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Copyright ©2014 Baishideng Publishing Group Inc.
World J Gastroenterol. Oct 28, 2014; 20(40): 14733-14746
Published online Oct 28, 2014. doi: 10.3748/wjg.v20.i40.14733
Table 5 Current phase III trials investigating adjuvant therapy in pancreatic cancer
Trial numberCo-ordinating countryFirst enrolmentTarget sample size (n)Adjuvant treatment armsPrimary outcomeSecondary outcomes (clinical only)
ISRCTN96397434United Kingdom20081396(I) GemcitabineOSToxicity
(ESPAC-4)(II) Gemcitabine plus capecitabineQuality of life
OS at 2 and 5 yr
DFS at 5 yr
DRKS00000247Germany2008436(I) GemcitabineDFSOS
(CONKO-005)(II) Gemcitabine plus erlotinibToxicity
NCT01013649United States2009950(I) GemcitabineOSDFS
(RTOG 0848)(II) Gemcitabine plus erlotinibToxicity
If DFS at end of treatment (I) or (II), further randomisation to:Correlation between baseline fatigue and survival
(III) A further course of (I) or (II) as previously received plus Capcitabine CRT
(IV) A further course of (I) or (II) as previously received plus 5-FU CRT
NCT01072981United States2010722Gemcitabine +/- 5-FU CRT +/- HyperAcute®-Pancreas (algenpantucel-L) immunotherapyOS
NCT01526135France/Canada2012490(I) GemcitabineDFS at 3 yrOS at 3 yr
(II) mFolfirinox (5-FU, folinic acid, irinotecan, oxaliplatin)
NCT01077427Germany2012336(I) GemcitabineDFSOS
(II) Gemcitabine plus cisplatin plus regional hyperthermia
NCT01964430United StatesNot yet active-(I) GemcitaineDFS/OS
(II) Gemcitabine plus nab-paclitaxel