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

Stefan Heinrich, Bernhard Pestalozzi, Mickael Lesurtel, Frederik Berrevoet UGent, Stéphanie Laurent UGent, Jean-Robert Delpero, Jean-Luc Raoul, Phillippe Bachellier, Patrick Dufour and Markus Moehler, et al. (2011) BMC CANCER. 11.
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 degrees or major visceral arteries are considered exclusion criteria. Eligible patients will be randomized to surgery followed by adjuvant gemcitabine (1000 mg/m(2)) for 6 months or neoadjuvant chemotherapy (gemcitabine 1000 mg/m(2), oxaliplatin 100 mg/m(2)) 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.
Please use this url to cite or link to this publication:
author
organization
year
type
journalArticle (original)
publication status
published
subject
keyword
CONTROLLED-TRIAL, CURATIVE RESECTION, CHEMOTHERAPY, ADENOCARCINOMA, PANCREATICODUODENECTOMY, CHEMORADIOTHERAPY, RADIOTHERAPY, RADIATION, SURGERY, THERAPY
journal title
BMC CANCER
BMC Cancer
volume
11
article_number
346
pages
7 pages
Web of Science type
Article
Web of Science id
000295229600001
JCR category
ONCOLOGY
JCR impact factor
3.011 (2011)
JCR rank
77/190 (2011)
JCR quartile
2 (2011)
ISSN
1471-2407
DOI
10.1186/1471-2407-11-346
language
English
UGent publication?
yes
classification
A1
copyright statement
I have retained and own the full copyright for this publication
id
2004646
handle
http://hdl.handle.net/1854/LU-2004646
date created
2012-01-26 11:44:08
date last changed
2012-02-27 10:20:46
@article{2004646,
  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 {\textrangle} 180 degrees or major visceral arteries are considered exclusion criteria. Eligible patients will be randomized to surgery followed by adjuvant gemcitabine (1000 mg/m(2)) for 6 months or neoadjuvant chemotherapy (gemcitabine 1000 mg/m(2), oxaliplatin 100 mg/m(2)) 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.},
  articleno    = {346},
  author       = {Heinrich, Stefan and Pestalozzi, Bernhard and Lesurtel, Mickael and Berrevoet, Frederik and Laurent, St{\'e}phanie and Delpero, Jean-Robert and Raoul, Jean-Luc and Bachellier, Phillippe and Dufour, Patrick and Moehler, Markus and Weber, Achim and Lang, Hauke and Rogiers, Xavier and Clavien, Pierre-Alain},
  issn         = {1471-2407},
  journal      = {BMC CANCER},
  keyword      = {CONTROLLED-TRIAL,CURATIVE RESECTION,CHEMOTHERAPY,ADENOCARCINOMA,PANCREATICODUODENECTOMY,CHEMORADIOTHERAPY,RADIOTHERAPY,RADIATION,SURGERY,THERAPY},
  language     = {eng},
  pages        = {7},
  title        = {Adjuvant gemcitabine versus NEOadjuvant gemcitabine/oxaliplatin plus adjuvant gemcitabine in resectable pancreatic cancer: a randomized multicenter phase III study (NEOPAC study)},
  url          = {http://dx.doi.org/10.1186/1471-2407-11-346},
  volume       = {11},
  year         = {2011},
}

Chicago
Heinrich, Stefan, Bernhard Pestalozzi, Mickael Lesurtel, Frederik Berrevoet, Stéphanie Laurent, Jean-Robert Delpero, Jean-Luc Raoul, et al. 2011. “Adjuvant Gemcitabine Versus NEOadjuvant Gemcitabine/oxaliplatin Plus Adjuvant Gemcitabine in Resectable Pancreatic Cancer: a Randomized Multicenter Phase III Study (NEOPAC Study).” Bmc Cancer 11.
APA
Heinrich, S., Pestalozzi, B., Lesurtel, M., Berrevoet, F., Laurent, S., Delpero, J.-R., Raoul, J.-L., et al. (2011). Adjuvant gemcitabine versus NEOadjuvant gemcitabine/oxaliplatin plus adjuvant gemcitabine in resectable pancreatic cancer: a randomized multicenter phase III study (NEOPAC study). BMC CANCER, 11.
Vancouver
1.
Heinrich S, Pestalozzi B, Lesurtel M, Berrevoet F, Laurent S, Delpero J-R, et al. Adjuvant gemcitabine versus NEOadjuvant gemcitabine/oxaliplatin plus adjuvant gemcitabine in resectable pancreatic cancer: a randomized multicenter phase III study (NEOPAC study). BMC CANCER. 2011;11.
MLA
Heinrich, Stefan, Bernhard Pestalozzi, Mickael Lesurtel, et al. “Adjuvant Gemcitabine Versus NEOadjuvant Gemcitabine/oxaliplatin Plus Adjuvant Gemcitabine in Resectable Pancreatic Cancer: a Randomized Multicenter Phase III Study (NEOPAC Study).” BMC CANCER 11 (2011): n. pag. Print.