title: A Phase II/III study comparing carboplatin and irinotecan with carboplatin and etoposide for the treatment of elderly patients with extensive-disease small-cell lung cancer (JCOG1201).
abstract: A randomized Phase II/III trial commenced in Japan in December 2013. Carboplatin plus etoposide is the current standard treatment for elderly extensive-disease small-cell lung cancer. The purpose of this study is to confirm the superiority of carboplatin plus irinotecan in terms of overall survival over carboplatin plus etoposide for elderly extensive-disease small-cell lung cancer patients in a Phase II/III design. A total of 370 patients will be accrued from 38 Japanese institutions within 5 years. In the Phase II part, the primary endpoint is the response rate of the carboplatin plus irinotecan arm and the secondary endpoint is adverse events. In the Phase III part, the primary endpoint is overall survival and the secondary endpoints are progression-free survival, response rate, adverse events, serious adverse events and symptom score. This trial has been registered at the UMIN Clinical Trials Registry as UMIN000012605 (http://www.umin.ac.jp/ctr/index.htm).
authors.affiliation: JCOG Data Center/Operations Office, Center for Research Administration and Support, National Cancer Center, Tokyo.
authors.forename: Junko
authors.initials: J
authors.lastname: Eba
authors.affiliation: Department of Respiratory Medicine, Yokohama Municipal Citizen's Hospital, Kanagawa ts00-shimokawa@city.yokohama.jp.
authors.forename: Tsuneo
authors.initials: T
authors.lastname: Shimokawa
authors.affiliation: JCOG Data Center/Operations Office, Center for Research Administration and Support, National Cancer Center, Tokyo.
authors.forename: Kenichi
authors.initials: K
authors.lastname: Nakamura
authors.affiliation: JCOG Data Center/Operations Office, Center for Research Administration and Support, National Cancer Center, Tokyo.
authors.forename: Taro
authors.initials: T
authors.lastname: Shibata
authors.affiliation: Department of Respiratory Medicine, Yokohama Municipal Citizen's Hospital, Kanagawa.
authors.forename: Yuki
authors.initials: Y
authors.lastname: Misumi
authors.affiliation: Department of Respiratory Medicine, Yokohama Municipal Citizen's Hospital, Kanagawa.
authors.forename: Hiroaki
authors.initials: H
authors.lastname: Okamoto
authors.affiliation: Division of Thoracic Oncology, National Cancer Center Hospital, Tokyo.
authors.forename: Noboru
authors.initials: N
authors.lastname: Yamamoto
authors.affiliation: Division of Thoracic Oncology, National Cancer Center Hospital, Tokyo.
authors.forename: Yuichiro
authors.initials: Y
authors.lastname: Ohe
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives; D016190:Carboplatin / Q000008:administration & dosage; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005047:Etoposide / Q000008:administration & dosage; D005260:Female; D006801:Humans; D000077146:Irinotecan; D007564:Japan; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D018579:Patient Selection; D055752:Small Cell Lung Carcinoma / Q000188:drug therapy* / Q000473:pathology; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D005047:Etoposide; D000077146:Irinotecan; D016190:Carboplatin; D002166:Camptothecin
keywords: Phase II/III; chemotherapy; elderly; extensive-disease; small-cell lung carcinoma