Table 1.
Comparison of study design, MOSAIC and NSABP C-07
| MOSAICa | NSABP C-07b | |
|---|---|---|
| Sample size | 2246 | 2407 |
| Study design | Randomized, phase III | Randomized, phase III |
| Tumor stage | Resected stage II, III | Resected stage II, III |
| Stratification | • T stage: 2, 3 vs. T4 | N stage: 0, 1, 2 |
| • N stage: 0, 1, 2 | ||
| • Perforation or obstruction or venous invasion | ||
| Planned cumulative doses: | ||
| Oxaliplatin | 1020 mg/m2 | 765 mg/m2 |
| 5-FU | 24,000 mg/m2 | 9,000 mg/m2 |
| Primary endpoint | DFS | DFS |
| DFS definedc | Time to relapse or death whichever comes first (non-colorectal cancers were disregarded in the analysis) | Time to first recurrence, death or second primary cancer |
| Primary analysis cut-off | 3 years from enrollment of last patient or 303 events (relapse or death) in test arm whichever comes later | 675 events on the combined arms (estimated to be at approximately 3 years from enrollment of last patient) |
| Secondary endpoints | Safety, overall survival, long-term adverse events | Safety, overall survival, and recurrence-free interval |
| Statistical power | 90% to detect a 6% increase in DFS at 3 years | 89% to detect a 5.4% increase in DFS at 3 years |
a
André, T et al. N Eng J Med. 2004, 350:2343–2351.
b
Kuebler, JP et al. J Clin Oncol. 2007, 25:2198–2204.
c
Primary efficacy variable definition was different between the two trials.