Status:
UNKNOWN
Evaluate Efficacy and Safety of XELOX in Potentially Resectable Liver Metastasis From Colorectal Cancer(CRC)
Lead Sponsor:
Guangdong Provincial People's Hospital
Conditions:
Potentially Resectable Liver Metastasis From CRC
Colorectal Cancer
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
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 liv...
Detailed Description
To investigate the progression free survival (PFS) advantage of Xeloda plus oxaliplatin in the peri-operative treatment of potential resectable metastatic colorectal cancer
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2015
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT00997685
Start Date
November 1 2009
End Date
October 1 2015
Last Update
October 19 2009
Active Locations (1)
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1
Guangdong General Hospital
Guangzhou, Guangdong, China, 510080