Transhepatic Arterial Chemotherapy (TAC) Versus Transcatheter Arterial Chemoembolization (TACE) Plus Folfox4 as the Treatment of Unresectable Liver Metastasis of Colorectal Cancer

Study Overview
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Brief Summary
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The purpose of this study is to investigate whether TAC plus FOLFOX4 or TACE plus folfox4 are able to improve resection rate and overall survival in patients receiving primary colorectal tumor resection than given FOLFOX4 only.

Detailed Description
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We administered three cycles FOLFOX4 plus TAC(oxaliplatin,FUDR and MMC) or FOLFOX4 plus TACE(oxaliplatin,FUDR,MMC and embolision) 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
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TAC vs TACE Plus folfox4 as the Treatment of Unresectalbe Liver Metastasis of Colorectal Cancer With Resection of the Primary Tumor: a Prospective, Randomized, Control Trial

Conditions
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Colorectal Cancer, Liver Metastasis

Intervention / Treatment
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* Procedure: TACE + folfox 4
* Procedure: TAC + folfox4


Participation Criteria
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Eligibility Criteria
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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
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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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 chemoembolision (TACE) using oxaliplatin, fudr, mmc and iodine. Then begin folfox4 again. | Procedure: TACE + folfox 4<br>* tace: oxaliplatin 100mg + fudr 1g + mmc 10mg + iodine 2ml folfox4<br>|
| Active Comparator: 2<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<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| resection rate of liver metastasis progression-free survival |  | 5 years after operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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liver metastasis, colorectal cancer, oxaliplatine, transartery chemotherapy, embolision, Unresectable Liver Metastasis of Colorectal Cancer