MRI Brain Surveillance Alone Versus MRI Surveillance and Prophylactic Cranial Irradiation (PCI): A Randomized Phase III Trial in Small-Cell Lung Cancer (MAVERICK)
SWOG Cancer Research Network
Summary
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.
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 cog…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 documenting no evidence of brain metastases or leptomeningeal disease. Patient also must not have a history of brain metastases or leptomeningeal disease * Immunotherapy concurrent with and/or adjuvant to first-line therapy is allowed at the discretion of the treating physician. Patients with limited-stage (LS)-SCLC must have completed platinum-based chemotherapy and either definitive thoracic radio…
Interventions
- ProcedureMagnetic Resonance Imaging
Undergo MRI
- RadiationProphylactic Cranial Irradiation
Undergo PCI
Locations (446)
- University of Alabama at Birmingham Cancer CenterBirmingham, Alabama
- Katmai Oncology GroupAnchorage, Alaska
- Fairbanks Memorial HospitalFairbanks, Alaska
- University of Arizona Cancer Center-Orange Grove CampusTucson, Arizona
- University of Arizona Cancer Center-North CampusTucson, Arizona
- City of Hope CoronaCorona, California