Clinical trial · Interventional
Stereotactic Radiosurgery in Metastatic Spinal Cord Compression
A Randomized Trial of Stereotactic Radiosurgery Versus Decompressive Surgery Followed by Postoperative Radiotherapy in Metastatic Spinal Cord Compression
NCT02167633CI-TRIAL-00050614StereocordterminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Due to low accrual rate
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasm Metastasis | — | UNRESOLVED | — |
| Spinal Cord Compression | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Decompression surgery | Procedure | — | UNRESOLVED |
| Fractionated Radiotherapy | Radiation | — | UNRESOLVED |
| Glucocorticoids | Drug | — | UNRESOLVED |
| Pantoprazole | Drug | — | UNRESOLVED |
| Radiosurgery | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Decompression surgery plus fractionated radiotherapy
- interventionNames
- Procedure: Decompression surgery
- Radiation: Fractionated Radiotherapy
- Drug: Glucocorticoids
- Drug: Pantoprazole
- type
- EXPERIMENTAL
- label
- Radiosurgery
- 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
- interventionNames
- Radiation: Radiosurgery
- Drug: Glucocorticoids
- Drug: Pantoprazole
Primary outcomes (1)
- measure
- Ability to walk
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (17)
- BACKGROUNDMorgen 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. PMID 23574811
- BACKGROUNDPatchell 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. PMID 16112300
- BACKGROUNDRades 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. PMID 20606090
- BACKGROUNDGeorge 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. PMID 18843728
- BACKGROUNDRock 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. PMID 15527098
- BACKGROUNDGerszten 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. PMID 17224814
- BACKGROUNDRyu 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.