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

• Status: Unknown status
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: All

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 liver metastasis from colorectal cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Guangdong General Hospital; Guangdong Provincial People's Hospital
• Treatments: Capecitabine; Oxaliplatin

Criteria

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.