Table 1 Overview of all published and ongoing randomised (neo-)adjuvant phase II/phase III clinical trials in patients with resectable gastric cancer and/or GOJ cancer (published from 1990), in order of key-publication
Author | Year key- publication | Year of accrual | Study code/ acronym | Phase (n=) | Design | Treatment | Eligibility | Results | Location |
|---|---|---|---|---|---|---|---|---|---|
|  | 2017-present | CRITICS-II | Phase II (n = 207) | CT→S CT + CRT→S CRT→S | 4×DOC→D2 2×DOC→45Gy + 5×PCa→D2 45Gy + 5×PCa→D2 | Adenocarcinoma of the stomach, stage IB-IIIC | In progress | The Netherlands | |
|  | 2016-present | FLOT7/RAMSES | Phase-II/III (n = 908) | CT→S→CT CT + IT→S→CT + IT | 4×FLOT→S→4×FLOT 4×FLOT + R→S→4×FLOT + R | Adenocarcinoma of the stomach or GOJ, cT2 any N, any T N+ | In progress | Germany | |
|  | 2013-present | ARTIST-II | Phase-II (900) | S→CT S→CT S→CT→CRT→CT | D2→8×S-1 D2→8×S-1 + O D2→2×S-1 + O→45Gy + S-1→4×S-1 + O | Adenocarcinoma of the stomach or GOJ, stage II-III N+ | In progress | Korea | |
|  | 2009-present | TOPGEAR | Phase III | CT→S→CT CT→CRT→S→CT | 3×ECF/ECX→D2→3×ECF/ECX 2×ECF→45Gy + 5FU/X→D2→3×ECF | Adenocarcinoma of the stomach or GOJ, stage IB-IIIC | In progress | Australia Europe | |
|  | 2005-2016 | HKIT-GC | Phase III (n = 280) | S→CT S→CT + IT | S→15×S-1 S→15×S-1 + PSK (12 months) | Adenocarcinoma of the stomach, stage II, IIIA | In progress | Japan | |
Cats/Jansen et al. [11] | 2018 | 2007–2015 | CRITICS | Phase III (n = 788) | CT→S→CT CT→S→CRT | 3×EOX/ECX→D1+→3×EOX/ECX 3×EOX/ECX→D1+→45Gy + CX | Adenocarcinoma of the stomach or GOJ, stage II-IV (M0) | No difference in OS | The Netherlands Scandinavia |
Fuchs et al. [29] | 2017 | 2002–2009 | CALGB 80101 (Alliance) | Phase III (n = 546) | S→CT→CRT→CT S→CT→CRT→CT | S→5×5FU + LV→45Gy + 5FU→10×5FU + LV S→1×ECF→45Gy + 5FU→2×ECF | Adenocarcinoma of the stomach or GOJ, stage IB-IV (M0) | No difference in OS | USA |
Moon et al. [30] | 2017 | 1997–2003 |  | (n = 229) | S S→CT S→CT S→CT | S S→5FU (12 months) S→5’DFUR (12 months) S→UFT(12 months) | Adenocarcinoma of the stomach, stage IB-IIIA | No difference in OS | Japan |
Cunningham et al. [31] | 2017 | 2007–2014 | UK Medical Research Council ST03 | Phase II/III (n = 1063) | CT→S→CT CT + IT→S→CT + IT | 3×ECX→S→3×ECX 3×ECX + B→S→3×ECX + B | Adenocarcinoma of the stomach | No difference in OS | UK |
Yoshikawa et al. [32] | 2016 | 2009–2011 | COMPASS | Phase II (n = 83) | CT→S CT→S CT→S CT→S | 2×SC + S 4×SC + S 2×PC + S 4×PC + S | Adenocarcinoma of the stomach, stage III | No difference in OS | Japan |
Hashemzadeh et al. [33] | 2014 | 2011–2014 |  | Phase III (n = 60) | S CT→S | S 6×DCF→S | Adenocarcinoma of the stomach, stage II-IIIB | Improvement of operability (OS not mentioned) | Iran |
Tsuburaya et al. [34] | 2014 | 2004–2009 | SAMIT | Phase III (n = 1495) | S→CT S→CT S→CT→CT S→CT→CT | D2→12×UFT D2→16×S-1 D2→8×P→9×UFT D2→8×P→12×S-1 | Adenocarcinoma of the stomach, stage T4a or T4b | S-1 better OS than UFT. No improvement of OS with sequential therapy | Japan |
Kang et al. [35] | 2013 | 2001–2007 | AMC0101 | Phase III (n = 640) | S→CT S→ipCT→CT→CT | D2→2×MMC→5’DFUR(3 months) D2→1x ipC→1×MMC→6×C + 5’DFUR (12 months) | Adenocarcinoma of the stomach, stage I-IV (M0) | Improvement of OS by iaCT | Korea |
Tatebe et al. [36] | 2013 | 2005–2009 |  | Phase II (n = 73) | S→CT S→CT | D2→8×S-1 (daily during 28 days, 14 days rest) D2→16×S-1 (alternate days during 15 months) (both total 224 days) | Carcinoma of the stomach, stage II-IIIB | No difference in OS, increased treatment compliance in arm 2 | Japan |
Kang et al. [37] | 2013 | 2002–2006 | AMC0201 | Phase III (n = 855) | S→CT S→CT | D2→2×MMC→5’DFUR(3 months) D2→1×MMC→6×C→5’DFUR(12 months) | Adenocarcinoma of the stomach, stage II-IV (M0) | No difference in OS | Japan |
Kim et al. [38] | 2012 | 2002–2006 |  | Phase III | S→CT S→CRT | D2→5×(5FU + LV) D2→1×(5FU + LV)→45Gy + 5FU + LV→2×(5FU + LV) | Adenocarcinoma of the stomach | No difference in OS | Korea |
Lee et al. [39] | 2012 | 2004–2008 | ARTIST | Phase III (n = 458) | S→CT S→CT→CRT | D2→6×XC D2→2×XC→45Gy + X→2×XC | Adenocarcinoma of the stomach, stage IB-IV (M0) | No difference in OS | Korea |
Bang et al. [40] | 2012 | 2006–2009 | CLASSIC | Phase III (n = 1035) | S S→CT | D2 D2→8×CAPOX | Adenocarcinoma of the stomach, stage II-IIIB | Improvement of OS by postoperative CT | Korea China Taiwan |
Schumacher et al. [41] | 2010 | 1999–2004 | EORTC 40,954 | Phase III (n = 144) Closed due to insufficient accrual | S CT→S | D2 2×(C + 6×5FU)→D2 | Adenocarcinoma of the stomach or GOJ, stage II or III | No difference in OS, higher R0 rate | Germany |
Kulig et al. [42] | 2010 | 1995–1999 |  | Phase III (n = 309) | S S→CT | S S→3×EAC | Adenocarcinoma of the stomach, M0 | No difference in OS | Poland |
Bamias et al. [43] | 2010 | 2002–2005 |  | Phase III (n = 147) | S→CT S→CRT | S→6×DC/Ca S→45Gy + 6×DC/Ca | Adenocarcinoma of the stomach, M0 | No difference in OS | Greece |
Biffi et al. [44] | 2010 | 1999–2005 | SAKK32/99 | Phase III (n = 69) Closed due to insufficient accrual | CT→S S→CT | 4×DCF→S S→4×DCF | Adenocarcinoma of the stomach, stage IB-IV (M0) | No difference in OS | Italy Switzerland UK France |
Schwartz et al. [45] | 2009 | 2001–2004 | RTOG-0114 | Phase II (n = 78) | S→CRT S→CRT | S→2× PCF→45Gy + 5FU + P S→2× PC→45Gy + C + P | Adenocarcinoma of the stomach, stage IB-IIIB | DFS higher in arm 2, arm 2 has too high toxicity rates | USA |
Di Constanzo et al. [46] | 2008 | 1995–2000 |  | Phase III (n = 258) | S S→CT | S S→4×PELF | Adenocarcinoma of the stomach, stage IB-IV (M0) | No difference in OS | Italia |
Jeung et al. [47] | 2007 | 1984–1989 |  | Phase III (n = 292) | S→CT S→CT + IT | D2/3→12×DOC + 5FU (18 months) D2/3→12×DOC + 12xpolyA:U + 5FU (18 months) | Adenocarcinoma of the stomach, curatively resected | Improved OS in the CT + IT group | Korea |
Nakijima et al. [48] | 2007 | 1997–2001 |  | Phase III (n = 190) | S S→CT | D2 D2→UFT (16 months) | Adenocarcinoma of the stomach, curatively resected | Improved OS in the CT group | Japan |
De Vita et al. [49] | 2007 | 1996–2001 | GOIM 9602 Study | Phase III (n = 228) | S S→CT | S S→6×ELFE | Adenocarcinoma of the stomach or GOJ, stage IB-IIIB | No difference in OS | Italy |
Cascinu et al. [50] | 2007 | 1998–2003 |  | Phase III (n = 201) | S S→CT | S→6×(5FU + LV) S→8×PELFw | High risk adenocarcinoma of the stomach, stage pT3 N0/pT2/pT3N+ | No difference in OS | Italy |
Sakuramoto et al. [51] | 2007 | 2001–2004 | ACTS-GC | Phase III (n = 1059) | S S→CT | D2 D2→S-1(12months) | Carcinoma of the stomach, stage II-IIIB | Improvement of OS in the CT group | Japan |
Nishikawa et al. [52] | 2006 (key publication 2001 in Japanese) | 1987–1990 | JRFMTC Study no. 10 | Phase III (n = 1410) | S→CT S→CT | S→1×MMC + UFT (three capsules; 6 months) S→5×MMC + UFT (six capsules; 6 months) | Stomach carcinoma with (sub)serosal invasion | No difference in OS | Japan |
Bouché et al. [53] | 2005 | 1989–1997 | 8801 | Phase III (n = 260) Closed due to insufficient accrual | S S→CT | D2 D2→1×5FU→4×(5FU + C) | Adenocarcinoma of the stomach; R0; positive lymph nodes and/or T3/T4 tumour | No difference in OS | France |
Nashimoto et al. [54] | 2003 | 1993–1994 | JOCG 9206–1 | Phase III (n = 252) | S S→CT | D2 D2→6×(MMC + 5FU + AraC)→oral 5FU (18 months) | Adenocarcinoma of the stomach; N2 or less, macroscopically serosa negative | No difference in OS | Japan |
Macdonald et al. [2] | 2001 | 1991–1998 | SWOG-Intergroup 0116 | Phase III (n = 559) | S S→CRT | S S→45Gy + 5FU + LV | Adenocarcinoma of the stomach or GOJ, stage IB-IV(M0) | Improvement of OS in the CRT group | USA |
Cirera et al. [55] | 1999 | 1988–1994 |  | Phase III (n = 148) | S S→CT | S S→1×MMC→oral 5FU (3 months) | Adenocarcinoma of the stomach, stage III | Improved OS in CT group | Spain |
Nakajima et al. [56] | 1999 | 1988–1992 |  | Phase III (n = 579) | S S→CT | S S→6×(MMC + 5FU)→ oral UFT (18 months) | Adenocarcinoma of the stomach, stage T1N+ or T2 | No difference in OS | Japan |
Lise et al. [57] | 1995 | 1980–1989 |  | Phase III (n = 314) | S S→CT | S S→7×(5-FU + DOX + MMC) | Adenocarcinoma of the stomach, stage II or III | No difference in OS | Belgium France Germany Italy The Netherlands Portugal Spain Switzerland |
Macdonald et al. [58] | 1995 | 1978–1991 | A Southwest Oncology Group Study | Phase III (n = 193) | S S→CT | S S→6×FAM | Gastric carcinoma, stage I-III | No difference in OS | USA |