. 2013 Jul;6(4):321–337. doi: 10.1177/1756283X13478680

Table 2.

Phase III randomized trials with gemcitabine comparison in advanced PDA.

Study^*	Accrual period	Number of patients	Treatment groups	Median OS		Response rate
Study^*	Accrual period	Number of patients	Treatment groups	Months	p	%	p
[Burris et al. 1997]	1992-1994	126	5-FU	4.4	0.0025	0	NS
[Burris et al. 1997]	1992-1994	126	Gemcitabine	5.6		5.4
[Bramhall et al. 2001]	1997-1998	239	GemG + marimistat	5.55.5	NS	1116	NS
[Moore et al. 2003]	1997-1999	277	GemG + BAY 12-9566 (MMP inhibitor)	6.63.7	<0.001	NRNR
[Heinemann et al. 2006]	1997-2002	195	GemG + cisplatin	6.07.5	NS	8.210.2	NS
[Berlin et al. 2002]	1998-1999	322	GemG + 5-FU	5.4	NS	5.66.9	NS
[Berlin et al. 2002]	1998-1999	322	GemG + 5-FU	6.7	NS	5.66.9	NS
[Van Cutsem et al. 2004]	1999-2001	688	Gem	6.1	NS	8	NS
[Van Cutsem et al. 2004]	1999-2001		G + tipifarnib	6.4		6
[Rocha Lima et al. 2004]	2000-2001	360	Gem	6.6	NS	4.1	<0.001
[Rocha Lima et al. 2004]	2000-2001		G + irinotecan	6.3		16.1
[Louvet et al. 2005]	2001-2003	313	Gem	7.1	NS	17.3	0.044
[Louvet et al. 2005]	2001-2003		G + oxaliplatin	9.0		26.8
[Herrmann et al. 2007]	2001-2004	319	GemG + capecitabine	7.28.4	NS	7.810	NS
[Abou-Alfa et al. 2006]	2001-2003	349	Gem	6.2	NS	5.2	NS
[Abou-Alfa et al. 2006]	2001-2003	349	G+ exatecan	6.7		6.8
[Moore et al. 2007]	2001-2003	569	Gem	5.9	0.038	8.0	NS
[Moore et al. 2007]	2001-2003		G + erlotinib	6.2		8.6
[Oettle et al. 2005]	2001-2003	565	GemG + pemetrexed	6.36.2	NS	7.114.8	0.004
[Colucci et al. 2010]	2002-2007	400	Gem	8.3	NS	10.1	NS
[Colucci et al. 2010]	2002-2007		G + cisplatin	7.2		12.9
[Cunningham et al. 2009]	2002-2005	533	GemG + capecitabine	6.2	NS	12.4	0.034
[Cunningham et al. 2009]	2002-2005		GemG + capecitabine	7.1		19.1
[Poplin et al. 2009]	2003-2005	832	Gem (standard rate)Gem-FDRGem-FDR + oxaliplatin	4.96.25.7	NS	6109	NS
[Philip et al. 2010]	2004-2006	745	GemG + cetuximab	5.9	NS	7	NS
[Philip et al. 2010]	2004-2006		GemG + cetuximab	6.3		8
[Kindler et al. 2010]	2004-2006	602	Gem	5.9	NS	10	NS
[Kindler et al. 2010]	2004-2006		G + bevacizumab	5.8		13
[Van Cutsem et al. 2009]	2005-2006	607	Gem + erlotinibGem + erlotinib + bevacizumab	6.07.1	NS	8.613.5	NS
[Conroy et al. 2011]	2005-2009	342	GemFOLFIRINOX	6.811.1	<0.001	9.431.6	<0.001
[Heinemann et al. 2012]	2006-2008	281	Gem + erlotininb (capecitabine for second line)Capecitabine + erlotinib (gem for second line)	6.26.9	NS	165	NR
[Goncalves et al. 2012]	2006-2009	104	GemG + sorafenib	9.28	NS	19	NS
[Goncalves et al. 2012]	2006-2009	104	GemG + sorafenib	9.28		23	NS
[Kindler et al. 2011]	2007-2008	632	GemG + axitinib	8.38.5	NS	25	0.018

5-FU: fluorouracil; FDR: fixed dose rate.G and Gem: gemcitabine; NR: not reported; NS: not statistically significant (p > 0.05);

In addition to these trials, several phase III trials have been completed or terminated and remain unpublished. These include fluorouracil plus triacetyluridine [ClinicalTrials.gov identifier: NCT24427], aflibercept [ClinicalTrials.gov identifier: NCT574275], TS-1 [ClinicalTrials.gov identifier: NCT498225], GV1001 vaccine [ClinicalTrials.gov identifier: NCT358566], virulizin [ClinicalTrials.gov identifier: NCT40092] and AMG 479- ganitumab [ClinicalTrials.gov identifier: NCT1231347].