Table 1.
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.
The significant treatment effect differences were shown among the arms in original publications based on individual trial data.