Phase 3 Study of Surgery Combined With Neoadjuvant Chemotherapy(XELOX) in Colorectal Cancer With Resectable Liver Metastasis
NCT ID: NCT00630045
Last Updated: 2008-03-06
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
PHASE3
392 participants
INTERVENTIONAL
2008-01-31
2015-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
2\~3 cycles of neoadjuvant chemotherapy before resection of liver metastasis
neoadjuvant chemotherapy with oxaliplatin and capecitabine
oxaliplatin: 130mg/m2, d1(Q3w) capecitabine:1000mg/m2 bid, d1-14(Q3w)
resection of liver metastasis
surgery with the aim of R0 resection
2
no neoadjuvant chemotherapy, resect the liver metastasis directly
resection of liver metastasis
surgery with the aim of R0 resection
Interventions
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neoadjuvant chemotherapy with oxaliplatin and capecitabine
oxaliplatin: 130mg/m2, d1(Q3w) capecitabine:1000mg/m2 bid, d1-14(Q3w)
resection of liver metastasis
surgery with the aim of R0 resection
Eligibility Criteria
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Inclusion Criteria
2. Liver metastasis should be resected with R0 resection and to save enough normal liver tissue
3. Anticipated liver resection: for normal liver, ﹤70%; for liver with cirrhosis, ﹤50%
4. No metastasis of other organs or lymph nodes in abdominal cavity
5. No previous use of oxaliplatin and capecitabine, or previous adjuvant treatment ended more than 6 months
6. Age 18 to 75 years old
7. Karnofsky performance status ≥70
8. Life expectancy of ≥3 month
9. Bilirubin level \< 1.5mg/dL
10. Serum creatinine \<1.0 times ULN
11. Absolute neutrophil count ≥2000/mm3, platelet\>100,000/mm3, Hb\>9g/dl
12. Having signed informed consent
Exclusion Criteria
2. No R0 resection or not enough normal liver tissue left
3. previous radiotherapy of target lesions
4. accompanied with unresectable other metastasis or malignant pleural fluids or ascites.
5. complete or uncompleted liver obstruction
6. peripheral neuropathy(NCI-CTC grade 1 or more)
7. mental disturbance neuropathy that influence the cognition, including brain metastasis
8. 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
9. Other previous malignancy within 5 year, except non-melanoma skin cancer
10. accompany with other anti-tumor therapies,including immune therapy, intervention or injection with chemotherapeutical agents into serous cavity, or participating other clinical trials.
11. Pregnancy or lactation period
18 Years
75 Years
ALL
No
Sponsors
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Peking University
OTHER
Sanofi
INDUSTRY
Peking University People's Hospital
OTHER
Responsible Party
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Peking University People's Hospital,Department of General Surgery
Principal Investigators
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Shan Wang, MD
Role: PRINCIPAL_INVESTIGATOR
Peking University People's Hospital, Department of General Surgery
Lin Shen, MD
Role: PRINCIPAL_INVESTIGATOR
Peking University, School of Oncology, Department of GI Oncology
Locations
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Peking University, School of Oncology
Beijing, Beijing Municipality, China
Peking University, People's Hospital
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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OXALIC
Identifier Type: -
Identifier Source: org_study_id
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