Compare FOFLOX4 in Preoperative and Postoperative and Postoperative in Resectable Liver Metastasis Colorectal Cancer (MCC)

Official Title: “Phase III Study to Compared Preoperative and Postoperative With FOFLOX4 Chemotherapy and Postoperative With FOFLOX4 Chemotherapy in Patients With Resectable Liver Metastasis From Colorectal Cancer”

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.

To investigate the three-year progression free survival (PFS) advantage of FOLFOX4 in the treatment of resectable metastatic colorectal cancer.

Intervention(s) in this Clinical Trial

• Drug: FOFLOX4
  • FOLFOX4:Oxaliplatin 85mg/m2 ivgtt d1 2hr calcium leucovorin:200mg/m2 ivgtt d1 d2 2hr fluorouracil:400mg/m2 iv d1 d2 fluorouracil:600mg/m2 civ d1 d2 22hr 2 weeks repeated one cycles

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: FOFLOX4,resectable liver metastasis from CRC

Primary Measures

• progression free survival (PFS)
  • Time Frame: 3 years
    Safety Issue?: No

Secondary Measures

• response rate, incidence of postoperative complications,pathological response rate,R0 resection rate, 5-year overall survival,duration of disease control
  • Time Frame: 5 years
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Guangdong General Hospital Other

Overall Clinical Trial Officials and Contacts

Feng Lin, Dr Principal Investigator Guangdong General Hospital  

Overall Contact: Feng Lin, Dr 86-20-83827812-60910 

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01035385

Study ID Number: VORP019

ClinicalTrials.gov Identifier: NCT01035385

Health Authority: China: Ethics Committee