Status:
UNKNOWN
Phase 3 Study of Surgery Combined With Neoadjuvant Chemotherapy(XELOX) in Colorectal Cancer With Resectable Liver Metastasis
Lead Sponsor:
Peking University People's Hospital
Collaborating Sponsors:
Peking University
Sanofi
Conditions:
Colorectal Cancer
Resectable Liver Metastasis
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
This study aims to discuss the efficacy and safety of neoadjuvant chemotherapy with XELOX regimen (oxaliplatin plus capecitabine) .
Detailed Description
Liver metastasis is the most important prognostic factor of colorectal cancer. Reasonable multidisciplinary therapy might improve the prognosis of patients with liver metastasis. Surgery has been the ...
Eligibility Criteria
Inclusion
- Histologically confirmed colorectal cancer with liver metastasis(all patients should have the pathological report of colorectal cancer. The chances of hepatocellular carcinoma or metastasis from other primary lesions should be excluded. )
- Liver metastasis should be resected with R0 resection and to save enough normal liver tissue
- Anticipated liver resection: for normal liver, ﹤70%; for liver with cirrhosis, ﹤50%
- No metastasis of other organs or lymph nodes in abdominal cavity
- No previous use of oxaliplatin and capecitabine, or previous adjuvant treatment ended more than 6 months
- Age 18 to 75 years old
- Karnofsky performance status ≥70
- Life expectancy of ≥3 month
- Bilirubin level \< 1.5mg/dL
- Serum creatinine \<1.0 times ULN
- Absolute neutrophil count ≥2000/mm3, platelet\>100,000/mm3, Hb\>9g/dl
- Having signed informed consent
Exclusion
- previous use of oxaliplatin or fluorouracil-based chemotherapy in 6 months.
- No R0 resection or not enough normal liver tissue left
- previous radiotherapy of target lesions
- accompanied with unresectable other metastasis or malignant pleural fluids or ascites.
- complete or uncompleted liver obstruction
- peripheral neuropathy(NCI-CTC grade 1 or more)
- mental disturbance neuropathy that influence the cognition, including brain metastasis
- other serious disease such as uncontrollable active infection, heart infarction with 1 year, un controlled hypertension, arrhythmia with high risk, or unstable heart infarction,heart failure, coronary artery disease, myocardial infarction within the last 6 months
- Other previous malignancy within 5 year, except non-melanoma skin cancer
- accompany with other anti-tumor therapies,including immune therapy, intervention or injection with chemotherapeutical agents into serous cavity, or participating other clinical trials.
- Pregnancy or lactation period
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2015
Estimated Enrollment :
392 Patients enrolled
Trial Details
Trial ID
NCT00630045
Start Date
January 1 2008
End Date
June 1 2015
Last Update
March 6 2008
Active Locations (2)
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1
Peking University, School of Oncology
Beijing, Beijing Municipality, China, 100036
2
Peking University, People's Hospital
Beijing, China, 100044