A multicenter phase II study of preoperative chemoradiotherapy with S-1 plus oxaliplatin for locally advanced rectal cancer (SHOGUN trial).
OBJECTIVE
This study was designed to evaluate the safety and efficacy of adding oxaliplatin to preoperative chemoradiotherapy (CRT) with S-1 in patients with locally advanced rectal carcinoma (LARC).


METHODS
This was a multicenter phase II study in patients with histologically proven clinical stage T3 or T4 (any N, M0) LARC. Patients preoperatively received oral S-1 (80 mg/m(2)/day on days 1-5, 8-12, 22-27, and 29-33) and infusional oxaliplatin (60 mg/m(2) days on 1, 8, 22, and 29) plus radiotherapy (50.4 Gy), with a chemotherapy gap in the third week of radiotherapy. Pathological complete response (pCR) was the primary endpoint. Secondary endpoints included toxicity, compliance, R0 resection rate, and downstaging rate.


RESULTS
A total of 45 patients were enrolled at six centers in Japan. All 45 patients received CRT, and 44 underwent operation. A pCR was achieved in 12 (27.3%) of the 44 patients who underwent surgery. Near-total tumor regression was confirmed in 47.7%. There were no grade 4 adverse events, and 11.1% of the patients had grade 3 adverse events. R0 resection was achieved in 95.5% of the patients.


CONCLUSIONS
Preoperative CRT with S-1 plus oxaliplatin had a high pCR rate and a favorable toxicity profile.
Department of Gastroenterology, Cancer Institute Hospital, Koto-ku, Japan.
Satoshi
S
Matsusaka
Department of Surgical Oncology, University of Tokyo, Bunkyo-ku, Japan.
Soichiro
S
Ishihara
Department of General & Gastroenterological Surgery, Osaka Medical College, Takatsuki, Japan.
Keisaku
K
Kondo
Department of Surgery, School of Medicine, Jichi Medical University, Shimotsuke, Japan.
Hisanaga
H
Horie
Division of Surgical Oncology, Department of Surgery, Nagoya University, Japan.
Keisuke
K
Uehara
Department of Radiation Oncology, Cancer Institute Hospital, Koto-ku, Japan.
Masahiko
M
Oguchi
Department of Radiation Oncology, Cancer Institute Hospital, Koto-ku, Japan.
Keiko
K
Murofushi
Department of Gastroenterological Surgery, Cancer Institute Hospital, Koto-ku, Japan.
Masashi
M
Ueno
Department of Gastroenterology, Cancer Institute Hospital, Koto-ku, Japan.
Nobuyuki
N
Mizunuma
Department of Radiology, Osaka Medical College, Takatsuki, Japan.
Taiju
T
Shimbo
Department of Radiology, Teikyo University, Itabashi-ku, Japan.
Daiki
D
Kato
Department of General & Gastroenterological Surgery, Osaka Medical College, Takatsuki, Japan.
Junji
J
Okuda
Department of Surgery, Teikyo University, Itabashi-ku, Japan.
Yojiro
Y
Hashiguchi
Department of Radiology, School of Medicine, Jichi Medical University, Shimotsuke, Japan.
Masanori
M
Nakazawa
Department of Surgical Oncology, University of Tokyo, Bunkyo-ku, Japan.
Eiji
E
Sunami
Department of Surgical Oncology, University of Tokyo, Bunkyo-ku, Japan.
Kazushige
K
Kawai
Department of Radiology, University of Tokyo, Bunkyo-ku, Japan.
Hideomi
H
Yamashita
Department of Radiology, Nagoya University, Japan.
Tohru
T
Okada
Japanese Foundation for Cancer Research, Koto-ku, Japan.
Yuichi
Y
Ishikawa
Japan Clinical Cancer Research Organization, Chuo-ku, Japan.
Toshifusa
T
Nakajima
Department of Surgical Oncology, University of Tokyo, Bunkyo-ku, Japan. Electronic address: toshwatanabe@yahoo.co.jp.
Toshiaki
T
Watanabe
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D059248:Chemoradiotherapy / Q000009:adverse effects / Q000379:methods*; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000009:adverse effects; D000077150:Oxaliplatin; D011300:Preoperative Care; D012004:Rectal Neoplasms / Q000628:therapy*; D012074:Remission Induction / Q000379:methods; D055815:Young Adult
D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D005472:Fluorouracil
Locally advanced rectal carcinoma; Oxaliplatin; Pathological complete response; Preoperative chemoradiotherapy; S-1