Journal
JAPANESE JOURNAL OF CLINICAL ONCOLOGY
Volume 45, Issue 3, Pages 303-306Publisher
OXFORD UNIV PRESS
DOI: 10.1093/jjco/hyu205
Keywords
gastric cancer; nab-paclitaxel; Phase III; second-line chemotherapy; weekly
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Funding
- Taiho Pharmaceutical Co., Ltd.
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Paclitaxel is an agent widely used in second-line chemotherapy for advanced gastric cancer. The aim of this trial is to evaluate the efficacy and safety of 3-weekly or weekly doses of nanoparticle albumin-bound-paclitaxel compared with weekly doses of Cremophor-based paclitaxel in patients with unresectable or recurrent gastric cancer refractory to first-line chemotherapy comprising fluoropyrimidines. A total of 730 patients will be enrolled from 72 institutions. The primary endpoint is the overall survival, and the secondary endpoints are progression-free survival, time to treatment failure, overall response rate, disease control rate, quality of life (by using the EQ-5D system) and safety.
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