An interventional study of Proton Radiation for MPNST and Proton Radiation for neurofibromas in Nerve Sheath Tumors and Neurofibroma, sponsored by University of Florida. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-02-10.
Sponsored by University of Florida · Not applicable, Interventional, and Treatment
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.
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.
33 studies on the registry are indexed under Neurofibroma; 9 are open to participants now.
Browse Neurofibroma studies →University of Florida is the lead sponsor of 1,287 studies on the registry; 199 are open to participants now.
Of its 180 completed or terminated interventional studies of FDA-regulated products, 143 (79%) have results posted.
Compared within Neurofibroma, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Nerve Sheath Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Proton radiation 30 cobalt gray equivalent(CGE)at 6 CGE per fraction
Radiation: Proton Radiation for MPNST
Proton radiation 25 cobalt gray equivalent(CGE) at 5 CGE per fraction
Radiation: Proton Radiation for neurofibromas
30 CGE at 6 CGE/Fx
25 CGE at 5 CGE/Fx
Local Control
Time frame: 7 years after completion of RT
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
No study locations are listed for this record.
Plan to share: No
The record gives a start of Jun 2013, a primary completion of Aug 2015 and a completion of Aug 2015. It does not say whether these dates are actual or estimated.
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This study is withdrawn, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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