title: 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).
abstract: 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].
authors.affiliation: Department of Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka ohue-ma@mc.pref.osaka.jp.
authors.forename: Masayuki
authors.initials: M
authors.lastname: Ohue
authors.affiliation: Gastrointestinal Medical Oncology Division, National Cancer Center Hospital, Tokyo.
authors.forename: Satoru
authors.initials: S
authors.lastname: Iwasa
authors.affiliation: Colorectal Surgery Division, National Cancer Center Hospital, Tokyo.
authors.forename: Yukihide
authors.initials: Y
authors.lastname: Kanemitsu
authors.affiliation: Gastrointestinal Medical Oncology Division, National Cancer Center Hospital, Tokyo.
authors.forename: Tetsuya
authors.initials: T
authors.lastname: Hamaguchi
authors.affiliation: Department of Gastrointestinal Surgery, Kanagawa Cancer Center, Yokohama.
authors.forename: Manabu
authors.initials: M
authors.lastname: Shiozawa
authors.affiliation: Department of Colorectal Surgery, National Cancer Center Hospital East, Chiba.
authors.forename: Masaaki
authors.initials: M
authors.lastname: Ito
authors.affiliation: Department of Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka.
authors.forename: Masayoshi
authors.initials: M
authors.lastname: Yasui
authors.affiliation: JCOG Data Center/Operations Ofﬁce, National Cancer Center, Tokyo.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Katayama
authors.affiliation: JCOG Data Center/Operations Ofﬁce, National Cancer Center, Tokyo.
authors.forename: Junki
authors.initials: J
authors.lastname: Mizusawa
authors.affiliation: Clinical Oncology Division, Kochi Health Sciences Center, Kochi, Japan.
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Shimada
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000627:therapeutic use; D006801:Humans; D007275:Injections, Intravenous; D007564:Japan; D002955:Leucovorin / Q000008:administration & dosage / Q000627:therapeutic use; D008198:Lymph Nodes / Q000473:pathology; D008207:Lymphatic Metastasis; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000627:therapeutic use; D000077150:Oxaliplatin; D011184:Postoperative Period; D057234:Preoperative Period; D012004:Rectal Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000601:surgery
chemical_list: D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D002955:Leucovorin; D005472:Fluorouracil
keywords: lateral pelvic node dissection; lateral pelvic node metastasis; lower rectal cancer; mFOLFOX6; randomized controlled trial