title: A randomized Phase III trial of weekly or 3-weekly doses of nab-paclitaxel versus weekly doses of Cremophor-based paclitaxel in patients with previously treated advanced gastric cancer (ABSOLUTE Trial).
abstract: 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.
authors.affiliation: Department of Gastroenterology, Kitasato University School of Medicine, Sagamihara-shi, Kanagawa koizumi@med.kitasato-u.ac.jp.
authors.forename: Wasaburo
authors.initials: W
authors.lastname: Koizumi
authors.affiliation: Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto-shi, Kyoto.
authors.forename: Satoshi
authors.initials: S
authors.lastname: Morita
authors.affiliation: Misawa City Hospital, Misawa-shi, Aomori, Japan.
authors.forename: Yuh
authors.initials: Y
authors.lastname: Sakata
mesh_terms: D000284:Administration, Oral; D000418:Albumins / Q000008:administration & dosage*; D018450:Disease Progression; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D019008:Drug Resistance, Neoplasm; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D017239:Paclitaxel / Q000008:administration & dosage*; D011092:Polyethylene Glycols / Q000008:administration & dosage; D011446:Prospective Studies; D011788:Quality of Life; D013274:Stomach Neoplasms / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: C520255:130-nm albumin-bound paclitaxel; D000418:Albumins; C022131:cremophor; D011092:Polyethylene Glycols; D017239:Paclitaxel
keywords: Phase III; gastric cancer; nab-paclitaxel; second-line chemotherapy; weekly