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 participants 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 participants' 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.
Additional locations may be listed on ClinicalTrials.gov for NCT04155034 .
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PRIMARY OBJECTIVE:
I. To compare cognitive failure free survival (CFFS) in participants randomized to MRI surveillance with or without prophylactic cranial irradiation (PCI) for the treatment of small lung cancer (SCLC).
SECONDARY OBJECTIVES:
I. To evaluate whether overall survival (OS) with MRI surveillance alone is not inferior to MRI surveillance combined with prophylactic cranial irradiation (PCI) for the treatment of small cell lung cancer (SCLC).
II. To compare brain-metastasis-free survival between the arms.
III. To compare the cumulative incidence of cognitive failure with death as a competing event between the arms.
IV. To compare the frequency and severity of toxicities between the two arms.
ADDITIONAL OBJECTIVE:
I. To collect blood for banking.
II. To collect brain MRIs for National Cancer Institute (NCI) approved MRI Imaging Ancillary Study.
HEALTH-RELATED QUALITY OF LIFE OBJECTIVES:
I. To compare participant-reported cognitive functioning between arms at 6 months from randomization using the cognitive factor score of the MD Anderson Symptom Inventory - Brain Tumor (MDASI-BT).
II. To compare participant-reported cognitive functioning between arms at 6 months from randomization using the Patient Reported Outcomes Measurement Information System (PROMIS) Cognitive Function Short Form 4A.
EXPLORATORY OBJECTIVES:
I. To compare OS between the arms within the subgroups of participants with limited-stage and extensive-stage disease.
II. To compare CFFS between the arms within the subgroups of participants with limited-stage and extensive-stage disease.
III. To compare progression free survival (PFS) between arms.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Participants undergo conventional or hippocampal avoidance PCI over 20 minutes 5 days per week for 2 weeks. Participants also undergo MRI scan at 3, 6, 9, 12, 18, and 24 months.
ARM II: Participants undergo MRI scan at 3, 6, 9, 12, 18, and 24 months.
Participants undergo computed tomography (CT) scan, positron emission tomography (PET) scan and blood sample collection throughout the study.
Participants are followed at least every 6 months during year 3 then annually during years 4 and 5 after randomization.
Lead Organization SWOG
Principal Investigator Chad George Rusthoven