Phase II Evaluation of Proton Beam Therapy for Skull Base Chondrosarcoma
Patients who have skull base chondrosarcoma require complicated treatment because of its
challenging location and nearness to critical structures within the brain.
Pathology will be confirmed prior to discussion of the study.
If you are found to be eligible to take part in this study, you will receive proton beam
therapy, no sooner than 2 weeks after the last surgery to remove 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.
If your doctor feels it is necessary, the proton beam therapy may be combined with standard
After the proton beam, and possibly photon beam, therapy, you will be asked to come in for
study follow-up visits every year, until the study is completed. At these visits, you will
have magnetic resonance imaging (MRI) scans, blood draws (less than 1 teaspoon) to monitor
your pituitary function, and neuropsychological testing. For the neuropsychological
testing, you will be interviewed and tested by a neuropsychologist to evaluate your memory,
fluency (the ability to talk and form words) complex thinking ability, planning ability, and
coordination. These tests could last from 1-2 hours. You will also have eye exams performed
by an ophthalmologist from MD Anderson and hearing exams. It is anticipated that it will
take about 5 years to complete this study.
This is an investigational study. The proton beam center and its treatment are approved by
the FDA for patient use. A total of up to 15 patients will take part in this study. All
will be enrolled at MD Anderson.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Time to Local Recurrence (local recurrence defined as progression on MRI or CT if MRI is contraindicated)
Baseline to local recurrence (evaulation every six months during estimated 5 year study)
David Grosshans, MD,PHD
M.D. Anderson Cancer Center
United States: Institutional Review Board
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