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Japanese Journal of Clinical Oncology 34:159-161 (2004)
© 2004 Foundation for Promotion of Cancer Research

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

Satoshi Morita1, Yasuo Ohashi2, Kosei Hirakawa3, Bunzo Nakata3, Shigetoyo Saji4 and Junichi Sakamoto1,+

1 Department of Epidemiological and Clinical Research Information Management, Kyoto University, Kyoto, 2 School of Health Sciences and Nursing, University of Tokyo, Tokyo, 3 Department of Surgical Oncology, Osaka City University Graduate School of Medicine, Osaka and 4 Japanese Foundation for Multidisciplinary Treatment of Cancer, Tokyo, Japan

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.

+ For reprints and all correspondence: Satoshi Morita, Department of Epidemiological and Clinical Research Information Management, Kyoto University Graduate School of Medicine, Yoshidakonoe-cho, Sakyo-ku, Kyoto 606-8501, Japan. E-mail: smorita{at}pbh.med.kyoto-u.ac.jp


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 Jpn J Clin OncolHome page
S. Morita, B. Nakata, A. Tsuji, Y. Mitachi, T. Shirasaka, S. Saji, Y. Ohashi, J. Sakamoto, and K. Hirakawa
A Phase I Study of Combination Therapy of the Oral Fluorinated Pyrimidine Compound S-1 with Low-dose Cisplatin Twice-a-week Administration (JFMC27-9902 Step2) in Patients with Advanced Gastric Cancer Using a Continual Reassessment Method
Jpn. J. Clin. Oncol., December 1, 2007; 37(12): 924 - 929.
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