Having a large clinical trial portfolio means giving patients treatment options often not available anywhere else, and years before they become the standard of care. To learn more about Karmanos Cancer Institute clinical trials or to see if a trial is right for you, please call 1-800-KARMANOS (1-800-527-6266) or request an appointment below
  • A Randomized Phase II/III Trial of Prophylactic Cranial Irradiation with or without Hippocampal Avoidance for Small Cell Lung Cancer

    Cancer Categories
    • Lung
    Karmanos Trial ID
    • NRG-CC003
    NCT ID
    • NCT02635009
    Age Group
    • Adult
    Scope
    • National
    PhaseClick for Clinical Trial Phase DefinitionPhase II
    Includes controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in participants with the disease or condition under study and to determine the common short-term side effects and risks.
    • Phase II/III
    Principal Investigator

    Objective:

    Primary Objectives:
    • Randomized Phase II Component (Non-Inferiority): Determine whether the 12-month intracranial relapse rate following HA-PCI is non-inferior to the rate following PCI for patients with SCLC.
    • Phase III Component (Efficacy): Determine whether HA-PCI reduces the likelihood of 6-month deterioration from baseline in HVLT-R delayed recall compared to PCI for patients with SCLC.
    Secondary Objectives:
    • Compare time to cognitive failure, as measured by a battery of tests (HVLT-R, COWA test, and TMT Parts A and B), after PCI versus HA-PCI in SCLC.
    • Compare time to cognitive failure as separately measured by each test (HVLT-R for Total Recall and Delayed Recognition, COWA test, and TMT Parts A and B), after PCI versus HA-PCI for SCLC.
    • Compare patient-reported cognitive functioning and other quality of life domains (assessed by the EORTC QLQ-C30 and BN20) between PCI versus HA-PCI for patients with SCLC.
    • Compare overall survival after PCI versus HA-PCI for patients with SCLC.
    • Compare 12-month intracranial relapse rate (at completion of phase III) and time to intracranial relapse after PCI versus HA-PCI for patients with SCLC.
    • Evaluate adverse events according to CTCAE criteria.
    • Correlate changes in HRQOL domains with changes in cognitive testing outcomes following PCI versus HA-PCI for patients with SCLC.
    • Assess cost-effectiveness of HA-PCI (MRT) and PCI (3DCRT) using the EuroQOL-5D health state classification (EQ-5D-5L).
    • Correlate miRNA signatures with cognitive failure in SCLC patients who received PCI and HA-PCI
    • Evaluate APOE genotyping as potential predictor of neurocognitive decline, hippocampal atrophy after brain irradiation and/or differential benefit from hippocampal avoidance.
    • Evaluate baseline MR imaging biomarkers of white matter injury and hippocampal volumetry as potential predictors of cognitive decline and differential benefit from HA-PCI as compared to PCI.
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