Proton Radiation Therapy for Spinal Tumors

Study Overview
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Brief Summary
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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.

Detailed Description
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Proton therapy may provide the benefits of local control or palliation, while reducing the risk associated with photon radiation, by delivering therapeutic doses to a well-defined target area with significant reduction in the integral dose. A dosimetry comparison of protons and photons at the University of Florida Proton Therapy Institute confirmed the feasibility of proton irradiation of these tumors with less exposure of normal tissue to radiation than expected with photon techniques. This reduced radiation exposure to uninvolved normal tissues is expected to decrease the risk of radiation-induced second malignancies and neoplasms.

Official Title
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Spinal Tumor Proton Protocol

Conditions
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Nerve Sheath Tumors, Neurofibroma

Intervention / Treatment
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* Radiation: Proton Radiation for MPNST
* Radiation: Proton Radiation for neurofibromas


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Proton Radiation for MPNST<br>Proton radiation 30 cobalt gray equivalent(CGE)at 6 CGE per fraction | Radiation: Proton Radiation for MPNST<br>* 30 CGE at 6 CGE/Fx<br>|
| Experimental: Proton Radiation for neurofibromas<br>Proton radiation 25 cobalt gray equivalent(CGE) at 5 CGE per fraction | Radiation: Proton Radiation for neurofibromas<br>* 25 CGE at 5 CGE/Fx<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local Control |  | 7 years after completion of RT | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression or palliation of pain, numbness, or weakness |  | At 3, 6, 12, 24 and 60 months after RT | 
| Number of adverse events |  | At 3, 6, 12, 24, 60 months and 15 years after RT | 
| Quality of Life |  | 3, 6, 12, 24 and 60 months after RT | 
| Rate of malignant transformation within the high-dose volume |  | 15 years after RT | 
| Rate of second malignant primaries outside of high dose volume, but located in tissues exposed to radiation within the beam path |  | 15 years after RT | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Proton Radiation Therapy, Spinal tumors, Neurofibroma(NF1), Malignant peripheral nerve sheath tumor(MPNST)