Skip to main content

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

From: CRITICS-II: a multicentre randomised phase II trial of neo-adjuvant chemotherapy followed by surgery versus neo-adjuvant chemotherapy and subsequent chemoradiotherapy followed by surgery versus neo-adjuvant chemoradiotherapy followed by surgery in resectable gastric cancer

Author Year key- publication Year of accrual Study code/ acronym Phase (n=) Design Treatment Eligibility Results Location
https://clinicaltrials.gov/ct2/show/NCT02931890   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
https://clinicaltrials.gov/ct2/show/NCT02661971   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
https://clinicaltrials.gov/ct2/show/NCT01761461   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
https://clinicaltrials.gov/ct2/show/NCT01924819   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
https://clinicaltrials.gov/ct2/show/NCT00216034   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
  1. S surgery, D2 surgery+D2 lymph node dissection, CT chemotherapy, CRT chemoradiotherapy,  ipCT intraperitoneal CT IT immune therapy
  2. 5’DFUR doxifluridine, 5-FU 5-fluorouracil, Ara-C cytarabine, B bevacizumab, C cisplatin, CAPOX capecitabine+oxaliplatin, CX cisplatin+capecitabine, DC/Ca docetaxel+cisplatin/carboplatin, DCF docetaxel+cisplatin+5FU, DOC docetaxel+oxaliplatin+capecitabine, DOX doxorubicin, EAC etoposide+doxorubicin+cisplatin, ECF epirubicin+cisplatin+5FU, ECX epirubicin+cisplatin+capecitabine, ELFE epirubicin+leucovorin+5FU+etoposide, EOX epirubicin+oxaliplatin+capecitabine, FAM 5-FU+doxorubicin+mitomycin-C, FLOT 5FU+folinic acid+oxaliplatin+docetaxel, ipC intraperitoneal cisplatin, LV leucovorin, MMC mitomycin C, O oxaliplatin, P paclitaxel, PC paclitaxel+cisplatin, PCa paclitaxel+carboplatin, PCF paclitaxel+cisplatin+5FU, PELF cisplatin+epirubicin+5-FU+leucovorin, PELFw 5FU+epidoxorubicin+leucovorin+cisplatin, polyA:U polyadenylicpolyuridylic acid, PSK Krestin, R ramucirumab, S-1 combination tegafur/gimeracil/oteracil, SC S-1+cisplatin, UFT uracil/tegafur, X capecitabine, XC capecitabine+cisplatin