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

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01035385

Enrollment

340

Registered

2009-12-18

Start date

2009-09-30

Completion date

2015-12-31

Last updated

2009-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer, Liver Metastasis

Keywords

FOFLOX4, resectable liver metastasis from colorectal cancer

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.

Interventions

DRUGFOFLOX4

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame
progression free survival (PFS)	3 years

Secondary

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

Countries

China

Contacts

Primary ContactFeng Lin, Dr

86-20-83827812-60910

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026