A randomized phase II selection trial in patients with advanced/recurrent gastric cancer: Trial for Advanced Stomach Cancer (TASC).
A randomized phase II clinical trial is being conducted for patients with advanced or recurrent gastric cancer, in order to select the most promising treatment for subsequent evaluation in a large-scale phase III trial. We compare four chemotherapeutic treatments, which include two sequential and two combination regimens using paclitaxel with 5-fluorouracil or S-1, an oral fluorouracil derivative. The primary endpoint is 10-month overall survival rate, while the secondary endpoints are adverse events, time to treatment failure and progression-free survival. A Bayesian method is used to provide a statistical rule for monitoring the trial. Forty patients per treatment regimen (160 in total) were randomized into one of the four regimens using a centralized dynamic method.
Morita
Satoshi
S
Department of Medical Administration, Program in Health and Community Medicine, Nagoya University Graduate School of Medicine, Nagoya, Japan. smorita@med.nagoya-u.ac.jp
Baba
Hideo
H
Tsuburaya
Akira
A
Takiuchi
Hiroya
H
Matsui
Takanori
T
Maehara
Yoshihiko
Y
Sakamoto
Junichi
J
D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage*; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage; D004338:Drug Combinations; D005472:Fluorouracil / Q000008:administration & dosage*; D006801:Humans; D009364:Neoplasm Recurrence, Local; D010094:Oxonic Acid / Q000008:administration & dosage*; D017239:Paclitaxel / Q000008:administration & dosage*; D013274:Stomach Neoplasms / Q000188:drug therapy*; D005641:Tegafur / Q000008:administration & dosage*
D000964:Antimetabolites, Antineoplastic; D000972:Antineoplastic Agents, Phytogenic; D004338:Drug Combinations; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid; D017239:Paclitaxel; D005472:Fluorouracil