Evaluate Efficacy and Safety of XELOX in Potentially Resectable Liver Metastasis From Colorectal Cancer(CRC)
Conditions
Potentially Resectable Liver Metastasis From CRC - Colorectal Cancer
Conditions: official terms
Colorectal Neoplasms - Liver Neoplasms - Neoplasm Metastasis
Conditions: Keywords
XELOX, potentially resectable liver metastasis from CRC
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Capecitabine plus oxaliplatin
Type: Drug
Overall Status
Not yet recruiting
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.
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
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 65 Years
Minimum Age: 18 Years
Gender: Both
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.
Location
Guangdong General Hospital
Guangzhou, Guangdong, China
Status: Not yet recruiting
Contact: Yong Li, Dr - yongyongsamrt@yahoo.cn
Start Date
November 2009
Completion Date
October 2015
Sponsors
Guangdong General Hospital
Source
Guangdong General Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page