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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Withdrawn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
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    March 13, 2012
    Last Updated
    February 9, 2017
    Sponsor
    University of Florida
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    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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