Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Nerve Sheath Tumors
- Sponsor
- University of Florida
- Primary Endpoint
- Local Control
- Status
- Withdrawn
- Last Updated
- 9 years ago
Overview
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.
Investigators
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.
Outcomes
Primary Outcomes
Local Control
Time Frame: 7 years after completion of RT
Secondary Outcomes
- 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)