Study on Chemotherapy and Radiation Therapy for Treating IDH Wildtype Gliomas or Molecular Glioblastomas

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04623931

Provider View

This clinical trial is exploring how well a combination of chemotherapy and radiation therapy works in treating patients with certain types of brain tumors called IDH wildtype gliomas or molecular glioblastomas. The study aims to see if this treatment can effectively control the disease and improve patient outcomes.

Patient Parameters

Program Overview

This study is investigating the effectiveness of combining chemotherapy with radiation therapy to treat patients with specific brain tumors known as IDH wildtype gliomas or molecular glioblastomas. Radiation therapy uses high-energy x-rays to target and shrink tumors, while chemotherapy drugs like temozolomide work to stop tumor cells from growing and spreading. The goal is to compare new radiation therapy doses and methods with the previous standard treatment to see if they offer better control of the disease.

Description

The main goal of this study is to determine how long patients can live without their disease getting worse after starting treatment with a combination of chemotherapy and radiation therapy. This is known as progression-free survival (PFS). The study will also look at the overall survival rate of patients over three years and assess how well the treatment controls the tumor locally.

Participants will receive the chemotherapy drug temozolomide by mouth every day and undergo radiation therapy five days a week for six weeks. After finishing radiation therapy, they will continue taking temozolomide for 12 months, as long as the disease does not progress and there are no severe side effects.

The study will also evaluate the impact of the treatment on patients' cognitive function, symptoms, and quality of life. Follow-up visits will occur at various intervals up to 36 months after completing the study treatment.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with specific types of IDH wildtype gliomas, such as diffuse astrocytoma or anaplastic astrocytoma.
  • Tumors must be IDH wildtype gliomas or molecularly defined high-grade gliomas.
  • Recent medical exams and a performance status score of 70 or higher.
  • Must have a post-surgery MRI with contrast for radiation therapy planning.
  • Blood tests showing adequate levels of neutrophils, platelets, hemoglobin, and normal liver and kidney function.
  • Able to provide specific MRI images for planning purposes.

Exclusion Criteria

  • Evidence of cancer spreading to other parts of the body.
  • History of other invasive cancers unless disease-free for at least three years.
  • Previous radiation or chemotherapy for any brain tumor.
  • Certain types of brain tumors like gliosarcoma or pilocytic astrocytoma.
  • Multiple brain tumors or cancer spread to the brain's lining.
  • Inability to undergo MRI scans.
  • Severe heart, lung, liver, or kidney conditions.
  • Active infections requiring treatment.
  • HIV positive with low CD4 count or other severe immune system issues.
  • Active connective tissue disorders like lupus.
  • End-stage kidney disease requiring dialysis.
  • Any other major medical or psychiatric conditions that could interfere with the study.

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