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A Phase III Trial Evaluating the Addition of Cetuximab to Paclitaxel, Cisplatin, and Radiation for Patients With Esophageal Cancer Who Are Treated Without Surgery

Primary To evaluate if the addition of cetuximab to paclitaxel, cisplatin, and radiation improves overall survival compared to paclitaxel, cisplatin, and radiation alone in patients with esophageal cancer who are treated without surgery. Secondary To evaluate if the addition of cetuximab to paclitaxel, cisplatin, and radiation improves local control by increasing the clinical complete response and decreasing local recurrence for patients with esophageal cancer who are treated without surgery. To evaluate adverse events. To evaluate endoscopic complete response rates. To evaluate if the addition of cetuximab to paclitaxel, cisplatin, and radiation improves the Esophageal Cancer Subscale score of the FACT-E quality of life tool. To evaluate the quality-adjusted survival of each treatment arm using EQ-5D if the primary endpoint supports the primary hypothesis. To implement a well-controlled tissue handling/storage protocol to facilitate future laboratory correlative studies.

Primary To evaluate if the addition of cetuximab to paclitaxel, cisplatin, and radiation improves overall survival compared to paclitaxel, cisplatin, and radiation alone in patients with esophageal cancer who are treated without surgery. Secondary To evaluate if the addition of cetuximab to paclitaxel, cisplatin, and radiation improves local control by increasing the clinical complete response and decreasing local recurrence for patients with esophageal cancer who are treated without surgery. To evaluate adverse events. To evaluate endoscopic complete response rates. To evaluate if the addition of cetuximab to paclitaxel, cisplatin, and radiation improves the Esophageal Cancer Subscale score of the FACT-E quality of life tool. To evaluate the quality-adjusted survival of each treatment arm using EQ-5D if the primary endpoint supports the primary hypothesis. To implement a well-controlled tissue handling/storage protocol to facilitate future laboratory correlative studies.