Total neoadjuvant FOLFIRINOX versus neoadjuvant gemcitabine-based chemoradiotherapy and adjuvant gemcitabine for resectable and borderline resectable pancreatic cancer (PREOPANC-2 trial): study protocol for a nationwide multicenter randomized controlled trial
BMC Cancer, vol. 21, pp. 300
Abstract
BACKGROUND: Neoadjuvant therapy has several potential advantages over upfront surgery in patients with localized pancreatic cancer; more patients receive systemic treatment, fewer patients undergo futile surgery, and R0 resection rates are higher, thereby possibly improving overall survival (OS). Two recent randomized trials have suggested benefit of neoadjuvant chemoradiotherapy over upfront surgery, both including single-agent chemotherapy regimens. Potentially, the multi-agent FOLFIRINOX regimen (5-fluorouracil with leucovorin, irinotecan, and oxaliplatin) may further improve outcomes in the neoadjuvant setting for localized pancreatic cancer, but randomized studies are needed. The PREOPANC-2 trial investigates whether neoadjuvant FOLFIRINOX improves OS compared with neoadjuvant gemcitabine-based chemoradiotherapy and adjuvant gemcitabine in resectable and borderline resectable pancreatic cancer patients. METHODS: This nationwide multicenter phase III randomized controlled trial includes patients with pathologically confirmed resectable and borderline resectable pancreatic cancer with a WHO performance score of 0 or 1. Resectable pancreatic cancer is defined as no arterial and ≤ 90 degrees venous involvement; borderline resectable pancreatic cancer is defined as ≤90 degrees arterial and ≤ 270 degrees venous involvement without occlusion. Patients receive 8 cycles of neoadjuvant FOLFIRINOX chemotherapy followed by surgery without adjuvant treatment (arm A), or 3 cycles of neoadjuvant gemcitabine with hypofractionated radiotherapy (36 Gy in 15 fractions) during the second cycle, followed by surgery and 4 cycles of adjuvant gemcitabine (arm B). The primary endpoint is OS by intention-to-treat. Secondary endpoints include progression-free survival, quality of life, resection rate, and R0 resection rate. To detect a hazard ratio of 0.70 with 80% power, 252 events are needed. The number of events is expected to be reached after inclusion of 368 eligible patients assuming an accrual period of 3 years and 1.5 years follow-up. DISCUSSION: The PREOPANC-2 trial directly compares two neoadjuvant regimens for patients with resectable and borderline resectable pancreatic cancer. Our study will provide evidence on the neoadjuvant treatment of choice for patients with resectable and borderline resectable pancreatic cancer. TRIAL REGISTRATION: Primary registry and trial identifying number: EudraCT: 2017-002036-17 . Date of registration: March 6, 2018. Secondary identifying numbers: The Netherlands National Trial Register - NL7094 , NL61961.078.17, MEC-2018-004.
Authors 20
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Affiliation as printed
Department of Surgery, Erasmus MC University Medical Center, Rotterdam, The Netherlands
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Leiden University Medical Center · Erasmus MC
Affiliation as printed
Department of Surgery, Erasmus MC University Medical Center, Rotterdam, The Netherlands
Department of Surgery, Leiden University Medical Center, Leiden, The Netherlands
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Leiden University Medical Center · Tjongerschans
Affiliation as printed
Department of Surgery, Leiden University Medical Center, Leiden, The Netherlands
Department of Medical Oncology, Tjongerschans Hospital, Heerenveen, The Netherlands
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Maasstad Ziekenhuis · Jeroen Bosch Ziekenhuis
Affiliation as printed
Department of Surgery, Jeroen Bosch Hospital, Den Bosch, The Netherlands
Department of Surgery, Maasstad Hospital, Rotterdam, The Netherlands
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Erasmus MC · Maasstad Ziekenhuis
Affiliation as printed
Department of Surgery, Maasstad Hospital, Rotterdam, The Netherlands
Department of Surgery, Erasmus MC University Medical Center, Rotterdam, The Netherlands
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Catharina Ziekenhuis · Erasmus MC
Affiliation as printed
Department of Surgery, Erasmus MC University Medical Center, Rotterdam, The Netherlands
Department of Surgery, Catharina Hospital, Eindhoven, The Netherlands
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Affiliation as printed
Department of Surgery, Catharina Hospital, Eindhoven, The Netherlands
Department of Surgery, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands
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Radboud University Medical Center · OLVG
Affiliation as printed
Department of Surgery, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands
Department of Surgery, Radboud University Medical Center, Nijmegen, The Netherlands
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Radboud University Medical Center · Isala
Affiliation as printed
Department of Surgery, Radboud University Medical Center, Nijmegen, The Netherlands
Department of Surgery, Isala Hospital, Zwolle, The Netherlands
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Medisch Spectrum Twente · Isala
Affiliation as printed
Department of Surgery, Isala Hospital, Zwolle, The Netherlands
Department of Surgery, Medisch Spectrum Twente, Enschede, The Netherlands
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Utrecht University · Medisch Spectrum Twente · University Medical Center Utrecht
Affiliation as printed
Department of Surgery, Medisch Spectrum Twente, Enschede, The Netherlands
Department of Surgery, Regional Academic Cancer Center Utrecht, St. Antonius Hospital and University Medical Center Utrecht, Utrecht, The Netherlands
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Utrecht University · University Medical Center Utrecht · Amphia Ziekenhuis
Affiliation as printed
Department of Surgery, Regional Academic Cancer Center Utrecht, St. Antonius Hospital and University Medical Center Utrecht, Utrecht, The Netherlands
Department of Medical Oncology, Amphia Hospital, Breda, The Netherlands
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Maastricht University Medical Centre · Amphia Ziekenhuis
Affiliation as printed
Department of Medical Oncology, Amphia Hospital, Breda, The Netherlands
Department of Internal Medicine, Division of Medical Oncology, GROW - School for Oncology and Developmental Biology, Maastricht UMC+, Maastricht, The Netherlands
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Maastricht University Medical Centre · Amsterdam University Medical Centers · Cancer Center Amsterdam · Vrije Universiteit Amsterdam
Affiliation as printed
Department of Internal Medicine, Division of Medical Oncology, GROW - School for Oncology and Developmental Biology, Maastricht UMC+, Maastricht, The Netherlands
Department of Surgery, Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit, Amsterdam, The Netherlands
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Erasmus MC · Amsterdam University Medical Centers · Cancer Center Amsterdam · Vrije Universiteit Amsterdam
Affiliation as printed
Department of Surgery, Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit, Amsterdam, The Netherlands
Department of Medical Oncology, Erasmus MC University Medical Center, Rotterdam, The Netherlands
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Erasmus MC · Amsterdam UMC Location University of Amsterdam · Amsterdam University Medical Centers · Cancer Center Amsterdam · University of Amsterdam
Affiliation as printed
Department of Medical Oncology, Erasmus MC University Medical Center, Rotterdam, The Netherlands
Department of Radiation Oncology, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands
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Amsterdam UMC Location University of Amsterdam · Amsterdam University Medical Centers · Cancer Center Amsterdam · University of Amsterdam
Affiliation as printed
Department of Radiation Oncology, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands
Department of Surgery, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands
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Amsterdam University Medical Centers · Cancer Center Amsterdam · University of Amsterdam
Affiliation as printed
Department of Surgery, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands
Department of Medical Oncology, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands
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Erasmus MC · Amsterdam University Medical Centers · Cancer Center Amsterdam · University of Amsterdam
Affiliation as printed
Department of Medical Oncology, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands
Department of Surgery, Erasmus MC University Medical Center, Rotterdam, The Netherlands
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Bas Groot Koerkamp corresponding
Affiliation as printed
Department of Surgery, Erasmus MC University Medical Center, Rotterdam, The Netherlands. b.grootkoerkamp@erasmusmc.nl
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