Actively Recruiting
Phase II Trial of Treatment Intensification for IDH Wildtype, Non-Histological Glioblastoma, Gliomas (IDH Wildtype Lower Grade Glioma Treatment Intensification)
Led by M.D. Anderson Cancer Center · Updated on 2026-01-14
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effects of temozolomide combined with radiation therapy in treating patients who have IDH wildtype lower grade gliomas or molecular glioblastomas. This phase II trial aims to compare new radiation therapy doses and volumes with the previous standard treatment for these specific brain tumors. The study also evaluates how this combined treatment may help to control disease progression and improve patient outcomes. Participants receive temozolomide orally every day along with radiation therapy five days a week for six weeks. After completing radiation therapy, they continue with temozolomide treatment for 12 months if the disease does not progress and side effects are manageable. Follow-up visits occur regularly at various time points up to 36 months after treatment to monitor patients' health and response. During the study, patients will have physical exams, MRI scans with contrast for treatment planning, and assessments of their neurological and cognitive functions. Researchers will also evaluate symptoms, quality of life, and disease control using questionnaires and imaging criteria. The primary outcome is progression-free survival, and secondary outcomes include overall survival at three years. Safety and treatment effects will be closely monitored throughout the study period.
CONDITIONS
Brief Title
Chemotherapy and Radiation Therapy for the Treatment of IDH Wildtype Gliomas or Non-histological (Molecular) Glioblastomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Historical grade II and III IDH wildtype gliomas including diffuse astrocytoma, anaplastic astrocytoma, oligodendroglioma, anaplastic oligodendroglioma, oligoastrocytoma, anaplastic oligoastrocytoma
- Molecularly defined IDH wildtype high grade glioma or molecular glioblastoma
- Karnofsky performance status of 70 or higher within 30 days before enrollment
- Post-operative MRI with contrast required for radiation therapy planning
- Preferably thin-slice 3D T1 pre and post contrast and axial T2/FLAIR MRI sequences
- Absolute neutrophil count of at least 1,500 cells/mm3 within 60 days before registration
- Platelet count of at least 100,000 cells/mm3 within 60 days before registration
- Hemoglobin level of 10.0 g/dl or higher within 60 days before registration (transfusion allowed)
- Bilirubin less than or equal to 1.5 times the upper limit of normal within 60 days before registration
- ALT and AST less than or equal to 3 times the upper limit of normal within 60 days before registration
- Blood urea nitrogen less than 30 mg/dl within 60 days before registration
- Serum creatinine less than 1.5 mg/dl within 60 days before registration
You will not qualify if you...
- Evidence of metastatic disease
- Prior invasive cancer unless disease-free for at least 3 years (except non-melanoma skin cancer)
- Previous cranial or head and neck radiotherapy overlapping planned treatment fields
- Prior chemotherapy or radiotherapy for any brain tumor
- Diagnosis of gliosarcoma (WHO grade IV) or pilocytic astrocytoma (WHO grade I)
- Multicentric glioblastoma
- Leptomeningeal disease
- Unable to undergo MRI with and without contrast
- Severe active heart conditions including unstable angina or recent heart failure hospitalization
- Recent myocardial infarction or significant ECG changes indicating ischemia
- Serious uncontrolled arrhythmia
- Serious or non-healing wounds, ulcers, fractures, or recent major surgery excluding craniotomy
- Acute bacterial or fungal infections requiring IV antibiotics
- Liver failure causing jaundice or coagulation problems
- Severe respiratory illness requiring hospitalization
- HIV positive with CD4 count under 200 cells/microliter or AIDS
- Other severe immune deficiencies
- Active connective tissue diseases posing high radiation risk
- End-stage kidney disease requiring dialysis
- Other major medical or psychiatric conditions preventing treatment or study completion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 13 months
Participants receive daily temozolomide and radiation therapy 5 days a week for 6 weeks. After a 28-day break, participants continue temozolomide daily for up to 12 months if there is no disease progression or unacceptable side effects.
5 visits per week for 6 weeks during radiation therapy, then regular follow-up visits during 12 months of temozolomide treatment
Duration - Up to 36 months
After treatment completion, participants are followed up to monitor overall health and disease status.
Visits at 1, 3, 5, 7, 9, 12, 15, 18, 21, 24, 28, 32, and 36 months after treatment
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
D
Debra N Yeboa
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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