapy in the Treatment of Metastatic Epidural Spinal Cord Compression (SCC): A Phase I Feasibility Trial
Spinal cord compression (SCC) is a devastating complication of advanced malignancy, and can cause significant deterioration in function and quality of life (QoL). The goal of treatment is to improve functional status and symptoms, but the optimal treatment regimen for these patients has not been thoroughly established. Many patients with SCC present with uncontrolled systemic disease and poor performance status, and are not eligible for standard surgical resection. They are generally treated with 3D conformal palliative RT (3DCRT) alone, however recent trials suggest that less than 70% of patients are ambulatory, that the re-establishment of ambulation in non-ambulatory patients is poor, and the duration of improvement is guarded with radiotherapy alone.
Recently, stereotactic body radiotherapy (SBRT) used alone or after previous radiotherapy to treat spinal metastasis has demonstrated superior results in pain control, tumour response and durability. SBRT requires time for careful planning, and many patients with neurologic symptoms must be treated immediately to prevent progression. Therefore the role of SBRT is still unclear in this patient population, although it seems to be a potential alternative to surgical decompression in patient not suitable for surgery. The investigators propose a feasibility study to investigate the potential benefits of dose escalation with a sequential SBRT boost to urgent 3D CRT in the setting of SCC. This regimen will allow inoperable patients to receive urgent 3DCRT while simultaneously creating the opportunity for superior outcomes with SBRT. The investigators also aim to characterize the effect on motor function and ambulation, pain and QoL. This study could stimulate further multi-center randomized trials in this area, improve motor function and patient-reported QoL, and contribute to improving oncology care in Canada in a meaningful way.
- Being tested
- 3D CRT plus SBRT boost
- Medical subject headings
- Spinal Cord Compression, Cauda Equina Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D CRT plus SBRT boostRadiation
Patients will receive urgent standard 3D conformal radiotherapy (3D CRT) of plus stereotactic boost to tumor causing spinal cord compression (SCC). Initial dose for 3D CRT will be either 8Gy in 1 fraction or 20Gy in 5 fractions, with SBRT boost dose15Gy in 2 fractions of 12Gy in 2 fractions (depending on 8Gy/1 or 20Gy/5 initial RT dose respectively), delivered within three weeks of first treatment.
| Study group | Role | What they receive |
|---|---|---|
| SBRT boost | Experimental | Standard radiotherapy (3D conformal, urgent palliative radiotherapy) plus stereotactic body radiotherapy (SBRT) boost Receives: Radiation: 3D CRT plus SBRT boost |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of accrual
Success determined by accrual of 30 patients with SBRT boost is planned and delivered to 80% of these
Measured: up to 12 months
Secondary outcomes (7)
Motor Function Description:
Motor strength evaluated by 8 point scale (0= Complete paraplegia, 1= Palpable or visible muscle contractions, 2= Active movement of the leg without gravity, 3= Active movement of the leg against gravity, 4= Active movement againt mild resistance, 5= Active movement against intermediate resistance, 6= Active movement against strong resistance, 7= Normal strength)
Measured: 4 weeks (primary), 12 weeks, 6 months
Overall Quality of Life (QoL)
Change in total QoL score over time per European Organization for Research and Treatment of Cancer Quality of Life Questionnaire core 30 (EORTC QLQ-c30)
Measured: 4 weeks, 12 weeks, 6 months
Pain Response
Change in level of pain over time on 10 point scale with 0 meaning no pain and 10 meaning severe pain (patient-reported)
Measured: 4 weeks, 12 weeks, 6 months
Local Control
Assessment of tumor volume (maximum size in 3 dimension) by Magnetic Resonance Imaging (MRI)
Measured: 12 weeks, 6 months
Toxicity
Treatment-related toxicity graded by Common Terminology for Adverse Events (CTCAE 4.03)
Measured: 4 weeks, 12 weeks, 6 months
Overall Survival
Survival time from first radiotherapy treatment (3D CRT) in days
Measured: 4 weeks, 12 weeks, 6 months
Bone metastasis- specific Quality of Life
Change in total QoL score over time per European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Bone Metastasis-22 (EORTC QLQ BM-22)
Measured: 4 weeks, 12 weeks, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2018
- Study start1 Jun 2018
- Primary completion1 Jun 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord CompressionStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm pilot study of standard of care 3D conformal radiotherapy plus Stereotactic body radiotherapy (SBRT) boost
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Juravinski Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Hamilton Health Sciences Corporation, Juravinski Cancer Centre Foundation
- Responsible party
- Principal investigator, Elysia Donovan, Juravinski Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03529708
- Sponsor's protocol ID
- 4760
- Acronym
- CRUSSH
- Status last verified
- Jan 2020
- First submitted
- 24 Apr 2018
- Last updated
- 29 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Donovan EK, Greenspoon J, Schnarr KL, Whelan TJ, Wright JR, Hann C, Whitton A, Chow T, Parpia S, Swaminath A. A pilot study of stereotactic boost for malignant epidural spinal cord compression: clinical significance and initial dosimetric evaluation. Radiat Oncol. 2020 Nov 18;15(1):267. doi: 10.1186/s13014-020-01710-4.
PubMed 33208170
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stereotactic Body Radiotherapy (SBRT) Boost Following Urgent 3D Conformal Radiotherapy in the Treatment of Metastatic Epidural Spinal Cord Compression (SCC): A Phase I Feasibility Trial
- ClinicalTrials.gov ID
- NCT03529708
- Acronym / sponsor ID
- CRUSSH / 4760
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Juravinski Cancer CenterUniversity, hospital or other
- Collaborators
- Hamilton Health Sciences Corporation, Juravinski Cancer Centre Foundation
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Jun 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 18 May 2018 (actual)
- 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.
Spinal cord compression (SCC) is a devastating complication of advanced malignancy, and can cause significant deterioration in function and quality of life (QoL). The goal of treatment is to improve functional status and symptoms, but the optimal treatment regimen for these patients has not been thoroughly established. Many patients with SCC present with uncontrolled systemic disease and poor performance status, and are not eligible for standard surgical resection. They are generally treated with 3D conformal palliative RT (3DCRT) alone, however recent trials suggest that less than 70% of patients are ambulatory, that the re-establishment of ambulation in non-ambulatory patients is poor, and the duration of improvement is guarded with radiotherapy alone.
Recently, stereotactic body radiotherapy (SBRT) used alone or after previous radiotherapy to treat spinal metastasis has demonstrated superior results in pain control, tumour response and durability. SBRT requires time for careful planning, and many patients with neurologic symptoms must be treated immediately to prevent progression. Therefore the role of SBRT is still unclear in this patient population, although it seems to be a potential alternative to surgical decompression in patient not suitable for surgery. The investigators propose a feasibility study to investigate the potential benefits of dose escalation with a sequential SBRT boost to urgent 3D CRT in the setting of SCC. This regimen will allow inoperable patients to receive urgent 3DCRT while simultaneously creating the opportunity for superior outcomes with SBRT. The investigators also aim to characterize the effect on motor function and ambulation, pain and QoL. This study could stimulate further multi-center randomized trials in this area, improve motor function and patient-reported QoL, and contribute to improving oncology care in Canada in a meaningful way.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm pilot study of standard of care 3D conformal radiotherapy plus Stereotactic body radiotherapy (SBRT) boost
| Arm | Type | Receives |
|---|---|---|
| SBRT boost | Experimental | Radiation: 3D CRT plus SBRT boostStandard radiotherapy (3D conformal, urgent palliative radiotherapy) plus stereotactic body radiotherapy (SBRT) boost |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of metastatic malignancy (radiologic or pathologic)
- Evidence of disease in vertebral body with epidural component such that Bilsky radiologic score is 1c-2 on MRI (abuts spinal cord without cord compression (1c), or spinal cord compression but with visible CSF (2)
- Motor function (MF) of 3 or greater
Key exclusion criteria (11 listed)
- Surgical candidate
- Instability of vertebral bodies with or without bony retropulsion requiring surgical intervention or hardware placement
- Previous radiotherapy course to same region of spine with overlapping fields (prior to phase I course) at discretion of treating radiation oncologist
- No CT or MRI within previous 3 months
- Life expectancy estimated <3 months
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 |
|---|---|---|
| 3D CRT plus SBRT boostPatients will receive urgent standard 3D conformal radiotherapy (3D CRT) of plus stereotactic boost to tumor causing spinal cord compression (SCC). Initial dose for 3D CRT will be either 8Gy in 1 fraction or 20Gy in 5 fractions, with SBRT boost dose15Gy in 2 fractions of 12Gy in 2 fractions (depending on 8Gy/1 or 20Gy/5 initial RT dose respectively), delivered within three weeks of first treatment. | Radiation | SBRT boost |
Primary outcome
Feasibility of accrual
Time frame: up to 12 months
Success determined by accrual of 30 patients with SBRT boost is planned and delivered to 80% of these
7 secondary outcomes
Motor Function Description:
Time frame: 4 weeks (primary), 12 weeks, 6 months
Overall Quality of Life (QoL)
Time frame: 4 weeks, 12 weeks, 6 months
Pain Response
Time frame: 4 weeks, 12 weeks, 6 months
Local Control
Time frame: 12 weeks, 6 months
Toxicity
Time frame: 4 weeks, 12 weeks, 6 months
Overall Survival
Time frame: 4 weeks, 12 weeks, 6 months
Bone metastasis- specific Quality of Life
Time frame: 4 weeks, 12 weeks, 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2020.
- Derived from this study: PubMed 33208170Donovan EK, Greenspoon J, Schnarr KL, Whelan TJ, Wright JR, Hann C, Whitton A, Chow T, Parpia S, Swaminath A. A pilot study of stereotactic boost for malignant epidural spinal cord compression: clinical significance and initial dosimetric evaluation. Radiat Oncol. 2020 Nov 18;15(1):267. doi: 10.1186/s13014-020-01710-4.
- Individual participant dataSharing planned: No
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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.
Shelley Chambers, MA contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D CRT plus SBRT boost in people with Spinal Cord Compression and Cauda Equina Syndrome, run by Juravinski Cancer Center at 1 site in Canada.
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 3 inclusion and 11 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 29 Jan 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elysia K Donovan, MD,FRCPC (9053879495, donovane@hhsc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of accrual (time frame: up to 12 months). 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 NCT03529708, which also lists 1 linked publication.
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 29 Jan 2020.