"A Phase II Trial of Hippocampal-Sparing Cranial Irradiation (PCI) for Small-Cell Lung Cancer (SCLC)"
-The standard of care in management of small cell lung cancer consists of chemotherapy plus
thoracic radiation followed by prophylactic cranial irradiation (PCI) based on a randomized
trial that demonstrated a significant improvement in overall survival (OS) with PCI.
Unfortunately radiation therapy to the brain is associated with neurocognitive toxicity,
which may be at least in part related to radiation induced injury to neural progenitor cells
in the hippocampus. Both human and animal data suggest an inverse relationship between
radiation dose to the hippocampus and performance on neuropsychological testing. We
hypothesize that hippocampal sparing PCI will allow improved performance on tests of short
term memory and executive function compared to a historical control (RTOG 0212) receiving
the same dose of conventional PCI. The primary objective of this study is to evaluate
performance on the Hopkins Verbal Learning Test-Revised for delayed recall at 6 months
following hippocampal-sparing PCI relative to the historical control. Secondary objectives
are to estimate: 1) composite cognitive function following hippocampal-sparing PCI relative
to the historical control and 2) the rate of metastases in the hippocampus at 2 years
following hippocampal-sparing PCI. The long term goal of this research is to reduce the
long term sequelae of radiation therapy for both primary and metastatic brain tumors.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Effect of Hippocampal-sparing PCI on possible delayed recall toxicity.
Evaluate performance on the Hopkins Verbal Learning Test-Revised for delayed recall (HVLT-R-Delayed Recall) at 6 months following hippocampal-sparing PCI relative to historical control receiving standard PCI.
Baseline, 6 months and 12 months post radiation treatment
Kristin Redmond, M.D.
Johns Hopkins University
United States: Food and Drug Administration
|The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231|