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NCT06344130 · ClinicalTrials.gov registry record · Phase 1
Hypofractionation Trial of Re-irradiation in Good Prognosis Recurrent Glioblastoma
A Phase 1 study of Glioma and Recurrent Glioblastoma, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
- 1
- Study location
NCT06344130: Recruiting Phase 1 study of Glioma and Recurrent Glioblastoma, sponsored by National Cancer Institute (NCI).
NCT06344130 is a Phase 1 study of Glioma and Recurrent Glioblastoma that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 28 participants, below the 210-participant average among 87 other Glioma trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06344130, a Phase 1 study of Glioma and Recurrent Glioblastoma, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: Glioblastoma (GBM) is a cancer of the brain. Current survival rates for people with GBM are poor; survival ranges from 5.2 months to 39 months. Most tumors come back within months or years after treatment, and when they do, they are worse: Overall survival drops to less than 10 months. No standard treatment exists for people whose GBM has returned after radiation therapy. Objective: To find a safe schedule for using radiation to treat GBM tumors that returned after initial radiation treatment. Eligibility: People aged 18 years and older with grade 4 GBM that returned after initial radiation treatment. Design: Participants will be screened. They will have a physical exam with blood tests. A sample of tumor tissue may be collected. Participants will undergo re-irradiation planning: They will wear a plastic mask over their head during imaging scans. These scans will pinpoint the exact location of the tumor. This spot will be the target of the radiation treatments. Participants will undergo radiation treatment 4 times per week. Some people will have this treatment for 3 weeks, some for 2 weeks, and some for 1 week. Blood tests and other exams will be repeated at each visit. Participants will complete questionnaires about their physical and mental health. They will answer these questions before starting radiation treatment; once a week during treatment; and at intervals for up to 3 years after treatment ends. Participants will have follow-up visits 1 month after treatment and then every 2 months for 6 months. Follow-up clinic visits will continue up to 3 years. Follow-ups by phone or email will continue an additional 2 years.
Primary Outcome
The number of participants experiencing DLTs within the DLT period will be reported for each hypofractionation schema. The MTD will be identified, and the proportion of participants treated with the MTD experiencing DLT will be reported.
Conditions Studied
Interventions
- RADIATION Radiation Therapy
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2024-10-01 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 1 |
What NCT06344130 shows while recruiting
NCT06344130 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 210-participant average among 87 other Glioma trials with a reported enrollment target (87% lower).
The record links to 3 conditions, with Glioma appearing as the primary indexed condition, and to 1 intervention - of which Radiation Therapy is the first listed.
NCT06344130 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT06344130 about?
NCT06344130 is a clinical study titled "Hypofractionation Trial of Re-irradiation in Good Prognosis Recurrent Glioblastoma". Background: Glioblastoma (GBM) is a cancer of the brain. Current survival rates for people with GBM are poor; survival ranges from 5.2 months to 39 months. Most tumors come back within months or years after treatment, and when they do, they are worse: Overall survival drops to less than 10 months. ...
What is the current status of trial NCT06344130?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2024-10-01. Estimated completion is 2027-12-31.
What conditions does trial NCT06344130 study?
This clinical trial studies the following conditions: Glioma, Recurrent Glioblastoma, Astrocytoma.
What interventions are being tested in trial NCT06344130?
The interventions under investigation include: Radiation Therapy (RADIATION).
Who is sponsoring clinical trial NCT06344130?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06344130 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06344130's enrollment target sits among peer trials
28 59th of 87 higher than 27 of 87 other Glioma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Glioma 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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