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Japanese Journal of Clinical Oncology Advance Access published online on July 8, 2005
Japanese Journal of Clinical Oncology, doi:10.1093/jjco/hyi124
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© 2005 Foundation for Promotion of Cancer Research
Received May 19, 2005
Accepted May 26, 2005

Clinical Trial Note

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

Seigo Kitano 1*, Masafumi Inomata 1, Akihiro Sato 2, Kenichi Yoshimura 3, Yoshihiro Moriya 4, and for the Colorectal Cancer Study Group (CCSG) of Japan Clinical Oncology Group

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

* To whom correspondence should be addressed.
Seigo Kitano, E-mail: colonrct{at}med.oita-u.ac.jp


  Abstract

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.

Keywords: 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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