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Open Access Study protocol

An open label randomized multicentre phase IIIb trial comparing parenteral substitution versus best supportive nutritional care in subjects with pancreatic adenocarcinoma receiving 5-FU plus oxaliplatin as 2nd or higher line chemotherapy regarding clinical benefit - PANUSCO

Angela Märten12*, Moritz N Wente12, Jennifer Ose12, Markus W Büchler1, Ingeborg Rötzer2, Christiane Decker-Baumann2, Irini Karapanagiotou-Schenkel2, Sabine Harig12, Jan Schmidt1 and Dirk Jäger2

Author Affiliations

1 University of Heidelberg, Department of Surgery, Im Neuenheimer Feld 110, 69120 Heidelberg, Germany

2 National Center for Tumor Diseases, Im Neuenheimer Feld 350, 69120 Heidelberg, Germany

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BMC Cancer 2009, 9:412  doi:10.1186/1471-2407-9-412

Published: 27 November 2009

Abstract

Background

Pancreatic cancer is an extremely aggressive malignancy. Subjects are afflicted with a variety of disconcerting symptoms, including profound cachexia. Recent data indicate that the outcome of oncological patients suffering from cancer cachexia could be improved by parenteral nutrition and that parenteral nutrition results in an improvement of quality of life and in prolonged survival.

Currently, there is no recommendation of routine use of parenteral nutrition. Furthermore, there is no clear recommendation for 2nd line therapy (or higher) for pancreatic adenocarcinoma but often asked for.

Methods/Design

PANUSCO is an open label, controlled, prospective, randomized, multicentre phase IIIb trial with two parallel arms. All patients will be treated with 5-fluorouracil, folinic acid and oxaliplatin on an outpatient basis at the study sites. Additionally, all patients will receive best supportive nutritional care (BSNC). In the experimental group BSNC will be expanded with parenteral nutrition (PN). In contrast, patients in the control group obtain solely BSNC. Parenteral nutrition will be applied overnight and at home by experienced medical staff.

A total of 120 patients are planned to be enrolled. Primary endpoint is the comparison of the treatment groups with respect to event-free survival (EFS), defined as the time from randomization till time to development of an event defined as either an impairment (change from baseline of at least ten points in EORTC QLQ-C30, functional domain total score) or withdrawal due to fulfilling the special defined stopping criteria for chemotherapy as well as for nutritional intervention (NI) or death from any cause (whichever occurs first).

Discussion

The aim of this clinical trial is to evaluate whether parenteral nutrition in combination with defined 2nd line or higher chemotherapy has an impact on quality of life for patients suffering from pancreatic adenocarcinoma.

Trial registration

Current Controlled Trials ISRCTN60516908.