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Site for MRI Brain Surveillance Alone Versus MRI Surveillance and Prophylactic Cranial Irradiation (PCI): A Randomized Phase III Trial in Small-Cell Lung Cancer (MAVERICK) (S1827) (PSCI# 20-086)

The purpose of this study is to compare the effects of using brain MRIs alone versus brain MRIs plus PCI on the lifespan of patients with small cell lung cancer. The use of brain MRIs alone could reduce side effects of receiving PCI. This study is hoping to show that monitoring with MRI scans alone (delaying radiation until the actual spread of the cancer) is at least as good as the combination of PCI with MRI scans. There will be about 668 people taking part in this study.
18 year(s) or older
This study is NOT accepting healthy volunteers
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Inclusion Criteria:
Patient must have a histologically confirmed diagnosis of small-cell lung cancer (SCLC).
Patient must have an MRI of the brain performed within 28 days prior to registration.
Patient must have Zubrod Performance Status of 0-2
Patient must be ≥ 18 years of age.
All adverse events from prior treatment must have resolved to ≤ Grade 2 (CTCAE Version 5.0) prior to randomization.
Exclusion Criteria:
Patient must not have a contraindication to gadolinium contrast administration during MR imaging, such as allergy or insufficient renal function
Patient must not have other metastatic malignancies requiring current active treatment.
Patient must not have any severe active comorbidities
Patient must not have received prior radiotherapy to the brain or whole brain radiotherapy.
Patient must not have a contraindication to MR imaging, such as implanted metal devices or foreign bodies
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Hershey, PA