Neoadjuvant FOLFOX6 + Cetuximab in Patients With Colorectal Cancer and Unresectable Liver Metastasis
Unresectable Liver Metastasis
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Neoadjuvant FOLFOX6 Plus Cetuximab in Patients With Colorectal Cancer and Unresectable Liver Metastasis|
- To evaluate overall R0 resection rates following neoadjuvant FOLFOX6 plus cetuximab in patients with colorectal cancer and unresectable liver-only metastasis [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
- Response rate (according to RECIST) [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
- Progression-free survival time [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
- Overall survival timeToxicity profile (according to NCI CTCAE v3) [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
- Correlative analyses between pretreatment EGFR, KRAS mutation and response rate/survival [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2008|
|Study Completion Date:||June 2012|
|Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
NEO : Neoadjuvant therapy with FOLFOX6 plus cetuximab
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00743678
|Korea, Republic of|
|Samsung Medical Center|
|Seoul, Korea, Republic of, 135-710|
|Principal Investigator:||Young Suk Park, M.D.,Ph.D.||Samsung Medical Center, Seoul, Korea|