Colorectal cancer - null regimens

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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 colorectal cancer page for regimens that include active anticancer treatment.
=Adjuvant therapy=
==Observation==
===Regimen===
Study 	Dates of enrollment	Evidence 	Comparator 	Comparative Efficacy
Gray et al. 2000 (QUASAR part 2)	1994-05 to 2003-12 	Phase 3 (C)	FULV 	Shorter OS
Hasegawa et al. 2016 	2004-2010 	Phase 3 (C)	Tegafur, Uracil, Leucovorin	Shorter RFSMedian RFS: 0.7 vs 1.45 years(HR 1.79, 95% CI 1.20-2.63)
No systemic treatment after surgery.
====Preceding treatment====
*Surgery
===References===
#QUASAR part 2: Gray R, Barnwell J, McConkey C, Hills RK, Williams NS, Kerr DJ; Quasar Collaborative Group. Adjuvant chemotherapy versus observation in patients with colorectal cancer: a randomised study. Lancet. 2007 Dec 15;370(9604):2020-9. link to original article EuroPMC NCT00005586
#Hasegawa K, Saiura A, Takayama T, Miyagawa S, Yamamoto J, Ijichi M, Teruya M, Yoshimi F, Kawasaki S, Koyama H, Oba M, Takahashi M, Mizunuma N, Matsuyama Y, Watanabe T, Makuuchi M, Kokudo N. Adjuvant oral uracil-tegafur with leucovorin for colorectal cancer liver metastases: A randomized controlled trial. PLoS One. 2016 Sep 2;11(9):e0162400. eCollection 2016. link to original article link to PMC article EuroPMC UMIN C000000013
=Therapy for oligometastatic disease, including perioperative therapy and hyperthermic intra-peritoneal chemotherapy=
==Observation==
===Regimen===
Study 	Dates of enrollment	Evidence 	Comparator 	Comparative Efficacy
Allen-Mersh et al. 1994 	1988-1993 	Phase 3 (C)	Intrahepatic floxuridine	Seems to have shorter OS
Kemeny et al. 1999 	Not reported 	Phase 3 (C)	Intrahepatic floxuridine	Seems to have shorter OS
Portier et al. 2006 (FFCD 9002) 	1991-2001 	Phase 3 (C)	FULV 	Might have shorter PFS1
Nordlinger et al. 2008 (EORTC 40983)	2000-2004 	Phase 3 (C)	FOLFOX4 	Shorter PFSPFS36: 28.1% vs 35.4%(HR 1.27, 95.66% CI 0.98-1.61)
1Reported efficacy for FFCD 9002 is based on the 2008 pooled update.
No treatment other than surgical resection of oligometastatic disease.
===References===
#Allen-Mersh TG, Earlam S, Fordy C, Abrams K, Houghton J. Quality of life and survival with continuous hepatic-artery floxuridine infusion for colorectal liver metastases. Lancet. 1994 Nov 5;344(8932):1255-60. link to original article EuroPMC
#Kemeny N, Huang Y, Cohen AM, Shi W, Conti JA, Brennan MF, Bertino JR, Turnbull AD, Sullivan D, Stockman J, Blumgart LH, Fong Y. Hepatic arterial infusion of chemotherapy after resection of hepatic metastases from colorectal cancer. N Engl J Med. 1999 Dec 30;341(27):2039-48. link to original article EuroPMC
#FFCD 9002: Portier G, Elias D, Bouche O, Rougier P, Bosset JF, Saric J, Belghiti J, Piedbois P, Guimbaud R, Nordlinger B, Bugat R, Lazorthes F, Bedenne L. Multicenter randomized trial of adjuvant fluorouracil and folinic acid compared with surgery alone after resection of colorectal liver metastases: FFCD ACHBTH AURC 9002 trial. J Clin Oncol. 2006 Nov 1;24(31):4976-82. link to original article EuroPMC
##Pooled update: Mitry E, Fields AL, Bleiberg H, Labianca R, Portier G, Tu D, Nitti D, Torri V, Elias D, O'Callaghan C, Langer B, Martignoni G, Bouché O, Lazorthes F, Van Cutsem E, Bedenne L, Moore MJ, Rougier P. Adjuvant chemotherapy after potentially curative resection of metastases from colorectal cancer: a pooled analysis of two randomized trials. J Clin Oncol. 2008 Oct 20;26(30):4906-11. Epub 2008 Sep 15. link to original article EuroPMC
#EORTC 40983: Nordlinger B, Sorbye H, Glimelius B, Poston GJ, Schlag PM, Rougier P, Bechstein WO, Primrose JN, Walpole ET, Finch-Jones M, Jaeck D, Mirza D, Parks RW, Collette L, Praet M, Bethe U, Van Cutsem E, Scheithauer W, Gruenberger T; EORTC Gastro-Intestinal Tract Cancer Group; Cancer Research UK; Arbeitsgruppe Lebermetastasen und-tumoren in der Chirurgischen Arbeitsgemeinschaft Onkologie; Australasian Gastro-Intestinal Trials Group; Fédération Francophone de Cancérologie Digestive. Perioperative chemotherapy with FOLFOX4 and surgery versus surgery alone for resectable liver metastases from colorectal cancer (EORTC Intergroup trial 40983): a randomised controlled trial. Lancet. 2008 Mar 22;371(9617):1007-16. link to original article link to PMC article does not contain dosing details EuroPMC NCT00006479
##Update: Nordlinger B, Sorbye H, Glimelius B, Poston GJ, Schlag PM, Rougier P, Bechstein WO, Primrose JN, Walpole ET, Finch-Jones M, Jaeck D, Mirza D, Parks RW, Mauer M, Tanis E, Van Cutsem E, Scheithauer W, Gruenberger T; EORTC Gastro-Intestinal Tract Cancer Group; Cancer Research UK; Arbeitsgruppe Lebermetastasen und–tumoren in der Chirurgischen Arbeitsgemeinschaft Onkologie; Australasian Gastro-Intestinal Trials Group; Fédération Francophone de Cancérologie Digestive. Perioperative FOLFOX4 chemotherapy and surgery versus surgery alone for resectable liver metastases from colorectalcancer (EORTC 40983): long-term results of a randomised, controlled, phase 3 trial. Lancet Oncol. 2013 Nov;14(12):1208-15. Epub 2013 Oct 11. link to original article EuroPMC
=Metastatic disease, first-line=
==Best supportive care==
===Regimen===
Study 	Dates of enrollment	Evidence 	Comparator	Comparative Efficacy
Goldberg et al. 1995 	1988-1992 	Phase 3 (C)	Octreotide	Did not meet co-primary endpoints of PFS/OS
Smyth et al. 1995 (N-trial)	1989-1992 	Phase 3 (C)	TCNU 	Did not meet endpoint of OS50%
No active treatment.
===References===
# Goldberg RM, Moertel CG, Wieand HS, Krook JE, Schutt AJ, Veeder MH, Mailliard JA, Dalton RJ; North Central Cancer Treatment Group. A phase III evaluation of a somatostatin analogue (octreotide) in the treatment of patients with asymptomatic advanced colon carcinoma. Cancer. 1995 Sep 15;76(6):961-6. link to original article EuroPMC
# N-trial: Smyth JF, Hardcastle JD, Denton G, Alderson D, Grace RH, Mansi JL, Yosef HM, Nordle O, Lauri H, Wählby S. Two phase III trials of tauromustine (TCNU) in advanced colorectal cancer. Ann Oncol. 1995 Nov;6(9):948-9. link to original article EuroPMC
=Maintenance after first-line therapy=
==Observation==
===Regimen===
Study 	Dates of enrollment	Evidence 	Comparator 	Comparative Efficacy
Koeberle et al. 2015 (SAKK 41/06)	2007-2012 	Phase 3 (C)	Bevacizumab 	Inconclusive whether non-inferior TTP (primary endpoint)Median TTP: 2.9 vs 4.1 mo(HR 1.35, 95% CI 1.04-1.72)
Simkens et al. 2015 (CAIRO3) 	2007-2012 	Phase 3 (C)	CAP-B 	Shorter PFS-2Median PFS: 8.5 vs 11.7 mo(HR 1.49, 95% CI 1.23-1.79)
Luo et al. 2016 	2010-2013 	Phase 3 (C)	Capecitabine	Shorter PFSMedian PFS: 3.4 vs 6.4 mo(HR 1.85, 95% CI 1.43-2.38)
Aparicio et al. 2018 (PRODIGE 9) 	2010-2013 	Phase 3 (C)	Bevacizumab 	Did not meet primary endpoint of TCD
No further treatment after first-line induction.
====Preceding treatment====
*CAIRO3: First-line CAPOX-B x 6
*Luo et al. 2016: First-line FOLFOX or XELOX
===References===
#SAKK 41/06: Koeberle D, Betticher DC, von Moos R, Dietrich D, Brauchli P, Baertschi D, Matter K, Winterhalder R, Borner M, Anchisi S, Moosmann P, Kollar A, Saletti P, Roth A, Frueh M, Kueng M, Popescu RA, Schacher S, Hess V, Herrmann R. Bevacizumab continuation versus no continuation after first-line chemotherapy plus bevacizumab in patients with metastatic colorectal cancer: a randomized phase III non-inferiority trial (SAKK 41/06). Ann Oncol. 2015 Apr;26(4):709-14. Epub 2015 Jan 20. link to original article EuroPMC NCT00544700
#CAIRO3: Simkens LH, van Tinteren H, May A, ten Tije AJ, Creemers GJ, Loosveld OJ, de Jongh FE, Erdkamp FL, Erjavec Z, van der Torren AM, Tol J, Braun HJ, Nieboer P, van der Hoeven JJ, Haasjes JG, Jansen RL, Wals J, Cats A, Derleyn VA, Honkoop AH, Mol L, Punt CJ, Koopman M; Dutch Colorectal Cancer Group. Maintenance treatment with capecitabine and bevacizumab in metastatic colorectal cancer (CAIRO3): a phase 3 randomised controlled trial of the Dutch Colorectal Cancer Group. Lancet. 2015 May 9;385(9980):1843-52. Epub 2015 Apr 7. link to original article EuroPMC NCT00442637
##Update: Goey KKH, Elias SG, van Tinteren H, Laclé MM, Willems SM, Offerhaus GJA, de Leng WWJ, Strengman E, Ten Tije AJ, Creemers GM, van der Velden A, de Jongh FE, Erdkamp FLG, Tanis BC, Punt CJA, Koopman M. Maintenance treatment with capecitabine and bevacizumab versus observation in metastatic colorectal cancer: updated results and molecular subgroup analyses of the phase 3 CAIRO3 study. Ann Oncol. 2017 Sep 1;28(9):2128-2134. link to original article EuroPMC
#Luo HY, Li YH, Wang W, Wang ZQ, Yuan X, Ma D, Wang FH, Zhang DS, Lin DR, Lin YC, Jia J, Hu XH, Peng JW, Xu RH. Single-agent capecitabine as maintenance therapy after induction of XELOX (or FOLFOX) in first-line treatment of metastatic colorectal cancer: randomized clinical trial of efficacy and safety. Ann Oncol. 2016 Jun;27(6):1074-81. Epub 2016 Mar 2. link to original article EuroPMC NCT02027363
#PRODIGE 9: Aparicio T, Ghiringhelli F, Boige V, Le Malicot K, Taieb J, Bouché O, Phelip JM, François E, Borel C, Faroux R, Dahan L, Jacquot S, Genet D, Khemissa F, Suc E, Desseigne F, Texereau P, Lepage C, Bennouna J; PRODIGE 9 Investigators. Bevacizumab maintenance versus no maintenance during chemotherapy-free intervals in metastatic colorectal cancer: a randomized phase III trial (PRODIGE 9). J Clin Oncol. 2018 Mar 1;36(7):674-681. Epub 2018 Jan 18. link to original article EuroPMC NCT00952029
=Advanced or metastatic disease, subsequent lines of therapy=
==Best supportive care==
===Regimen===
Study 	Dates of enrollment 	Evidence 	Comparator 	Comparative Efficacy
Cunningham et al. 1998 (V301) 	1995 to not reported	Phase 3 (C) 	Irinotecan 	Shorter OS
Jonker et al. 2007 (NCIC-CTG CO.17)	2003-2005 	Phase 3 (C) 	Cetuximab 	Shorter OSMedian OS: 4.6 vs 6.1 mo(HR 1.30, 95% CI 1.09-1.56)
Van Cutsem et al. 2007 (20020408) 	2004-01 to 2005-06 	Phase 3 (C) 	Panitumumab 	Shorter PFSMedian PFS: 7.3 vs 8 weeks(HR 1.85, 95% CI 1.52-2.27)
Kim et al. 2016 (20100007) 	2011-2013 	Phase 3 (C) 	Panitumumab 	Shorter OSMedian OS: 6.9 vs 10 mo(HR 1.39, 95% CI 1.06-1.82)
Chen et al. 2020 (NCIC-CTG CO.26) 	2016-2017 	Randomized Phase 2 (C)	Durvalumab & Tremelimumab	Might have shorter OSMedian OS: 4.1 vs 6.6 mo(HR 1.39, 90% CI 1.03-1.85)
No treatment except for supportive care.
===References===
#V301: Cunningham D, Pyrhönen S, James RD, Punt CJ, Hickish TF, Heikkila R, Johannesen TB, Starkhammar H, Topham CA, Awad L, Jacques C, Herait P. Randomised trial of irinotecan plus supportive care versus supportive care alone after fluorouracil failure for patients with metastatic colorectal cancer. Lancet. 1998 Oct 31;352(9138):1413-8. link to original article EuroPMC
#20020408: Van Cutsem E, Peeters M, Siena S, Humblet Y, Hendlisz A, Neyns B, Canon JL, Van Laethem JL, Maurel J, Richardson G, Wolf M, Amado RG. Open-label phase III trial of panitumumab plus best supportive care compared with best supportive care alone in patients with chemotherapy-refractory metastatic colorectal cancer. J Clin Oncol. 2007 May 1;25(13):1658-64. link to original article EuroPMC NCT00113763
##HRQoL analysis: Odom D, Barber B, Bennett L, Peeters M, Zhao Z, Kaye J, Wolf M, Wiezorek J. Health-related quality of life and colorectal cancer-specific symptoms in patients with chemotherapy-refractory metastatic disease treated with panitumumab. Int J Colorectal Dis. 2011 Feb;26(2):173-81. Epub 2010 Dec 29. link to original article link to PMC article EuroPMC
#NCIC-CTG CO.17: Jonker DJ, O'Callaghan CJ, Karapetis CS, Zalcberg JR, Tu D, Au HJ, Berry SR, Krahn M, Price T, Simes RJ, Tebbutt NC, van Hazel G, Wierzbicki R, Langer C, Moore MJ. Cetuximab for the treatment of colorectal cancer. N Engl J Med. 2007 Nov 15;357(20):2040-8. link to original article EuroPMC NCT00079066
##Subgroup analysis: Karapetis CS, Khambata-Ford S, Jonker DJ, O'Callaghan CJ, Tu D, Tebbutt NC, Simes RJ, Chalchal H, Shapiro JD, Robitaille S, Price TJ, Shepherd L, Au HJ, Langer C, Moore MJ, Zalcberg JR. K-ras mutations and benefit from cetuximab in advanced colorectal cancer. N Engl J Med. 2008 Oct 23;359(17):1757-65. link to original article EuroPMC
##Subgroup analysis: Asmis TR, Powell E, Karapetis CS, Jonker DJ, Tu D, Jeffery M, Pavlakis N, Gibbs P, Zhu L, Dueck DA, Whittom R, Langer C, O'Callaghan CJ. Comorbidity, age and overall survival in cetuximab-treated patients with advanced colorectal cancer (ACRC)--results from NCIC-CTG CO.17: a phase III trial of cetuximab versus best supportive care. Ann Oncol. 2011 Jan;22(1):118-26. Epub 2010 Jul 5. link to original article EuroPMC
#20100007: Kim TW, Elme A, Kusic Z, Park JO, Udrea AA, Kim SY, Ahn JB, Valencia RV, Krishnan S, Bilic A, Manojlovic N, Dong J, Guan X, Lofton-Day C, Jung AS, Vrdoljak E. A phase 3 trial evaluating panitumumab plus best supportive care vs best supportive care in chemorefractory wild-type KRAS or RAS metastatic colorectal cancer. Br J Cancer. 2016 Nov 8;115(10):1206-1214. Epub 2016 Oct 13. link to original article link to PMC article EuroPMC NCT01412957
#NCIC-CTG CO.26: Chen EX, Jonker DJ, Loree JM, Kennecke HF, Berry SR, Couture F, Ahmad CE, Goffin JR, Kavan P, Harb M, Colwell B, Samimi S, Samson B, Abbas T, Aucoin N, Aubin F, Koski S, Wei AC, Magoski NM, Tu D, O'Callaghan CJ. Effect of Combined Immune Checkpoint Inhibition vs Best Supportive Care Alone in Patients With Advanced Colorectal Cancer: The Canadian Cancer Trials Group CO.26 Study. JAMA Oncol. 2020;6(6):831–838. link to article link to PMC article EuroPMC NCT02870920
==Placebo==
===Regimen===
Study 	Dates of enrollment 	Evidence 	Comparator 	Comparative Efficacy
Rao et al. 2004 	2000-03 to 2001-02 	Phase 3 (C) 	Tipifarnib 	Did not meet primary endpoint of OSMedian OS: 185 vs 174 days(HR not reported, p=0.376)
Yoshino et al. 2012 	2009-08-25 to 2010-04-12	Randomized Phase 2 (C)	Trifluridine and tipiracil	Shorter OSMedian OS: 6.6 vs 9 mo(HR 1.79, 95% CI 1.23-2.56)
Grothey et al. 2012 (CORRECT) 	2010-04-30 to 2011-03-22	Phase 3 (C) 	Regorafenib 	Shorter OSMedian OS: 5 vs 6.4 mo(HR 1.30, 95% CI 1.06-1.56)
Li et al. 2015 (CONCUR) 	2012-04-29 to 2013-02-06	Phase 3 (C) 	Regorafenib 	Shorter OSMedian OS: 6.3 vs 8.8 mo(HR 1.82, 95% CI 1.30-2.50)
Mayer et al. 2015 (RECOURSE) 	2012-06-17 to 2013-10-08	Phase 3 (C) 	Trifluridine and tipiracil	Shorter OSMedian OS: 5.3 vs 7.1 mo(HR 1.47, 95% CI 1.23-1.72)
Jonker et al. 2018 (NCIC-CTG CO.23) 	2013-04-15 to 2014-05-23	Phase 3 (C) 	Napabucasin 	Did not meet primary endpoint of OSMedian OS: 4.8 vs 4.4 mo(aHR 0.88, 95% CI 0.68-1.14)
Xu et al. 2017 (TERRA) 	2013-2015 	Phase 3 (C) 	Trifluridine and tipiracil	Seems to have shorter OSMedian OS: 7.1 vs 7.8 mo(HR 1.27, 95% CI 1.01-1.61)
Hickish et al. 2017 (2014-PT026) 	2014-05-20 to 2015-09-02	Phase 3 (C) 	MABp1 	Worse stable or increased lean body mass and stability or improvement in two of three symptoms (pain, fatigue, or anorexia) at week 8 compared with baseline measurements (primary endpoint)
Li et al. 2018 (FRESCO) 	2014-2016 	Phase 3 (C) 	Fruquintinib 	Shorter OSMedian OS: 6.6 vs 9.3 mo(HR 1.54, 95% CI 1.20-1.96)
Van Cutsem et al. 2018 (LUME-Colon 1)	2014-10 to 2016-01 	Phase 3 (C) 	Nintedanib 	Shorter PFS (co-primary endpoint)Median PFS: 1.4 vs 1.5 mo(HR 1.72, 95% CI 1.45-2.04)
Chi et al. 2021 (ALTER0703) 	2014-2016 	Phase 3 (C) 	Anlotinib 	Did not meet primary endpoint of OSMedian OS: 7.2 vs 8.6 mo(HR 0.98, 95% CI 0.79-1.22)
Dasari et al. 2023 (FRESCO-2) 	2020-08-12 to 2021-12-02	Phase 3 (C) 	Fruquintinib 	Shorter OSMedian OS: 4.8 vs 7.4 mo(HR 1.52, 95% CI 1.25-1.82)
No active antineoplastic treatment.
====Prior treatment criteria====
*FRESCO: At least 2 lines of chemotherapy but no prior VEGFR inhibitor therapy, with progression
*FRESCO-2: All current standard approved cytotoxic and targeted therapies and progressed on or were intolerant to trifluridine-tipiracil and/or regorafenib
===References===
#Rao S, Cunningham D, de Gramont A, Scheithauer W, Smakal M, Humblet Y, Kourteva G, Iveson T, Andre T, Dostalova J, Illes A, Belly R, Perez-Ruixo JJ, Park YC, Palmer PA. Phase III double-blind placebo-controlled study of farnesyl transferase inhibitor R115777 in patients with refractory advanced colorectal cancer. J Clin Oncol. 2004 Oct 1;22(19):3950-7. link to original article EuroPMC
#Yoshino T, Mizunuma N, Yamazaki K, Nishina T, Komatsu Y, Baba H, Tsuji A, Yamaguchi K, Muro K, Sugimoto N, Tsuji Y, Moriwaki T, Esaki T, Hamada C, Tanase T, Ohtsu A. TAS-102 monotherapy for pretreated metastatic colorectal cancer: a double-blind, randomised, placebo-controlled phase 2 trial. Lancet Oncol. 2012 Oct;13(10):993-1001. Epub 2012 Aug 28. link to original article EuroPMC JapicCTI-090880
#CORRECT: Grothey A, Van Cutsem E, Sobrero A, Siena S, Falcone A, Ychou M, Humblet Y, Bouché O, Mineur L, Barone C, Adenis A, Tabernero J, Yoshino T, Lenz HJ, Goldberg RM, Sargent DJ, Cihon F, Cupit L, Wagner A, Laurent D; CORRECT Study Group. Regorafenib monotherapy for previously treated metastatic colorectal cancer (CORRECT): an international, multicentre, randomised, placebo-controlled, phase 3 trial. Lancet. 2013 Jan 26;381(9863):303-12. Epub 2012 Nov 22. link to original article EuroPMC NCT01103323
##Dataset: Project Data Sphere
#CONCUR: Li J, Qin S, Xu R, Yau TC, Ma B, Pan H, Xu J, Bai Y, Chi Y, Wang L, Yeh KH, Bi F, Cheng Y, Le AT, Lin JK, Liu T, Ma D, Kappeler C, Kalmus J, Kim TW; CONCUR Investigators. Regorafenib plus best supportive care versus placebo plus best supportive care in Asian patients with previously treated metastatic colorectal cancer (CONCUR): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2015 Jun;16(6):619-29. Epub 2015 May 13. link to original article EuroPMC NCT01584830
#RECOURSE: Mayer RJ, Van Cutsem E, Falcone A, Yoshino T, Garcia-Carbonero R, Mizunuma N, Yamazaki K, Shimada Y, Tabernero J, Komatsu Y, Sobrero A, Boucher E, Peeters M, Tran B, Lenz HJ, Zaniboni A, Hochster H, Cleary JM, Prenen H, Benedetti F, Mizuguchi H, Makris L, Ito M, Ohtsu A; RECOURSE Study Group. Randomized trial of TAS-102 for refractory metastatic colorectal cancer. N Engl J Med. 2015 May 14;372(20):1909-19. link to original article EuroPMC NCT01607957
##Subgroup analysis: Van Cutsem E, Mayer RJ, Laurent S, Winkler R, Grávalos C, Benavides M, Longo-Munoz F, Portales F, Ciardiello F, Siena S, Yamaguchi K, Muro K, Denda T, Tsuji Y, Makris L, Loehrer P, Lenz HJ, Ohtsu A; RECOURSE Study Group. The subgroups of the phase III RECOURSE trial of trifluridine/tipiracil (TAS-102) versus placebo with best supportive care in patients with metastatic colorectal cancer. Eur J Cancer. 2018 Feb;90:63-72. Epub 2017 Dec 21. link to original article link to PMC article EuroPMC
#2014-PT026: Hickish T, Andre T, Wyrwicz L, Saunders M, Sarosiek T, Kocsis J, Nemecek R, Rogowski W, Lesniewski-Kmak K, Petruzelka L, Apte RN, Mohanty P, Stecher M, Simard J, de Gramont A. MABp1 as a novel antibody treatment for advanced colorectal cancer: a randomised, double-blind, placebo-controlled, phase 3 study. Lancet Oncol. 2017 Feb;18(2):192-201. Epub 2017 Jan 14. link to original article EuroPMC NCT02138422
#TERRA: Xu J, Kim TW, Shen L, Sriuranpong V, Pan H, Xu R, Guo W, Han SW, Liu T, Park YS, Shi C, Bai Y, Bi F, Ahn JB, Qin S, Li Q, Wu C, Ma D, Lin D, Li J. Results of a randomized, double-blind, placebo-controlled, phase III trial of trifluridine/tipiracil (TAS-102) monotherapy in Asian patients with previously treated metastatic colorectal cancer: The TERRA study. J Clin Oncol. 2018 Feb 1;36(4):350-358. Epub 2017 Dec 7. link to original article EuroPMC NCT01955837
#NCIC-CTG CO.23: Jonker DJ, Nott L, Yoshino T, Gill S, Shapiro J, Ohtsu A, Zalcberg J, Vickers MM, Wei AC, Gao Y, Tebbutt NC, Markman B, Price T, Esaki T, Koski S, Hitron M, Li W, Li Y, Magoski NM, Li CJ, Simes J, Tu D, O'Callaghan CJ. Napabucasin versus placebo in refractory advanced colorectal cancer: a randomised phase 3 trial. Lancet Gastroenterol Hepatol. 2018 Apr;3(4):263-270. Epub 2018 Feb 1. link to original article EuroPMC NCT01830621
#FRESCO: Li J, Qin S, Xu RH, Shen L, Xu J, Bai Y, Yang L, Deng Y, Chen ZD, Zhong H, Pan H, Guo W, Shu Y, Yuan Y, Zhou J, Xu N, Liu T, Ma D, Wu C, Cheng Y, Chen D, Li W, Sun S, Yu Z, Cao P, Chen H, Wang J, Wang S, Wang H, Fan S, Hua Y, Su W. Effect of fruquintinib vs placebo on overall survival in patients with previously treated metastatic colorectal cancer: the FRESCO randomized clinical trial. JAMA. 2018 Jun 26;319(24):2486-2496. link to original article link to PMC article EuroPMC NCT02314819
#LUME-Colon 1: Van Cutsem E, Yoshino T, Lenz HJ, Lonardi S, Falcone A, Limón ML, Saunders M, Sobrero A, Park YS, Ferreiro R, Hong YS, Tomasek J, Taniguchi H, Ciardiello F, Stoehr J, Oum'Hamed Z, Vlassak S, Studeny M, Argiles G. Nintedanib for the treatment of patients with refractory metastatic colorectal cancer (LUME-Colon 1): a phase III, international, randomized, placebo-controlled study. Ann Oncol. 2018 Sep 1;29(9):1955-1963. link to original article link to PMC article EuroPMC NCT02149108
##HRQoL analysis: Lenz HJ, Argiles G, Yoshino T, Lonardi S, Falcone A, Lim√≥n ML, Sobrero A, Hastedt C, Peil B, Voss F, Griebsch I, Van Cutsem E. Health-related Quality of Life in the Phase III LUME-Colon 1 Study: Comparison and Interpretation of Results From EORTC QLQ-C30 Analyses. Clin Colorectal Cancer. 2019 Dec;18(4):269-279.e5. link to original article link to EuroPMC
#ALTER0703: Chi Y, Shu Y, Ba Y, Bai Y, Qin B, Wang X, Xiong J, Xu N, Zhang H, Zhou J, Xu J, Cheng Y, Feng J, Hu C, Chen Y, Chen Z, Wang J, Dang C, Wang J, Wan Y, Tang Y, Wang D, Liu J, Wu M, Deng Y, Li X, Li Y, Dong J, Jiang D, Li G, Wu Q, Li J, Qi Y, Sun Y, Cai J. Anlotinib Monotherapy for Refractory Metastatic Colorectal Cancer: A Double-Blinded, Placebo-Controlled, Randomized Phase III Trial (ALTER0703). Oncologist. 2021 Oct;26(10):e1693-e1703. Epub 2021 Jun 25. link to original article link to PMC article EuroPMC NCT02332499
#FRESCO-2: Dasari A, Lonardi S, Garcia-Carbonero R, Elez E, Yoshino T, Sobrero A, Yao J, García-Alfonso P, Kocsis J, Cubillo Gracian A, Sartore-Bianchi A, Satoh T, Randrian V, Tomasek J, Chong G, Paulson AS, Masuishi T, Jones J, Csőszi T, Cremolini C, Ghiringhelli F, Shergill A, Hochster HS, Krauss J, Bassam A, Ducreux M, Elme A, Faugeras L, Kasper S, Van Cutsem E, Arnold D, Nanda S, Yang Z, Schelman WR, Kania M, Tabernero J, Eng C; FRESCO-2 Study Investigators. Fruquintinib versus placebo in patients with refractory metastatic colorectal cancer (FRESCO-2): an international, multicentre, randomised, double-blind, phase 3 study. Lancet. 2023 Jul 1;402(10395):41-53. Epub 2023 Jun 15. link to original article EuroPMC NCT04322539
Category:Colorectal cancer regimens
Category:Null regimens
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Category:Gastrointestinal cancers