Proton Radiation Therapy for Spinal Tumors (NF01)

University of Florida

Status: Withdrawn

Conditions: Nerve Sheath Tumors; Neurofibroma

Treatments: Radiation: Proton Radiation for neurofibromas; Radiation: Proton Radiation for MPNST

Study type: Interventional

Funder types: Other

Identifiers

NCT01567787

UFPTI 1101-NF01

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Proton Radiation for MPNST

Experimental group

Description:

Proton radiation 30 cobalt gray equivalent(CGE)at 6 CGE per fraction

Treatment:

Radiation: Proton Radiation for MPNST

Proton Radiation for neurofibromas

Experimental group

Description:

Proton radiation 25 cobalt gray equivalent(CGE) at 5 CGE per fraction

Treatment:

Radiation: Proton Radiation for neurofibromas