{"groups":[{"description":"Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin\n\nCisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT\n\nIMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.","id":"FG000","title":"IMRT + Cisplatin"},{"description":"Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab\n\nCetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks\n\nIMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.","id":"FG001","title":"IMRT + Cetuximab"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"17"},{"groupId":"FG001","numSubjects":"23"}],"type":"Protocol Violation"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"3"}],"type":"HIV positive"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"424"},{"groupId":"FG001","numSubjects":"425"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"406"},{"groupId":"FG001","numSubjects":"399"}],"comment":"All eligible participants","type":"Eligible"},{"achievements":[{"groupId":"FG000","numSubjects":"398"},{"groupId":"FG001","numSubjects":"394"}],"comment":"Eligible and started study treatment","type":"Started treatment"},{"achievements":[{"groupId":"FG000","numSubjects":"369"},{"groupId":"FG001","numSubjects":"363"}],"comment":"Eligible, started study treatment, and had adverse events (AE) assessment 1 month post-treatment","type":"AE assessed 1 month post-treatment (PT)"},{"achievements":[{"groupId":"FG000","numSubjects":"359"},{"groupId":"FG001","numSubjects":"367"}],"comment":"Eligible, started study treatment, and had adverse events assessment 3 months post-treatment","type":"AE assessed 3 months PT"},{"achievements":[{"groupId":"FG000","numSubjects":"361"},{"groupId":"FG001","numSubjects":"352"}],"comment":"Eligible, started study treatment, and had adverse events assessment 6 months post-treatment","type":"AE assessed 6 months PT"},{"achievements":[{"groupId":"FG000","numSubjects":"360"},{"groupId":"FG001","numSubjects":"351"}],"comment":"Eligible, started study treatment, and had adverse events assessment 1 year post-treatment","type":"AE assessment 1 year PT"},{"achievements":[{"groupId":"FG000","numSubjects":"311"},{"groupId":"FG001","numSubjects":"303"}],"comment":"Eligible, started study treatment, and had adverse events assessment 2 years post-treatment","type":"AE assessed 2 years PT"},{"achievements":[{"groupId":"FG000","numSubjects":"92"},{"groupId":"FG001","numSubjects":"86"}],"comment":"Eligible, started study treatment, and had adverse events assessment 5 years post-treatment","type":"AE assessed 5 years PT"},{"achievements":[{"groupId":"FG000","numSubjects":"267"},{"groupId":"FG001","numSubjects":"267"}],"comment":"Eligible, started study treatment, and had dental health assessment 1 year post-treatment","type":"Dental health assessed 1 year PT"},{"achievements":[{"groupId":"FG000","numSubjects":"208"},{"groupId":"FG001","numSubjects":"201"}],"comment":"Eligible, started study treatment, and had dental health assessment 2 years post-treatment","type":"Dental health assessed 2 years PT"},{"achievements":[{"groupId":"FG000","numSubjects":"44"},{"groupId":"FG001","numSubjects":"43"}],"comment":"Eligible, started study treatment, and had dental health assessment 5 years post-treatment","type":"Dental health assessed 5 years PT"},{"achievements":[{"groupId":"FG000","numSubjects":"368"},{"groupId":"FG001","numSubjects":"356"}],"comment":"Eligible, started study treatment, and had feeding tube assessment 1 year post-treatment","type":"Feeding tube assessed"},{"achievements":[{"groupId":"FG000","numSubjects":"76"},{"groupId":"FG001","numSubjects":"122"}],"comment":"Eligible and experienced local, regional, or distant progression or death","type":"Progressed"},{"achievements":[{"groupId":"FG000","numSubjects":"406"},{"groupId":"FG001","numSubjects":"399"}],"comment":"Subjects contributing any data to analysis are considered to have completed the study","type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"18"},{"groupId":"FG001","numSubjects":"26"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"Sites were required to submit participant tumor tissue for central p16 evaluation within one week of registration. If participants were determined to be p16-positive and continued on the study, then treatment arm was assigned. Of 987 participants registered, 849 were randomized."}