Table 1.
Recruitment | Eligibility criteria | Treatment | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Date of first randomization | Total randomized | Stage II randomized | Tumor site | Age limit (years) | Tumor stage | Start therapy after surgery (days) | Comparator | Treatment | Number of cycles | Duration (months) | Median follow‐up (years) | |
IMPACT (1999) | ||||||||||||
GIVIO | January 1989 | 888 | 449 | Colon | None | II and III1 | 35 | Control | FU + LV | 6 | 6 | 5.3 |
NCIC‐CTG | May 1987 | 370 | 221 | Colon | None | II and III1 | 56 | Control | FU + LV | 6 | 6 | 5.9 |
FFCD | October 1982 | 268 | 168 | Colon | <75 | II and III1 | 35 | Control | FU + LV | 6 | 6 | 5.2 |
NNCTG | February 1988 | 317 | 57 | Colon | None | II and III1 | 35 | Control | FU + LV | 6 | 6 | 6.4 |
Sienna | January 1985 | 239 | 121 | Colon | None | II and III1 | 21 | Control | FU + LV | 12 | 12 | 8.5 |
QUASAR (2007) | May 1994 | 3,239 | 2,963 | Colon/Rectum | None | I, II and III | 42 | Control | FU + LV | 6 | 6 | 5.5 |
Schippinger et al. (2007) | November 1993 | 500 | 500 | Colon | <80 | II | 42 | Control | 5‐FU + LV | 7 | 13 | 8.0 |
MOSAIC (2009) | October 1998 | 2,246 | 899 | Colon | <75 | II, III | 42 | LV5FU2 | FOLFOX4 | 12 | 6 | 6.8 |
NSABP C07 (2011) | February 2000 | 2,492 | 695 | Colon | None | II,III | NR | FULV | FLOX | 3 | 6 | 8.0 |
Dukes classification was used in these studies. Stage II: Dukes B2, tumor has grown through the gut, but not yet in lymph nodes. Stage III: Dukes C, tumor has grown into the regional lymph nodes.
Abbreviations: FOLFOX, regimen that includes the drugs leucovorin, fluoropyrimidine and oxaliplatin; FU, fluoropyrimidine; LV, leucovorin; NA, not applicable; NR, not reported.