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

Guangdong Provincial People's Hospital (Guangdong Provincial Academy of Medical Sciences)

Status and phase: Unknown; Phase 3

Conditions: Liver Metastasis; Colorectal Cancer

Treatments: Drug: FOFLOX4

Study type: Interventional

Funder types: Other

Identifiers

NCT01035385

VORP019

Details and patient eligibility

About

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.

Full description

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

Enrollment: 340 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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340 participants in 1 patient group

FOFLOX4,resectable liver metastasis from CRC

Experimental group

Treatment:

Drug: FOFLOX4