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. Author manuscript; available in PMC: 2014 Sep 1.
Published in final edited form as: Clin Colorectal Cancer. 2013 Jun 27;12(3):179–187. doi: 10.1016/j.clcc.2013.04.004

Table 1.

Treatment and Total Sample Size of Clinical Trials Included

Study Group Clinical Trial Control Arm Experimental Arm Total Sample Size
5-FU vs. surgery NCCTG-78-48-52a Surgery 5-FU + LEV 247
NCCTG-87-46-51a Surgery 5-FU + LV 408
INT-0035a Surgery 5-FU + LEV 926
FFCDa Surgery 5-FU + CF 256
NCICa Surgery 5-FU + CF 359
SIENAa Surgery 5-FU + CF 239
GIVIOa Surgery 5-FU + CF 846
C01 Surgery MOF 724
C02 Surgery PVI of 5-FU 896
5-FU vs. 5-FU variations NCCTG-89-46-51 5-FU + LV × 1 y 5-FU + LEV × 6 mo; 5-FU + LEV + LV × 1 y; 5-FU + LEV + LV × 6 mo 915
NCCTG-91-46-53 Standard dose; LEV + 5-FU + CF High dose; LEV + 5-FU + CF 878
S9415 5-FU + LV + LEV CI 5-FU + LV 939
C03 MOF 5-FU + LV 1042
C04 5-FU + LV 5-FU + LV + LEV; 5-FU + LEV 2083
C05 5-FU + LV 5-FU + LV + interferon 2136
GERCOR LV5FU2 FUFOL 902
INT-0089 LEV HDLV; LDLV; LEV + LDLV 3363
QUASAR 5-FU + 175 mg L-folinic acid + placebo 5-FU + 25 mg L-folinic acid + placebo; 5-FU + 25 mg L-folinic acid + levamisole; 5-FU + 175 mg L-folinic acid + levamisole 3517
5-FU vs. 5-FU + oxaliplatin MOSAICa 5-FU + LV FOLFOX4 2241
C07a 5-FU + LV FOLFOX 2434
5-FU vs. 5-FU + irinotecan C89803 5-FU + LV IFL 1264
PETACC3 5-FU + LV FOLFIRI 3188
5-FU vs. oral XACT 5-FU + LV Capecitabine 1986
C06 5-FU + LV Uracil/tegafur 1557

Abbreviations: 5-FU = fluorouracil; CF = cisplatin/5-FU; CI 5-FU = continuous infusion 5-FU; FOLFOX = 5-FU infusion/oxaliplatin/leucovorin; FUFOL = 5-FU bolus plus leucovorin; HDLV = high-dose leucovorin; IFL = 5-FU bolus/oxaliplatin/leucovorin; LDLV = low-dose leucovorin; LEV = levamisole; LV = leucovorin; MOF = semustine/vincristine/5-FU; PVI = protracted venous infusion.

a

The significant treatment effect differences were shown among the arms in original publications based on individual trial data.