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

Phase 3

• Conditions: Colorectal Cancer; Liver Metastasis
• Interventions: Drug: FOFLOX4

• Registration Number: NCT01035385
• Lead Sponsor: Guangdong Provincial People's Hospital

Brief 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.

Study Timeline

• Status Verified: 2009-09
• Study Start: 2009-09
• Study First Submitted: 2009-12-16
• Study First Submitted QC: 2009-12-17
• Last Update Submitted: 2009-12-17
• Study First Posted: 2009-12-18
• Last Update Posted: 2009-12-18
• Primary Completion: 2012-10
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 340

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FOFLOX4,resectable liver metastasis from CRC	FOFLOX4	-

Primary Outcome Measures

Name	Time	Method
progression free survival (PFS)	3 years

Secondary Outcome Measures

Name	Time	Method
response rate, incidence of postoperative complications,pathological response rate,R0 resection rate, 5-year overall survival,duration of disease control	5 years

Trial Locations

Locations (1)

Guangdong General Hospital; 🇨🇳 Guangzhou, Guangdong, China