Gastric cancer - null regimens

Back to Top
The purpose of this page is to provide references to "null therapy" such as placebo and observation. These references provide further insight into the historical development of the treatment landscape. See the main gastric cancer page for regimens that include active anticancer treatment.
=Neoadjuvant chemotherapy=
==No neoadjuvant therapy==
===Regimen===
Study 	Dates of enrollment	Evidence 	Comparator 	Comparative Efficacy
Schuhmacher et al. 2010 (EORTC 40954)	1999-2004 	Phase 3 (C)	FULV & Cisplatin	Did not meet primary endpoint of OS
Iwasaki et al. 2020 (JCOG0501) 	2005-2013 	Phase 3 (C)	Cisplatin & S-1 	Did not meet primary endpoint of OS
Kang et al. 2021 (PRODIGY) 	2012-2017 	Phase 3 (C)	DOS 	Seems to have shorter PFSSeems to have shorter OS1
1Reported OS efficacy for PRODIGY is based on the 2024 update.
No antineoplastic treatment prior to surgery.
====Subsequent treatment====
*EORTC 40954: Surgery
*JCOG0501 & PRODIGY: Surgery, then adjuvant S-1
===References===
#EORTC 40954: Schuhmacher C, Gretschel S, Lordick F, Reichardt P, Hohenberger W, Eisenberger CF, Haag C, Mauer ME, Hasan B, Welch J, Ott K, Hoelscher A, Schneider PM, Bechstein W, Wilke H, Lutz MP, Nordlinger B, Van Cutsem E, Siewert JR, Schlag PM. Neoadjuvant chemotherapy compared with surgery alone for locally advanced cancer of the stomach and cardia: European Organisation for Research and Treatment of Cancer randomized trial 40954. J Clin Oncol. 2010 Dec 10;28(35):5210-8. Epub 2010 Nov 8. link to original article link to PMC article EuroPMC NCT00004099
#JCOG0501: Iwasaki Y, Terashima M, Mizusawa J, Katayama H, Nakamura K, Katai H, Yoshikawa T, Ito S, Kaji M, Kimura Y, Hirao M, Yamada M, Kurita A, Takagi M, Lee SW, Takagane A, Yabusaki H, Hihara J, Boku N, Sano T, Sasako M. Gastrectomy with or without neoadjuvant S-1 plus cisplatin for type 4 or large type 3 gastric cancer (JCOG0501): an open-label, phase 3, randomized controlled trial. Gastric Cancer. 2021 Mar;24(2):492-502. Epub 2020 Nov 16. link to original article EuroPMC NCT00252161
#PRODIGY: Kang YK, Yook JH, Park YK, Lee JS, Kim YW, Kim JY, Ryu MH, Rha SY, Chung IJ, Kim IH, Oh SC, Park YS, Son T, Jung MR, Heo MH, Kim HK, Park C, Yoo CH, Choi JH, Zang DY, Jang YJ, Sul JY, Kim JG, Kim BS, Beom SH, Cho SH, Ryu SW, Kook MC, Ryoo BY, Kim HK, Yoo MW, Lee NS, Lee SH, Kim G, Lee Y, Lee JH, Noh SH. PRODIGY: A Phase III Study of Neoadjuvant Docetaxel, Oxaliplatin, and S-1 Plus Surgery and Adjuvant S-1 Versus Surgery and Adjuvant S-1 for Resectable Advanced Gastric Cancer. J Clin Oncol. 2021 Sep 10;39(26):2903-2913. Epub 2021 Jun 16. link to original article link to PMC article EuroPMC NCT01515748
##Update: Kang YK, Kim HD, Yook JH, Park YK, Lee JS, Kim YW, Kim JY, Ryu MH, Rha SY, Chung IJ, Kim IH, Oh SC, Park YS, Cheong JH, Jeong O, Heo MH, Kim HK, Park C, Yoo CH, Kang SY, Zang DY, Jang YJ, Sul JY, Kim JG, Kim BS, Beom SH, Hwang JE, Ryu SW, Kook MC, Ryoo BY, Kim H, Yoo MW, Lee NS, Lee SH, Noh SH. Neoadjuvant Docetaxel, Oxaliplatin, and S-1 Plus Surgery and Adjuvant S-1 for Resectable Advanced Gastric Cancer: Updated Overall Survival Outcomes From Phase III PRODIGY. J Clin Oncol. 2024 Sep 1;42(25):2961-2965. Epub 2024 Jul 12. link to original article EuroPMC
=Adjuvant therapy=
==Observation==
===Regimen===
Study 	Dates of enrollment 	Evidence 	Comparator 	Comparative Efficacy
Allum et al. 1989 	1976 to not reported	Phase 3 (C)	5-FU & Mitomycin 	Did not meet primary endpoint of OS
Macdonald et al. 1995 (SWOG-7804) 	1978-1991 	Phase 3 (C)	FAM 	Did not meet primary endpoint of OS
Lise et al. 1995 (EORTC 40813) 	1980-1989 	Phase 3 (C)	FAM2 	Might have shorter DFS
Coombes et al. 1990 	1981-1984 	Phase 3 (C)	FAM 	Did not meet efficacy endpoints of DFS/OS
Hallissey et al. 1994 	1981-1986 	Phase 3 (C)	1. FAM2. Radiation therapy 	Did not meet primary endpoint of OS
Nakajima et al. 1999 (JCOG8801) 	1988-1992 	Phase 3 (C)	5-FU & Mitomycin, then UFT 	Did not meet primary endpoint of OS
Cirera et al. 1999 	1988-1994 	Phase 3 (C)	Mitomycin & Tegafur 	Seems to have shorter OS
Bouché et al. 2005 (FFCD 8801) 	1989-1997 	Phase 3 (C)	Cisplatin & 5-FU 	Did not meet primary endpoint of OS
Nitti et al. 2005 	1990-1998 	Phase 3 (C)	1. FAMTX2. FEMTX 	Did not meet primary endpoint of OS
Macdonald et al. 2001 (INT-0116) 	1991-1998 	Phase 3 (C)	FULV & RT 	Shorter OS
Nashimoto et al. 2003 (JCOG 9206-1)	1993-01 to 1994-12 	Phase 3 (C)	5-FU, Ara-C, Mitomycin, then 5-FU	Did not meet primary endpoint of RFS
Miyashiro et al. 2011 (JCOG 9206-2)	1993-1998 	Phase 3 (C)	IV/IP Cisplatin, then UFT 	Did not meet primary endpoint of OS
Kulig et al. 2010 	1995-1999 	Phase 3 (C)	EAP 	Did not meet primary endpoint of OS
Di Costanzo et al. 2008 	1995-2000 	Phase 3 (C)	PELF 	Did not meet primary endpoint of OS
De Vita et al. 2007 (GOIM 9602) 	1996-2001 	Phase 3 (C)	ELFE 	Did not meet primary endpoint of OS
Nakajima et al. 2007 (NSAS-GC) 	1997-2001 	Phase 3 (C)	UFT 	Shorter OSOS60: 73% vs 86%(HR 2.08, 95% CI 1.12-3.85)
Sakuramoto et al. 2007 (ACTS-GC) 	2001-2004 	Phase 3 (C)	S-1 	Shorter OSOS60: 61% vs 72%(HR 1.49, 95% CI 1.20-1.85)
No further treatment after surgery.
====Preceding treatment====
*Surgery, with varying requirements for level of dissection (see papers for details)
===References===
#Allum WH, Hallissey MT, Kelly KA; British Stomach Cancer Group. Adjuvant chemotherapy in operable gastric cancer: 5 year follow-up of first British Stomach Cancer Group trial. Lancet. 1989 Mar 18;1(8638):571-4. link to original article EuroPMC
#Coombes RC, Schein PS, Chilvers CE, Wils J, Beretta G, Bliss JM, Rutten A, Amadori D, Cortes-Funes H, Villar-Grimalt A, McArdle C, Rauschecker HF, Boven E, Vassilopoulos P, Welvaart K, Pinto Ferreira E, Wiig J, Gisselbrecht C, Rougier P, Woods EMA; International Collaborative Cancer Group. A randomized trial comparing adjuvant fluorouracil, doxorubicin, and mitomycin with no treatment in operable gastric cancer. J Clin Oncol. 1990 Aug;8(8):1362-9. link to original article EuroPMC
#Hallissey MT, Dunn JA, Ward LC, Allum WH; British Stomach Cancer Group. The second British Stomach Cancer Group trial of adjuvant radiotherapy or chemotherapy in resectable gastric cancer: five-year follow-up. Lancet. 1994 May 28;343(8909):1309-12. link to original article EuroPMC
#EORTC 40813: Lise M, Nitti D, Marchet A, Sahmoud T, Buyse M, Duez N, Fiorentino M, Dos Santos JG, Labianca R, Rougier P, Gignoux M. Final results of a phase III clinical trial of adjuvant chemotherapy with the modified fluorouracil, doxorubicin, and mitomycin regimen in resectable gastric cancer. J Clin Oncol. 1995 Nov;13(11):2757-63. link to original article EuroPMC
#SWOG-7804: Macdonald JS, Fleming TR, Peterson RF, Berenberg JL, McClure S, Chapman RA, Eyre HJ, Solanki D, Cruz AB Jr, Gagliano R, Estes NC, Tangen CM, Rivkin S. Adjuvant chemotherapy with 5-FU, adriamycin, and mitomycin-C (FAM) versus surgery alone for patients with locally advanced gastric adenocarcinoma: A Southwest Oncology Group study. Ann Surg Oncol. 1995 Nov;2(6):488-94. link to original article EuroPMC
#JCOG8801: Nakajima T, Nashimoto A, Kitamura M, Kito T, Iwanaga T, Okabayashi K, Goto M; Gastric Cancer Surgical Study Group. Adjuvant mitomycin and fluorouracil followed by oral uracil plus tegafur in serosa-negative gastric cancer: a randomised trial. Lancet. 1999 Jul 24;354(9175):273-7. link to original article EuroPMC
#Cirera L, Balil A, Batiste-Alentorn E, Tusquets I, Cardona T, Arcusa A, Jolis L, Saigí E, Guasch I, Badia A, Boleda M. Randomized clinical trial of adjuvant mitomycin plus tegafur in patients with resected stage III gastric cancer. J Clin Oncol. 1999 Dec;17(12):3810-5. link to original article EuroPMC
#INT-0116: Macdonald JS, Smalley SR, Benedetti J, Hundahl SA, Estes NC, Stemmermann GN, Haller DG, Ajani JA, Gunderson LL, Jessup JM, Martenson JA. Chemoradiotherapy after surgery compared with surgery alone for adenocarcinoma of the stomach or gastroesophageal junction. N Engl J Med. 2001 Sep 6;345(10):725-30. link to original article EuroPMC
##Update: Smalley SR, Benedetti JK, Haller DG, Hundahl SA, Estes NC, Ajani JA, Gunderson LL, Goldman B, Martenson JA, Jessup JM, Stemmermann GN, Blanke CD, Macdonald JS. Updated analysis of SWOG-directed intergroup study 0116: a phase III trial of adjuvant radiochemotherapy versus observation after curative gastric cancer resection. J Clin Oncol. 2012 Jul 1;30(19):2327-33. Epub 2012 May 14. link to original article link to PMC article EuroPMC
#JCOG 9206-1: Nashimoto A, Nakajima T, Furukawa H, Kitamura M, Kinoshita T, Yamamura Y, Sasako M, Kunii Y, Motohashi H, Yamamoto S; Gastric Cancer Surgical Study Group, Japan Clinical Oncology Group. Randomized trial of adjuvant chemotherapy with mitomycin, Fluorouracil, and Cytosine arabinoside followed by oral Fluorouracil in serosa-negative gastric cancer: Japan Clinical Oncology Group 9206-1. J Clin Oncol. 2003 Jun 15;21(12):2282-7. link to original article EuroPMC
#FFCD 8801: Bouché O, Ychou M, Burtin P, Bedenne L, Ducreux M, Lebreton G, Baulieux J, Nordlinger B, Martin C, Seitz JF, Tigaud JM, Echinard E, Stremsdoerfer N, Milan C, Rougier P; Fédération Francophone de Cancérologie Digestive Group. Adjuvant chemotherapy with 5-fluorouracil and cisplatin compared with surgery alone for gastric cancer: 7-year results of the FFCD randomized phase III trial (8801). Ann Oncol. 2005 Sep;16(9):1488-97. Epub 2005 Jun 6. link to original article EuroPMC
#Nitti D, Wils J, Dos Santos JG, Fountzilas G, Conte PF, Sava C, Tres A, Coombes RC, Crivellari D, Marchet A, Sanchez E, Bliss JM, Homewood J, Couvreur ML, Hall E, Baron B, Woods E, Emson M, Van Cutsem E, Lise M; EORTC GI Group; ICCG. Randomized phase III trials of adjuvant FAMTX or FEMTX compared with surgery alone in resected gastric cancer: a combined analysis of the EORTC GI Group and the ICCG. Ann Oncol. 2006 Feb;17(2):262-9. Epub 2005 Nov 17. link to original article EuroPMC
#GOIM 9602: De Vita F, Giuliani F, Orditura M, Maiello E, Galizia G, Di Martino N, Montemurro F, Cartenì G, Manzione L, Romito S, Gebbia V, Ciardiello F, Catalano G, Colucci G; Gruppo Oncologico Italia Meridionale. Adjuvant chemotherapy with epirubicin, leucovorin, 5-fluorouracil and etoposide regimen in resected gastric cancer patients: a randomized phase III trial by the Gruppo Oncologico Italia Meridionale (GOIM 9602 Study). Ann Oncol. 2007 Aug;18(8):1354-8. Epub 2007 May 24. link to original article EuroPMC
#ACTS-GC: Sakuramoto S, Sasako M, Yamaguchi T, Kinoshita T, Fujii M, Nashimoto A, Furukawa H, Nakajima T, Ohashi Y, Imamura H, Higashino M, Yamamura Y, Kurita A, Arai K; ACTS-GC Group. Adjuvant chemotherapy for gastric cancer with S-1, an oral fluoropyrimidine. N Engl J Med. 2007 Nov 1;357(18):1810-20. Erratum in: N Engl J Med. 2008 May 1;358(18):1977. link to original article EuroPMC NCT00152217
##Update: Sasako M, Sakuramoto S, Katai H, Kinoshita T, Furukawa H, Yamaguchi T, Nashimoto A, Fujii M, Nakajima T, Ohashi Y. Five-year outcomes of a randomized phase III trial comparing adjuvant chemotherapy with S-1 versus surgery alone in stage II or III gastric cancer. J Clin Oncol. 2011 Nov 20;29(33):4387-93. Epub 2011 Oct 17. link to original article EuroPMC
#NSAS-GC: Nakajima T, Kinoshita T, Nashimoto A, Sairenji M, Yamaguchi T, Sakamoto J, Fujiya T, Inada T, Sasako M, Ohashi Y; National Surgical Adjuvant Study of Gastric Cancer Group. Randomized controlled trial of adjuvant uracil-tegafur versus surgery alone for serosa-negative, locally advanced gastric cancer. Br J Surg. 2007 Dec;94(12):1468-76. link to original article EuroPMC NCT00152243
#Di Costanzo F, Gasperoni S, Manzione L, Bisagni G, Labianca R, Bravi S, Cortesi E, Carlini P, Bracci R, Tomao S, Messerini L, Arcangeli A, Torri V, Bilancia D, Floriani I, Tonato M; Italian Oncology Group for Cancer Research. Adjuvant chemotherapy in completely resected gastric cancer: a randomized phase III trial conducted by GOIRC. J Natl Cancer Inst. 2008 Mar 19;100(6):388-98. Epub 2008 Mar 11. link to original article EuroPMC
#Kulig J, Kolodziejczyk P, Sierzega M, Bobrzynski L, Jedrys J, Popiela T, Dadan J, Drews M, Jeziorski A, Krawczyk M, Starzynska T, Wallner G. Adjuvant chemotherapy with etoposide, adriamycin and cisplatin compared with surgery alone in the treatment of gastric cancer: a phase III randomized, multicenter, clinical trial. Oncology. 2010;78(1):54-61. Epub 2010 Mar 6. link to original article EuroPMC
#JCOG 9206-2: Miyashiro I, Furukawa H, Sasako M, Yamamoto S, Nashimoto A, Nakajima T, Kinoshita T, Kobayashi O, Arai K; Gastric Cancer Surgical Study Group in the Japan Clinical Oncology Group. Randomized clinical trial of adjuvant chemotherapy with intraperitoneal and intravenous cisplatin followed by oral fluorouracil (UFT) in serosa-positive gastric cancer versus curative resection alone: final results of the Japan Clinical Oncology Group trial JCOG9206-2. Gastric Cancer. 2011 Aug;14(3):212-8. Epub 2011 Feb 19. link to original article EuroPMC NCT00147147
=Metastatic or locally advanced disease, first-line=
==Best supportive care==
===Regimen===
Study 	Dates of enrollment	Evidence 	Comparator	Comparative Efficacy
Pyrhönen et al. 1995	1986-1992 	Phase 3 (C)	FEMTX 	Shorter OS
No antineoplastic treatment.
===References===
# Pyrhönen S, Kuitunen T, Nyandoto P, Kouri M. Randomised comparison of fluorouracil, epidoxorubicin and methotrexate (FEMTX) plus supportive care with supportive care alone in patients with non-resectable gastric cancer. Br J Cancer. 1995 Mar;71(3):587-91. link to original article link to PMC article EuroPMC
=Metastatic or locally advanced disease, subsequent lines of therapy=
==Best supportive care==
===Regimen===
Study 	Dates of enrollment	Evidence 	Comparator 	Comparative Efficacy
Thuss-Patience et al. 2011 	2002-2006 	Phase 3 (C)	Irinotecan 	Shorter OSMedian OS: 2.4 vs 4 mo(HR 2.08, 95% CI 1.09-4.00)
Kang et al. 2012 (SMC 2008-08-055)	2008-2010 	Phase 3 (C)	1a. Docetaxel1b. Irinotecan	Shorter OS
Ford et al. 2014 (COUGAR-02) 	2008-2012 	Phase 3 (C)	Docetaxel 	Shorter OS
Ohtsu et al. 2013 (GRANITE-1) 	2009-07 to 2010-11 	Phase 3 (C)	Everolimus 	Did not meet primary endpoint of OS
No active antineoplastic treatment. Used as a comparator arm and here for reference purposes only.
Thuss-Patience et al. patients: ~58% gastric, 43% GEJ. 21% of patients had an ECOG of 2.
GRANITE-1 study patients: 29% had GEJ involvement. 7.9% of patients had an ECOG of 2.
===References===
#Thuss-Patience PC, Kretzschmar A, Bichev D, Deist T, Hinke A, Breithaupt K, Dogan Y, Gebauer B, Schumacher G, Reichardt P. Survival advantage for irinotecan versus best supportive care as second-line chemotherapy in gastric cancer--a randomised phase III study of the Arbeitsgemeinschaft Internistische Onkologie (AIO). Eur J Cancer. 2011 Oct;47(15):2306-14. link to original article EuroPMC NCT00144378
#SMC 2008-08-055: Kang JH, Lee SI, Lim DH, Park KW, Oh SY, Kwon HC, Hwang IG, Lee SC, Nam E, Shin DB, Lee J, Park JO, Park YS, Lim HY, Kang WK, Park SH. Salvage chemotherapy for pretreated gastric cancer: a randomized phase III trial comparing chemotherapy plus best supportive care with best supportive care alone. J Clin Oncol. 2012 May 1;30(13):1513-8. Epub 2012 Mar 12. Erratum in: J Clin Oncol. 2012 Aug 20;30(24):3035. link to original article EuroPMC NCT00821990
#COUGAR-02: Ford HE, Marshall A, Bridgewater JA, Janowitz T, Coxon FY, Wadsley J, Mansoor W, Fyfe D, Madhusudan S, Middleton GW, Swinson D, Falk S, Chau I, Cunningham D, Kareclas P, Cook N, Blazeby JM, Dunn JA; COUGAR-02 Investigators. Docetaxel versus active symptom control for refractory oesophagogastric adenocarcinoma (COUGAR-02): an open-label, phase 3 randomised controlled trial. Lancet Oncol. 2014 Jan;15(1):78-86. Epub 2013 Dec 10. link to original article EuroPMC NCT00978549
#GRANITE-1: Ohtsu A, Ajani JA, Bai YX, Bang YJ, Chung HC, Pan HM, Sahmoud T, Shen L, Yeh KH, Chin K, Muro K, Kim YH, Ferry D, Tebbutt NC, Al-Batran SE, Smith H, Costantini C, Rizvi S, Lebwohl D, Van Cutsem E. Everolimus for previously treated advanced gastric cancer: results of the randomized, double-blind, phase III GRANITE-1 study. J Clin Oncol. 2013 Nov 1;31(31):3935-43. Epub 2013 Sep 16. link to original article link to PMC article EuroPMC NCT00879333
==Placebo==
===Regimen===
Study 	Dates of enrollment 	Evidence 	Comparator 	Comparative Efficacy
Fuchs et al. 2013 (REGARD) 	2009-2012 	Phase 3 (C) 	Ramucirumab 	Seems to have shorter OS (primary endpoint)Median OS: 3.8 vs 5.2 mo(HR 1.28, 95% CI 1.002-1.67)
Pavlakis et al. 2016 (INTEGRATE) 	2012-2014 	Randomized Phase 2 (C)	Regorafenib 	Shorter PFSMedian PFS: 0.9 vs 2.6 mo(HR 2.50, 95% CI 1.69-3.57)
Kang et al. 2017 (ATTRACTION-2) 	2014-2016 	Phase 3 (C) 	Nivolumab 	Shorter OS1 (primary endpoint)Median OS: 4.1 vs 5.3 mo(HR 1.61, 95% CI 1.33-2.00)
Shitara et al. 2018 (TAGS) 	2016-2018 	Phase 3 (C) 	Trifluridine/tipiracil	Shorter OSMedian OS: 3.6 vs 5.7 mo(HR 1.45, 95% CI 1.18-1.79)
Pavlakis et al. 2025 (INTEGRATE IIa)	2016-10 to 2021-09 	Phase 3 (C) 	Regorafenib 	Shorter OS (primary endpoint)Median OS: 4 vs 4.5 mo(HR 1.47, 95% CI 1.11-1.92)
Kang et al. 2024 (ANGEL) 	2017-03-14 to 2018-10-31	Phase 3 (C) 	Apatinib 	Did not meet primary endpoint of OSMedian OS: 5.13 vs 5.78 mo(HR 1.08, 95% CI 0.87-1.35)
1Reported efficacy for ATTRACTION-2 is based on the 2021 update.
All studies included patients with GE junction malignancy:
*REGARD: 75% gastric, 25% GE junction
*INTEGRATE: 62% stomach or other, 38% GE junction
*ATTRACTION-2: 82.6% gastric, 8.5% GE junction
Patients in REGARD previously had "disease progression within 4 months of the last dose of first-line platinum-containing or fluoropyrimidine-containing chemotherapy for metastatic disease, or within 6 months of the last dose of platinum-containing or fluoropyrimidine-containing adjuvant treatment."
No active antineoplastic treatment.
===References===
#REGARD: Fuchs CS, Tomasek J, Yong CJ, Dumitru F, Passalacqua R, Goswami C, Safran H, dos Santos LV, Aprile G, Ferry DR, Melichar B, Tehfe M, Topuzov E, Zalcberg JR, Chau I, Campbell W, Sivanandan C, Pikiel J, Koshiji M, Hsu Y, Liepa AM, Gao L, Schwartz JD, Tabernero J; REGARD Trial Investigators. Ramucirumab monotherapy for previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (REGARD): an international, randomised, multicentre, placebo-controlled, phase 3 trial. Lancet. 2014 Jan 4;383(9911):31-9. Epub 2013 Oct 3. link to original article EuroPMC NCT00917384
#INTEGRATE: Pavlakis N, Sjoquist KM, Martin AJ, Tsobanis E, Yip S, Kang YK, Bang YJ, Alcindor T, O'Callaghan CJ, Burnell MJ, Tebbutt NC, Rha SY, Lee J, Cho JY, Lipton LR, Wong M, Strickland A, Kim JW, Zalcberg JR, Simes J, Goldstein D. Regorafenib for the treatment of advanced gastric cancer (INTEGRATE): A multinational placebo-controlled phase II trial. J Clin Oncol. 2016 Aug 10;34(23):2728-35. Epub 2016 Jun 20. link to original article link to PMC article EuroPMC ANZCTR12612000239864
#ATTRACTION-2: Kang YK, Boku N, Satoh T, Ryu MH, Chao Y, Kato K, Chung HC, Chen JS, Muro K, Kang WK, Yeh KH, Yoshikawa T, Oh SC, Bai LY, Tamura T, Lee KW, Hamamoto Y, Kim JG, Chin K, Oh DY, Minashi K, Cho JY, Tsuda M, Chen LT. Nivolumab in patients with advanced gastric or gastro-oesophageal junction cancer refractory to, or intolerant of, at least two previous chemotherapy regimens (ONO-4538-12, ATTRACTION-2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2017 Dec 2;390(10111):2461-2471. Epub 2017 Oct 6. link to original article EuroPMC NCT02267343
#TAGS: Shitara K, Doi T, Dvorkin M, Mansoor W, Arkenau HT, Prokharau A, Alsina M, Ghidini M, Faustino C, Gorbunova V, Zhavrid E, Nishikawa K, Hosokawa A, Yalçın Ş, Fujitani K, Beretta GD, Van Cutsem E, Winkler RE, Makris L, Ilson DH, Tabernero J. Trifluridine/tipiracil versus placebo in patients with heavily pretreated metastatic gastric cancer (TAGS): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2018 Nov 1;19(11):1437-48. Epub 2018 Oct 18. link to original article EuroPMC NCT02500043
##HRQoL analysis: Tabernero J, Alsina M, Shitara K, Doi T, Dvorkin M, Mansoor W, Arkenau HT, Prokharau A, Ghidini M, Faustino C, Gorbunova V, Zhavrid E, Nishikawa K, Ando T, Yalçın Ş, Van Cutsem E, Sabater J, Skanji D, Leger C, Amellal N, Ilson DH. Health-related quality of life associated with trifluridine/tipiracil in heavily pretreated metastatic gastric cancer: results from TAGS. Gastric Cancer. 2020 Jul;23(4):689-698. Epub 2020 Mar 4. link to original article link to PMC article EuroPMC
#ANGEL: Kang YK, Ryu MH, Di Bartolomeo M, Chau I, Yoon H, Kim JG, Lee KW, Oh SC, Takashima A, Kryzhanivska A, Chao Y, Evesque L, Schenker M, McGinn A, Zhao Y, Lee J, Wyrwicz L, Boku N. Rivoceranib, a VEGFR-2 inhibitor, monotherapy in previously treated patients with advanced or metastatic gastric or gastroesophageal junction cancer (ANGEL study): an international, randomized, placebo-controlled, phase 3 trial. Gastric Cancer. 2024 Mar;27(2):375-386. Epub 2024 Jan 28. link to original article link to PMC article EuroPMC NCT03042611
#INTEGRATE IIa: Pavlakis N, Shitara K, Sjoquist K, Martin A, Jaworski A, Tebbutt N, Bang YJ, Alcindor T, O'Callaghan C, Strickland A, Rha SY, Lee KW, Kim JS, Bai LY, Hara H, Oh DY, Yip S, Zalcberg J, Price T, Simes J, Goldstein D. INTEGRATE IIa Phase III Study: Regorafenib for Refractory Advanced Gastric Cancer. J Clin Oncol. 2025 Feb;43(4):453-463. link to original article link to EuroPMC NCT02773524
Category:Gastric cancer regimens
Category:Disease-specific pages
Category:Gastroesophageal cancers
Category:Null regimens