Table 3.
Major Phase III Trials of Adjuvant Chemotherapy and Chemoradiotherapy for Gastric Cancer.
| Trial name | Published
year |
No. of
patients |
Eligible patients | Treatment groups | Survival
(%) |
P-value |
|---|---|---|---|---|---|---|
| ACTS-GC (39), (40) | 2007, 2011 | 1059 | pStage II-III
(D2 gastrectomy) |
no treatment (surgery alone)
S-1 |
3-year OS: 70.1
3-year OS: 80.1 |
0.003 |
| SAMIT (41) | 2014 | 1495 | cT4a-T4b
(D2 gastrectomy) |
UFT with or without paclitaxel
S-1 with or without paclitaxel |
3-year DFS: 53.0
3-year DFS: 58.2 |
0.0048 |
| CLASSIC (42) | 2014 | 1035 | pStage II-III
(D2 gastrectomy) |
no treatment (surgery alone)
Capecitabine + oxaliplatin |
3-year DFS: 59
3-year DFS: 74 |
<0.0001 |
| OPAS-1 (43) | 2017 | 528 | pStage II | S-1 (6 months)
S-1 (12 months) |
3-year RFS: 88.9
3-year RFS: 95.3 |
0.93*
(for non-inferiority) |
| START-2 (44) | 2018 | 951 | pStage III | S-1
S-1 + docetaxel |
3-year RFS: 49.6
3-year RFS: 65.9 |
0.0007 |
| INT-0116 (45) | 2001 | 556 | pStage IB-III
(D0/D1 gastrectomy) |
no treatment (surgery alone)
5-FU + LV + RT |
3-year OS: 41
3-year-OS: 50 |
0.005 |
| ARTIST (46) | 2015 | 458 | pStage IB-III
(D2 gastrectomy) |
Capecitabine + cisplatin
Capecitabine + cisplatin + CRT (Capecitabine + RT) |
3-year DFS: 74.2
3-year DFS: 78.2 |
0.0862 |
| CRITICS (47) | 2018 | 788 | cStage IB-III
(D1+/D2 gastrectomy) |
ECX or EOX
ECX or EOX + RT |
5-year OS: 42
5-year OS: 40 |
0.90 |
* one-sided p-value.
Abbreviations: OS, overall survival; DFS, disease-free survival; RFS, recurrence-free survival; MST, median survival time; UFT, uracil–tegafur; CRT, chemoradiotherapy; RT, radiotherapy; 5-FU, fluorouracil; LV, leucovorin; ECX, epirubicin plus cisplatin plus capecitabine; EOX, epirubicin plus oxaliplatin plus capecitabine.