{"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"description":"Descriptive statistics will be used to describe the mean plasma cisplatin and selenium at each time point. Repeated measures analysis of variance will be used to evaluate the changes in plasma cisplatin and selenium over time. Analysis of pharmacodynamic markers will be conducted using statistical methods appropriate for within-patient sequential analyses, such as repeated measures analysis of variance.","groups":[{"description":"Patients receive placebo PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin IV over 3 hours once in weeks 2, 5, and 8 and undergo radiotherapy 5 days a week in weeks 2-8.\n\nplacebo: Given PO\n\ncisplatin: Given IV\n\nradiation therapy: Undergo radiotherapy\n\nquality-of-life assessment: Ancillary studies","id":"OG000","title":"Arm I (Placebo, Cisplatin, and Radiotherapy)"},{"description":"Patients receive selenomethionine PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin and undergo radiotherapy as in arm I.\n\nselenomethionine: Given PO\n\ncisplatin: Given IV\n\nradiation therapy: Undergo radiotherapy\n\nquality-of-life assessment: Ancillary studies","id":"OG001","title":"Arm II (Selenomethionine, Cisplatin, and Radiotherapy)"}],"populationDescription":"Due to the study's early termination and inadequate number of patients, no patients were analyzed.","reportingStatus":"POSTED","timeFrame":"Up to 3 months post-treatment","title":"Plasma Cisplatin and Selenium PK and PD Markers (NZ Only)","type":"SECONDARY"}