Second Line Chemotherapy for S-1 Refractory Advanced Gastric Cancer

Sponsor
Japan Clinical Cancer Research Organization
Study ID
NCT00639327
Phase
PHASE2/PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • S-1 + irinotecan — DRUG
    Irinotecan 150mg/m2 iv on day one and S-1 po days 1 to 14 every 3 weeks until PD
  • irinotecan — DRUG
    Irinotecan 150mg/m2 iv on day one every two weeks until PD

Study Details

The purpose of this study is compare overall survival of the test arm (CPT-11/S-1 combination) to the control arm (CPT-11 alone) in the subjects with S-1 refractory advanced gastric cancer.

Key Dates

Start date
Mar 31, 2008
Status verified
Jun 2011
Primary completion
Apr 30, 2011
Completion
Jun 30, 2011

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: A
    CPT-11+ S-1
  • Active Comparator: B
    CPT-11

Primary Outcome Measure

In phase II part, progressive disease rate will be measured for the safety. In phase III part, overall survival will be measured for the benefit of doublet. [ Time Frame: Phase II: 6 weeks from treatment, Phase III: 2 years OS from randomization ]

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