A Phase II Study of Irinotecan, Oxaliplatin, Plus TS-1 in Untreated Metastatic Gastric Cancer

Sponsor
National Cancer Center, Korea
Study ID
NCT00512681
Phase
PHASE2
Status
Completed

Conditions

  • Stomach Neoplasms

Eligibility Criteria

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

Interventions

  • Irinotecan, Oxaliplatin, TS-1 — DRUG
    * S-1 40 mg/m2/day every 12-h p.o. on days 1(evening)-15 (morning) * Irinotecan 150 mg/m2 mixed in d5w 500 ml iv over 90-min on days 1 * Oxaliplatin 85 mg/m2 mixed in d5w 250 ml iv over 2-h on days 1

Study Details

Patients will be treated with irinotecan (150mg/m2) followed by oxaliplatin (85mg/m2)on day 1 and S-1(80mg/m2/day) from day 1 to 14 every 3 weeks. Patients will receive up to a planned treatment of maximum 12 cycles of chemotherapy. Response assessement will be performed every 2 cycles of chemotherapy.

Key Dates

Start date
Jul 31, 2007
Status verified
Sep 2009
Primary completion
Jul 31, 2009
Completion
Jul 31, 2009

Study Design

Enrollment
44 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Primary Outcome Measure

Maximal overall response rate [ Time Frame: During chemotherapy ]

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