Chordoma Clinical Trial
Official title:
Phase II Evaluation of Proton Beam Therapy for Skull Base Chordoma
Verified date | May 2024 |
Source | M.D. Anderson Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 chordoma. The safety of this treatment will also be studied.
Status | Active, not recruiting |
Enrollment | 19 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: 1. Pathologically confirmed chordoma of the skull base 2. Contrast enhanced postoperative MRI (CT in case MRI is contraindicated) of the skull base obtained within 90 days of study registration 3. MDACC surgeons have determined that optimal debulking of disease has been performed. 4. Karnofsky Performance status greater than or equal to 60 5. Signed informed consent Exclusion Criteria: 1. Previous irradiation of the skull base 2. Documented evidence of disseminated metastatic disease 3. Any concurrent malignancy (other than non-melanoma skin cancers) in the last 3 years |
Country | Name | City | State |
---|---|---|---|
United States | University of Texas MD Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to Local Recurrence | Recurrence classified as "central," "in-field", "marginal," "peripheral," or "distant" depending upon its relationship to the dose distribution on the original treatment plan.
MRI (or CT in case MRI is contraindicated) of the skull base used to document the status of disease in the following categories: 1) stable disease, 2) progressive disease, 3) partial response/complete response. A post-operative MRI (or CT) obtained within 90 days of study registration serves as baseline with annual follow up till disease progression or death for any reason. |
1 year after radiation treatments |
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