A Phase II Study of Neoadjuvant FOLFOX6 Plus Cetuximab in Patients With Colorectal Cancer and Unresectable Liver Metastasis
We will include the patients with unresectable liver-only metastatic disease independent of
EGFR status. The results of this study will show the resection rate with neoadjuvant
treatment in patients with colorectal cancer with liver-only metastasis.
Restaging including CT after #3, #6, #9, and #12 cycles of FOLFOX + Cetuximab
If any time, patients have PD, Off-study SD, Continue study treatment until resectable, up
to #12 cycles, PD, or toxicities PR or more, If resectable, go to surgery : resection of
liver metastasis and primary tumor, if present If unresectable, continue until resectable,
up to #12 cycles, PD, or toxicities
Overall, a total of 12 cycles of treatment including neoadjuvant therapy will be given
either before, after or without surgery.
CT scans will be performed every 3 cycles during the first 12 cycles (6 months). After that,
CT scans will be performed every 2 months for another 6 months, then every 3 months for 6
months, then once a year or earlier if a PD is probable.
AEs will be evaluated once every cycle and during the CT evaluation visit.. Patients that
can only undergo R1 resection or are unable to get surgery at all, will be evaluated
regularly until PD.
Radiofrequency ablation (RFA) may be allowed as a palliative local therapy in patients that
are suitable for it. RFA is not considered equal to a resection.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate overall R0 resection rates following neoadjuvant FOLFOX6 plus cetuximab in patients with colorectal cancer and unresectable liver-only metastasis
Young Suk Park, M.D.,Ph.D.
Samsung Medical Center, Seoul, Korea
Korea: Food and Drug Administration