Status:
COMPLETED
Second-line Therapy Versus Supportive Care for Pretreated Advanced Gastric Cancer
Lead Sponsor:
Samsung Medical Center
Conditions:
Advanced Gastric Cancer
Eligibility:
All Genders
Up to 75 years
Phase:
PHASE3
Brief Summary
Because well-designed, randomized, controlled clinical trials are lacking in patients with advanced gastric cancer (AGC), and because randomly allocating patients to treatments that do not accord with...
Detailed Description
Fluoropyrimidine and/or platinum-based chemotherapy is now regarded as a standard first-line treatment in AGC patients because it has shown superiority in terms of response rate and time to disease pr...
Eligibility Criteria
Inclusion
- aged 75 year or younger
- advanced gastric cancer
- ECOG performance status 0 or 1
- previous failure after chemotherapy with fluoropyrimidine and platinum
- adequate major organ functions
Exclusion
- severe concurrent illness and/or active infection
- previously treated with taxanes and irinotecan
- active CNS metastases
- pregnant or lactating women
- who have not recovered from prior treatments
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2011
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00821990
Start Date
September 1 2008
End Date
June 1 2011
Last Update
January 20 2012
Active Locations (1)
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1
Samsung Medical Center
Seoul, South Korea, 135 710