Clinical Trial: Proton Radiation Therapy for Spinal Tumors
Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional
Official Title: Spinal Tumor Proton Protocol
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 Summary: 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.
Sponsor: University of Florida
Current Primary Outcome: Local Control [ Time Frame: 7 years after completion of RT ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Progression or palliation of pain, numbness, or weakness [ Time Frame: At 3, 6, 12, 24 and 60 months after RT ]
- Number of adverse events [ Time Frame: At 3, 6, 12, 24, 60 months and 15 years after RT ]
- Quality of Life [ Time Frame: 3, 6, 12, 24 and 60 months after RT ]
- Rate of malignant transformation within the high-dose volume [ Time Frame: 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 [ Time Frame: 15 years after RT ]
Original Secondary Outcome: Same as current
Information By: University of Florida
Dates:
Date Received: March 13, 2012
Date Started: June 2013
Date Completion:
Last Updated: February 9, 2017
Last Verified: February 2017
