Proton Radiation Therapy for Spinal Tumors (NF01)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01567787
Recruitment Status : Withdrawn (Feasibility issues)
First Posted : March 30, 2012
Last Update Posted : February 10, 2017
Information provided by (Responsible Party):
University of Florida

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.

Condition or disease Intervention/treatment Phase
Nerve Sheath Tumors Neurofibroma Radiation: Proton Radiation for MPNST Radiation: Proton Radiation for neurofibromas Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Spinal Tumor Proton Protocol
Study Start Date : June 2013
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Arm Intervention/treatment
Experimental: Proton Radiation for MPNST
Proton radiation 30 cobalt gray equivalent(CGE)at 6 CGE per fraction
Radiation: Proton Radiation for MPNST
30 CGE at 6 CGE/Fx

Experimental: Proton Radiation for neurofibromas
Proton radiation 25 cobalt gray equivalent(CGE) at 5 CGE per fraction
Radiation: Proton Radiation for neurofibromas
25 CGE at 5 CGE/Fx

Primary Outcome Measures :
  1. Local Control [ Time Frame: 7 years after completion of RT ]

Secondary Outcome Measures :
  1. Progression or palliation of pain, numbness, or weakness [ Time Frame: At 3, 6, 12, 24 and 60 months after RT ]
  2. Number of adverse events [ Time Frame: At 3, 6, 12, 24, 60 months and 15 years after RT ]
  3. Quality of Life [ Time Frame: 3, 6, 12, 24 and 60 months after RT ]
  4. Rate of malignant transformation within the high-dose volume [ Time Frame: 15 years after RT ]
  5. 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 ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01567787

Sponsors and Collaborators
University of Florida
Principal Investigator: Randal H Henderson, MD University of Florida Proton Therapy Institute

Schadev S, Dodd RL, Chang SD, Soltys SG, Adler JR, Luxton G, Choi CYH, Tupper LA, Gibbs IC. Stereotactic Radiosurgery Yields Long-term Control for Benign Intradural, Extramedullary Spine Tumors. Int J Radiat Oncol Biol Phys 2009; 75:101 (Abstract)

Responsible Party: University of Florida Identifier: NCT01567787     History of Changes
Other Study ID Numbers: UFPTI 1101-NF01
First Posted: March 30, 2012    Key Record Dates
Last Update Posted: February 10, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by University of Florida:
Proton Radiation Therapy
Spinal tumors
Malignant peripheral nerve sheath tumor(MPNST)

Additional relevant MeSH terms:
Nerve Sheath Neoplasms
Spinal Cord Neoplasms
Spinal Neoplasms
Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Peripheral Nervous System Neoplasms
Nervous System Neoplasms
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Neoplastic Syndromes, Hereditary
Neurocutaneous Syndromes
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Central Nervous System Neoplasms
Neoplasms by Site
Spinal Cord Diseases
Central Nervous System Diseases
Bone Neoplasms
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases