Clinical trial NCT00997685: Evaluate Efficacy and Safety of XELOX in Potentially Resectable Liver Metastasis From Colorectal Cancer(CRC)
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Potentially Resectable Liver Metastasis From CRC
Colorectal Cancer
Keywords: XELOX
potentially resectable liver metastasis from CRC
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
First posted: 2009-10-19
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility 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.

Primary outcomes:
measure: To investigate the progression free survival (PFS) advantage of Xeloda plus oxaliplatin in the peri-operative treatment of potential resectable metastatic colorectal cancer
timeFrame: 3.6 years
Secondary outcomes:
measure: To investigate the response rate
timeFrame: 3.6 years
measure: To evaluate the R0 resection rate
timeFrame: 3.6 years
measure: To evaluate the safety profile of XELOX peri-operative treatment
timeFrame: 3.6 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong General Hospital
state: Guangdong
Study officials:
affiliation: Guangdong Provincial People's Hospital
name: Feng Lin
role: PRINCIPAL_INVESTIGATOR
References: