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

Phase 2

• Conditions: Colorectal Cancer; Potentially Resectable Liver Metastasis From CRC
• Interventions: Drug: Capecitabine plus oxaliplatin

• Registration Number: NCT00997685
• Lead Sponsor: Guangdong Provincial People's Hospital

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 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

Study Timeline

• Status Verified: 2009-10
• Study First Submitted: 2009-10-18
• Study First Submitted QC: 2009-10-18
• Last Update Submitted: 2009-10-18
• Study First Posted: 2009-10-19
• Last Update Posted: 2009-10-19
• Study Start: 2009-11
• Primary Completion: 2015-10
• Study Completion: 2015-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 110

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Capecitabine plus oxaliplatin，mCRC	Capecitabine plus oxaliplatin	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
To evaluate the safety profile of XELOX peri-operative treatment	3.6 years
To evaluate the R0 resection rate	3.6 years
To investigate the response rate	3.6 years

Trial Locations

Locations (1)

Guangdong General Hospital; 🇨🇳 Guangzhou, Guangdong, China