Journal Article

A Randomized Phase II Selection Trial in Patients with Advanced/Recurrent Gastric Cancer: Trial for Advanced Stomach Cancer (TASC)

Satoshi Morita, Hideo Baba, Akira Tsuburaya, Hiroya Takiuchi, Takanori Matsui, Yoshihiko Maehara and Junichi Sakamoto

in Japanese Journal of Clinical Oncology

Volume 37, issue 6, pages 469-472
Published in print June 2007 | ISSN: 0368-2811
Published online June 2007 | e-ISSN: 1465-3621 | DOI: https://dx.doi.org/10.1093/jjco/hym046
A Randomized Phase II Selection Trial in Patients with Advanced/Recurrent Gastric Cancer: Trial for Advanced Stomach Cancer (TASC)

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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.

Keywords: Randomized phase II trial; gastric cancer; chemotherapy; Bayesian trial monitoring

Journal Article.  1541 words.  Illustrated.

Subjects: Medical Oncology

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