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Testing the Addition of the Chemotherapy Drug Lomustine (Gleostine) to the Usual Treatment (Temozolomide and Radiation Therapy) for Newly Diagnosed MGMT Methylated Glioblastoma
NCT05095376 · View on ClinicalTrials.gov ↗
Study Summary
This phase III trial compares the effect of adding lomustine to standard chemotherapy with temozolomide and radiation therapy versus temozolomide and radiation therapy alone in shrinking or stabilizing newly diagnosed MGMT methylated glioblastoma. MGMT methylated tumors are more likely to respond to temozolomide chemotherapy. Temozolomide is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill tumor cells and slow down or stop tumor growth. Lomustine is a chemotherapy drug and in a class of medications called alkylating agents. It damages the cell's DNA and may kill tumor cells. Radiation therapy uses high energy x-ray photons to kill tumor cells and shrink tumors. Adding lomustine to standard chemotherapy with temozolomide and radiation therapy may shrink or stabilize glioblastoma.
Conditions Studied
Interventions
- PROCEDURE Magnetic Resonance Imaging
- OTHER Questionnaire Administration
- DRUG Temozolomide
- DRUG Lomustine
- RADIATION Photon Beam Radiation Therapy
Study Locations (20)
California
- Kaiser Permanente-Anaheim — Anaheim
- Kaiser Permanente-Deer Valley Medical Center — Antioch
- Sutter Auburn Faith Hospital — Auburn
- Sutter Cancer Centers Radiation Oncology Services-Auburn — Auburn
- Kaiser Permanente-Bellflower — Bellflower
- Alta Bates Summit Medical Center-Herrick Campus — Berkeley
- Mercy Cancer Center - Carmichael — Carmichael
- Mercy San Juan Medical Center — Carmichael
- John Muir Medical Center-Concord — Concord
- City of Hope Comprehensive Cancer Center — Duarte
- Kaiser Permanente Dublin — Dublin
- Mercy Cancer Center - Elk Grove — Elk Grove
- Kaiser Permanente-Fremont — Fremont
- Palo Alto Medical Foundation-Fremont — Fremont
- Fresno Cancer Center — Fresno
Arkansas
- Highlands Oncology Group - Fayetteville — Fayetteville
- University of Arkansas for Medical Sciences — Little Rock
- Highlands Oncology Group - Rogers — Rogers
- Highlands Oncology Group — Springdale
Alaska
- Fairbanks Memorial Hospital — Fairbanks
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 265 participants |
| Start Date | 2022-03-28 |
| Est. Completion | 2026-08-08 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05095376
The ClinicalTrials.gov registry entry for NCT05095376 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 265 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NRG Oncology, which has 162 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Glioblastoma appearing as the primary indexed condition, and to 5 interventions — of which Magnetic Resonance Imaging is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05095376 reports 20 study locations spanning 3 distinct geographic areas — top geographies include California, Arkansas, Alaska. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05095376 about?
NCT05095376 is a clinical study titled "Testing the Addition of the Chemotherapy Drug Lomustine (Gleostine) to the Usual Treatment (Temozolomide and Radiation Therapy) for Newly Diagnosed MGMT Methylated Glioblastoma". This phase III trial compares the effect of adding lomustine to standard chemotherapy with temozolomide and radiation therapy versus temozolomide and radiation therapy alone in shrinking or stabilizing newly diagnosed MGMT methylated glioblastoma. MGMT methylated tumors are more likely to respond to...
What is the current status of trial NCT05095376?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 265 participants. The study started on 2022-03-28. Estimated completion is 2026-08-08.
What conditions does trial NCT05095376 study?
This clinical trial studies the following conditions: Glioblastoma, Gliosarcoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05095376?
The interventions under investigation include: Magnetic Resonance Imaging (PROCEDURE), Questionnaire Administration (OTHER), Temozolomide (DRUG), Lomustine (DRUG), Photon Beam Radiation Therapy (RADIATION). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05095376?
This trial is sponsored by NRG Oncology, which has 162 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05095376 being conducted?
This trial has 20 study locations across Alaska, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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