MRI Brain Surveillance Alone Versus MRI Surveillance and Prophylactic Cranial Irradiation (PCI): A Randomized Phase III Trial in Small-Cell Lung Cancer (MAVERICK)

Histologically confirmed diagnosis of small-cell lung cancer (SCLC). MRI of the brain within 28 days prior to reg documenting no evidence of brain metastases or leptomeningeal disease. No history of brain metastases or leptomeningeal disease. Immunotherapy concurrent with and/or adjuvant to first-line therapy allowed at the discretion of the treating physician. Patients with LS-SCLC must have completed platinum-based chemotherapy and either definitive thoracic radiotherapy (including SBRT for early-stage T1-2 N0 M0 disease who do not undergo surgery) or definitive surgical resection; thoracic radiation in addition to definitive surgical resection is allowed at the discretion of the treating physician, but is not required. Patients with ES-SCLC must have completed platinum-based chemotherapy either with or without thoracic radiotherapy at the discretion of the treating physician. All adverse events from prior treatment must have resolved to less than or equal to Grade 2 (CTCAE Version 5.0) prior to randomization. Must have had a response to first-line therapy and no evidence of progression in opinion of the treating investigator. Systemic imaging (CT or PET/CT including the chest and abdomen) must be performed within 28 days prior to randomization. No more than 8 weeks may have elapsed between Day 1 of the last cycle of chemotherapy and randomization. Must not have received prior radiotherapy to the brain or whole brain radiotherapy. Patients who have undergone prior stereotactic radiosurgery for benign tumors or conditions (e.g., acoustic neuroma, grade I meningioma, trigeminal neuralgia) may be considered on a case-by-case basis. At least18 years of age. Zubrod Performance Status 0-2. Must not have a contraindication to MR imaging, such as implanted metal devices or foreign bodies. Must not have a contraindication to gadolinium contrast administration during MR imaging, such as allergy or insufficient renal function. Must not have other metastatic malignancies requiring current active treatment. Must not have any severe active comorbidities defined in Section 5.3.f. Must not be pregnant. Patients who speak and understand English or French must agree to participate in cognitive function testing.