Protocol of a prospective, monocentric phase I/II feasibility study investigating the safety of multimodality treatment with a combination of intraoperative chemotherapy and surgical resection in locally confined or borderline resectable pancreatic cancer: the combiCaRe study.
Antineoplastic Combined Chemotherapy Protocols
/ administration & dosage
Carcinoma, Pancreatic Ductal
/ therapy
Feasibility Studies
Fluorouracil
/ administration & dosage
Humans
Intraoperative Care
/ methods
Leucovorin
/ administration & dosage
Pancreatectomy
/ methods
Pancreatic Fistula
/ epidemiology
Pancreatic Neoplasms
/ therapy
Perioperative Care
Postoperative Complications
/ epidemiology
gastroenterology
gastrointestinal tumours
pancreatic disease
pancreatic surgery
Journal
BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874
Informations de publication
Date de publication:
20 08 2019
20 08 2019
Historique:
entrez:
23
8
2019
pubmed:
23
8
2019
medline:
1
9
2020
Statut:
epublish
Résumé
Pancreatic cancer is a devastating disease with an exceptionally poor prognosis. Complete resection of the primary tumour followed by adjuvant chemotherapy is the current standard treatment for patients with resectable disease and the only curative treatment option. However, long-term survival remains rare. Tumour cell dissemination due to manipulation during surgery may increase the rate of future metastases and local recurrence, and perioperative chemotherapy might diminish local, distant and circulating minimal residual disease. Yet, safety and feasibility of systemic chemotherapeutic treatments during pancreatic cancer resection have to be evaluated in a first instance. This is a prospective, single-centre phase I/II feasibility study to investigate the safety and tolerability of a combination of intraoperative chemotherapy and surgical resection in pancreatic cancer. Forty patients with locally confined or borderline resectable pancreatic cancer, meeting all proposed criteria will be included. Participants will receive 400 mg/m CombiCaRe has been approved by the German Federal Institute for Drugs and Medical Devices (reference number 4042787) and the Medical Ethics Committee of Heidelberg University (reference number AFmo-269/2018). The results of this trial will be presented at national and international conferences and published in peer-reviewed journals. German Clinical Trials Register (DRKS00015766).
Identifiants
pubmed: 31434770
pii: bmjopen-2018-028696
doi: 10.1136/bmjopen-2018-028696
pmc: PMC6707702
doi:
Substances chimiques
Leucovorin
Q573I9DVLP
Fluorouracil
U3P01618RT
Banques de données
DRKS
['DRKS00015766']
Types de publication
Clinical Trial Protocol
Clinical Trial, Phase I
Clinical Trial, Phase II
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
e028696Commentaires et corrections
Type : ErratumIn
Informations de copyright
© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
Déclaration de conflit d'intérêts
Competing interests: None declared.
Références
Ann Surg. 2007 Aug;246(2):173-80
pubmed: 17667493
Surgery. 2017 Feb;161(2):365-372
pubmed: 27692778
Ann Surg Oncol. 2011 Apr;18(4):1110-5
pubmed: 21046268
Surgery. 2005 Jul;138(1):8-13
pubmed: 16003309
Ann Surg. 2018 Mar;267(3):411-417
pubmed: 28379871
Dig Dis. 2013;31(1):51-6
pubmed: 23797123
Langenbecks Arch Surg. 2014 Jan;399(1):41-53
pubmed: 24249036
Lancet. 2016 Jul 16;388(10041):248-57
pubmed: 27265347
Cell. 2012 Jan 20;148(1-2):349-61
pubmed: 22265420
J Clin Oncol. 2017 Oct 10;35(29):3330-3337
pubmed: 28817370
Ann Surg Oncol. 2011 May;18(5):1319-26
pubmed: 21499862
Hepatogastroenterology. 2004 Sep-Oct;51(59):1500-3
pubmed: 15362786
Z Gastroenterol. 2013 Dec;51(12):1395-440
pubmed: 24338757
Ann Surg Oncol. 2016 Aug;23(8):2556-61
pubmed: 26957499
Surgery. 2017 Mar;161(3):584-591
pubmed: 28040257
J Natl Compr Canc Netw. 2017 Aug;15(8):1028-1061
pubmed: 28784865
Arch Surg. 1985 Aug;120(8):899-903
pubmed: 4015380
J Clin Oncol. 2017 Feb 10;35(5):515-522
pubmed: 27621388
Br J Cancer. 2009 Jan 27;100(2):246-50
pubmed: 19127260
J Clin Oncol. 2017 Jul 10;35(20):2324-2328
pubmed: 28398845
Pancreatology. 2018 Jan;18(1):2-11
pubmed: 29191513
JAMA. 2010 Sep 8;304(10):1073-81
pubmed: 20823433
CA Cancer J Clin. 2018 Jan;68(1):7-30
pubmed: 29313949
Lancet. 2017 Mar 11;389(10073):1011-1024
pubmed: 28129987
Surgery. 2007 Nov;142(5):761-8
pubmed: 17981197
Nat Rev Dis Primers. 2016 Apr 21;2:16022
pubmed: 27158978
Gastroenterol Res Pract. 2012;2012:506571
pubmed: 22693491
World J Surg. 1997 Feb;21(2):195-200
pubmed: 8995078
N Engl J Med. 2004 Mar 18;350(12):1200-10
pubmed: 15028824
Cell. 2012 Jan 20;148(1-2):362-75
pubmed: 22265421
Pancreatology. 2018 Dec;18(8):962-970
pubmed: 30292643
Cancer. 1990 Jul 1;66(1):56-61
pubmed: 2354408
Ann Surg. 1999 Dec;230(6):776-82; discussion 782-4
pubmed: 10615932
J Clin Oncol. 2012 Nov 20;30(33):4077-83
pubmed: 23008325
JAMA Surg. 2014 May;149(5):482-5
pubmed: 24599353
N Engl J Med. 2009 Oct 1;361(14):1368-75
pubmed: 19797283
Surgery. 2007 Jul;142(1):20-5
pubmed: 17629996
J Am Coll Surg. 2009 Apr;208(4):520-7
pubmed: 19476785
Surgery. 2014 Jun;155(6):977-88
pubmed: 24856119
Ann Surg. 2004 Aug;240(2):205-13
pubmed: 15273542
Lancet. 2001 Nov 10;358(9293):1576-85
pubmed: 11716884
Ann Surg Oncol. 2018 Apr;25(4):1000-1008
pubmed: 29442211
Ann Surg. 2018 Sep;268(3):408-420
pubmed: 30080739
Ann Intern Med. 2013 Feb 5;158(3):200-7
pubmed: 23295957
Ann Surg. 2016 Sep;264(3):457-63
pubmed: 27355262
JAMA. 2008 Mar 5;299(9):1019-26
pubmed: 18319412
Cancer Treat Res. 1996;82:79-100
pubmed: 8849945
Ann Surg. 2020 Mar;271(3):549-558
pubmed: 30216219
Lancet Oncol. 2013 Oct;14(11):e476-e485
pubmed: 24079875
JAMA. 2007 Jan 17;297(3):267-77
pubmed: 17227978
Dtsch Arztebl Int. 2008 Apr;105(14):255-62
pubmed: 19629206
Ann Surg. 2018 Aug;268(2):215-222
pubmed: 29462005
Surgery. 2017 Mar;161(3):592-601
pubmed: 28341441