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

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT04623931
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jan 30, 2020
Status verified
Jan 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (temozolomide, radiation therapy)
    Patients receive temozolomide 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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030
Debra N. Yeboa
713-563-2300
Debra N. Yeboa (PRINCIPAL_INVESTIGATOR)

Find similar trials in Houston, TX

By condition
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By specialty
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By research site
M D Anderson Cancer Center· Houston, TX

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