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Compare FOFLOX4 in Preoperative and Postoperative and Postoperative in Resectable Liver Metastasis Colorectal Cancer (MCC)
Conditions
Colorectal Cancer - Liver Metastasis
Conditions: official terms
Colorectal Neoplasms - Liver Neoplasms - Neoplasm Metastasis
Conditions: Keywords
FOFLOX4, resectable liver metastasis from colorectal cancer
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: FOFLOX4
Type: Drug
Overall Status
Recruiting
Summary
This study is a multicenter, open-label, randomized ,controlled phase III study to compare preoperative and postoperative with FOFLOX4 chemotherapy and postoperative with FOFLOX4 chemotherapy in patients with resectable liver metastasis from colorectal cancer.
Detailed Description
To investigate the three-year progression free survival (PFS) advantage of FOLFOX4 in the treatment of resectable metastatic colorectal cancer.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 80 Years
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:
1. Resectable liver metastasis from colorectal cancer(the distance from the tumor lower edge to anal more than 12cm),no visible extrahepatic metastatic tumors. Curable by resection, as determined by a surgeon and imaging physicians. The minimum of the liver metastases needs ≥2cm. Patients can be recruited if meet the conditions about:
- Primary tumor had been removed of the metachronous liver metastasis patients and no residue from the eyes or microscope.
- Primary tumor has been removed more than 1 month of the simultaneous liver metastasis patients.
2. Age of≥18 and ≤80
3. ECOG≤2
4. Signed written informed consent
Exclusion Criteria:
1. Peripheral neuropathy(CTC＞1)
2. Had a neurological or mental disorders
3. Active infection
4. Allergy to Platinum-based and other drugs
5. Other acute diseases including infection, heart-disease(CHF, stable or unstable angina)
6. Pregnant or nursing patients
1. Resectable liver metastasis from colorectal cancer(the distance from the tumor lower edge to anal more than 12cm),no visible extrahepatic metastatic tumors. Curable by resection, as determined by a surgeon and imaging physicians. The minimum of the liver metastases needs ≥2cm. Patients can be recruited if meet the conditions about:
- Primary tumor had been removed of the metachronous liver metastasis patients and no residue from the eyes or microscope.
- Primary tumor has been removed more than 1 month of the simultaneous liver metastasis patients.
2. Age of≥18 and ≤80
3. ECOG≤2
4. Signed written informed consent
Exclusion Criteria:
1. Peripheral neuropathy(CTC＞1)
2. Had a neurological or mental disorders
3. Active infection
4. Allergy to Platinum-based and other drugs
5. Other acute diseases including infection, heart-disease(CHF, stable or unstable angina)
6. Pregnant or nursing patients
Location
Guangdong General Hospital
Guangzhou, Guangdong, China
Status: Recruiting
Contact: Yong Li, Dr - yongyongsamrt@yahoo.cn
Start Date
September 2009
Completion Date
December 2015
Sponsors
Guangdong General Hospital
Source
Guangdong General Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
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