This phase II trial studies how well temozolomide and radiation therapy work in treating patients with IDH wildtype historically lower grade gliomas or non-histological molecular glioblastomas. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving chemotherapy with radiation therapy may kill more tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. The goal of this clinical research study is to compare receiving new radiation therapy doses and volumes to the prior standard treatment for patients with historically grade II or grade III IDH wild-type gliomas, which may now be referred to as IDH wildtype molecular glioblastomas at some institutions. Receiving temozolomide in combination with radiation therapy may also help to control the disease.
Historical grade II and III gliomas IDH wildtype gliomas by including; diffuse astrocytoma, anaplastic astrocytoma, oligodendroglioma, anaplastic oligodendroglioma, oligoastrocytoma, anaplastic oligoastrocytoma
IDH wildtype gliomas (molecularly defined high grade glioma or molecularly defined glioblastoma [GBM])
History & physical exam, and Karnofsky performance status (KFS) of >= 70 within 30 days prior to enrollment
Post-operative magnetic resonance imaging (MRI) with contrast is mandatory and necessary for radiation therapy (RT) planning
Definitive clinical or radiologic evidence of metastatic disease; if applicable
Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years. (For example, carcinoma in situ of the breast, oral cavity or cervix are permissible)
Prior cranial radiotherapy or radiotherapy to the head and neck where potential field overlaps would exist
Prior chemotherapy or radiotherapy for any brain tumor
Single group
Quality-of-Life Assessment
Other interventionAncillary studies
Questionnaire Administration
Other interventionAncillary studies
Radiation Therapy
RadiationUndergo radiation therapy
Temozolomide
DrugGiven PO
Progression free survival (PFS)
Tumor progression is defined by the Response Assessment in Neuro-Oncology glioma criteria. PFS time will be estimated using the Kaplan-Meier method. The 1-year PFS rate will be estimated along with a 95% confidence interval. Patient or tumor characteristics (ex. grade, age, etc) will be compared within the single study cohort. Cox regression models will be applied to assess the effect of covariates of interest on PFS.
Overall survival (OS) rate
The 3-year OS rate is defined as the proportion of participants that are alive at 3-year after the start of treatment, which will be estimated along a 95% confidence interval. OS time will be estimated using the Kaplan-Meier method. Patient or tumor characteristics (ex. grade, age, etc) will be compared within the single study cohort. Cox regression models will be applied to assess the effect of covariates of interest on OS.
Local control patterns (site of 1st progression)
Will be summarized with frequency and proportion.
Neuro-cognitive function
Assessed by the Neurocognitive Clinical Trial Battery, and summarized with descriptive summary statistics.
Symptom burden
Assessed by the M.D. Anderson Symptom Inventory Brain Tumor (MDASI-BT), and summarized using standard descriptive statistics such as mean, standard deviation, median and range. Wilcoxon rank-sum test or Kruskal Wallis test will be used to examine the difference on MDASI-BT between or among patients' characteristics groups.
Quality of life
Assessed by linear analog self-assessment (LASA) scale, will be summarized using standard descriptive statistics such as mean, standard deviation, median and range. Wilcoxon rank-sum test or Kruskal-Wallis test will be used to examine the difference on LASA scale between or among patients' characteristics groups.
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