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Chemotherapy and Radiation for IDH Wildtype Gliomas

This study is looking at how well a chemotherapy drug called temozolomide, given by mouth, works with radiation therapy for people with certain types of brain tumors (IDH wildtype gliomas or glioblastomas). These tumors are identified as "IDH wildtype" based on specific genetic features. The study aims to see if this combination treatment can help prevent the cancer from growing or coming back (this is called progression-free survival). Researchers will also look at how the treatment affects your quality of life and any symptoms you might have. The study plans to enroll 40 participants and is currently unclear about its recruitment status. You may be able to join if you are 18 or older and have one of the specified IDH wildtype glioma types.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 40 participants.
What's involved
You would receive temozolomide daily and radiation therapy five days a week for six weeks. After a break, you would take temozolomide for 12 months. You will have follow-up appointments for up to 36 months after treatment.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed up for up to 36 months after completing treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04623931

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
M.D. Anderson Cancer Center
~40 participants
Updated 2026-07-16 on ClinicalTrials.gov
What's tested:Quality-of-Life AssessmentQuestionnaire AdministrationRadiation TherapyTemozolomide

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression free survival (PFS)
Measured over From start of treatment until objective tumor progression or death, whichever happens first, assessed up to 52 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

Explore related trials

GliomaIDH1 wt Allele

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Debra N Yeboa · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Debra N Yeboa
[email protected]
713-563-2300
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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 mm) three-dimensional (3D) T1 pre and post contrast and axial T2/fluid-attenuated inversion recovery (FLAIR) sequences for planning purposes are highly encouraged to obtain.
Absolute neutrophil count (ANC) \>= 1,500 cells/mm\^3 (within 60 days prior to registration)
Platelets \>= 100,000 cells/mm\^3 (within 60 days prior to registration)
Hemoglobin \>= 10.0 g/dl (within 60 days prior to registration) (Note: The use of transfusion or other intervention to achieve hemoglobin \[Hgb\] \>= 10.0 g/dl is acceptable)
Bilirubin =\< 1.5 upper limit of normal (ULN) (within 60 days prior to registration)
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 3 x ULN (within 60 days prior to registration)
Blood urea nitrogen (BUN) \< 30 mg/dl (within 60 days prior to registration)
Serum creatinine \< 1.5 mg/dl (within 60 days prior to registration)

Exclusion

Definitive clinical or radiologic evidence of metastatic disease; if applicable
Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years. (For example, carcinoma in situ of the breast, oral cavity or cervix are permissible)
Prior cranial radiotherapy or radiotherapy to the head and neck where potential field overlaps would exist
Prior chemotherapy or radiotherapy for any brain tumor
Histologic diagnosis of gliosarcoma World Health Organization (WHO grade IV) or pilocytic astrocytoma (WHO grade I)
Multicentric glioblastoma
Leptomeningeal disease
Inability to undergo MRI with and without contrast
Severe, active co-morbidity defined as follows:
Unstable angina or congestive heart failure requiring hospitalization within 6 months prior to enrollment
Transmural myocardial infarction within the last 6 months prior to registration. Evidence of recent myocardial infarction or ischemia by the findings of S-T elevations of \>= 2 mm using the analysis of an electrocardiogram (EKG) performed within 28 days prior to registration. (Note: EKG to be performed only if clinical suspicion of cardiac issue)
Serious and inadequately controlled arrhythmia at step 2 registration
Serious or non-healing wound, ulcer or bone fracture or history of abdominal fistula, intra-abdominal abscess requiring major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to registration, with the exception of the craniotomy for surgical resection
Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for coagulation parameters are not required for entry into this protocol
Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
Human immunodeficiency virus (HIV) positive with CD4 count \< 200 cells/microliter. Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is because the treatments involved in this protocol may be significantly immunosuppressive with potentially fatal outcomes in patients already immunosuppressed
Any other severe immunocompromised condition
Active connective tissue disorders, such as lupus or scleroderma that in the opinion of the treating physician may put the patient at high risk for radiation toxicity
End-stage renal disease (i.e., on dialysis or dialysis has been recommended)
Any other major medical illnesses or psychiatric treatments that in the investigator's opinion will prevent administration or completion of protocol therapy

What this trial measures

  • Progression free survival (PFS)From start of treatment until objective tumor progression or death, whichever happens first, assessed up to 52 months

    Tumor progression is defined by the Response Assessment in Neuro-Oncology glioma criteria. PFS time will be estimated using the Kaplan-Meier method. The 1-year PFS rate will be estimated along with a 95% confidence interval. Patient or tumor characteristics (ex. grade, age, etc) will be compared within the single study cohort. Cox regression models will be applied to assess the effect of covariates of interest on PFS.