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NCT04623931 · ClinicalTrials.gov registry record · Phase 2
Chemotherapy and Radiation Therapy for the Treatment of IDH Wildtype Gliomas or Non-histological (Molecular) Glioblastomas
A Phase 2 study of Glioblastoma and Oligodendroglioma, sponsored by M.D. Anderson Cancer Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT04623931: Recruiting Phase 2 study of Glioblastoma and Oligodendroglioma, sponsored by M.D. Anderson Cancer Center.
NCT04623931 is a Phase 2 study of Glioblastoma and Oligodendroglioma that is actively recruiting participants, run by M.D. Anderson Cancer Center. The registered enrollment target is 40 participants, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (63% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04623931, a Phase 2 study of Glioblastoma and Oligodendroglioma, is actively recruiting participants, sponsored by M.D. Anderson Cancer Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
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.
Conditions Studied
Interventions
- OTHER Quality-of-Life Assessment
- OTHER Questionnaire Administration
- RADIATION Radiation Therapy
- DRUG Temozolomide
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2020-01-30 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 2 |
What NCT04623931 shows while recruiting
NCT04623931 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (63% lower).
The record links to 9 conditions, with Glioblastoma appearing as the primary indexed condition, and to 4 interventions - of which Quality-of-Life Assessment is the first listed.
NCT04623931 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04623931 about?
NCT04623931 is a clinical study titled "Chemotherapy and Radiation Therapy for the Treatment of IDH Wildtype Gliomas or Non-histological (Molecular) Glioblastomas". 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 ...
What is the current status of trial NCT04623931?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2020-01-30. Estimated completion is 2026-12-31.
What conditions does trial NCT04623931 study?
This clinical trial studies the following conditions: Glioblastoma, Oligodendroglioma, Anaplastic Oligodendroglioma, WHO Grade III Glioma, Anaplastic Oligoastrocytoma.
What interventions are being tested in trial NCT04623931?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Questionnaire Administration (OTHER), Radiation Therapy (RADIATION), Temozolomide (DRUG).
Who is sponsoring clinical trial NCT04623931?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04623931 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04623931's enrollment target sits among peer trials
40 103rd of 199 higher than 94 of 199 other Glioblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Glioblastoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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