Randomized controlled trial to evaluate laparoscopic surgery for colorectal cancer: Japan Clinical Oncology Group Study JCOG 0404.
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.
Kitano
Seigo
S
Department of Gastroenterological Surgery, Oita University Faculty of Medicine, 1-1 Hasama-machi, Oita, 879-5593, Japan. colonrct@med.oita-u.ac.jp
Inomata
Masafumi
M
Sato
Akihiro
A
Yoshimura
Kenichi
K
Moriya
Yoshihiro
Y
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D017024:Chemotherapy, Adjuvant; D003110:Colonic Neoplasms / Q000188:drug therapy / Q000401:mortality / Q000601:surgery; D015179:Colorectal Neoplasms / Q000188:drug therapy / Q000401:mortality / Q000601:surgery*; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D023381:Endpoint Determination; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D010535:Laparoscopy / Q000401:mortality; D002955:Leucovorin / Q000008:administration & dosage; D008197:Lymph Node Excision / Q000401:mortality; D008875:Middle Aged; D012004:Rectal Neoplasms / Q000188:drug therapy / Q000401:mortality / Q000601:surgery; D012811:Sigmoid Neoplasms / Q000188:drug therapy / Q000401:mortality / Q000601:surgery; D015996:Survival Rate; D016896:Treatment Outcome
D002955:Leucovorin; D005472:Fluorouracil