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Japanese journal of clinical oncology v.47 no.1, 2017년, pp.84 - 87   SCIE
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A Phase II/III randomized controlled trial comparing perioperative versus postoperative chemotherapy with mFOLFOX6 for lower rectal cancer with suspected lateral pelvic node metastasis: Japan Clinical Oncology Group Study JCOG1310 (PRECIOUS study)

Ohue, Masayuki (Department of Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka ) ; Iwasa, Satoru (Gastrointestinal Medical Oncology Division, National Cancer Center Hospital, Tokyo ) ; Kanemitsu, Yukihide (Colorectal Surgery Division, National Cancer Center Hospital, Tokyo ) ; Hamaguchi, Tetsuya (Gastrointestinal Medical Oncology Division, National Cancer Center Hospital, Tokyo ) ; Shiozawa, Manabu (Department of Gastrointestinal Surgery, Kanagawa Cancer Center, Yokohama ) ; Ito, Masaaki (Department of Colorectal Surgery, National Cancer Center Hospital East, Chiba ) ; Yasui, Masayoshi (Department of Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka ) ; Katayama, Hiroshi (JCOG Data Center/Operations Office, National Cancer Center, Tokyo ) ; Mizusawa, Junki (JCOG Data Center/Operations Office, National Cancer Center, Tokyo ) ; Shimada, Yasuhiro (Clinical Oncology Division, Kochi Health Sciences Center, Kochi, Japan ) ;
  • 초록  

    This is a randomized controlled trial to confirm the superiority of perioperative mFOLFOX6 to postoperative mFOLFOX6 in the treatment of lower rectal cancer with suspected lateral lymph node metastasis. A randomized phase II/III trial was started in May 2015 comparing perioperative versus postoperative chemotherapy with modified infusional fluorouracil and folinic acid with oxaliplatin for lower rectal cancer patients with suspected lateral pelvic node metastasis. The standard arm is total mesorectal excision or tumor-specific mesorectal excision with lateral pelvic node dissection (LND) followed by postoperative chemotherapy (modified infusional fluorouracil and folinic acid with oxaliplatin; 12 cycles). The experimental (perioperative chemotherapy) arm is six courses of modified infusional fluorouracil and folinic acid with oxaliplatin before and six courses after total mesorectal excision with lateral pelvic node dissection. The aim of this trial is to confirm the superiority of perioperative chemotherapy. A total of 330 patients will be enrolled over 7 years. The primary endpoint in Phase II part is proportion of R0 resection and that in Phase III part is overall survival. Secondary endpoints are progression-free survival, local progression-free survival, etc. This trial has been registered in the UMIN Clinical Trials Registry as UMIN000017603 [http://www.umin.ac.jp/ctr/index-j.htm].


  • 주제어

    randomized controlled trial .   lower rectal cancer .   lateral pelvic node metastasis .   lateral pelvic node dissection .   mFOLFOX6.  

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