About this trial
This study examines whether repeated magnetic resonance imaging (MRI)s scan helps identify changes in the tumor during radiation and chemotherapy treatment in patients with high grade glioma. Additional MRIs scan may help researchers to see changes in the status of the disease. Seeing these changes may result in changes to the treatment plan.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All patients with histologic confirmation of high grade glioma
Patients must be age >= 18 years
Patients must sign informed consent indicating that they are aware of the investigational nature of this study in keeping with the policies of the hospital. The only acceptable consent form is the one attached at the end of this protocol, and has been approved and amended by the MD Anderson Cancer Center (MDACC) Institutional Review Board (IRB)
Patients must have Karnofsky performance status (KPS) >= 60
Disqualifiers
None
Trial population
Patients with histologic confirmation of high grade glioma
Trial design
Cohort
Prospective
Treatments tested in this trial
Magnetic Resonance Imaging
Procedure/SurgeryUndergo MRI
Neurocognitive Assessment
Other interventionUndergo neurocognitive testing
Quality-of-Life Assessment
Other interventionAncillary studies
Questionnaire Administration
Other interventionAncillary studies
Treatment groups
Trial outcomes
Primary outcomes
Differences in the delineated target and organ at risk volumes and dosimetry
Will be compared between the plans generated using the immediate post-op MRI versus (vs.) MR simulation. A Kolmogorov-Smirnov test will be used to assess distributional (histogram) changes between the two scenarios.
Cumulative dosimetric differences for the target volume and normal structures
Cumulative dosimetric differences for the target volume and normal structures between an adaptive radiotherapy approach based on serial MR images vs. the conventionally delivered radiotherapy plan. A Kolmogorov-Smirnov test will be used to assess distributional (histogram) changes between the two scenarios.
Secondary outcomes
Incidence and temporal relationship of tumor progression between surgery and radiation therapy
Specifically, the rate of change in volume between surgery and radiation therapy (RT) will be measured and reported.
Local tumor control
Local control is defined as stable disease, partial response or complete response using Response Assessment in Neuro-Oncology (RANO) criteria.
Local tumor control
Local control is defined as stable disease, partial response or complete response using RANO criteria.
Overall survival (OS)
A Cox proportional hazards regression model will be constructed to associate post-op progression with OS, after adjusting for age, IDH mutation, Karnofsky performance status and extent-of-resection.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.