Proton Radiation Therapy for Spinal Tumors (NF01)
Primary Purpose
Nerve Sheath Tumors, Neurofibroma
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Proton Radiation for MPNST
Proton Radiation for neurofibromas
Sponsored by
About this trial
This is an interventional treatment trial for Nerve Sheath Tumors focused on measuring Proton Radiation Therapy, Spinal tumors, Neurofibroma(NF1), Malignant peripheral nerve sheath tumor(MPNST)
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Proton Radiation for MPNST
Proton Radiation for neurofibromas
Arm Description
Proton radiation 30 cobalt gray equivalent(CGE)at 6 CGE per fraction
Proton radiation 25 cobalt gray equivalent(CGE) at 5 CGE per fraction
Outcomes
Primary Outcome Measures
Local Control
Secondary Outcome Measures
Progression or palliation of pain, numbness, or weakness
Number of adverse events
Quality of Life
Rate of malignant transformation within the high-dose volume
Rate of second malignant primaries outside of high dose volume, but located in tissues exposed to radiation within the beam path
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01567787
Brief Title
Proton Radiation Therapy for Spinal Tumors
Acronym
NF01
Official Title
Spinal Tumor Proton Protocol
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Feasibility issues
Study Start Date
June 2013 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nerve Sheath Tumors, Neurofibroma
Keywords
Proton Radiation Therapy, Spinal tumors, Neurofibroma(NF1), Malignant peripheral nerve sheath tumor(MPNST)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Proton Radiation for MPNST
Arm Type
Experimental
Arm Description
Proton radiation 30 cobalt gray equivalent(CGE)at 6 CGE per fraction
Arm Title
Proton Radiation for neurofibromas
Arm Type
Experimental
Arm Description
Proton radiation 25 cobalt gray equivalent(CGE) at 5 CGE per fraction
Intervention Type
Radiation
Intervention Name(s)
Proton Radiation for MPNST
Intervention Description
30 CGE at 6 CGE/Fx
Intervention Type
Radiation
Intervention Name(s)
Proton Radiation for neurofibromas
Intervention Description
25 CGE at 5 CGE/Fx
Primary Outcome Measure Information:
Title
Local Control
Time Frame
7 years after completion of RT
Secondary Outcome Measure Information:
Title
Progression or palliation of pain, numbness, or weakness
Time Frame
At 3, 6, 12, 24 and 60 months after RT
Title
Number of adverse events
Time Frame
At 3, 6, 12, 24, 60 months and 15 years after RT
Title
Quality of Life
Time Frame
3, 6, 12, 24 and 60 months after RT
Title
Rate of malignant transformation within the high-dose volume
Time Frame
15 years after RT
Title
Rate of second malignant primaries outside of high dose volume, but located in tissues exposed to radiation within the beam path
Time Frame
15 years after RT
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Randal H Henderson, MD
Organizational Affiliation
University of Florida Proton Therapy Institute
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Proton Radiation Therapy for Spinal Tumors
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