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

Guangdong Provincial People's Hospital (Guangdong Provincial Academy of Medical Sciences)

Status and phase: Unknown; Phase 2

Conditions: Potentially Resectable Liver Metastasis From CRC; Colorectal Cancer

Treatments: Drug: Capecitabine plus oxaliplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT00997685

ML22298

Details and patient eligibility

About

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.

Full description

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

Enrollment: 110 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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110 participants in 1 patient group

Capecitabine plus oxaliplatin，mCRC

Experimental group

Treatment:

Drug: Capecitabine plus oxaliplatin