title: Phase I/II study of combination therapy of oral fluorinated pyrimidine compound S-1 with low-dose cisplatin in patients with unresectable and/or recurrent advanced gastric cancer: a novel study design to evaluate safety and efficacy.
abstract: A phase I/II clinical trial has been planned to evaluate the safety and efficacy of combination therapy of S-1 with low-dose cisplatin in patients with unresectable or recurrent gastric cancer. A new statistically as well as clinically deliberated study design is applied to determine the maximal benefits of combination chemotherapy. This trial uses a 'continual reassessment method' for evaluating toxicity and a "two-stage method" for assessing the response rate to determine the combination that achieves adequate tumor response without toxicity in a high proportion of patients. Three specialized institutions will recruit 10-16 patients for the phase I part of the trial, and 14 institutions, in conjunction with the three specialized ones, will enroll 42 patients for the phase II part. The goal of this trial is to establish a useful chemotherapeutic treatment in an outpatient setting.
authors.affiliation: Department of Epidemiological and Clinical Research Information Management, Kyoto University Graduate School of Medicine, Yoshida-konoe-cho, Sakyo-ku, Kyoto 606-8501, Japan. smorita@pbh.kyoto-u.ac.jp
authors.forename: Satoshi
authors.initials: S
authors.lastname: Morita
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Ohashi
authors.forename: Kosei
authors.initials: K
authors.lastname: Hirakawa
authors.forename: Bunzo
authors.initials: B
authors.lastname: Nakata
authors.forename: Shigetoyo
authors.initials: S
authors.lastname: Saji
authors.forename: Junichi
authors.initials: J
authors.lastname: Sakamoto
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000553:Ambulatory Care; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004338:Drug Combinations; D005260:Female; D006801:Humans; D007970:Leukopenia / Q000139:chemically induced; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D009503:Neutropenia / Q000139:chemically induced; D010094:Oxonic Acid / Q000008:administration & dosage / Q000009:adverse effects; D011725:Pyridines / Q000008:administration & dosage / Q000009:adverse effects; D013274:Stomach Neoplasms / Q000188:drug therapy*; D005641:Tegafur / Q000008:administration & dosage / Q000009:adverse effects; D013921:Thrombocytopenia / Q000139:chemically induced
chemical_list: D004338:Drug Combinations; D011725:Pyridines; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid; D002945:Cisplatin