gemcitabine versus NEOadjuvant gemcitabine/oxaliplatin or FOLFIRINOX
plus adjuvant gemcitabine in resectable PAncreatic Cancer: a
randomized multicenter phase III study
ClinicalTrials.gov Identifier: NCT01314027
Pancreatic cancer has a dismal prognosis. The majority of patients present in an advanced disease stage which precludes curative surgery. Even after a curative resection in the absence of distant metastases, overall survival is limited with 5-year survival rates ranging from 10% to 30% in series.
Surgery followed by adjuvant chemotherapy is currently considered the standard treatment for resectable pancreatic cancer. However, a significant proportion (25-50%) of patients cannot receive adjuvant chemotherapy due to the morbidity of pancreas surgery. Neoadjuvant (preoperative) chemotherapy appears particularly attractive since it can be applied to all patients and has resulted in a significant histological tumor response with a median survival superior to adjuvant chemotherapy (Heinrich, Clavien et al. J Clin Oncol. 2008 20;26:2526-31).
We designed the NEOPAC prospective randomized controlled trial aiming at defining the additional value of neoadjuvant chemotherapy using either GemOx (gemcitabine + oxaliplatin) or Folfirinox (oxaliplatin, irinotecan, leucovorin and fluorouracil) to the standard treatment for resectable pancreatic cancer (surgery + adjuvant chemotherapy). Patients with cytologically proven adenocarcinoma of the pancreatic head are randomly allocated to one of the following arms:
- Arm A: neoadjuvant chemotherapy + resection (Whipple operation) + adjuvant chemotherapy
- Arm B: resection + adjuvant chemotherapy
The primary endpoint is 1-year progression-free survival.
To achieve the number of patients required (n=310), an international network of pancreatic cancer centers has been organized. Data management and monitoring is performed by the Clinical Trial Unit Zurich and our Swiss HPB Center is recruiting patients. Several centers have been opened in Europe: Paoli Calmettes Institut, Marseille, France (Prof Delpero,) University Hospital of Strasbourg, France (Prof Bachelier), University Hospital of Mainz, Germany (Prof Lang) and University Hospital in Gent, Belgium (Prof Berrevoet).
The objective of the NEOPAC study is to determine for the first time the efficacy of this short-term neoadjuvante chemotherapy in addition to the current standard treatment. Based on the results of our phase II-trial, we hypothesize that the postoperative course of the pancreaticoduodenectomy (Whipple operation) will be less complicated following neoadjuvant chemotherapy due to the improvement of the nutritional status. Therefore, these patients will presumably receive adjuvant chemotherapy to a higher percentage, which should result in a better long-term survival.
The study protocol was published in Bio Med Central Cancer (Heinrich et al. BMC Cancer 2011, 11:346). The NEOPAC study is opened to all centers that would like to participate.
- Pierre-Alain Clavien, Departement of Surgery and Transplantation, University Hospital Zurich
- Mickael Lesurtel, Departement of Surgery and Transplantation, University Hospital Zurich
- Bernhard C. Pestalozzi, Department of Oncology, University Hospital Zurich
- Stefan Heinrich, Department of Surgery, University Hospital, Mainz, Germany
- Peter Bauerfeind, Department of Gastroenterology, University Hospital Zurich
- Achim Weber, Department of Pathology, University Hospital Zurich
- Jean-René Delpero, Department of Surgery, Paoli-Calmettes Institute, Marseille, France
- Philippe Bachelier, Department of Surgery, University Hospital, Strasbourg, France
- Frederik Berrevoet, General and Hepatobiliary Surgery and Liver Transplantation, University Hospital, Gent, Belgium
18F-FDG-Positron Emission Tomography CT showing a FDG-positive cancer of the head of the pancreas.
Ihre Ansprechpartner bei Fragen:
Prof. Pierre-Alain Clavien und Dr. med. Christian Oberkofler
Klinik für Viszeral- und Transplantationschirurgie
Tel. +41 (0)44 255 33 00