The Role of Neoadjuvant Chemotherapy in Locally Advanced Colon Cancer

Figures & data

Table 1 Completed and ongoing clinical trials using neoadjuvant chemotherapy for locally advanced colon cancer

Phase/trial name or lead institution	Regimen	Intervention	Control	Primary outcome	Results
Phase II^Citation7,Citation93	FOLFOX or FOLFOX + cetuximab	Neo (4 cycles) + Adj (8 cycles)	Adj (12 cycles)	Histological tumor response (considered significant if 10% achieved TRG1^a)	8% TRG1^a
					36% TRG2^b
PRODIGE-22/ECKINOXE
Phase III	CAPOX or FOLFOX ± panitumumab	Neo (12 weeks) + Adj (18 weeks)	Adj (24 weeks)	RFS, tumor downstaging	2-year failure rate 14% vs 18% (HR 0.77, 95% CI 0.56–1.06; p=0.11)
FOxTROT^Citation80,Citation94
					T stage and N stage lower in intervention arm (both MH^c <0.0001)
Phase III^Citation95	Choice of FOLFOX, CAPOX, FOLFIRI, or capecitabine	Neo + Adj (6 months)	Adj (6 months)	3-year DFS	Ongoing
Nanjing Medical University
Phase III^Citation96	FOLFOX	Neo (4 cycles) + Adj (8 cycles)	Adj (12 cycles)	3-year RFS	Ongoing
Kyungpook National University Hospital
Phase III^Citation97	CAPOX	Neo (3 cycles)	Adj (4 or 8 cycles)	2-year DFS	Ongoing
				Number requiring adjuvant chemotherapy
		Adj (5 cycles), only if indicated
Vejle Hospital
Phase II^Citation98	CAPOX	Neo (3 cycles) + Adj (5 cycles)	Adj (8 cycles)	2-year DFS	Ongoing
ELECLA
Phase II^Citation99	Foxy5, FOLFOX	Neo Foxy-5 + Adj Foxy5 plus FOLFOX in Wnt-low tumors	Adj (6 months)	Safety and tolerability, ctDNA	Ongoing
WntResearch AB
Phase II^Citation76	FOLFOXIRI	Neo (4 cycles) single arm	—	Tumor downstaging	Ongoing
China Medical University
Phase II/III^Citation100	CAPOX or FOLFOX (T4 tumors only)	Neo (4 cycles)	Surgery alone	3-year DFS	Ongoing
Fudan University
Phase III^Citation84	CAPOX plus radiotherapy (unresectable tumors only)	Neo (4 cycles) plus radiotherapy + Adj	CAPOX Neo + Adj (without radiotherapy)	5-year OS	Ongoing
Sun Yat-Sen University

Abbreviations: Neo, neoadjuvant; Adj, adjuvant; DFS, disease-free survival; RFS, relapse-free survival; TRG, tumor-regression grade.^acomplete or near-complete response;^{67 b}significant tumor regression;⁶⁷ cMantel–Haenszel statistic.

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