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

Guangdong Provincial People's Hospital1 site in 1 country340 target enrollmentSeptember 2009

ConditionsColorectal Cancer Liver Metastasis

InterventionsFOFLOX4

DrugsFOFLOX4

Overview

Phase: Phase 3
Intervention: FOFLOX4
Conditions: Colorectal Cancer
Sponsor: Guangdong Provincial People's Hospital
Enrollment: 340
Locations: 1
Primary Endpoint: progression free survival (PFS)
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2009

End Date

December 2015

Last Updated

16 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Guangdong Provincial People's Hospital

Eligibility Criteria

Inclusion Criteria

•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.
•Age of≥18 and ≤80
•Signed written informed consent

Exclusion Criteria

•Peripheral neuropathy(CTC\>1)
•Had a neurological or mental disorders
•Active infection
•Allergy to Platinum-based and other drugs
•Other acute diseases including infection, heart-disease(CHF, stable or unstable angina)
•Pregnant or nursing patients

Arms & Interventions

FOFLOX4,resectable liver metastasis from CRC

Intervention: FOFLOX4

Outcomes

Primary Outcomes

progression free survival (PFS)

Time Frame: 3 years

Secondary Outcomes

response rate, incidence of postoperative complications,pathological response rate,R0 resection rate, 5-year overall survival,duration of disease control(5 years)