title: Dose-finding and efficacy confirmation trial of superselective intra-arterial infusion of cisplatin and concomitant radiotherapy for patients with locally advanced maxillary sinus cancer (JCOG1212, RADPLAT-MSC).
abstract: A dose-finding and efficacy confirmation trial was started in Japan in April 2014 to evaluate the efficacy and safety of superselective intra-arterial infusion of cisplatin and concomitant radiotherapy for locally advanced maxillary sinus cancer. A total of 18 patients will be enrolled in the dose-finding phase for the determination of the recommended number of cisplatin cycles, and 65 patients with T4aN0M0 and 62 patients with T4bN0M0, including those who received the recommended number of or fewer cycles in the dose-finding phase, will be enrolled from 16 institutions within a 5-year period in the efficacy confirmation phase. The primary endpoints of the dose-finding and the efficacy confirmation phases are dose-limiting toxicities and 3-year overall survival, respectively. This trial was registered at the UMIN Clinical Trials Registry (http://www.umin.ac.jp/ctr/) under Trial No. UMIN000013706.
authors.affiliation: Department of Otolaryngology-Head and Neck Surgery, Hokkaido University Graduate School of Medicine, Sapporo ak-homma@med.hokudai.ac.jp.
authors.forename: Akihiro
authors.initials: A
authors.lastname: Homma
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: Division of Head and Neck Surgery, Miyagi Cancer Center, Sendai.
authors.forename: Kazuto
authors.initials: K
authors.lastname: Matsuura
authors.affiliation: JCOG Data Center/Operations Office, Center for Research Administration and Support, National Cancer Center, Tokyo.
authors.forename: Junki
authors.initials: J
authors.lastname: Mizusawa
authors.affiliation: Department of Radiology, Hokkaido University Graduate School of Medicine, Sapporo.
authors.forename: Rikiya
authors.initials: R
authors.lastname: Onimaru
authors.affiliation: Department of Otolaryngology-Head and Neck Surgery, Hokkaido University Graduate School of Medicine, Sapporo.
authors.forename: Haruhiko
authors.initials: H
authors.lastname: Fukuda
authors.affiliation: Department of Otolaryngology, National Hospital Organization Tokyo Medical Center, Tokyo, Japan.
authors.forename: Masato
authors.initials: M
authors.lastname: Fujii
mesh_terms: D000970:Antineoplastic Agents / Q000008:administration & dosage*; D059248:Chemoradiotherapy; D002945:Cisplatin / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D007261:Infusions, Intra-Arterial; D007564:Japan; D008297:Male; D008444:Maxillary Sinus Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*; D008875:Middle Aged; D009367:Neoplasm Staging; D018579:Patient Selection
chemical_list: D000970:Antineoplastic Agents; D002945:Cisplatin
keywords: chemoradiotherapy; cisplatin; intra-arterial; maxillary sinus cancer; squamous cell carcinoma