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NCT02394665 · ClinicalTrials.gov registry record · Phase 2
Dose Escalated MRSI Guided Radiation Therapy in Glioblastoma
A Phase 2 study, sponsored by University of Miami.
- Terminated
- Registry status
- Phase 2
- Development phase
- 1
- Enrollment target
NCT02394665: Clinical Trial Phase 2 study, sponsored by University of Miami.
NCT02394665 is a Phase 2 study that was terminated before completion, run by University of Miami. The registered enrollment target is 1 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02394665, a Phase 2 study, was terminated before completion, sponsored by University of Miami.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 1 participants
- Enrollment target
Study Summary
In summary, the overall prognosis of glioblastoma (GBM) patients remains poor. Although clinical gains have been achieved in the past, these have been modest, with a majority of patients succumbing to local disease progression within 2 years. New strategies for treatment need to be identified which enhance local control above the current treatment regimen in order to achieve further clinical gains in this disease. Favorable early experience with magnetic resonance spectroscopy imaging (MRSI) demonstrates that metabolic imaging can identify active tumor beyond standard MRI as well as high risk regions at risk for local failure. There is also clinical evidence that limited field dose escalation with either simultaneous integrated boost (SIB) or stereotactic radiosurgery (SRS) is feasible and safe. Coupling these findings provide the rationale for this proposed Phase II trial designed to define efficacy and toxicity of the novel treatment approach of whole brain volumetric 3D MRSI guided dose-escalated radiation therapy (RT) in newly diagnosed GBM patients.
Primary Outcome
The efficacy of 3D MRSI-guided, dose escalated radiation in newly diagnosed glioblastoma (GBM) patients as measured by overall survival (OS). Overall survival (OS) is defined as the time elapsed from the start of study treatment until death. Surviving patients (including patients lost to follow up) will be censored at the date of last contact.
Interventions
- DRUG Temozolomide
- RADIATION Intensity Modulated Radiation Therapy
- BEHAVIORAL Functional Assessment of Cancer Therapy-Brain (FACT-Br)
- RADIATION Stereotactic Radiosurgery Boost
- RADIATION Simultaneous Integrated Boost
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2015-03 |
| Est. Completion | 2016-09 |
| Phase | Phase 2 |
Why NCT02394665 stopped before completion
NCT02394665 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 5 interventions - of which Temozolomide is the first listed.
NCT02394665 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02394665 about?
NCT02394665 is a clinical study titled "Dose Escalated MRSI Guided Radiation Therapy in Glioblastoma". In summary, the overall prognosis of glioblastoma (GBM) patients remains poor. Although clinical gains have been achieved in the past, these have been modest, with a majority of patients succumbing to local disease progression within 2 years. New strategies for treatment need to be identified which ...
What is the current status of trial NCT02394665?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 1 participants. The study started on 2015-03. Estimated completion is 2016-09.
What interventions are being tested in trial NCT02394665?
The interventions under investigation include: Temozolomide (DRUG), Intensity Modulated Radiation Therapy (RADIATION), Functional Assessment of Cancer Therapy-Brain (FACT-Br) (BEHAVIORAL), Stereotactic Radiosurgery Boost (RADIATION), Simultaneous Integrated Boost (RADIATION).
Who is sponsoring clinical trial NCT02394665?
This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02394665's enrollment target sits among peer trials
1 2001st of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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