Efficacy Study of Paclitaxel Versus Irinotecan in Patients With Recurrent or Metastatic Gastric Cancer Who Progress Following First-line Therapy

Sponsor
Korean Cancer Study Group
Study ID
NCT01224652
Phase
PHASE3
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • Paclitaxel — DRUG
    Paclitaxel, 70 mg/m2 will be administered as an intravenous (IV) infusion over 1 hour on Days 1, 8 and 15 of a 28-day cycle
  • Irinotecan — DRUG
    irinotecan 150 mg/m2 will be administered as an intravenous (IV) infusion over 1 hour on Days 1 and 15 of a 28-day cycle

Study Details

The primary objectives of this study is to compare the efficacy of paclitaxel monotherapy with irinotecan monotherapy as defined by progression-free survival (PFS), in all patients with recurrent and metastatic gastric cancer who progress following first line therapy.

Key Dates

Status verified
Oct 2010

Study Design

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

Arms

  • Experimental: paclitaxel
    Paclitaxel 70 mg/m2 on Days 1, 8 and 15 of a 28-day cycle
  • Experimental: irinotecan
    irinotecan 150 mg/m2 on Days 1 and 15 of a 28-day cycle

Primary Outcome Measure

progression-free survival [ Time Frame: every 8 weeks ]

Central Contacts

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