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Japanese Journal of Clinical Oncology Advance Access originally published online on July 8, 2005
Japanese Journal of Clinical Oncology 2005 35(8):475-477; doi:10.1093/jjco/hyi124
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© 2005 Foundation for Promotion of Cancer Research

Clinical Trial Note

Randomized Controlled Trial to Evaluate Laparoscopic Surgery for Colorectal Cancer: Japan Clinical Oncology Group Study JCOG 0404

Seigo Kitano1, Masafumi Inomata1, Akihiro Sato2, Kenichi Yoshimura3, Yoshihiro Moriya4 for the Colorectal Cancer Study Group (CCSG) of Japan Clinical Oncology Group

1 Department of Gastroenterological Surgery, Oita University Faculty of Medicine, Oita, 2 Medical Oncology Division, 4 Colorectal Surgery Division, National Cancer Center Hospital and 3 Statistics and Cancer Control Division, National Cancer Center Research Center for Cancer Prevention and Screening, Tokyo, Japan

For reprints and all correspondence: Seigo Kitano, Department of Gastroenterological Surgery, Oita University Faculty of Medicine, 1-1 Hasama-machi, Oita, 879-5593, Japan. E-mail: colonrct{at}med.oita-u.ac.jp

Received May 19, 2005; accepted May 26, 2005

A randomized controlled trial was started in Japan to evaluate whether laparoscopic surgery is the optimal treatment for colorectal cancer. Patients with T3 or deeper carcinoma in the colorectum without transverse and descending colons are pre-operatively randomized to either open or laparoscopic colorectal resection. Surgeons in 24 specialized institutions will recruit 818 patients. The primary end-point is overall survival. Secondary end-points are relapse-free survival, short-term clinical outcome, adverse events, the proportion of conversion from laparoscopic surgery to open surgery, and the proportion of completion of laparoscopic surgery.

Key Words: colorectal cancer • laparoscopic surgery • randomized controlled trial

Seigo Kitano, study chair; Masafumi Inomata, study coordinator; Akihiro Sato, protocol coordinator; Kenichi Yoshimura, study statistician; Yoshihiro Moriya, group chair


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