Back to resultsStereotactic Radiosurgery in Metastatic Spinal Cord Compression (Stereocord)
Primary Purpose
Spinal Cord Compression, Neoplasm Metastasis
Status
Terminated
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Decompression surgery
Radiosurgery
Fractionated Radiotherapy
Glucocorticoids
Pantoprazole
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Compression focused on measuring Radiosurgery, Laminectomy, Radiotherapy, Spinal Cord Compression, Neoplasm Metastasis, Randomized Controlled Trial
Eligibility Criteria
Inclusion Criteria:
- Patients must have histological or cytological confirmed malignancy that is metastatic or unresectable and for which standard curative measures do not exist or are no longer effective
- Patients must have localized spine metastasis from first cervical to last lumbar vertebra with evidence of radiological SCC (rSCC) on a diagnostic MRI defined as involvement or compression of either the spinal cord or the cauda equina by an epidural mass lesion or metastatic disease causing impingement, indentation or loss of definition of the thecal sac
- A maximum of two separate sites requiring treatment is allowed with maximum two vertebra pr. site
- Eligible for surgery defined by technical assessment by surgeon whether surgical decompression is possible with proper stabilization of the spine
- No medical co-morbidity contradicting anesthesia
- Patient without former treatment for metastatic spinal cord compression with either decompressive surgery and/or radiation therapy
- Patient with mild to moderate neurologic signs are eligible. These neurological signs include radiculopathy, dermatomal sensory change, and muscle strength of involved extremity 4/5 on MRC scale
- Age ≥18 years
- ECOG performance status ≤2
- Life expectancy of greater than 3 months
- The effects of ionizing radiation on the developing human fetus are known to be teratogenic. For this reason women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of radiation therapy administration
- Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
- Histology of myeloma or lymphoma
- Patients with any spine metastasis that is not planned to be treated per protocol
- Spine instability due to a compression fracture or impending vertebral compression fracture
- Patients with rapid neurologic decline within 24 hours
- Bony retropulsion causing neurologic abnormality
- Prior radiation to the index spine
- Patients for whom an MRI of the spine is medically contraindicated
- Patients allergic to contrast dye used in MRIs
- Patients who are receiving any other investigational agents
- Patients with more than two known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
- Patient with any serious neurologic condition other than MSCC that could confound the diagnosis and interpretation of radiation induced myelopathy
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Sites / Locations
- Rigshospitalet
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Decompression surgery plus fractionated radiotherapy
Radiosurgery
Arm Description
Patients treated with radiosurgery/SBRT will receive a prescribed dose of 16 Gy in one fraction to cover as large a fraction as possible the defined target volume
Outcomes
Primary Outcome Measures
Ability to walk
Ability to walk determined by EQ-5D-5L
Secondary Outcome Measures
Self reported pain
self reported pain determined by EQ-5D-5L
Self reported bladder control
reported by questionnaire
Quality of life
QOL determined by EQ-5D-5L
Response rate
Post interventional MRI scan with response classified according to RECIST 1.1
Toxicity and interventional related complications
Determined by CTCAE 4.0
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02167633
Brief Title
Stereotactic Radiosurgery in Metastatic Spinal Cord Compression
Acronym
Stereocord
Official Title
A Randomized Trial of Stereotactic Radiosurgery Versus Decompressive Surgery Followed by Postoperative Radiotherapy in Metastatic Spinal Cord Compression
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Terminated
Why Stopped
Due to low accrual rate
Study Start Date
July 2014 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To determine whether stereotactic radiosurgery of metastatic spinal cord compression is equivalent to decompressive surgery followed by external body radiation therapy to maintain ability to walk at 6 weeks.
Detailed Description
Metastatic spinal cord compression (MSCC) is an acute event demanding treatment which otherwise would eventually lead to paraplegia in all patients. This is a serious condition for the individual cancer patient and burdensome for the healthcare system. A surgical intervention plus fractionated radiation therapy (FRT) is currently the standard treatment.
Proposed Solution: If spinal cord dose is respected, local tumor control could be equivalent using stereotactic body radiation therapy (SBRT) with minimal risk in comparison to decompression surgery and postoperative conventional radiotherapy without the additional burden on the patient of performing an invasive surgical procedure.
Clinical Impact:
Patients currently requiring surgery plus radiation therapy will potentially benefit form the proposed method. Patients will potentially benefit from reduced toxicity by avoiding the surgical procedure. In addition, a shorter treatment protocol with only one fraction is beneficial.
Aims:
The investigators' hypothesis is that stereotactic body radiation therapy (SBRT) could be equivalent alternative in the case of patients presenting with metastatic spinal cord compression with minor neurologic deficits.
Specific aims:
Determine the feasibility of recruiting patients to be randomized towards SBRT vs. of surgery plus FRT
Determine the ability to walk after 6 weeks measured from the starting date of treatment
Determine the side-effects and quality of life metrics following both treatment arms
Determine the rate of local control following therapy using MRI scan
Project Plan:
The investigators intend to investigate if stereotactic body radiation therapy (SBRT) could be equivalent alternative in the case of patients presenting with metastatic spinal cord compression with minor neurologic deficits
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Compression, Neoplasm Metastasis
Keywords
Radiosurgery, Laminectomy, Radiotherapy, Spinal Cord Compression, Neoplasm Metastasis, Randomized Controlled Trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Decompression surgery plus fractionated radiotherapy
Arm Type
Active Comparator
Arm Title
Radiosurgery
Arm Type
Experimental
Arm Description
Patients treated with radiosurgery/SBRT will receive a prescribed dose of 16 Gy in one fraction to cover as large a fraction as possible the defined target volume
Intervention Type
Procedure
Intervention Name(s)
Decompression surgery
Other Intervention Name(s)
laminectomy
Intervention Description
Patients will undergo posterior decompression/laminectomy on relevant spinal levels depending on neurological symptoms. If there is a need of spinal stabilization after decompression, patients will undergo posterior instrumentation with pedicle screws and titanium rods. Instrumentation will be done two or three levels above and below each level with metastatic affection.
Intervention Type
Radiation
Intervention Name(s)
Radiosurgery
Other Intervention Name(s)
Stereotactic Body Radiotherapy
Intervention Description
Patients treated with radiosurgery/SBRT will receive a prescribed dose of 16 Gy in 1 fraction to cover as large a fraction as possible the defined target volume
Intervention Type
Radiation
Intervention Name(s)
Fractionated Radiotherapy
Intervention Description
Patients allocated to surgery will receive postoperative radiotherapy commencing between 10 to 21 days after decompressive surgery. Target should include the entire vertebral body and the vertebral arch at the operated level of the vertebral column.
Patients receiving postoperative radiotherapy will receive 30 Gy in 10 fractions with 3 Gy pr. fraction. The prescribed dose should cover at least 90 % of the defined target volume.
Intervention Type
Drug
Intervention Name(s)
Glucocorticoids
Other Intervention Name(s)
steroids
Intervention Description
All patients referred with clinical suspicion of metastatic spinal cord compression will receive high dose glucocorticoids. Dose adjusted to risc of side effects.
Intervention Type
Drug
Intervention Name(s)
Pantoprazole
Other Intervention Name(s)
Proton pump inhibitor (PPI)
Intervention Description
All patients receiving high dose glucocorticoids will also be prescribed with pantoprazole 40/daily to prevent gastric ulcers
Primary Outcome Measure Information:
Title
Ability to walk
Description
Ability to walk determined by EQ-5D-5L
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Self reported pain
Description
self reported pain determined by EQ-5D-5L
Time Frame
0, 6, 12, 26, 52 weeks
Title
Self reported bladder control
Description
reported by questionnaire
Time Frame
0, 6, 12, 26, 52 weeks
Title
Quality of life
Description
QOL determined by EQ-5D-5L
Time Frame
0, 6, 12, 26, 52
Title
Response rate
Description
Post interventional MRI scan with response classified according to RECIST 1.1
Time Frame
6 weeks
Title
Toxicity and interventional related complications
Description
Determined by CTCAE 4.0
Time Frame
0, 6, 12, 26, 52 weeks
Other Pre-specified Outcome Measures:
Title
Days of treatment
Description
measurement of therapy related treatment days both as ambulatory and admitted to the hospital
Time Frame
52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients must have histological or cytological confirmed malignancy that is metastatic or unresectable and for which standard curative measures do not exist or are no longer effective
Patients must have localized spine metastasis from first cervical to last lumbar vertebra with evidence of radiological SCC (rSCC) on a diagnostic MRI defined as involvement or compression of either the spinal cord or the cauda equina by an epidural mass lesion or metastatic disease causing impingement, indentation or loss of definition of the thecal sac
A maximum of two separate sites requiring treatment is allowed with maximum two vertebra pr. site
Eligible for surgery defined by technical assessment by surgeon whether surgical decompression is possible with proper stabilization of the spine
No medical co-morbidity contradicting anesthesia
Patient without former treatment for metastatic spinal cord compression with either decompressive surgery and/or radiation therapy
Patient with mild to moderate neurologic signs are eligible. These neurological signs include radiculopathy, dermatomal sensory change, and muscle strength of involved extremity 4/5 on MRC scale
Age ≥18 years
ECOG performance status ≤2
Life expectancy of greater than 3 months
The effects of ionizing radiation on the developing human fetus are known to be teratogenic. For this reason women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of radiation therapy administration
Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
Histology of myeloma or lymphoma
Patients with any spine metastasis that is not planned to be treated per protocol
Spine instability due to a compression fracture or impending vertebral compression fracture
Patients with rapid neurologic decline within 24 hours
Bony retropulsion causing neurologic abnormality
Prior radiation to the index spine
Patients for whom an MRI of the spine is medically contraindicated
Patients allergic to contrast dye used in MRIs
Patients who are receiving any other investigational agents
Patients with more than two known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
Patient with any serious neurologic condition other than MSCC that could confound the diagnosis and interpretation of radiation induced myelopathy
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Morten H Suppli, MD
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Svend Aage Engelholm, MD
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Benny Dahl, MD
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Helle Pappot, MD
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Per Munck af Rosenschöld, Medical Physicist
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Søren S Morgen, MD
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ivan Vogelius, Medicial Physicist
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Study Chair
Facility Information:
Facility Name
Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
12. IPD Sharing Statement
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Stereotactic Radiosurgery in Metastatic Spinal Cord Compression
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