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Protocol No. 2016IS112 Principal Investigator Lou, Emil
Phase Phase III (Cancer Control)
Age Group Adult Scope National
Secondary Protocol No. EF-25
Title METIS: Pivotal, open-label, randomized study of radiosurgery with or without Tumor Treating Fields (TTFields) for 1-10 brain metastases from non-small cell lung cancer (NSCLC)
Objective Primary: -Time to first cerebral progression Secondary: -Time to second cerebral progression -Time to first and second cerebral progression in two cohorts of patients: 1-4 brain metastases and 5-10 brain metastasis -Radiological response rate following study treatments -Rate of cerebral progression at 2-,4-,6-,8-,10- and 12 months after SRS alone versus SRS plus NovoTTF-100M -Intracranial progression free survival (including the infratentorial region) after SRS alone versus SRS plus NovoTTF-100M -Time to distant progression in the supratentorial region (accounting only for a new lesion) -Overall survival -Time to neurocognitive failure -Rate of decline in HVLT-R free recall, delayed recall and delayed recognition, COWAT and TMT Parts A and B -Neurocognitive failure-free survival -Adverse events, severity and frequency based on CTCAE V4.0
Key Eligibility New diagnosis of brain metastases from a histologically or cytologically confirmed primary or metastatic NSCLC tumor within 5 years of registration on the study. 1 inoperable brain metastasis or 2 10 brain lesions per screening MRI, confirmed by contrast enhanced MRI amenable to SRS according to the following criteria: a. largest tumor volume < 10 cc. Tumor volume will be approximated by measuring the lesions three perpendicular diameters on the screening contrast-enhanced, T1-weighted MRI, and dividing the product of those diameters by 2 (i.e. xyz/2) b. longest tumor diameter < 3 cm c. Cumulative volume of all tumors &#8804; 15 cc (based on the same approximated calculation of measuring the lesions three perpendicular diameters on the screening contrastenhanced, T1-weighted MRI, and dividing the product of those diameters by 2 (i.e. xyz/2) 6. At least one measurable lesion per RANO-BM Criteria for brain metastasis
Applicable Disease Sites Lung
Therapies Involved Radiotherapy
Status Open
Participating Institutions Masonic Cancer Center
Treatment Type Treatment
Contact Katie Mellskog Phone:612-624-6490
Email:mells003@umn.edu