Clinical trial · Interventional
Proton Radiation Therapy for Spinal Tumors
Spinal Tumor Proton Protocol
NCT01567787CI-TRIAL-00025927NF01withdrawnN/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): Feasibility issues
Summary
Brief summary (as posted)
The purpose of this study is to determine if Proton Therapy can provide effective and safe treatment for Malignant Peripheral Nerve Sheath Tumors of the spine and Neurofibromas of the spine.
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 |
|---|---|---|---|
| Nerve Sheath Tumors | Nerve Sheath Neoplasm | ALIAS | 0.90 |
| Neurofibroma | Neurofibroma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Proton Radiation for MPNST | Radiation | — | UNRESOLVED |
| Proton Radiation for neurofibromas | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Proton Radiation for MPNST
- description
- Proton radiation 30 cobalt gray equivalent(CGE)at 6 CGE per fraction
- interventionNames
- Radiation: Proton Radiation for MPNST
- type
- EXPERIMENTAL
- label
- Proton Radiation for neurofibromas
- description
- Proton radiation 25 cobalt gray equivalent(CGE) at 5 CGE per fraction
- interventionNames
- Radiation: Proton Radiation for neurofibromas
Primary outcomes (1)
- measure
- Local Control
- timeFrame
- 7 years after completion of RT
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * MPNSTs that are biopsy-positive and resected, subtotally resected or unresectable. * Symptomatic (pain, numbness, or weakness) NF1 neurofibromas that are biopsy-positive and unresectable or subtotally resected. * Symptomatic NF1 neurofibromas that are unbiopsied and PET-negative, if the patient refuses biopsy/surgery or is medically inoperable. * Asymptomatic NF1 neurofibromas with radiologic progression after surgery. * PET-positive, unbiopsied lesions in NF1 patients who refuse biopsy/surgery or are medically inoperable. Exclusion Criteria: * Spinal instability. * Metal stabilization hardware within the target area. * Previously irradiated at this disease site. * Spinal cord compression with complete loss of function.
References
Publications (26)
- BACKGROUNDHottinger AF, Khakoo Y. Neuro-oncology of Neurofibromatosis Type 1. Curr Treat Options Neurol. 2009 Jul;11(4):306-14. doi: 10.1007/s11940-009-0034-4. PMID 19523356
- BACKGROUNDFriedman JM, Birch PH. Type 1 neurofibromatosis: a descriptive analysis of the disorder in 1,728 patients. Am J Med Genet. 1997 May 16;70(2):138-43. doi: 10.1002/(sici)1096-8628(19970516)70:23.0.co;2-u. PMID 9128932
- BACKGROUNDCnossen MH, de Goede-Bolder A, van den Broek KM, Waasdorp CM, Oranje AP, Stroink H, Simonsz HJ, van den Ouweland AM, Halley DJ, Niermeijer MF. A prospective 10 year follow up study of patients with neurofibromatosis type 1. Arch Dis Child. 1998 May;78(5):408-12. doi: 10.1136/adc.78.5.408. PMID 9659085
- BACKGROUNDMautner VF, Asuagbor FA, Dombi E, Funsterer C, Kluwe L, Wenzel R, Widemann BC, Friedman JM. Assessment of benign tumor burden by whole-body MRI in patients with neurofibromatosis 1. Neuro Oncol. 2008 Aug;10(4):593-8. doi: 10.1215/15228517-2008-011. Epub 2008 Jun 17. PMID 18559970
- BACKGROUNDSeppala MT, Haltia MJ, Sankila RJ, Jaaskelainen JE, Heiskanen O. Long-term outcome after removal of spinal neurofibroma. J Neurosurg. 1995 Apr;82(4):572-7. doi: 10.3171/jns.1995.82.4.0572. PMID 7897516
- BACKGROUNDThakkar SD, Feigen U, Mautner VF. Spinal tumours in neurofibromatosis type 1: an MRI study of frequency, multiplicity and variety. Neuroradiology. 1999 Sep;41(9):625-9. doi: 10.1007/s002340050814. PMID 10525761
- BACKGROUNDTonsgard JH. Clinical manifestations and management of neurofibromatosis type 1. Semin Pediatr Neurol. 2006 Mar;13(1):2-7. doi: 10.1016/j.spen.2006.01.005. PMID 16818170
- BACKGROUNDNeedle MN, Cnaan A, Dattilo J, Chatten J, Phillips PC, Shochat S, Sutton LN, Vaughan SN, Zackai EH, Zhao H, Molloy PT. Prognostic signs in the surgical management of plexiform neurofibroma: the Children's Hospital of Philadelphia experience, 1974-1994. J Pediatr. 1997 Nov;131(5):678-82. doi: 10.1016/s0022-3476(97)70092-1.