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Sponsored by: |
M.D. Anderson Cancer Center |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00496522 |
Primary Objective:
Secondary Objectives:
Condition | Intervention | Phase |
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Chondrosarcoma |
Procedure: Proton Beam Therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase II Evaluation of Proton Beam Therapy for Skull Base Chondrosarcoma |
Estimated Enrollment: | 70 |
Study Start Date: | April 2006 |
Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1
Proton Beam Therapy
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Procedure: Proton Beam Therapy
A total dose of up to 70 CGE given at 2.0 CGE per daily fraction for 35 fractions.
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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.
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. Women who are able to have children must have a negative blood or urine pregnancy test. You will have an evaluation to learn if additional surgery to remove more tumor is possible. If further surgery is needed, the proton therapy (radiation) will be given (if needed) after you heal from surgery.
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.
After the proton beam therapy, you will be asked to come in for study follow-up visits every 6 months, 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 M. D. 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 70 patients will take part in this study. All will be enrolled at M. D. Anderson.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Eric L. Chang, MD | 713-563-2300 |
United States, Texas | |
U.T.M.D. Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Principal Investigator: Eric L. Chang, MD |
Principal Investigator: | Eric L. Chang, MD | U.T.M.D. Anderson Cancer Center |
Responsible Party: | U.T.M.D. Anderson Cancer Center ( Eric L. Chang, MD/Associate Professor ) |
Study ID Numbers: | 2004-0915 |
Study First Received: | July 2, 2007 |
Last Updated: | December 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00496522 History of Changes |
Health Authority: | United States: Institutional Review Board |
Skull Base Chondrosarcoma Proton Beam Therapy Chondrosarcoma CNS |
Neoplasms, Connective and Soft Tissue Soft Tissue Sarcomas Malignant Mesenchymal Tumor Chondrosarcoma Sarcoma |
Neoplasms, Connective and Soft Tissue Neoplasms Neoplasms by Histologic Type |
Chondrosarcoma Sarcoma Neoplasms, Connective Tissue |