NCT04623931

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

Phase II Trial of Treatment Intensification for IDH Wildtype, Non-Histological Glioblastoma, Gliomas (IDH Wildtype Lower Grade Glioma Treatment Intensification)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 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. 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. 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.

Conditions

• Anaplastic Astrocytoma, IDH-Wildtype
• Anaplastic Oligoastrocytoma
• Anaplastic Oligodendroglioma
• Diffuse Astrocytoma, IDH-Wildtype
• Glioblastoma
• Oligoastrocytoma
• Oligodendroglioma
• WHO Grade II Glioma
• WHO Grade III Glioma

Interventions

Type	Name	Description
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies
RADIATION	Radiation Therapy	Undergo radiation therapy
DRUG	Temozolomide	Given PO

Timeline

• Start date: 2020-01-30
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2020-11-10
• Last updated: 2026-01-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study