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multi-center, prospective, randomized, open-label phase III
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This is a prospective, randomized, open-label phase III study of adjuvant chemotherapy after curative resection in patients with pathologic stage IB (by AJCC 6th edition) gastric cancer with at least one additional risk factor (additional risk factors for recurrence include age >65 years, male gender, presence of lymphovascular invasion, presence of perineural invasion). The superiority design will compare the efficacy and safety profiles of adjuvant capecitabine (Arm A) versus observation alone (Arm B).
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870 participants in 2 patient groups
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Hyung-Don Kim, M.D.,Ph.D; Min-Hee Ryu, MD, PhD
Data sourced from clinicaltrials.gov
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