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

Q. P. Janssen; J. L. van Dam; B. A. Bonsing; H. Bos; K. P. Bosscha; P. P. L. O. Coene; C. H. J. van Eijck; I. H. J. T. de Hingh; T. M. Karsten; M. B. van der Kolk; G. A. Patijn; M. S. L. Liem; H. C. van Santvoort; O. J. L. Loosveld; J. De Vos-Geelen; B. M. Zonderhuis; M. Y. Homs; G. van Tienhoven; M. G. Besselink; J. W. Wilmink; B. Groot Koerkamp; Dutch Pancreatic Canc Grp

doi:10.1186/s12885-021-08031-z

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

Q. P. Janssen, J. L. van Dam, B. A. Bonsing, H. Bos, K. P. Bosscha, P. P. L. O. Coene, C. H. J. van Eijck, I. H. J. T. de Hingh, T. M. Karsten, M. B. van der Kolk, G. A. Patijn, M. S. L. Liem, H. C. van Santvoort, O. J. L. Loosveld, J. De Vos-Geelen, B. M. Zonderhuis, M. Y. Homs, G. van Tienhoven, M. G. Besselink, J. W. WilminkB. Groot Koerkamp^*, Dutch Pancreatic Canc Grp

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

Abstract

BackgroundNeoadjuvant 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.MethodsThis 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

Original language	English
Article number	300
Number of pages	8
Journal	BMC Cancer
Volume	21
Issue number	1
DOIs	https://doi.org/10.1186/s12885-021-08031-z
Publication status	Published - 23 Mar 2021

Keywords

Neoadjuvant
FOLFIRINOX
Gemcitabine
Chemoradiotherapy
Localized pancreatic cancer
Intention-to-treat
Randomized controlled trial
Overall survival
Quality of life

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Janssen, Q. P., van Dam, J. L., Bonsing, B. A., Bos, H., Bosscha, K. P., Coene, P. P. L. O., van Eijck, C. H. J., de Hingh, I. H. J. T., Karsten, T. M., van der Kolk, M. B., Patijn, G. A., Liem, M. S. L., van Santvoort, H. C., Loosveld, O. J. L., De Vos-Geelen, J., Zonderhuis, B. M., Homs, M. Y., van Tienhoven, G., Besselink, M. G., ... Dutch Pancreatic Canc Grp (2021). 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, 21(1), Article 300. https://doi.org/10.1186/s12885-021-08031-z

@article{b62d53d4ee524ff1a5cd8f4cdf01fad0,

title = "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",

abstract = "BackgroundNeoadjuvant 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.MethodsThis 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",

keywords = "Neoadjuvant, FOLFIRINOX, Gemcitabine, Chemoradiotherapy, Localized pancreatic cancer, Intention-to-treat, Randomized controlled trial, Overall survival, Quality of life",

author = "Janssen, {Q. P.} and {van Dam}, {J. L.} and Bonsing, {B. A.} and H. Bos and Bosscha, {K. P.} and Coene, {P. P. L. O.} and {van Eijck}, {C. H. J.} and {de Hingh}, {I. H. J. T.} and Karsten, {T. M.} and {van der Kolk}, {M. B.} and Patijn, {G. A.} and Liem, {M. S. L.} and {van Santvoort}, {H. C.} and Loosveld, {O. J. L.} and {De Vos-Geelen}, J. and Zonderhuis, {B. M.} and Homs, {M. Y.} and {van Tienhoven}, G. and Besselink, {M. G.} and Wilmink, {J. W.} and Koerkamp, {B. Groot} and {Dutch Pancreatic Canc Grp}",

year = "2021",

month = mar,

day = "23",

doi = "10.1186/s12885-021-08031-z",

language = "English",

volume = "21",

journal = "BMC Cancer",

issn = "1471-2407",

publisher = "BioMed Central Ltd",

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Janssen, QP, van Dam, JL, Bonsing, BA, Bos, H, Bosscha, KP, Coene, PPLO, van Eijck, CHJ, de Hingh, IHJT, Karsten, TM, van der Kolk, MB, Patijn, GA, Liem, MSL, van Santvoort, HC, Loosveld, OJL, De Vos-Geelen, J, Zonderhuis, BM, Homs, MY, van Tienhoven, G, Besselink, MG, Wilmink, JW, Koerkamp, BG & Dutch Pancreatic Canc Grp 2021, '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, no. 1, 300. https://doi.org/10.1186/s12885-021-08031-z

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. / Janssen, Q. P.; van Dam, J. L.; Bonsing, B. A. et al.
In: BMC Cancer, Vol. 21, No. 1, 300, 23.03.2021.

Research output: Contribution to journal › Article › Academic › peer-review

TY - JOUR

T1 - Total neoadjuvant FOLFIRINOX versus neoadjuvant gemcitabine-based chemoradiotherapy and adjuvant gemcitabine for resectable and borderline resectable pancreatic cancer (PREOPANC-2 trial)

T2 - study protocol for a nationwide multicenter randomized controlled trial

AU - Janssen, Q. P.

AU - van Dam, J. L.

AU - Bonsing, B. A.

AU - Bos, H.

AU - Bosscha, K. P.

AU - Coene, P. P. L. O.

AU - van Eijck, C. H. J.

AU - de Hingh, I. H. J. T.

AU - Karsten, T. M.

AU - van der Kolk, M. B.

AU - Patijn, G. A.

AU - Liem, M. S. L.

AU - van Santvoort, H. C.

AU - Loosveld, O. J. L.

AU - De Vos-Geelen, J.

AU - Zonderhuis, B. M.

AU - Homs, M. Y.

AU - van Tienhoven, G.

AU - Besselink, M. G.

AU - Wilmink, J. W.

AU - Koerkamp, B. Groot

AU - Dutch Pancreatic Canc Grp

PY - 2021/3/23

Y1 - 2021/3/23

N2 - BackgroundNeoadjuvant 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.MethodsThis 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

AB - BackgroundNeoadjuvant 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.MethodsThis 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

KW - Neoadjuvant

KW - FOLFIRINOX

KW - Gemcitabine

KW - Chemoradiotherapy

KW - Localized pancreatic cancer

KW - Intention-to-treat

KW - Randomized controlled trial

KW - Overall survival

KW - Quality of life

U2 - 10.1186/s12885-021-08031-z

DO - 10.1186/s12885-021-08031-z

M3 - Article

C2 - 33757440

SN - 1471-2407

VL - 21

JO - BMC Cancer

JF - BMC Cancer

IS - 1

M1 - 300

ER -

Janssen QP, van Dam JL, Bonsing BA, Bos H, Bosscha KP, Coene PPLO et al. 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. 2021 Mar 23;21(1):300. doi: 10.1186/s12885-021-08031-z