Genotype-drive Study of Irinotecan-Cisplatin Combination for Advanced Gastric Cancer

Sponsor
Chinese Academy of Medical Sciences
Study ID
NCT01444521
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • irinotecan and cisplatin — DRUG
    irinotecan 125 mg/m2 will be administered as an intravenous (IV) infusion over half a hour on Days 1; Cisplatin 60 mg/m2 will be administered as an intravenous (IV) infusion on Days 2, and to take enough hydration in the day and the next day. 14 days as a cycle, up to 8 cycles.

Study Details

The purpose of this study is to evaluate the efficacy and safety of first-line chemotherapy with cisplatin and irinotecan in advanced gastric cancer, and try to find out the optimal dosage of combination chemotherapy.

Key Dates

Start date
Apr 30, 2011
Status verified
May 2014
Primary completion
May 31, 2014
Completion
May 31, 2014

Study Design

Enrollment
50 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: single-arm Irinotecan-Cisplatin

Primary Outcome Measure

Overall response rate [ Time Frame: 1 year ]

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