Study on Proton Beam Therapy for Skull Base Chondrosarcoma
Sponsor: M.D. Anderson Cancer Center
ClinicalTrials ID:NCT00496522
This clinical trial is exploring whether proton beam therapy, alone or with photon beam radiation, is effective and safe for treating skull base chondrosarcoma, a type of bone cancer near the brain.
Patient Parameters
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Program Overview
The purpose of this study is to find out if proton beam therapy, with or without additional photon beam radiation, can effectively treat skull base chondrosarcoma, a rare type of bone cancer located near the brain. The study will also assess the safety of this treatment approach.
Description
Patients with skull base chondrosarcoma face complex treatment challenges due to the tumor's location near critical brain structures. Before joining the study, your diagnosis will be confirmed.
If you qualify for the study, you will receive proton beam therapy starting at least two weeks after your last surgery to remove the tumor. This therapy will be administered once a day, five days a week, for about seven weeks (totaling around 35 treatments). Each session will take place at the Proton Center in Houston and last up to one hour.
In some cases, your doctor may decide to combine proton beam therapy with standard photon therapy.
After completing the therapy, you will have yearly follow-up visits until the study ends. During these visits, you will undergo MRI scans, blood tests to check your pituitary gland function, and neuropsychological tests to assess memory, speech, thinking, planning, and coordination. These tests may take 1-2 hours. You will also have eye and hearing exams. The study is expected to last about five years.
This study is investigational, but the proton beam center and its treatments are FDA-approved. Up to 15 patients will participate, all at MD Anderson.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with Grade 1-3 chondrosarcoma of the skull base.
- Have had a contrast-enhanced MRI or CT scan of the skull base within 90 days of joining the study.
- Evaluated by MD Anderson surgeons to have had the maximum possible tumor removal surgery.
- Have a Karnofsky Performance status score of 60 or higher, indicating the ability to care for oneself with some assistance.
- Have signed an informed consent form agreeing to participate in the study.
Exclusion Criteria
- Have had previous radiation treatment to the skull base.
- Have evidence of cancer that has spread to other parts of the body.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| MD Anderson Cancer Center | 77030 | Houston | Texas |
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