Unresectable Liver Metastasis of Colorectal Cancer
Conditions
Keywords
liver metastasis, colorectal cancer
Brief summary
The purpose of this study is to investigate whether TAC plus FOLFOX4 are able to improve resection rate and overall survival in patients receiving primary colorectal tumor resection than given FOLFOX4 only.
Detailed description
We administered three cycles FOLFOX4 plus on TAC (oxaliplatin, FUDR and MMC) or FOLFOX4 only to primary colorectal tumor resected patients with unresected liver metastasis. The study endpoints were resection rate of liver metastasis, progression-free survival, overall survival as evaluated by intent-to-treat analysis.
Interventions
PROCEDUREtac + folfox4
tac: oxaliplatin 100mg + fudr 1g + mmc 10mg folfox4 Folfox4 chemotherapy was done within 28 days after primary surgery. Per 3 weeks, patients will receive one cycle. After 3 cycles, patients will received transhepatic arterial chemotherapy(TAC) using oxaliplatin, fudr and mmc. Then begin folfox4 again.
PROCEDUREFolfox4
folfox4 Folfox4 chemotherapy was done within 28 days after primary surgery. Per 3 weeks, patients will receive one cycle
Sponsors
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* age \< 75 years with histologically proven adenocarcinoma of the colon or rectum * no severe major organ dysfunction * WHO performance status of 0 or 1 * no prior cancer therapy * with measurable unresectableliver metastasis * without other metastasis
Exclusion criteria
* age \>= 75 * severe major organ dysfunction * WHO performance status of \>1 * prior cancer therapy * with other metastasis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival | 5 years after diagnosis |
Secondary
| Measure | Time frame |
|---|---|
| progression free survival | 5 years after diagonsis |
Countries
China
Outcome results
None listed