Adjuvant gemcitabine versus Neoadjuvant gemcitabine/oxaliplatin plus adjuvant gemcitabine in resectable Pancreatic Cancer: A randomized multicenter phase III study (NEOPAC study) Full Text
BMC Cancer, 08/13/2011  Clinical Article

Heinrich S et al. – The NEOPAC study will determine the efficacy of neoadjuvant chemotherapy in pancreatic cancer for the first time and offers a unique potential for translational research. Furthermore, this trial will provide the unbiased overall survival of all patients undergoing surgery for resectable cancer of the pancreatic head.

• Prospective randomized phase III trial
• Patients with resectable cytologically proven adenocarcinoma of the pancreatic head are eligible for this study
• All patients must be at least 18 years old and must provide written informed consent
• An infiltration of the superior mesenteric vein >180degrees or major visceral arteries are considered exclusion criteria
• Eligible patients will be randomized to surgery followed by adjuvant gemcitabine (1000mg/m2) for 6 months or neoadjuvant chemotherapy (gemcitabine 1000mg/m², oxaliplatin 100mg/m²) followed by surgery and the same adjuvant treatment
• Neoadjuvant chemotherapy is given 4 times every 2 weeks
• Staging as well as restaging protocol after neoadjuvant chemotherapy include computed tomography of chest and abdomen and diagnostic laparoscopy
• Primary study endpoint is PFS
• According to sample size calculation, 155 patients need to be randomized to each treatment arm
• Disease recurrence will be documented by scheduled computed tomography scans 9, 12, 15, 21 and thereafter every 6 months until disease progression
• For quality control, circumferential resection margins are marked intraoperatively, and representative histological sections will be centrally reviewed by dedicated pathologist