Proton Beam Therapy for Chondrosarcoma
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Evaluation of Proton Beam Therapy for Skull Base Chondrosarcoma|
- Time to Local Recurrence [ Time Frame: Baseline to local recurrence (evaulation every six months during estimated 5 year study) ] [ Designated as safety issue: No ]Local recurrence defined as progression on magnetic resonance imaging (MRI) or CT if MRI is contraindicated.
|Study Start Date:||April 2006|
|Estimated Primary Completion Date:||April 2017 (Final data collection date for primary outcome measure)|
Proton Beam Therapy
Proton Beam Therapy - A total dose of up to 70 CGE given at 2.0 CGE per daily fraction for 35 fractions.
Procedure: Proton Beam Therapy
A total dose of up to 70 CGE given at 2.0 CGE per daily fraction for 35 fractions.
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 photon therapy.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00496522
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||David Grosshans, MD,PHD||M.D. Anderson Cancer Center|