Evaluate Efficacy and Safety of XELOX in Potentially Resectable Liver Metastasis From Colorectal Cancer(CRC)

Study Overview
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Brief Summary
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This is a single arm, open-label phase II study to evaluate the efficacy and safety of Capecitabine plus oxaliplatin (XELOX) in the peri-operative treatment of patients with potentially resectable liver metastasis from colorectal cancer.

Detailed Description
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To investigate the progression free survival (PFS) advantage of Xeloda plus oxaliplatin in the peri-operative treatment of potential resectable metastatic colorectal cancer

Official Title
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A Single Arm, Open-label Phase II Study to Evaluate the Efficacy and Safety of Capecitabine Plus Oxaliplatin (XELOX) in the Peri-operative Treatment of Patients With Potentially Resectable Liver Metastasis From Colorectal Cancer

Conditions
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Potentially Resectable Liver Metastasis From CRC, Colorectal Cancer

Intervention / Treatment
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* Drug: Capecitabine plus oxaliplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age of 18 and 65 Histologically confirmed colorectal cancer and two methords of imaging detection confirmed liver metastasis Potentially curable by resection, as determined by a surgeon with hepatic surgery expertise No evidence of extrahepatic disease by chest x-ray or CT scan of the chest, abdomen, and pelvis Patients with adequate hepative, renal and bone marrow function Signed written informed consent Exclusion Criteria: Pregnant or nursing patients (fertile patients must use effective contraception) Other malignancy within the past 5 years except completely resected nonmelanoma skin cancer or carcinoma in situ of the cervix Preexisting grade 2 or greater peripheral neuropathy Concurrent uncontrolled illness Ongoing or active infection Psychiatric illness or social situation that would preclude study compliance Less than 6 months since prior adjuvant fluorouracil-based chemotherapy Prior chemotherapy for liver metastasis Prior oxaliplatin for colorectal cancer Prior or concurrent hepatic artery infusion chemotherapy for metastatic disease Prior or concurrent radiotherapy for metastatic disease Prior or concurrent radiofrequency ablation for metastatic disease concurrent treatment with any other anti-cancer therapy.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Capecitabine plus oxaliplatin，mCRC<br> | Drug: Capecitabine plus oxaliplatin<br>* Xeloda: 1000mg/m2 bid, d1-14, q3w, Oxaliplatin:130mg/m2 d1, q3w, 4 pre-operative cycles, 4 post-operative cycles<br>* Other names: XELOX;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate the progression free survival (PFS) advantage of Xeloda plus oxaliplatin in the peri-operative treatment of potential resectable metastatic colorectal cancer |  | 3.6 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate the response rate |  | 3.6 years | 
| To evaluate the R0 resection rate |  | 3.6 years | 
| To evaluate the safety profile of XELOX peri-operative treatment |  | 3.6 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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XELOX, potentially resectable liver metastasis from CRC