Official Title: “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”

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.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: October 2015

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

Intervention(s) in this Clinical Trial

• Drug: Capecitabine plus oxaliplatin
  • Xeloda: 1000mg/m2 bid, d1-14, q3w, Oxaliplatin:130mg/m2 d1, q3w, 4 pre-operative cycles, 4 post-operative cycles

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Capecitabine plus oxaliplatin，mCRC

Primary Measures

• To investigate the progression free survival (PFS) advantage of Xeloda plus oxaliplatin in the peri-operative treatment of potential resectable metastatic colorectal cancer
  • Time Frame: 3.6 years
    Safety Issue?: No

Secondary Measures

• To investigate the response rate
  • Time Frame: 3.6 years
    Safety Issue?: No
• To evaluate the R0 resection rate
  • Time Frame: 3.6 years
    Safety Issue?: No
• To evaluate the safety profile of XELOX peri-operative treatment
  • Time Frame: 3.6 years
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Guangdong General Hospital

Overall Clinical Trial Officials and Contacts

Feng Lin Principal Investigator Guangdong General Hospital  

Overall Contact: Feng Lin, Dr +8613903018609 

Information obtained from ClinicalTrials.gov on February 08, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00997685

Study ID Number: ML22298

ClinicalTrials.gov Identifier: NCT00997685

Health Authority: China: Ethics Committee