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To establish the efficacy of proton beam therapy with or without photon beam radiation therapy for skull base chordoma.
1. To determine the patterns of failure of the treatment using dosimetric parameters
2. To measure and characterize the late effects of proton therapy treatment by conducting longitudinal neuroimaging, neuropsychological, neuro-endocrine, neuro-ophthalmological testing and audiometry.
Proton therapy is a kind of external beam radiation therapy where protons are directed to a tumor site. Researchers are trying to determine what level of proton therapy gives the most benefit without causing toxic side effects. Researchers will also be testing the treatment's effect.
Before you can start treatment on this study, you will have what are called "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. You will have a magnetic resonance imaging (MRI) and computerized tomography (CT) scan of the skull base within 90 days before starting treatment. You will have neuropsychological testing and hearing and vision tests, including formal visual field testing. The neurological exam involves testing upper and lower motor strength, sensation to light touch, reflexes, a mental exam, and an evaluation of the way you walk. Blood (about 1 teaspoon) will also be collected for routine tests. Women who are able to have children must have a negative blood or urine pregnancy test.
If you are eligible to take part in this study, you will receive proton beam therapy no sooner than 2 weeks after the last surgery to remove the tumor. You will receive proton beam therapy once a day for about 35 treatments (7 weeks). Treatment will be given for 5 days in a row each week (except for Saturdays, Sundays and holidays) at the Proton Center in Houston. The whole process should take up to 1 hour each day.
This is an investigational study. The proton beam machine used to deliver treatment is approved by the FDA for patient use. The doses being studied are experimental. About 15 participants will take part in this study. All will be enrolled at M. D. Anderson.
Allocation: Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Proton Beam Therapy, Proton Beam Therapy
U.T.M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
Published on BioPortfolio: 2014-08-27T03:37:37-0400
The goal of this clinical research study is to learn if proton beam therapy, with or without photon beam radiation therapy, is effective in the treatment of skull base chondrosarcoma. The ...
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The use of an external beam of PROTONS as radiotherapy.
The science and application of a double-beam transmission interference microscope in which the illuminating light beam is split into two paths. One beam passes through the specimen while the other beam reflects off a reference mirror before joining and interfering with the other. The observed optical path difference between the two beams can be measured and used to discriminate minute differences in thickness and refraction of non-stained transparent specimens, such as living cells in culture.
A complex of enzymes and PROTON PUMPS located on the inner membrane of the MITOCHONDRIA and in bacterial membranes. The protein complex provides energy in the form of an electrochemical gradient, which may be used by either MITOCHONDRIAL PROTON-TRANSLOCATING ATPASES or BACTERIAL PROTON-TRANSLOCATING ATPASES.
Energy that is generated by the transfer of protons or electrons across an energy-transducing membrane and that can be used for chemical, osmotic, or mechanical work. Proton-motive force can be generated by a variety of phenomena including the operation of an electron transport chain, illumination of a PURPLE MEMBRANE, and the hydrolysis of ATP by a proton ATPase. (From Singleton & Sainsbury, Dictionary of Microbiology and Molecular Biology, 2d ed, p171)
Stable elementary particles having the smallest known positive charge, found in the nuclei of all elements. The proton mass is less than that of a neutron. A proton is the nucleus of the light hydrogen atom, i.e., the hydrogen ion.
Neurology - Central Nervous System (CNS)
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