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Clinical Trial 18555
Study Type: Treatment
Phase of Study: Phase II/III
- Bradford Perez
A Randomized Phase II/III Trial of Prophylactic Cranial Irradiation with or without Hippocampal Avoidance for Small Cell Lung Cancer
The purpose of this study is to compare any good and bad effects of avoiding the hippocampus during whole-brain radiation to the usual whole-brain radiation. The first portion of this study will test if avoiding the hippocampus during whole-brain radiation is as effective as the usual treatment (whole-brain radiation) in decreasing the chance of cancer spreading to the brain. The second portion of the study will test if hippocampal avoidance decreases memory and thinking side effects.
Primary Objectives: 1. Randomized Phase II Component (Non-Inferiority): Determine whether the 12-month intracranial relapse rate following HA-PCI is non-inferior compared to the rate following PCI for patients with SCLC. 2. 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: 1. 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. 2. 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. 3. 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. 4. Compare overall survival after PCI versus HA-PCI for patients with SCLC. 5. 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. 6. Evaluate adverse events according to CTCAE criteria. 7. Correlate changes in HRQOL domains with changes in cognitive testing outcomes following PCI versus HA-PCI for patients with SCLC. 8. Assess cost-effectiveness of HA-PCI (MRT) and PCI (3DCRT) using the EQ-5D-5L. Exploratory Objectives: 1. Collect serum and whole blood for future translational research analyses. 2. Evaluate baseline MR imaging biomarkers of white matter injury and hippocampal volumetry as potential predictors of cognitive decline and differential benefit from HAPCI as compared to PCI. 3. Compare levels of hopefulness between PCI versus HA-PCI for patients with SCLC.