Phase II Study of Temozolomide and Radiation Therapy for Treating IDH Wildtype Lower Grade Gliomas and Molecular Glioblastomas

What this Trial Is About

Researchers are evaluating how well temozolomide combined with radiation therapy works in treating patients with IDH wildtype gliomas, including historically lower grade gliomas and non-histological molecular glioblastomas. This phase II trial aims to compare new radiation therapy doses and volumes to the previous standard treatment for these specific brain tumors. The study also assesses progression-free survival, overall survival, local tumor control, cognitive function, symptom impact, and quality of life. Participants receive oral temozolomide daily alongside radiation therapy given five days a week for six weeks. After completing radiation, temozolomide is continued orally for up to 12 months if the disease does not progress and side effects are tolerable. The treatment period includes concurrent chemoradiation followed by adjuvant temozolomide. During the study, patients undergo regular imaging scans using RANO criteria to monitor tumor progression, along with evaluations of cognitive function and symptom questionnaires. Follow-up visits occur at multiple intervals up to 36 months after treatment to assess survival and quality of life. Blood tests and physical exams ensure patients meet safety criteria and monitor health throughout the trial.

Chemotherapy and Radiation Therapy for the Treatment of IDH Wildtype Gliomas or Non-histological (Molecular) Glioblastomas