Table 1.
Ongoing neoadjuvant therapy trials in localized colon cancer
| Trial Number | Intervention | Population | Status | Phase | Accrual Goal | Location(s) | Primary Endpoint |
|---|---|---|---|---|---|---|---|
| NCT03125980 | CAPOX ×4 → surgery → CAPOX ×4 Vs. surgery → CAPOX ×8 |
LACC | Recruiting | III | 1370 | China | 3-year DFS |
| NCT03426904 | neoadjuvant FOLFOX ×4 → surgery → adjuvant FOLFOX ×8 vs. surgery → adjuvant FOLFOX × 12 |
LACC | Recruiting | III | 560 | Korea | RFS |
| NCT01918527 | neoadjuvant CAPOX ×3 → surgery → adjuvant CAPOX (if indicated based on pathology) vs. surgery → adjuvant CAPOX ×4–8 |
LACC | Recruiting | III | 250 | Denmark Sweden Norway |
2-year DFS |
| NCT02972541 (NACSOC) | colonic stent → FOLFOX ×3 or CAPOX ×2 → surgery → FOLFOX ×5–9 or CAPOX ×4–6 vs. colonic stent → surgery → FOLFOX ×8–12 or CAPOX ×6–8 |
LACC | Recruiting | 248 | China | DFS | |
| NCT04188158 (ELECLA) | neoadjuvant CAPOX ×3 → surgery → adjuvant CAPOX ×5 vs. surgery → adjuvant CAPOX ×8 |
LACC | Recruiting | II | 238 | Spain | 2-year DFS |
| NCT01675999 (ECKINOXE) | neoadjuvant FOLFOX ×4 ± cetuximab → surgery → adjuvant FOLFOX ×8 ± cetuximab vs. surgery → adjuvant FOLFOX ×12 |
LACC | Recruiting | II | 186 | France | Tumor response by TRG |
| NCT03026140 (NICHE) | ipilimumab + nivolumab ± celecoxib → surgery | Stages I–III CC | Recruiting | II | 60 | Netherlands | Safety |
| NCT04231526 | pembrolizumab → surgery vs. surgery |
LACC | Not yet recruiting | II | 46 | USA | Feasibility |
| NCT03985891 | toripalimab (anti-PD1) + FOLFOX ×6 → surgery → same ×6 vs. FOLFOX ×6 → surgery → FOLFOX ×6 |
LACC | Not yet recruiting | I/II | 40 | China | pCR rate rCR rate ORR |
| NCT03484195 | FOLFOXIRI ×4 → surgery | LACC | Not yet recruiting | II | 30 | China | Tumor downstaging |
Abbreviations: CAPOX = capecitabine+oxaliplatin, LACC = locally advanced colon cancer, DFS = disease free survival, FOLFOX = 5-fluorouracil+folinic acid + oxaliplatin, RFS = relapse free survival, TRG = tumor response grade, CC = colon cancer, pCR = pathologic complete response, rCR = radiographic complete response, ORR = objective response rate, FOLFOXIRI = 5-FU + folinic acid + oxaliplatin + irinotecan.