Proton Radiation Therapy for Spinal Tumors (NF01)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2015 by University of Florida
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01567787
First received: March 13, 2012
Last updated: March 10, 2015
Last verified: March 2015
  Purpose

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 Intervention Phase
Nerve Sheath Tumors
Neurofibroma
Radiation: Proton Radiation for MPNST
Radiation: Proton Radiation for neurofibromas
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Spinal Tumor Proton Protocol

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Local Control [ Time Frame: 7 years after completion of RT ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression or palliation of pain, numbness, or weakness [ Time Frame: At 3, 6, 12, 24 and 60 months after RT ] [ Designated as safety issue: No ]
  • Number of adverse events [ Time Frame: At 3, 6, 12, 24, 60 months and 15 years after RT ] [ Designated as safety issue: Yes ]
  • Quality of Life [ Time Frame: 3, 6, 12, 24 and 60 months after RT ] [ Designated as safety issue: No ]
  • Rate of malignant transformation within the high-dose volume [ Time Frame: 15 years after RT ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 34
Study Start Date: June 2013
Estimated Study Completion Date: May 2033
Estimated Primary Completion Date: May 2025 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01567787

Contacts
Contact: Intake Coordinator 877-686-6009

Locations
United States, Florida
University of Florida Proton Therapy Institute Recruiting
Jacksonville, Florida, United States, 32206
Contact: Intake Coordinator    877-686-6009      
Principal Investigator: Randal H Henderson, MD         
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Randal H Henderson, MD University of Florida Proton Therapy Institute
  More Information

Publications:
Wentworth S, Pinn M, Bourland JD, deGuzman AF, Ekstrand K, Ellis TL, Glazier SS, McMullen KP, Munley M, Stieber VW, Tatter SB, Shaw EG. Clinical experience with radiation therapy in the management of neurofibromatosis-associated central nervous system tumors. Int J Radiat Oncol Biol Phys 2009;73:208-13
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
ClinicalTrials.gov Identifier: NCT01567787     History of Changes
Other Study ID Numbers: UFPTI 1101-NF01
Study First Received: March 13, 2012
Last Updated: March 10, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
Proton Radiation Therapy
Spinal tumors
Neurofibroma(NF1)
Malignant peripheral nerve sheath tumor(MPNST)

Additional relevant MeSH terms:
Nerve Sheath Neoplasms
Neurofibroma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nervous System Diseases
Nervous System Neoplasms
Neuromuscular Diseases
Peripheral Nervous System Diseases
Peripheral Nervous System Neoplasms

ClinicalTrials.gov processed this record on March 26, 2015