Proton Radiation Therapy for Spinal Tumors

Not Applicable

Withdrawn

• Conditions: Nerve Sheath Tumors; Neurofibroma
• Interventions: Radiation: Proton Radiation for MPNST; Radiation: Proton Radiation for neurofibromas

• Registration Number: NCT01567787
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2012-03-13
• Study First Submitted QC: 2012-03-28
• Study First Posted: 2012-03-30
• Study Start: 2013-06
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-09
• Last Update Posted: 2017-02-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Proton Radiation for MPNST	Proton Radiation for MPNST	Proton radiation 30 cobalt gray equivalent(CGE)at 6 CGE per fraction
Proton Radiation for neurofibromas	Proton Radiation for neurofibromas	Proton radiation 25 cobalt gray equivalent(CGE) at 5 CGE per fraction

Primary Outcome Measures

Name	Time	Method
Local Control	7 years after completion of RT

Secondary Outcome Measures

Name	Time	Method
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