Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT04623931

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

Led by M.D. Anderson Cancer Center · Updated on 2026-01-14

40

Participants Needed

1

Research Sites

361 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Historical grade II and III IDH wildtype gliomas including diffuse astrocytoma, anaplastic astrocytoma, oligodendroglioma, anaplastic oligodendroglioma, oligoastrocytoma, and anaplastic oligoastrocytoma
  • Molecularly defined high grade IDH wildtype gliomas or glioblastomas
  • Karnofsky performance status of 70 or higher within 30 days before enrollment
  • Post-operative MRI with contrast required for radiation therapy planning
  • Recommended thin-slice 3D T1 pre and post contrast and axial T2/FLAIR MRI sequences for planning
  • 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 (transfusions or interventions allowed)
  • Bilirubin less than or equal to 1.5 times the upper limit of normal within 60 days before registration
  • ALT and AST levels 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
Not Eligible

You will not qualify if you...

  • Evidence of metastatic disease
  • Prior invasive cancer unless disease free for at least 3 years (except certain skin cancers and carcinoma in situ)
  • Prior cranial or head and neck radiotherapy with overlapping fields
  • Prior chemotherapy or radiation 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 health conditions such as unstable angina, recent heart attack, serious arrhythmia, non-healing wounds, recent major surgery except craniotomy, severe infections requiring IV antibiotics, hepatic insufficiency with jaundice or coagulation defects, severe lung disease requiring hospitalization, HIV with low CD4 count or AIDS, severe immune system disorders, active connective tissue diseases risking radiation toxicity
  • End-stage kidney disease or dialysis
  • Other major medical or psychiatric illnesses that prevent study treatment or completion

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

M D Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

D

Debra N Yeboa

CONTACT

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