Clinical trial NCT01567787: Proton Radiation Therapy for Spinal Tumors
Official title: Spinal Tumor Proton Protocol
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Nerve Sheath Tumors
Neurofibroma
Keywords: Proton Radiation Therapy
Spinal tumors
Neurofibroma(NF1)
Malignant peripheral nerve sheath tumor(MPNST)
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2012-03-30
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Local Control
timeFrame: 7 years after completion of RT
Secondary outcomes:
measure: Progression or palliation of pain, numbness, or weakness
timeFrame: At 3, 6, 12, 24 and 60 months after RT
measure: Number of adverse events
timeFrame: At 3, 6, 12, 24, 60 months and 15 years after RT
measure: Quality of Life
timeFrame: 3, 6, 12, 24 and 60 months after RT
measure: Rate of malignant transformation within the high-dose volume
timeFrame: 15 years after RT
measure: Rate of second malignant primaries outside of high dose volume, but located in tissues exposed to radiation within the beam path
timeFrame: 15 years after RT
Other outcomes:
Locations:
Study officials:
affiliation: University of Florida Proton Therapy Institute
name: Randal H Henderson, MD
role: PRINCIPAL_INVESTIGATOR
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