Spinal Cord CompressionStereocordNCT02167633
Stereotactic Radiosurgery in Metastatic Spinal Cord Compression
A study testing Decompression surgery, Radiosurgery and Fractionated Radiotherapy in people with Spinal Cord Compression and Neoplasm Metastasis, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Compression, Neoplasm Metastasis
- What is being tested?
- Decompression surgery, Radiosurgery and Fractionated Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- Jul 2014to Sep 2016
- 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 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Trial of Stereotactic Radiosurgery Versus Decompressive Surgery Followed by Postoperative Radiotherapy in Metastatic Spinal Cord Compression
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.
Read the 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
- Conditions
- Spinal Cord Compression, Neoplasm Metastasis
- Being tested
- Decompression surgery, Radiosurgery, Fractionated Radiotherapy, Glucocorticoids, Pantoprazole
- Keywords
- Radiosurgery, Laminectomy, Radiotherapy, Spinal Cord Compression, Neoplasm Metastasis, Randomized Controlled Trial
- Medical subject headings
- Spinal Cord Compression, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decompression surgeryProcedure or surgery
Also called laminectomy
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.
RadiosurgeryRadiation
Also called Stereotactic Body Radiotherapy
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
Fractionated RadiotherapyRadiation
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.
GlucocorticoidsDrug
Also called steroids
All patients referred with clinical suspicion of metastatic spinal cord compression will receive high dose glucocorticoids. Dose adjusted to risc of side effects.
PantoprazoleDrug
Also called Proton pump inhibitor (PPI)
All patients receiving high dose glucocorticoids will also be prescribed with pantoprazole 40/daily to prevent gastric ulcers
| Study group | Role | What they receive |
|---|---|---|
| Decompression surgery plus fractionated radiotherapy | Active comparator | Not described Receives: Procedure: Decompression surgery; Radiation: Fractionated Radiotherapy; Drug: Glucocorticoids; Drug: Pantoprazole |
| Radiosurgery | Experimental | 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 Receives: Radiation: Radiosurgery; Drug: Glucocorticoids; Drug: Pantoprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability to walk
Ability to walk determined by EQ-5D-5L
Measured: 6 weeks
Secondary outcomes (5)
Self reported pain
self reported pain determined by EQ-5D-5L
Measured: 0, 6, 12, 26, 52 weeks
Self reported bladder control
reported by questionnaire
Measured: 0, 6, 12, 26, 52 weeks
Quality of life
QOL determined by EQ-5D-5L
Measured: 0, 6, 12, 26, 52
Response rate
Post interventional MRI scan with response classified according to RECIST 1.1
Measured: 6 weeks
Toxicity and interventional related complications
Determined by CTCAE 4.0
Measured: 0, 6, 12, 26, 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2014 (estimated)
- Study startJul 2014
- Primary completionSep 2016
- Study completionSep 2016
Why it stopped: Due to low accrual rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord CompressionStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Morten Hiul Suppli, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Morten H Suppli, MD, Principal investigator, Copenhagen University Hospital, RigshospitaletSvend Aage Engelholm, MD, Study director, Copenhagen University Hospital, RigshospitaletBenny Dahl, MD, Study chair, Copenhagen University Hospital, RigshospitaletHelle Pappot, MD, Study chair, Copenhagen University Hospital, RigshospitaletPer Munck af Rosenschöld, Medical Physicist, Study chair, Copenhagen University Hospital, RigshospitaletSøren S Morgen, MD, Study chair, Copenhagen University Hospital, RigshospitaletIvan Vogelius, Medicial Physicist, Study chair, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02167633
- Sponsor's protocol ID
- H-3-2014-050
- Other IDs
- RH SRS in MESCC 2014
- Acronym
- Stereocord
- Status last verified
- Mar 2021
- First submitted
- 17 Jun 2014
- Last updated
- 11 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Morgen SS, Lund-Andersen C, Larsen CF, Engelholm SA, Dahl B. Prognosis in patients with symptomatic metastatic spinal cord compression: survival in different cancer diagnosis in a cohort of 2321 patients. Spine (Phila Pa 1976). 2013 Jul 15;38(16):1362-7. doi: 10.1097/BRS.0b013e318294835b.
PubMed 23574811Patchell RA, Tibbs PA, Regine WF, Payne R, Saris S, Kryscio RJ, Mohiuddin M, Young B. Direct decompressive surgical resection in the treatment of spinal cord compression caused by metastatic cancer: a randomised trial. Lancet. 2005 Aug 20-26;366(9486):643-8. doi: 10.1016/S0140-6736(05)66954-1.
PubMed 16112300Rades D, Huttenlocher S, Dunst J, Bajrovic A, Karstens JH, Rudat V, Schild SE. Matched pair analysis comparing surgery followed by radiotherapy and radiotherapy alone for metastatic spinal cord compression. J Clin Oncol. 2010 Aug 1;28(22):3597-604. doi: 10.1200/JCO.2010.28.5635. Epub 2010 Jul 6.
PubMed 20606090George R, Jeba J, Ramkumar G, Chacko AG, Leng M, Tharyan P. Interventions for the treatment of metastatic extradural spinal cord compression in adults. Cochrane Database Syst Rev. 2008 Oct 8;(4):CD006716. doi: 10.1002/14651858.CD006716.pub2.
PubMed 18843728Rock JP, Ryu S, Yin FF, Schreiber F, Abdulhak M. The evolving role of stereotactic radiosurgery and stereotactic radiation therapy for patients with spine tumors. J Neurooncol. 2004 Aug-Sep;69(1-3):319-34. doi: 10.1023/b:neon.0000041890.01837.53.
PubMed 15527098Gerszten PC, Burton SA, Ozhasoglu C, Welch WC. Radiosurgery for spinal metastases: clinical experience in 500 cases from a single institution. Spine (Phila Pa 1976). 2007 Jan 15;32(2):193-9. doi: 10.1097/01.brs.0000251863.76595.a2.
PubMed 17224814Ryu S, Rock J, Jain R, Lu M, Anderson J, Jin JY, Rosenblum M, Movsas B, Kim JH. Radiosurgical decompression of metastatic epidural compression. Cancer. 2010 May 1;116(9):2250-7. doi: 10.1002/cncr.24993.
PubMed 20209611Jin R, Rock J, Jin JY, Janakiraman N, Kim JH, Movsas B, Ryu S. Single fraction spine radiosurgery for myeloma epidural spinal cord compression. J Exp Ther Oncol. 2009;8(1):35-41.
PubMed 19827269Sahgal A, Ma L, Gibbs I, Gerszten PC, Ryu S, Soltys S, Weinberg V, Wong S, Chang E, Fowler J, Larson DA. Spinal cord tolerance for stereotactic body radiotherapy. Int J Radiat Oncol Biol Phys. 2010 Jun 1;77(2):548-53. doi: 10.1016/j.ijrobp.2009.05.023. Epub 2009 Sep 16.
PubMed 19765914Kirkpatrick JP, van der Kogel AJ, Schultheiss TE. Radiation dose-volume effects in the spinal cord. Int J Radiat Oncol Biol Phys. 2010 Mar 1;76(3 Suppl):S42-9. doi: 10.1016/j.ijrobp.2009.04.095.
PubMed 20171517Timmerman RD. An overview of hypofractionation and introduction to this issue of seminars in radiation oncology. Semin Radiat Oncol. 2008 Oct;18(4):215-22. doi: 10.1016/j.semradonc.2008.04.001. No abstract available.
PubMed 18725106Boehling NS, Grosshans DR, Allen PK, McAleer MF, Burton AW, Azeem S, Rhines LD, Chang EL. Vertebral compression fracture risk after stereotactic body radiotherapy for spinal metastases. J Neurosurg Spine. 2012 Apr;16(4):379-86. doi: 10.3171/2011.11.SPINE116. Epub 2012 Jan 6.
PubMed 22225488Cunha MV, Al-Omair A, Atenafu EG, Masucci GL, Letourneau D, Korol R, Yu E, Howard P, Lochray F, da Costa LB, Fehlings MG, Sahgal A. Vertebral compression fracture (VCF) after spine stereotactic body radiation therapy (SBRT): analysis of predictive factors. Int J Radiat Oncol Biol Phys. 2012 Nov 1;84(3):e343-9. doi: 10.1016/j.ijrobp.2012.04.034. Epub 2012 Jun 1.
PubMed 22658511Choi D, Morris S, Crockard A, Albert T, Bunger C, Fehlings M, Harrop J, Kawahara N, Martin JA, Massicotte EM, Mazel C, Oner FC, Peul W, Tomita K, Wang M. Assessment of quality of life after surgery for spinal metastases: position statement of the Global Spine Tumour Study Group. World Neurosurg. 2013 Dec;80(6):e175-9. doi: 10.1016/j.wneu.2013.02.054. Epub 2013 Feb 16.
PubMed 23422266Cox BW, Spratt DE, Lovelock M, Bilsky MH, Lis E, Ryu S, Sheehan J, Gerszten PC, Chang E, Gibbs I, Soltys S, Sahgal A, Deasy J, Flickinger J, Quader M, Mindea S, Yamada Y. International Spine Radiosurgery Consortium consensus guidelines for target volume definition in spinal stereotactic radiosurgery. Int J Radiat Oncol Biol Phys. 2012 Aug 1;83(5):e597-605. doi: 10.1016/j.ijrobp.2012.03.009. Epub 2012 May 19.
PubMed 22608954
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Stereotactic Radiosurgery Versus Decompressive Surgery Followed by Postoperative Radiotherapy in Metastatic Spinal Cord Compression
- ClinicalTrials.gov ID
- NCT02167633
- Acronym / sponsor ID
- Stereocord / H-3-2014-050
- Conditions
- Spinal Cord Compression, Neoplasm Metastasis
- Keywords
- Radiosurgery, Laminectomy, Radiotherapy, Spinal Cord Compression, Neoplasm Metastasis, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to low accrual rate
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 19 Jun 2014 (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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Decompression surgery plus fractionated radiotherapy | Active comparator | Procedure: Decompression surgery, Radiation: Fractionated Radiotherapy, Drug: Glucocorticoids, Drug: Pantoprazole |
| Radiosurgery | Experimental | Radiation: Radiosurgery, Drug: Glucocorticoids, Drug: PantoprazolePatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (12 listed)
- 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
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 |
|---|---|---|
| Decompression surgeryAlso: laminectomyPatients 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. | Procedure or surgery | Decompression surgery plus fractionated radiotherapy |
| RadiosurgeryAlso: Stereotactic Body RadiotherapyPatients 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 | Radiation | Radiosurgery |
| Fractionated RadiotherapyPatients 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. | Radiation | Decompression surgery plus fractionated radiotherapy |
| GlucocorticoidsAlso: steroidsAll patients referred with clinical suspicion of metastatic spinal cord compression will receive high dose glucocorticoids. Dose adjusted to risc of side effects. | Drug | Decompression surgery plus fractionated radiotherapy, Radiosurgery |
| PantoprazoleAlso: Proton pump inhibitor (PPI)All patients receiving high dose glucocorticoids will also be prescribed with pantoprazole 40/daily to prevent gastric ulcers | Drug | Decompression surgery plus fractionated radiotherapy, Radiosurgery |
Primary outcome
Ability to walk
Time frame: 6 weeks
Ability to walk determined by EQ-5D-5L
5 secondary outcomes
Self reported pain
Time frame: 0, 6, 12, 26, 52 weeks
Self reported bladder control
Time frame: 0, 6, 12, 26, 52 weeks
Quality of life
Time frame: 0, 6, 12, 26, 52
Response rate
Time frame: 6 weeks
Toxicity and interventional related complications
Time frame: 0, 6, 12, 26, 52 weeks
Results and safety
The study was stopped early (reason given: Due to low accrual rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2021.
- Background: PubMed 23574811Morgen SS, Lund-Andersen C, Larsen CF, Engelholm SA, Dahl B. Prognosis in patients with symptomatic metastatic spinal cord compression: survival in different cancer diagnosis in a cohort of 2321 patients. Spine (Phila Pa 1976). 2013 Jul 15;38(16):1362-7. doi: 10.1097/BRS.0b013e318294835b.
- Background: PubMed 16112300Patchell RA, Tibbs PA, Regine WF, Payne R, Saris S, Kryscio RJ, Mohiuddin M, Young B. Direct decompressive surgical resection in the treatment of spinal cord compression caused by metastatic cancer: a randomised trial. Lancet. 2005 Aug 20-26;366(9486):643-8. doi: 10.1016/S0140-6736(05)66954-1.
- Background: PubMed 20606090Rades D, Huttenlocher S, Dunst J, Bajrovic A, Karstens JH, Rudat V, Schild SE. Matched pair analysis comparing surgery followed by radiotherapy and radiotherapy alone for metastatic spinal cord compression. J Clin Oncol. 2010 Aug 1;28(22):3597-604. doi: 10.1200/JCO.2010.28.5635. Epub 2010 Jul 6.
- Background: PubMed 18843728George R, Jeba J, Ramkumar G, Chacko AG, Leng M, Tharyan P. Interventions for the treatment of metastatic extradural spinal cord compression in adults. Cochrane Database Syst Rev. 2008 Oct 8;(4):CD006716. doi: 10.1002/14651858.CD006716.pub2.
- Background: PubMed 15527098Rock JP, Ryu S, Yin FF, Schreiber F, Abdulhak M. The evolving role of stereotactic radiosurgery and stereotactic radiation therapy for patients with spine tumors. J Neurooncol. 2004 Aug-Sep;69(1-3):319-34. doi: 10.1023/b:neon.0000041890.01837.53.
- Background: PubMed 17224814Gerszten PC, Burton SA, Ozhasoglu C, Welch WC. Radiosurgery for spinal metastases: clinical experience in 500 cases from a single institution. Spine (Phila Pa 1976). 2007 Jan 15;32(2):193-9. doi: 10.1097/01.brs.0000251863.76595.a2.
- Background: PubMed 20209611Ryu S, Rock J, Jain R, Lu M, Anderson J, Jin JY, Rosenblum M, Movsas B, Kim JH. Radiosurgical decompression of metastatic epidural compression. Cancer. 2010 May 1;116(9):2250-7. doi: 10.1002/cncr.24993.
- Background: PubMed 19827269Jin R, Rock J, Jin JY, Janakiraman N, Kim JH, Movsas B, Ryu S. Single fraction spine radiosurgery for myeloma epidural spinal cord compression. J Exp Ther Oncol. 2009;8(1):35-41.
- Background: PubMed 19765914Sahgal A, Ma L, Gibbs I, Gerszten PC, Ryu S, Soltys S, Weinberg V, Wong S, Chang E, Fowler J, Larson DA. Spinal cord tolerance for stereotactic body radiotherapy. Int J Radiat Oncol Biol Phys. 2010 Jun 1;77(2):548-53. doi: 10.1016/j.ijrobp.2009.05.023. Epub 2009 Sep 16.
- Background: PubMed 20171517Kirkpatrick JP, van der Kogel AJ, Schultheiss TE. Radiation dose-volume effects in the spinal cord. Int J Radiat Oncol Biol Phys. 2010 Mar 1;76(3 Suppl):S42-9. doi: 10.1016/j.ijrobp.2009.04.095.
- Background: PubMed 18725106Timmerman RD. An overview of hypofractionation and introduction to this issue of seminars in radiation oncology. Semin Radiat Oncol. 2008 Oct;18(4):215-22. doi: 10.1016/j.semradonc.2008.04.001. No abstract available.
- Background: PubMed 22225488Boehling NS, Grosshans DR, Allen PK, McAleer MF, Burton AW, Azeem S, Rhines LD, Chang EL. Vertebral compression fracture risk after stereotactic body radiotherapy for spinal metastases. J Neurosurg Spine. 2012 Apr;16(4):379-86. doi: 10.3171/2011.11.SPINE116. Epub 2012 Jan 6.
Related trials for Spinal Cord Compression
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingObservational study
Cervical Spinal Cord Signal Abnormalities in Patients With Cervical Radicular Pain
Cervical Radiculopathy, Cervical Myelomalacia
Active, not recruitingPhase 2
Thermal Ablation and Spine Stereotactic Radiosurgery in Treating Patients With Spine Metastases at Risk for Compressing the Spinal Cord
Malignant Digestive System Neoplasm, Metastatic Head and Neck Carcinoma
Active, not recruitingPhase 1
Phase I Study of Feasibility of Single Session Spine Stereotactic Radiosurgery (SSRS) in the Primary Management in Patients With Inoperable, Previously Unirradiated Metastatic Epidural Spinal Cord Compression (MESCC)
Metastatic Epidural Spinal Cord Compression
RecruitingPhase 2
Risk Adapted Spinal Cord/Cauda Constraint Relaxation for High-risk Patients With Metastatic Epidural Spinal Cord Compression Undergoing Spine Stereotactic Radiosurgery
Spinal Cord, Metastatic Epidural
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.
Morten H Suppli, MD principal investigator
Copenhagen University Hospital, Rigshospitalet
Svend Aage Engelholm, MD study director
Copenhagen University Hospital, Rigshospitalet
Benny Dahl, MD study chair
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decompression surgery, Radiosurgery and Fractionated Radiotherapy in people with Spinal Cord Compression and Neoplasm Metastasis, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 12 inclusion and 12 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 11 Mar 2021. 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 Denmark. 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: Due to low accrual rate). 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?
Ability to walk (time frame: 6 weeks). 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 NCT02167633, which also lists 17 linked publications.
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 11 Mar 2021.