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.
Additional locations may be listed on ClinicalTrials.gov for NCT04623931.
Locations matching your search criteria
United States
Texas
Houston
M D Anderson Cancer CenterStatus: Active
Contact: Debra Nana Yeboa
Phone: 713-563-2300
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 Neurocognitive Clinical Trial Battery (CTB).
III. To evaluate the treatment related symptoms, overall symptom impact, and disease related factor groupings utilizing the M.D. Anderson Symptom Inventory Brain Tumor (MDASI-BT).
IV. To assess the quality of life.
V. To assess rates of pseudoprogression on Advanced Brain Tumor Imaging (ABTI).
VI. To assess rates of radiation necrosis or pseudoprogression as a function of radiation delivery modality and concurrent chemotherapy with advance brain imaging on Advanced Brain Tumor Imaging (ABTI) and correlation with radiomics.
VII. To collect tissue and blood samples for future studies seeking to correlate changes in peripheral blood biomarkers (genes, micro-ribonucleic acid [RNA], proteins, lymphocyte count, etc) and the study endpoints.
OUTLINE:
Patients receive temozolomide orally (PO) daily and radiation therapy over 5 days a week (weekdays only) for 6 weeks. Beginning 28 days after the last dose of radiation therapy, patients receive temozolomide PO for 12 months in the absence of disease progression or unacceptable toxicity. Additionally, patients may undergo blood sample collection on study.
After completion of study treatment, patients are followed up at 1, 3, 5, 7, 9, 12, 15, 18, 21, 24, 28, 32, and 36 months.
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorDebra Nana Yeboa
