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Japanese Journal of Clinical Oncology 33:238-240 (2003)
© 2003 Foundation for Promotion of Cancer Research

A Phase II Clinical Trial to Evaluate the Effect of Paclitaxel in Patients with Ascites Caused by Advanced or Recurrent Gastric Carcinoma: a New Concept of Clinical Benefit Response for Non-measurable Type of Gastric Cancer

Junichi Sakamoto1, Satoshi Morita1, Takeyoshi Yumiba2, Hiroyuki Narahara3, Koichi Kinoshita4, Yasushi Nakane5, Haruhiko Imamoto6 and Hitoshi Shiozaki6 for the Ascitic Gastric Cancer Study Group of the Japan South West Oncology Group (JaSWOG)+

1 Department of Epidemiological and Clinical Research Information Management, Kyoto University, Kyoto, 2 Department of Surgery, Osaka Kousei Nenkin Hospital, Osaka, 3 Department of Gastrointestinal Oncology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, 4 Department of Surgery, Kitano Hospital, Osaka, 5 2nd Department of Surgery, Kansai Medical University, Osaka and 6 Department of Surgery, Kinki University School of Medicine, Osaka, Japan

A phase II clinical trial has started in the South West region of Japan to investigate the efficacy and safety of weekly paclitaxel chemotherapy for the treatment of patients with ascites-forming advanced gastric cancer. A novel trial design was created to assess more effectively prospective changes in symptomatology. The study design focuses on the typical features seen in patients with ascites-forming advanced gastric cancer, including girth of the abdomen and impaired performance status, which is evaluated in the endpoint of ‘Clinical Benefit Response – Gastric Cancer’. The more traditional endpoints, objective tumor response and survival, are also included. As nearly 40% of patients with this disease are excluded from traditional phase II trials owing to the absence of ‘measurable’ disease, this study should more precisely illustrate the disease entity affecting patients with advanced gastric cancer.

+ For reprints and all correspondence: Junichi Sakamoto, Department of Epidemiological and Clinical Research Information Management, Kyoto University, Kyoto, Japan. E-mail: sakamoto{at}pbh.med.kyoto-u.ac.jp


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