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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
518
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 150 mg/m2 will be administered as an intravenous (IV) infusion over 1 hour on Days 1 and 15 of a 28-day cycle
Yonsei University Gangnam Severance Hospital
Seoul, South Korea
RECRUITINGSeoul National University Hospital
Seoul, South Korea
RECRUITINGprogression-free survival
Tumor evaluation using RECIST v1.1
Time frame: every 8 weeks
Safety
Number of Participants and toxicity grade accordong to NCI-CTCAE v3.0 as a Measure of Safety
Time frame: up to 4 weeks after last administration of chemotherapy
Overall survival
Time frame: 1 year
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