Status:
UNKNOWN
Treatment Outcomes of Hepatic Metastasis After FOLFOX-4 Therapy
Lead Sponsor:
National Taiwan University Hospital
Collaborating Sponsors:
National Science and Technology Council, Taiwan
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
The role of surgical resection in the subset of patients with resectable hepatic metastases converted from initially non-resectable liver metastasis was still not clearly established. To further explo...
Detailed Description
In 2000, de Gramont et al. and Giacchetti et al. reported that combination chemotherapy including modulated infusional 5-Fu plus irinotecan and oxaliplatin could achieve a response rate of approximate...
Eligibility Criteria
Inclusion
- Secondary resectable hepatic metastasis converted by FOLFOX-4 regimen.
- age between 18-80 y/o.
- no extra-hepatic disease
- life expectancy ≥ 3 months
- Karnofsky performance status ≥ 50%.
- WBC count ≥ 4,000/μl, platelet count ≥ 100,000/μl, serum bilirubin ≤ 2.0 mg/dl and normal serum glucose and electrolyte levels.-
Exclusion
- Secondary resectable hepatic metastasis with extra-hepatic disease
- poor liver function including: serum bilirubin \> 2.0 mg/dl, GOT,GPT \>100 U/L
- severe steatosis hepatitis or sinusoidal dilation
- Karnoofsky performance status \<50%.-
Key Trial Info
Start Date :
January 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2017
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00610636
Start Date
January 1 2002
End Date
December 1 2017
Last Update
December 10 2012
Active Locations (1)
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1
Division of Colorectal Surgery, Department of Surgery , National Taiwan University Hospital
Taipei, Taiwan, 100