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Closed Protocol Summaries: 0018
Title: A Feasibility Study of Neurocognitive Evaluation in Patients Treated for Brain Metastases Patient Population: Objectives: To test the feasibility of performing a test battery consisting of five neurocognitive measures and a quality of life instrument in patients with brain metastasis. Schema:
Reference: Regine W, Schmitt F, Scott C, et al. Feasibility of Neurocognitive Outcome Evaluations in Patients with Brain Metastases in a Multi-Institutional Cooperative Group Setting: Results of Radiation Therapy Oncology Group (RTOG) Trial BR-0018. Int J Radiat Oncol Biol Phys 54:49, 2002. Purpose/Objective: A multi-institutional trial was conducted by the RTOG to test the feasibility of performing a neurocognitive test battery consisting of 5 measures and a quality of life instrument in patients with brain metastases. Materials/Methods: Major eligibility requirements included: 1) histological proof of a primary malignancy, 2) measurable single or multiple brain metastases, 3) Zubrod performance status 0–1, 4) neurological function status 0–2, and 5) ''certification'' for administration of neurocognitive assessments. This certification process required either attendance at an RTOG neurocognitive assessment training workshop, or review of an instructional video, followed by submission of an audio of mock/simulated test sessions for central review. The test battery included the following measures: 1) Mini-Mental State Exam (MMSE), 2) Hopkins Verbal Learning Test (HVLT), 3) Verbal Fluency/Controlled Word Association Test (COWAT), 4) Ruff 2 and 7 test ( 2 & 7 ), 5) Trailmaking Test (TMT), and 6) Profile of Mood States Short Form (POMS-SF). The primary objective of this trial was to establish whether patients were able to complete this test battery. Compliance was defined as successful completion of a test measure based on available data, as data for all patients was not available at this time. The test battery was to be administered just prior to, at completion of, and at 1 month following whole brain radiation therapy to 37.5 Gy at 2.5 Gy per fraction once daily. Between November 2000 and August 2001, 59 patients were enrolled to the trial. Results: Patient characteristics included: 32% > 65 years; 44% performance status 0; 81% with multiple brain metastases. Patient compliance with the test battery at the three time points is summarized in the table below. Overall compliance was >90%. The most common causes of non-compliance were patient related factors (e.g. performance status or inability to understand test instructions) and not institutional error. Conclusions: Neurocognitive evaluation of patients with brain metastases in a multi-institutional and cooperative group setting appears feasible using the test battery and certification process employed in this study. This battery and certification process will be incorporated into future RTOG brain tumor trials. Updated analyses will be presented at the ASTRO meeting.
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