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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


Phase 3
18 Years
80 Years
Open (Enrolling)
Both
Colorectal Cancer, Liver Metastasis

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Trial Information

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


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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

progression free survival (PFS)

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Feng Lin, Dr

Investigator Role:

Principal Investigator

Investigator Affiliation:

Guangdong General Hospital

Authority:

China: Ethics Committee

Study ID:

VORP019

NCT ID:

NCT01035385

Start Date:

September 2009

Completion Date:

December 2015

Related Keywords:

  • Colorectal Cancer
  • Liver Metastasis
  • FOFLOX4
  • resectable liver metastasis from colorectal cancer
  • Colorectal Neoplasms
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Liver Neoplasms

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