{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"7"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"7"}],"units":"Participants"}],"description":"Target number of patients for the study was 27. At the termination of the study, 8 patients were accrued and finished treatment but 1 patient dropped out before follow up, leaving an evaluable number of 7. As the enrollment in the study did not reach the target number of patients, we were not able to produce statistically reliable results to detect the expected difference. Therefore, we have decided to provide summary statistics of primary and secondary outcomes.\n\nAmong 3 cetuximab responders, two did not have progression within 2 year follow-up time and one had a locoregional recurrence and expired.","groups":[{"description":"Patients receive cetuximab IV over 60-120 minutes for 3 weeks. Patients then undergo EBRT over 6-7 weeks. Patients achieving response continue weekly doses of cetuximab until radiation therapy is completed. Patients unable to achieve response or progression receive cisplatin IV over 1-2 hours on days 1, 22, and 43 of radiation therapy.\n\ncetuximab: Given IV\n\ncisplatin: Given IV\n\nexternal beam radiation therapy: Undergo EBRT\n\nlaboratory biomarker analysis: Correlative studies","id":"OG000","title":"Treatment (Cetuximab, Cisplatin, EBRT)"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Target number of patients for the study was 27. At the termination of the study, 8 patients were accrued and finished treatment but 1 patient dropped out before follow up, leaving an evaluable number of 7. As the enrollment in the study did not reach the target number of patients, we were not able to produce statistically reliable results to detect the expected difference.","reportingStatus":"POSTED","timeFrame":"2 years","title":"Locoregional Control in Cetuximab Responders","type":"PRIMARY","unitOfMeasure":"Participants"}