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

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01035385
• Other study ID #: VORP019
• Status: Recruiting
• Phase: Phase 3
• First received: December 16, 2009
• Last updated: December 17, 2009
• Start date: September 2009
• Est. completion date: December 2015

Study information

• Verified date: September 2009
• Source: Guangdong General Hospital
• Contact: Feng Lin, Dr
• Phone: 86-20-83827812-60910
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 340
• Est. completion date: December 2015
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Liver Metastasis
• Liver Neoplasms
• Neoplasm Metastasis

Intervention

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

Locations

Country	Name	City	State
China	Guangdong General Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression free survival (PFS)		3 years	No
Secondary	response rate, incidence of postoperative complications,pathological response rate,R0 resection rate, 5-year overall survival,duration of disease control		5 years	Yes