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

Primary Objective:
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).

Secondary Objectives:
1. To compare cognitive failure free survival (CFFS) rate up to 12 months after
randomization between the arms.

2. To compare brain-metastasis-free survival between the arms.

3. To compare OS between the arms within the subgroups of patients with limited stage and extensive-stage disease.

4. To compare cognitive failure free survival (CFFS) rates at the assessment times between the arms.

5. To compare the cumulative incidence of cognitive failure with death as a competing risk between the arms.

6. To compare the frequency and severity of toxicities between the two arms.

Protocol Number: 032002
Phase: Phase III
Applicable Disease Sites: Lung
Principal Investigator: Matthew Deek
Scope: National
Therapies Involved: Radiotherapy
Participating Institutions:
  • RWJBarnabas Health
    • Community Medical Center
    • Monmouth Medical Center
    • Monmouth Medical Center Southern Campus
    • Robert Wood Johnson University Hospital, Hamilton
    • Robert Wood Johnson University Hospital, Somerset
    • Trinitas Hospital and Comprehensive Cancer Center
  • Rutgers University
Inclusion & Exclusion Criteria

Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

For further information about clinical trials, please contact us at 732-235-7356.