NeoFLOT: Multicenter phase II study of perioperative chemotherapy in resectable adenocarcinoma of the gastroesophageal junction or gastric adenocarcinoma.

4072 Background: The rationale of the NeoFLOT-trial was the intensification of neoadjuvant chemotherapy (NACT) by prolongation of preoperative treatment. This strategy is based on the notion that while perioperative treatment is notably beneficial in locally advanced gastroesophageal cancer (GEC), postoperative chemotherapy can only be applied in a fraction of patients (pts). Methods: Pts with T3, T4 and/or N+ adenocarcinoma (GEC) were eligible for this multicenter phase II trial. NACT consisted of 6 cycles of oxaliplatin 85 mg/m2, leucovorin 200 mg/m2, fluorouracil 2600 mg/m2 and docetaxel 50 mg/m2 (FLOT) applied q 2 wks. Staging was performed after 3 cycles to select pts with progressive disease (PD) for immediate surgery. Primary endpoint was the R0-resection rate. Secondary endpoints included the pathological complete response rate (pCR), histologic tumor regression grade (Becker 2003), safety, and progression-free survival (PFS). Results: From 10/2009 to 06/2011, 59 pts were enrolled of whom 58 pts w...