Glioblastoma Clinical Trial
Official title:
STRONG Trial - Stem Cell Radiotherapy (ScRT) and Temozolomide for Newly Diagnosed High-grade Glioma (HGG): A Prospective, Phase I/II Trial
There are preliminary studies that suggest that radiation therapy to areas of the brain
containing cancer stem cells (in addition to the area where the tumor was surgically
treated) may help patients with high-grade brain tumors live longer. The purpose of this
study is to determine whether the addition of stem-cell radiation therapy to the standard
chemoradiation will further improve the outcome. The investigators will collect information
about the patient's clinical status, disease control, neurocognitive effects, and quality of
life during follow-up in our department.
The purpose of the study is to improve the overall survival patients with newly diagnosed
malignant brain tumors treated with stem cell radiation therapy and chemotherapy. The
investigators will also measure how patients treated with this novel method of radiation
therapy do over time in terms of disease control, potential neurocognitive side effects,
overall function, and quality of life.
Even after optimal standard treatment, the outcome for patients suffering from glioblastoma
(GB) is currently dismal, and temozolomide adds a modest survival benefit at high monetary
cost and is accompanied by considerable toxicity. A possible explanation for the failure of
radiotherapy to cure GB is the observation that glioma cells migrate widely into healthy
bilateral brain tissue from one or more foci of origin. These isolated cells are not
detected by current radiological techniques or even imaging and therefore usually not
included into the target volume during radiotherapy. In this present study the investigators
would like to test the hypothesis that the dose prescribed to the normal tissue stem cell
niche in the adult brain will influence the effectiveness of radiotherapy for patients
suffering from HGG/GB as these niches may serve as a harbor for radioresistant glioma stem
cells, which are the only cells in a HGG believed to able to repopulate a tumor.
The hypothesis is based on previous reports showing that adult normal tissue stem cells
reside in the lateral periventricular regions of the lateral ventricles and animal studies
reporting that transformation of normal tissues stem cells but not differentiated cells lead
to tumor formation. This unique anatomical pattern of the brain that clearly separates stem
cell niches as a potential pool of cancer stem cell (CSC's) from differentiated tissue make
this an ideal model system to study the impact of radiation dose given to these stem cell
niches. Therefore, prospective, randomized clinical trials are needed to address the
efficacy and toxicity of including the CSC-containing subventricular region as additional
target volumes into treatment plans for patients suffering from HGG/GB. This intervention
could dramatically improve the outcomes of patients suffering from progressive, relapsing
disease despite our best efforts currently.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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