Nal-IRI with 5-fluorouracil (5-FU) and leucovorin or gemcitabine plus cisplatin in advanced biliary tract cancer - the NIFE trial (AIO-YMO HEP-0315) an open label, non-comparative, randomized, multicenter phase II study.
Antineoplastic Combined Chemotherapy Protocols
/ administration & dosage
Biliary Tract Neoplasms
/ drug therapy
Cisplatin
/ administration & dosage
Clinical Trials, Phase II as Topic
Deoxycytidine
/ administration & dosage
Disease-Free Survival
Female
Fluorouracil
/ administration & dosage
Humans
Irinotecan
/ administration & dosage
Leucovorin
/ administration & dosage
Male
Phospholipids
/ chemistry
Progression-Free Survival
Quality of Life
Randomized Controlled Trials as Topic
Gemcitabine
Biliary tract cancer
Chemotherapy
Cholangiocarcinoma
Nanoliposomal-irinotecan
Palliative treatment
Journal
BMC cancer
ISSN: 1471-2407
Titre abrégé: BMC Cancer
Pays: England
ID NLM: 100967800
Informations de publication
Date de publication:
23 Oct 2019
23 Oct 2019
Historique:
received:
05
04
2019
accepted:
09
09
2019
entrez:
25
10
2019
pubmed:
28
10
2019
medline:
27
2
2020
Statut:
epublish
Résumé
Biliary tract cancer (BTC) has a high mortality. Primary diagnosis is frequently delayed due to mostly unspecific symptoms, resulting in a high number of advanced cases at the time of diagnosis. Advanced BTCs are in principle chemotherapy sensitive as determined by improved disease control, survival and quality of life (QoL). However, median OS does not exceed 11.7 months with the current standard of care gemcitabine plus cisplatin. Thereby, novel drug formulations like nanoliposomal-irinotecan (nal-IRI) in combination with 5- fluorouracil (5-FU)/leucovorin may have the potential to improve therapeutic outcomes in this disease. NIFE is an interventional, prospective, randomized, controlled, open label, two-sided phase II study. Within the study, 2 × 46 patients with locally advanced, non-resectable or metastatic BTC are to be enrolled by two stage design of Simon. Data analysis will be done unconnected for both arms. Patients are allocated in two arms: Arm A (experimental intervention) nal-IRI mg/m The NIFE trial evaluates the potential of a nanoliposomal-irinotecan/5-FU/leucovorin combination in the first line therapy of advanced BTCs and additionally offers a unique chance for translational research. Clinicaltrials.gov NCT03044587. Registration Date February 7th 2017.
Sections du résumé
BACKGROUND
BACKGROUND
Biliary tract cancer (BTC) has a high mortality. Primary diagnosis is frequently delayed due to mostly unspecific symptoms, resulting in a high number of advanced cases at the time of diagnosis. Advanced BTCs are in principle chemotherapy sensitive as determined by improved disease control, survival and quality of life (QoL). However, median OS does not exceed 11.7 months with the current standard of care gemcitabine plus cisplatin. Thereby, novel drug formulations like nanoliposomal-irinotecan (nal-IRI) in combination with 5- fluorouracil (5-FU)/leucovorin may have the potential to improve therapeutic outcomes in this disease.
METHODS
METHODS
NIFE is an interventional, prospective, randomized, controlled, open label, two-sided phase II study. Within the study, 2 × 46 patients with locally advanced, non-resectable or metastatic BTC are to be enrolled by two stage design of Simon. Data analysis will be done unconnected for both arms. Patients are allocated in two arms: Arm A (experimental intervention) nal-IRI mg/m
DISCUSSION
CONCLUSIONS
The NIFE trial evaluates the potential of a nanoliposomal-irinotecan/5-FU/leucovorin combination in the first line therapy of advanced BTCs and additionally offers a unique chance for translational research.
TRIAL REGISTRATION
BACKGROUND
Clinicaltrials.gov NCT03044587. Registration Date February 7th 2017.
Identifiants
pubmed: 31646981
doi: 10.1186/s12885-019-6142-y
pii: 10.1186/s12885-019-6142-y
pmc: PMC6813114
doi:
Substances chimiques
Phospholipids
0
liposom
0
Deoxycytidine
0W860991D6
Irinotecan
7673326042
Cisplatin
Q20Q21Q62J
Leucovorin
Q573I9DVLP
Fluorouracil
U3P01618RT
Gemcitabine
0
Banques de données
ClinicalTrials.gov
['NCT03044587']
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
990Références
Nat Genet. 2015 Sep;47(9):1003-10
pubmed: 26258846
Cancer Res. 2014 Dec 1;74(23):7003-13
pubmed: 25273092
Br J Cancer. 2018 Aug;119(3):291-295
pubmed: 29955136
Eur J Cancer. 2009 Jan;45(2):228-47
pubmed: 19097774
Clin Cancer Res. 2018 Aug 1;24(15):3528-3538
pubmed: 29776953
N Engl J Med. 2004 Jun 3;350(23):2335-42
pubmed: 15175435
Dtsch Arztebl Int. 2014 Oct 31;111(44):748-54
pubmed: 25412632
Cancer Res. 1991 Aug 15;51(16):4187-91
pubmed: 1651156
Cancer Med. 2016 Apr;5(4):676-83
pubmed: 26806397
BMC Cancer. 2018 Jun 27;18(1):693
pubmed: 29945562
Eur J Cancer. 2014 Dec;50(18):3125-35
pubmed: 25446376
BMC Cancer. 2017 Apr 12;17(1):262
pubmed: 28403829
Cancer Res Treat. 2018 Oct;50(4):1324-1330
pubmed: 29334603
Cancer. 2016 Dec 1;122(23):3657-3666
pubmed: 27495988
World J Gastroenterol. 2015 Feb 21;21(7):2096-101
pubmed: 25717243
Cancer Res. 2006 Mar 15;66(6):3271-7
pubmed: 16540680
Expert Rev Anticancer Ther. 2016 Jul;16(7):697-703
pubmed: 27219482
J Natl Cancer Inst. 1993 Mar 3;85(5):365-76
pubmed: 8433390
Oncology. 2010;78(5-6):356-60
pubmed: 20798557
Eur J Cancer. 2010 Oct;46(15):2753-62
pubmed: 20724140
Nature. 2016 Mar 3;531(7592):47-52
pubmed: 26909576
J Gastrointest Cancer. 2017 Jun;48(2):170-175
pubmed: 27714651
Acta Psychiatr Scand. 1983 Jun;67(6):361-70
pubmed: 6880820
Chemotherapy. 2011;57(3):236-43
pubmed: 21597288
Lancet. 2016 Feb 6;387(10018):545-557
pubmed: 26615328
Cancer Res. 2006 Mar 1;66(5):2801-6
pubmed: 16510602
Lancet Oncol. 2014 Jul;15(8):819-28
pubmed: 24852116
J Hepatol. 2018 May;68(5):959-969
pubmed: 29360550
Am J Clin Oncol. 2007 Jun;30(3):319-24
pubmed: 17551313
Lancet Oncol. 2014 Oct;15(11):1224-35
pubmed: 25240821
Clin Cancer Res. 2015 Mar 1;21(5):1139-50
pubmed: 25733708
Ann Oncol. 2013 Dec;24(12):3061-5
pubmed: 24146220
Ann Oncol. 2013 Jun;24(6):1567-73
pubmed: 23406728
Br J Cancer. 2011 Feb 15;104(4):587-92
pubmed: 21266979
Br J Cancer. 2007 Mar 26;96(6):896-902
pubmed: 17325704
CA Cancer J Clin. 2017 Jan;67(1):7-30
pubmed: 28055103
Oncologist. 2016 May;21(5):594-9
pubmed: 27000463
World J Gastroenterol. 2012 Sep 7;18(33):4533-41
pubmed: 22969226
Qual Life Res. 2015 Jan;24(1):5-18
pubmed: 24277234
Psychother Psychosom Med Psychol. 1991 Feb;41(2):83-92
pubmed: 2027932
Clin Nutr. 1995 Oct;14(5):269-73
pubmed: 16843942
N Engl J Med. 2010 Apr 8;362(14):1273-81
pubmed: 20375404
Scand J Gastroenterol. 2011 Sep;46(9):1092-8
pubmed: 21692710