Phase II Trial of Treatment Intensification for IDH Wildtype, Non-Histological Glioblastoma, Gliomas (IDH Wildtype Lower Grade Glioma Treatment Intensification)
M.D. Anderson Cancer Center
Summary
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.
Description
PRIMARY OBJECTIVE: I. To determine the progression free survival (PFS) based on Response Assessment in Neuro-Oncology (RANO) imaging criteria from start of treatment with concurrent chemoradiation (CRT) and adjuvant temozolomide (TMZ). SECONDARY OBJECTIVE: I. To determine the 3-year overall survival (OS) of isocitrate dehydrogenase (IDH) wild-type grade II and grade III gliomas with dose escalation radiation with concurrent chemoradiation therapy. EXPLORATORY OBJECTIVES: I. To assess local control patterns (site of 1st progression). II. To evaluate neuro-cognitive function by the Neurocog…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 * Thin-slice (\< 1.5…
Interventions
- OtherQuality-of-Life Assessment
Ancillary studies
- OtherQuestionnaire Administration
Ancillary studies
- RadiationRadiation Therapy
Undergo radiation therapy
- DrugTemozolomide
Given PO
Location
- M D Anderson Cancer CenterHouston, Texas