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Open Access Highly Accessed Study protocol

Adjuvant gemcitabine versus NEOadjuvant gemcitabine/oxaliplatin plus adjuvant gemcitabine in resectable pancreatic cancer: a randomized multicenter phase III study (NEOPAC study)

Stefan Heinrich1, Bernhard Pestalozzi2, Mickael Lesurtel3, Frederik Berrevoet4, Stéphanie Laurent5, Jean-Robert Delpero6, Jean-Luc Raoul7, Phillippe Bachellier8, Patrick Dufour9, Markus Moehler10, Achim Weber11, Hauke Lang1, Xavier Rogiers4 and Pierre-Alain Clavien3*

Author Affiliations

1 Department of General and Abdominal Surgery, University Hospital of Mainz, Langenbeck-strasse 1, 55118 Mainz, Germany

2 Department of Medical Oncology, University Hospital of Zurich, Raemistrasse 100, 8091 Zuerich, Switzerland

3 Visceral and Transplantation Surgery, University Hospital of Zurich, Raemistrasse 100, 8091 Zuerich, Switzerland

4 Department of General and Hepatobiliary Surgery University Hospital of Ghent, De Pintelaan 185, B-9000 Ghent, Belgium

5 Department of Gastroenterology, Digestive Oncology, University Hospital of Ghent, De Pintelaan 185, B-9000 Ghent, Belgium

6 Department of Surgery, Institut Pauli Calmettes, 232 Bd Ste Marguerite, 13273 Marseille, France

7 Department of Oncology, Institut Pauli Calmettes, 232 Bd Ste Marguerite, 13273 Marseille, France

8 Department of Visceral Surgery, University Hospital of Strasbourg, Hôpital Hautepierre, Avenue Molière, 67098 Strasbourg, France

9 Department of Oncology, University Hospital of Strasbourg, Hôpital Hautepierre, Avenue Molière, 67098 Strasbourg, France

10 Department of Internal Medicine, Gastroenterology/Gastrointestinal Oncology, University Hospital of Mainz, Langenbeckstrasse 1, 55118 Mainz, Germany

11 Department of Pathology, University Hospital of Zurich, Raemistrasse 100, 8091 Zuerich, Switzerland

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BMC Cancer 2011, 11:346  doi:10.1186/1471-2407-11-346

Published: 10 August 2011

Abstract

Background

Despite major improvements in the perioperative outcome of pancreas surgery, the prognosis of pancreatic cancer after curative resection remains poor. Adjuvant chemotherapy increases disease-free and overall survival, but this treatment cannot be offered to a significant proportion of patients due to the surgical morbidity. In contrast, almost all patients can receive (neo)adjuvant chemotherapy before surgery. This treatment is safe and effective, and has resulted in a median survival of 26.5 months in a recent phase II trial. Moreover, neoadjuvant chemotherapy improves the nutritional status of patients with pancreatic cancer. This multicenter phase III trial (NEOPAC) has been designed to explore the efficacy of neoadjuvant chemotherapy.

Methods/Design

This is a 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 > 180° or major visceral arteries are considered exclusion criteria. Eligible patients will be randomized to surgery followed by adjuvant gemcitabine (1000 mg/m2) for 6 months or neoadjuvant chemotherapy (gemcitabine 1000 mg/m2, oxaliplatin 100 mg/m2) followed by surgery and the same adjuvant treatment. Neoadjuvant chemotherapy is given four times every two weeks. The staging as well as the restaging protocol after neoadjuvant chemotherapy include computed tomography of chest and abdomen and diagnostic laparoscopy. The primary study endpoint is progression-free survival. According to the 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 a dedicated pathologist.

Discussion

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.

Trial registration

clinicalTrials.gov NCT01314027