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Trials
Published in: Trials 1/2016

Open Access 01-12-2016 | Study protocol

Preoperative radiochemotherapy versus immediate surgery for resectable and borderline resectable pancreatic cancer (PREOPANC trial): study protocol for a multicentre randomized controlled trial

Authors: Eva Versteijne, Casper H. J. van Eijck, Cornelis J. A. Punt, Mustafa Suker, Aeilko H. Zwinderman, Miriam A. C. Dohmen, Karin B. C. Groothuis, Oliver R. C. Busch, Marc G. H. Besselink, Ignace H. J. T. de Hingh, Albert J. ten Tije, Gijs A. Patijn, Bert A. Bonsing, Judith de Vos-Geelen, Joost M. Klaase, Sebastiaan Festen, Djamila Boerma, Joris I. Erdmann, I. Quintus. Molenaar, Erwin van der Harst, Marion B. van der Kolk, Coen R. N. Rasch, Geertjan van Tienhoven, for the Dutch Pancreatic Cancer Group (DPCG)

Published in: Trials | Issue 1/2016

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Abstract

Background

Pancreatic cancer is the fourth largest cause of cancer death in the United States and Europe with over 100,000 deaths per year in Europe alone. The overall 5-year survival ranges from 2–7 % and has hardly improved over the last two decades. Approximately 15 % of all patients have resectable disease at diagnosis, and of those, only a subgroup has a resectable tumour at surgical exploration. Data from cohort studies have suggested that outcome can be improved by preoperative radiochemotherapy, but data from well-designed randomized studies are lacking. Our PREOPANC phase III trial aims to test the hypothesis that median overall survival of patients with resectable or borderline resectable pancreatic cancer can be improved with preoperative radiochemotherapy.

Methods/design

The PREOPANC trial is a randomized, controlled, multicentric superiority trial, initiated by the Dutch Pancreatic Cancer Group. Patients with (borderline) resectable pancreatic cancer are randomized to A: direct explorative laparotomy or B: after negative diagnostic laparoscopy, preoperative radiochemotherapy, followed by explorative laparotomy. A hypofractionated radiation scheme of 15 fractions of 2.4 gray (Gy) is combined with a course of gemcitabine, 1,000 mg/m2/dose on days 1, 8 and 15, preceded and followed by a modified course of gemcitabine. The target volumes of radiation are delineated on a 4D CT scan, where at least 95 % of the prescribed dose of 36 Gy in 15 fractions should cover 98 % of the planning target volume. Standard adjuvant chemotherapy is administered in both treatment arms after resection (six cycles in arm A and four in arm B). In total, 244 patients will be randomized in 17 hospitals in the Netherlands. The primary endpoint is overall survival by intention to treat. Secondary endpoints are (R0) resection rate, disease-free survival, time to locoregional recurrence or distant metastases and perioperative complications. Secondary endpoints for the experimental arm are toxicity and radiologic and pathologic response.

Discussion

The PREOPANC trial is designed to investigate whether preoperative radiochemotherapy improves overall survival by means of increased (R0) resection rates in patients with resectable or borderline resectable pancreatic cancer.

Trial registration

Trial open for accrual: 3 April 2013
The Netherlands National Trial Register – NTR3709 (8 November 2012)
EU Clinical Trials Register – 2012-003181-40 (11 December 2012)
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Metadata
Title
Preoperative radiochemotherapy versus immediate surgery for resectable and borderline resectable pancreatic cancer (PREOPANC trial): study protocol for a multicentre randomized controlled trial
Authors
Eva Versteijne
Casper H. J. van Eijck
Cornelis J. A. Punt
Mustafa Suker
Aeilko H. Zwinderman
Miriam A. C. Dohmen
Karin B. C. Groothuis
Oliver R. C. Busch
Marc G. H. Besselink
Ignace H. J. T. de Hingh
Albert J. ten Tije
Gijs A. Patijn
Bert A. Bonsing
Judith de Vos-Geelen
Joost M. Klaase
Sebastiaan Festen
Djamila Boerma
Joris I. Erdmann
I. Quintus. Molenaar
Erwin van der Harst
Marion B. van der Kolk
Coen R. N. Rasch
Geertjan van Tienhoven
for the Dutch Pancreatic Cancer Group (DPCG)
Publication date
01-12-2016
Publisher
BioMed Central
Published in
Trials / Issue 1/2016
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-016-1262-z

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