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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 is a Phase 2 study that was terminated before completion, run by University of Miami. The registered enrollment target is 1 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02394665
The ClinicalTrials.gov registry entry for NCT02394665 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Miami, which has 721 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Temozolomide is the first listed.
NCT02394665 reports 0 study locations.
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.
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