S1827, "A Randomized Phase III Trial of MRI Surveillance with or without Prophylactic Cranial Irradiation (PCI) in Small-Cell Lung Cancer"

Primary Objective

This phase III trial studies magnetic resonance imaging (MRI) surveillance and prophylactic cranial irradiation (PCI) to see how well they work compared to MRI surveillance alone in treating patients with small cell lung cancer. MRI scans are used to monitor the possible spread of the cancer with an MRI machine over time. PCI is radiation therapy that is delivered to the brain in hopes of preventing spread of cancer into the brain. The use of brain MRI alone may reduce side effects of receiving PCI and prolong patients' lifespan. Monitoring with MRI scans alone (delaying radiation until the actual spread of the cancer) may be at least as good as the combination of PCI with MRI scans.

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Description

PRIMARY OBJECTIVE: I. To evaluate whether overall survival (OS) with magnetic resonance imaging (MRI) surveillance alone is not inferior to MRI surveillance combined with prophylactic cranial irradiation (PCI) for the treatment of small cell lung cancer (SCLC). SECONDARY OBJECTIVES: I. To compare cognitive failure free survival (CFFS) rate up to 12 months after randomization between the arms. II. To compare brain-metastasis-free survival between the arms. III. To compare OS between the arms within the subgroups of patients with limited-stage and extensive-stage disease. IV. To compare cognitive failure free survival (CFFS) rates at the assessment times between the arms. V. To compare the cumulative incidence of cognitive failure with death as a competing risk between the arms. VI. To compare the frequency and severity of toxicities between the two arms. ADDITIONAL OBJECTIVE: I. To collect blood for banking. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients undergo conventional or hippocampal avoidance PCI over 20 minutes 5 days per week for 2 weeks. Patients also undergo MRI scan at 3, 6, 9, 12, 18, and 24 months. ARM II: Patients undergo MRI scan at 3, 6, 9, 12, 18, and 24 months.

Details
Age
Adult
Eligibility
Detailed eligibility criteria is available on clinicaltrials.gov. These requirements will be discussed with your doctor and/or study representative. Click the NCT number link below to learn more about this study on ClinicalTrials.gov
Locations

Greeley Campus
Harmony Campus
Highlands Ranch Hospital
Lone Tree Medical Center
Medical Center of the Rockies
Memorial Hospital Central
Memorial Hospital North
Poudre Valley Hospital
University of Colorado Hospital

Principal Investigator
Photograph of TIMOTHY WAXWEILER

TIMOTHY WAXWEILER

Study ID

Protocol Number: 20-0359

More information available at ClinicalTrials.gov: NCT04155034

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