Status:
COMPLETED
Glioblastoma Multiforme (GBM) Proton vs. Intensity Modulated Radiotherapy (IMRT)
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Brain Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The goal of this clinical research study is to compare IMRT with IMPT in patients with glioblastoma. Researchers want to learn about cognitive side effects (mental status changes) that may occur, such...
Detailed Description
Study Groups: If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. You will have an equal chance of being assig...
Eligibility Criteria
Inclusion
- Histological diagnosis of: Glioblastoma or Gliosarcoma (WHO Grade IV) adapted RPA class III, IV, or V.
- All patients must be \>/=18 years of age.
- All patients must sign informed consent verifying that they are aware of the investigational nature of this study in keeping with the rules and policies of MD Anderson Cancer Center. The only acceptable consent form is the one approved by MD Anderson IRB.
- All patients must have a baseline Mini Mental Status Examination score \>/=21.
- All patients must have a KPS \>/=70.
- All patients must be eligible to have either IMRT or IMPT as determined by the study radiation oncologist.
- All patients must be able to undergo MRI with and without contrast with a glomerular filtration rate (eGFR) greater than or equal to 30 mg/min/1.72 m2.
- All patients must have adequate liver, renal, and hematologic function within 14 days of registration as defined by Aspartate Amino Transferase (AST)/Alanine Amino Transferase (ALT)/Alkaline Phosphatase \< 3 times normal, creatinine \</=1.7 mg/dl, BUN \</= 35mg/dl, absolute neutrophil count \>/=1,800 cells/mm3, Hemoglobin \>/= 10 g/dl, and platelet count \> 100,000.
- All patients must be able to adequately read, write and speak to participate in the cognitive and quality of life assessments. However mild to moderate deficits in these functions due to tumor are allowed.
Exclusion
- Patients will be excluded if they are not planning to receive concurrent temozolomide.
- Patients will be excluded if they have had prior radiation to the brain.
- Patients will be excluded if they have had prior surgical resection of brain for other brain tumors.
- Patients will be excluded if they are pregnant as assessed by serum beta human chorionic gonadotropin (b-HCG). A serum b-HCG test will be performed no greater than 14 days prior to study registration for women of childbearing potential.
- Patients with gliomatosis will be excluded.
- Patients with Gliadel bis-chloroethylnitrosourea (BCNU) implanted wafers will be excluded.
- Patients weighing greater than 136 kilograms will be excluded.
Key Trial Info
Start Date :
May 17 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 13 2021
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT01854554
Start Date
May 17 2013
End Date
October 13 2021
Last Update
January 2 2024
Active Locations (1)
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1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030