title: A randomized phase II clinical trial of tailored CPT-11 + S-1 vs S-1 in patients with advanced or recurrent gastric carcinoma as the first line chemotherapy.
abstract: A randomized phase II clinical trial has been designed and started in the Japanese Foundation for Multidisciplinary Treatment of Cancer (JFMC) to select the better regimen between tailored CPT-11 + S-1 and the standard S-1 treatment for advanced or recurrent gastric cancer as the first line chemotherapy. Selection of the better treatment for general clinical practice in this clinical trial will lead to a more precise assignment of a promising regimen for a future phase III randomized trial, placing continuous 5-FU infusion as the reference arm. In this trial, subsidiary pharmacokinetic analysis for the tailored dose arm is also proposed. In order to continue chemotherapy for a long time and to obtain longer survival, our study design for the tailored therapy could be exploited, especially in the field of general clinical practice.
authors.affiliation: Department of Surgical Oncology, Cancer Research Institute, Kanazawa University, Kanazawa, Japan. takahasi@kenroku.kanazawa-u.ac.jp
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Takahashi
authors.forename: Junichi
authors.initials: J
authors.lastname: Sakamoto
authors.forename: Tetsuo
authors.initials: T
authors.lastname: Takeuchi
authors.forename: Masayoshi
authors.initials: M
authors.lastname: Mai
authors.forename: Tetsuro
authors.initials: T
authors.lastname: Kubota
authors.forename: Masaki
authors.initials: M
authors.lastname: Kitajima
authors.forename: Yusuke
authors.initials: Y
authors.lastname: Tanigawara
authors.forename: Yoshito
authors.initials: Y
authors.lastname: Komatsu
authors.forename: Tetsuya
authors.initials: T
authors.lastname: Toge
authors.forename: Shigetoyo
authors.initials: S
authors.lastname: Saji
mesh_terms: D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage* / Q000031:analogs & derivatives*; D004338:Drug Combinations; D005260:Female; D006801:Humans; D000077146:Irinotecan; D008297:Male; D009364:Neoplasm Recurrence, Local; D010094:Oxonic Acid / Q000008:administration & dosage*; D011725:Pyridines / Q000008:administration & dosage*; D013274:Stomach Neoplasms; D005641:Tegafur / Q000008:administration & dosage*
chemical_list: D000964:Antimetabolites, Antineoplastic; D004338:Drug Combinations; D011725:Pyridines; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid; D000077146:Irinotecan; D002166:Camptothecin