Neoadjuvant FOLFOXIRI Versus Immediate Surgery for Stage II and III Colon Cancers
Status:
Recruiting
Trial end date:
2026-12-01
Target enrollment:
Participant gender:
Summary
BACKGROUND:
In patients with high risk stage II and stage III colon cancer (CC), curative surgery
followed by adjuvant chemotherapy with FOLFOX or CAPOX regimens has become a standard
treatment. However, 20 to 30 % of these patients will develop distant metastasis, which
ultimately result in death. Perioperative chemotherapy is a promising strategy with potential
benefits that could be more effective at eradicating micrometastases. Moreover, shrinking
tumor before surgery not only facilitate removal of all the tumor by the surgeon but also
reduce tumor cell spreading during the procedure. With recent advances in radiology,
preoperative computed tomography allows a good prediction of tumor stage (wall penetration
and nodal involvement) prior to surgery. The investigators conducted the present randomized
study to explore whether perioperative chemotherapy with FOLFOXIRI regimen compared with
postoperative chemotherapy could improve disease-free survival in patients with
radiologically staged, High-risk, but resectable Stage II or III colon cancer.
OBJECTIVE:
The primary objective of this study is to evaluate the efficacy of perioperative chemotherapy
with FOLFOXIRI regimen compared to postoperative chemotherapy in patients with High-risk
Resectable Stage II and III colon cancer. Secondary objectives are efficacy in terms of R0
resection rate, overall survival (OS), relapse-free survival (RFS), down-staging of primary
tumors, and tolerability of perioperative therapy and postoperative complications.