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Open Access Highly Accessed Study protocol

Sequential neoadjuvant chemoradiotherapy (CRT) followed by curative surgery vs. primary surgery alone for resectable, non-metastasized pancreatic adenocarcinoma: NEOPA- a randomized multicenter phase III study (NCT01900327, DRKS00003893, ISRCTN82191749)

Michael Tachezy1, Florian Gebauer1, Cordula Petersen2, Dirk Arnold5, Martin Trepel3, Karl Wegscheider4, Phillipe Schafhausen3, Maximilian Bockhorn1, Jakob Robert Izbicki1* and Emre Yekebas16

  • * Corresponding author: Jakob R Izbicki izbicki@uke.de

  • † Equal contributors

Author Affiliations

1 Department of General, Visceral and Thoracic Surgery, University Medical Center Hamburg Eppendorf, Martinistr. 52, Hamburg 20246, Germany

2 Department of Radiotherapy and Radio-Oncology, Hamburg, Germany

3 University Cancer Center Hamburg (UCCH) - Hubertus Wald Tumor Center, Hamburg, Germany

4 Department of Medical Biometry and Epidemiology, University Medical Center Hamburg Eppendorf, Hamburg, Germany

5 Clinic for Medical Oncology, Tumor Biology Center- Freiburg im Breisgau, Breisgau, Germany

6 Departement of General, Visceral and Thoracic Surgery, Darmstadt Clinic, Darmstadt, Germany

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BMC Cancer 2014, 14:411  doi:10.1186/1471-2407-14-411

Published: 7 June 2014

Abstract

Background

Median OS after surgery in curative intent for non-metastasized pancreas cancer ranges under study conditions from 17.9 months to 23.6 months. Tumor recurrence occurs locally, at distant sites (liver, peritoneum, lungs), or both. Observational and autopsy series report local recurrence rates of up to 87% even after potentially “curative” R0 resection. To achieve better local control, neoadjuvant CRT has been suggested for preoperative tumour downsizing, to elevate the likelihood of curative, margin-negative R0 resection and to increase the OS rate. However, controlled, randomized trials addressing the impact of neoadjuvant CRT survival do not exist.

Methods/Design

The underlying hypothesis of this randomized, two-armed, open-label, multicenter, phase III trial is that neoadjuvant CRT increases the three-year overall survival by 12% compared to patients undergoing upfront surgery for resectable pancreatic cancer. A rigorous, standardized technique of histopathologically handling Whipple specimens will be applied at all participating centers. Overall, 410 patients (n = 205 in each study arm) will be enrolled in the trial, taking into regard an expected drop out rate of 7% and allocated either to receive neoadjuvant CRT prior to surgery or to undergo surgery alone. Circumferential resection margin status, i.e. R0 and R1 rates, respectively, surgical resectability rate, local and distant disease-free and global survival, and first site of tumor recurrence constitute further essential endpoints of the trial.

Discussion

For the first time, the NEOPA study investigates the impact of neoadjuvant CRT on survival of resectable pancreas head cancer in a prospectively randomized manner. The results of the study have the potential to change substantially the treatment regimen of pancreas cancer.

Trial registration

Clinical Trial gov: NCT01900327, DRKS00003893, ISRCTN82191749

Keywords:
Pancreas cancer; Surgery; Neoadjuvant chemoradiation; EBRT; Gemcitabine; Randomized trial