Randomized Multicenter Phase Ii/Iii Study With Adjuvant Gemcitabine Versus Neoadjuvant/Adjuvant Folfirinox In Resectable Pancreatic Cancer: The Nepafox Trial.

TPS4152 Background: The outcome of pancreatic cancer remains poor. Few patients (pts) can be assigned to surgery and 80% of resected pts experience a relapse. Currently, adjuvant ctx with gemcitabine is standard, but prognosis remains poor, with 5-year survival rates around 25%. FOLFIRINOX is superior to gemcitabine in the metastatic setting and may represent a valuable option in resectable stages. Therefore, we initiated this multicenter phase II/ III trial (NEPAFOX) to explore the efficacy of neoadjuvant FOLFIRINOX. Methods: This is a randomized phase II/III trial. Pts with locally limited, curatively resectable or borderline resectable adenocarcinoma of the pancreas without metastases are eligible. Eligible pts are randomized to (arm A) surgery followed by adjuvant gemcitabine (1000 mg/m2) for 6 months or (arm B) perioperative FOLFIRINOX (irinotecan 180 mg/m2, oxaliplatin 85 mg/m2, 5-FU 400mg/m² bolus, 5-FU 2400 mg/m², sodium folinate 400 mg/m2) with 6 cycles (12 weeks) pre and further 6 cycles post surgery. Staging includes CT of chest and abdomen and will be repeated after 3 cycles of neoadjuvant chemotherapy, before surgery and every 3 months after surgery. Follow-up will be two years for disease recurrence. As prophylaxis for neutropenia, pts will obtain Filgrastim (Nivestim) ( ≤ 70 kg KG 30MioU/0,5 mL and > 70 kg KG 48 MioU/0,5 mL) s.c. 1-0-0 d 5-7). The primary endpoint is median OS. Secondary endpoints are median PFS, perioperative morbidity and mortality, R0 resection rate, pathological complete remission and prevalence of iron deficiency anemia. 126 pts will be randomized 1:1. After an interims analysis, the trial can be continued as phase III (310 pts). Recruitment of the trial started in Nov 2014. Clinical trial information: NCT02172976.