drugset / Trial / NCT02394665

Dose Escalated MRSI Guided Radiation Therapy in Glioblastoma

NCT02394665 ↗

Phase 2 Terminated 1 enrolled University of Miami
Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2015-03
Primary completion
2016-09
Completion
2016-09

Outcome

Outcome not reported

Stopped (Enrollment): “Lack of Accrual/Enrollment”

Drugs

EvaluationDrugModalityDoseRoute
Subject Temozolomide Small molecule 150 mg/m2 Oral
Subject Temozolomide Small molecule 200 mg/m2 Oral

Indications