Compare FOFLOX4 in Preoperative and Postoperative and Postoperative in Resectable Liver Metastasis Colorectal Cancer (MCC)

Study Overview
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Brief Summary
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This study is a multicenter, open-label, randomized ,controlled phase III study to compare preoperative and postoperative with FOFLOX4 chemotherapy and postoperative with FOFLOX4 chemotherapy in patients with resectable liver metastasis from colorectal cancer.

Detailed Description
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To investigate the three-year progression free survival (PFS) advantage of FOLFOX4 in the treatment of resectable metastatic colorectal cancer.

Official Title
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Phase III Study to Compared Preoperative and Postoperative With FOFLOX4 Chemotherapy and Postoperative With FOFLOX4 Chemotherapy in Patients With Resectable Liver Metastasis From Colorectal Cancer

Conditions
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Colorectal Cancer, Liver Metastasis

Intervention / Treatment
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* Drug: FOFLOX4


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Resectable liver metastasis from colorectal cancer(the distance from the tumor lower edge to anal more than 12cm),no visible extrahepatic metastatic tumors. Curable by resection, as determined by a surgeon and imaging physicians. The minimum of the liver metastases needs ≥2cm. Patients can be recruited if meet the conditions about: Primary tumor had been removed of the metachronous liver metastasis patients and no residue from the eyes or microscope. Primary tumor has been removed more than 1 month of the simultaneous liver metastasis patients. Age of≥18 and ≤80 ECOG≤2 Signed written informed consent Exclusion Criteria: Peripheral neuropathy(CTC>1) Had a neurological or mental disorders Active infection Allergy to Platinum-based and other drugs Other acute diseases including infection, heart-disease(CHF, stable or unstable angina) Pregnant or nursing patients

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: FOFLOX4,resectable liver metastasis from CRC<br> | Drug: FOFLOX4<br>* FOLFOX4:Oxaliplatin 85mg/m2 ivgtt d1 2hr calcium leucovorin:200mg/m2 ivgtt d1 d2 2hr fluorouracil:400mg/m2 iv d1 d2 fluorouracil:600mg/m2 civ d1 d2 22hr 2 weeks repeated one cycles<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression free survival (PFS) |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| response rate, incidence of postoperative complications,pathological response rate,R0 resection rate, 5-year overall survival,duration of disease control |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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FOFLOX4, resectable liver metastasis from colorectal cancer