E2205: A phase II study to measure response rate and toxicity of neoadjuvant chemoradiotherapy (CRT) with oxaliplatin (OX) and infusional 5-fluorouracil (5-FU) plus cetuximab (C) followed by postoperative docetaxel (DT) and C in patients with operable adenocarcinoma of the esophagus.

摘要: 4064 Background: One approach to treating resectable esophageal adenocarcinoma is CRT followed by surgery; however, recurrence common. To improve on this, we designed a single-arm, phase II trial that added an EGF-R inhibitor, C, CRT. Methods: We aimed increase the pathologic complete response (pCR) rate from 25% 45%. A Simon two-stage design (α and β of 0.10) required pCR/enrolled 5/18 for stage I 14/40 total. 22 pts enrolled. CRT: OX 85 mg/m2 D1, 15, 29; infusional 5-FU 180 mg/m2/24 hr × 35 days; C 400 D1 then 250 D8, 22, 29 radiation (IMRT allowed) cGy/day 25 fractions (M-F). Following esophagectomy, adjuvant chemotherapy (CT): weekly DT 5/6 weeks 2 cycles. Endpoints: efficacy pCR toxicity. Results: Of patients enrolled, 18 had surgery (C reaction off study, died PE 4 days after CRT, G3 diarrhea during disease progression, sepsis/hypoxia CRT). = 7 patients. 13/18 started CT. 12/13 co...