Evaluate Efficacy and Safety of XELOX in Potentially Resectable Liver Metastasis From Colorectal Cancer(CRC)
NCT ID: NCT00997685
Last Updated: 2009-10-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
110 participants
INTERVENTIONAL
2009-11-30
2015-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Capecitabine plus oxaliplatin，mCRC
Capecitabine plus oxaliplatin
Xeloda: 1000mg/m2 bid, d1-14, q3w, Oxaliplatin:130mg/m2 d1, q3w,
4 pre-operative cycles, 4 post-operative cycles
Interventions
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Capecitabine plus oxaliplatin
Xeloda: 1000mg/m2 bid, d1-14, q3w, Oxaliplatin:130mg/m2 d1, q3w,
4 pre-operative cycles, 4 post-operative cycles
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Guangdong Provincial People's Hospital
OTHER
Responsible Party
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Guangdong General Hospital
Principal Investigators
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Feng Lin
Role: PRINCIPAL_INVESTIGATOR
Guangdong Provincial People's Hospital
Locations
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Guangdong General Hospital
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Feng Lin, Dr
Role: CONTACT
Facility Contacts
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Other Identifiers
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ML22298
Identifier Type: -
Identifier Source: org_study_id
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