Postoperative Folfox4 Only Versus Folfox4 Plus Transhepatic Arterial Chemotherapy (TAC) in the Treatment Unresectable Liver Metastasis of Colorectal Cancer

Study Overview
=================
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.

Official Title
-----------------
Postoperative folfox4 Only vs folfox4 Plus TAC in the Treatment Unresectable Liver Metastasis of Colorectal Cancer: a Randomized,Prospective,Control Trial

Conditions
-----------------
Unresectable Liver Metastasis of Colorectal Cancer

Intervention / Treatment
-----------------
* Procedure: tac + folfox4
* Procedure: Folfox4


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>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. | Procedure: tac + folfox4<br>* 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.<br>|
| Active Comparator: 2<br>folfox4 chemotherapy was done within 28 days after primary surgery. Per 3 weeks, patients will receive one cycle. | Procedure: Folfox4<br>* folfox4 Folfox4 chemotherapy was done within 28 days after primary surgery. Per 3 weeks, patients will receive one cycle<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | 5 years after diagnosis | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression free survival |  | 5 years after diagonsis | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
liver metastasis, colorectal cancer