Table 4.
Studies | Country | Years | Randomization arms | Surgery | Protocol | Patients (n) | Overall survival | P value | Disease free survival | P value |
INT 0116 trial[28,29] | United States | 2001 | Chemoradiotherapy and surgery | 10% D2 surgery | 5FU Mayo clinic/5FU RT | 281 | 50% at 3 yr1 | 0.005 | 48% at 3 yr1 | < 0.001 |
Surgery alone | 275 | 41% at 3 yr | 31% at 3 yr | |||||||
Chinese multicentre trial[33] | China | 2012 | Chemoradiotherapy and surgery | D2 surgery | 5FU RT | 186 | 48.4% at 5 yr | 0.122 | 45.2% at 5 yr1 | 0.029 |
Chemotherapy and surgery | 5FU chemotherapy | 165 | 41.8% at 5 yr | 35.8% at 5 yr | ||||||
ARTIST trial[31] | South Korea | 2012 | Chemoradiotherapy and surgery | D2 surgery | Xeloda CDDP/Xeloda RT | 230 | - | - | 74.2% at 3 yr | 0.086 |
Chemotherapy and surgery | Xeloda CDDP | 228 | - | 78.2% at 3 yr | ||||||
CALGB 80101 trial[30] | United States | 2011 | Chemoradiotherapy and surgery | Not available | ECF/5FU RT | 266 | 52% at 3 yr | 0.8 | 47% at 3 yr | 0.99 |
Chemoradiotherapy and surgery | 5FU Mayo/5FU RT | 280 | 50% at 3 yr | 46% at 3 yr |
Statistically significant result. 5FU: 5-fluorouracil; RT: Radiotherapy; CDDP: Cisplatin.