title: A randomized phase II/III trial of perioperative chemotherapy with adriamycin plus ifosfamide versus gemcitabine plus docetaxel for high-grade soft tissue sarcoma: Japan Clinical Oncology Group Study JCOG1306.
abstract: A randomized Phase II/III trial was planned to commence in March 2014. Perioperative chemotherapy with adriamycin plus ifosfamide is the current standard treatment for T2bN0M0 high-grade non-round cell soft tissue sarcoma. The purpose of this study is to confirm the non-inferiority of perioperative chemotherapy with gemcitabine and docetaxel to adriamycin plus ifosfamide for patients with T2bN0M0 or any TN1M0 non-round cell soft tissue sarcoma in the extremities and body wall. A total of 140 patients will be accrued from 28 Japanese institutions over 6 years. The primary endpoint in the Phase II part is the proportion of completion of pre-operative chemotherapy without progressive disease and overall survival in the Phase III part. The secondary endpoints are progression-free survival, response rate of pre-operative chemotherapy, pathological response rate, proportion of preservation of diseased limbs, disease control rate and proportion of adverse events. This trial has been registered in the UMIN Clinical Trials Registry as UMIN000013175 [http://www.umin.ac.jp/ctr/index.htm].
authors.affiliation: JCOG Data Center/Operations Office, Multi-institutional Clinical Trial Support Center, National Cancer Center, Tokyo.
authors.forename: Kozo
authors.initials: K
authors.lastname: Kataoka
authors.affiliation: Department of Endoprosthetic Surgery, Oita University, Oita.
authors.forename: Kazuhiro
authors.initials: K
authors.lastname: Tanaka
authors.affiliation: JCOG Data Center/Operations Office, Multi-institutional Clinical Trial Support Center, National Cancer Center, Tokyo.
authors.forename: Junki
authors.initials: J
authors.lastname: Mizusawa
authors.affiliation: JCOG Data Center/Operations Office, Multi-institutional Clinical Trial Support Center, National Cancer Center, Tokyo.
authors.forename: Aya
authors.initials: A
authors.lastname: Kimura
authors.affiliation: Department of Orthopaedic Surgery, Hokkaido Cancer Center, Sapporo.
authors.forename: Hiroaki
authors.initials: H
authors.lastname: Hiraga
authors.affiliation: Department of Orthopaedic Surgery, National Cancer Center Hospital, Tokyo.
authors.forename: Akira
authors.initials: A
authors.lastname: Kawai
authors.affiliation: Department of Orthopaedic Surgery, Graduate School of Medical Sciences, Kyushu University, Fukuoka.
authors.forename: Tomoya
authors.initials: T
authors.lastname: Matsunobu
authors.affiliation: Department of Orthopaedic Surgery, Mie University Graduate School of Medicine, Tsu.
authors.forename: Akihiko
authors.initials: A
authors.lastname: Matsumine
authors.affiliation: Department of Orthopaedic Surgery, Osaka Medical Center for Cancer and CVD, Osaka.
authors.forename: Nobuhito
authors.initials: N
authors.lastname: Araki
authors.affiliation: Department of Anatomic Pathology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
authors.forename: Yoshinao
authors.initials: Y
authors.lastname: Oda
authors.affiliation: JCOG Data Center/Operations Office, Multi-institutional Clinical Trial Support Center, National Cancer Center, Tokyo.
authors.forename: Haruhiko
authors.initials: H
authors.lastname: Fukuda
authors.affiliation: Department of Orthopaedic Surgery, Graduate School of Medical Sciences, Kyushu University, Fukuoka yiwamoto@ortho.med.kyushu-u.ac.jp.
authors.forename: Yukihide
authors.initials: Y
authors.lastname: Iwamoto
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D018572:Disease-Free Survival; D000077143:Docetaxel; D004317:Doxorubicin / Q000008:administration & dosage; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007069:Ifosfamide / Q000008:administration & dosage; D007564:Japan; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011184:Postoperative Period; D012509:Sarcoma / Q000188:drug therapy* / Q000401:mortality; D012983:Soft Tissue Neoplasms / Q000188:drug therapy* / Q000401:mortality; D043823:Taxoids / Q000008:administration & dosage; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D043823:Taxoids; D003841:Deoxycytidine; D000077143:Docetaxel; D004317:Doxorubicin; D007069:Ifosfamide; D000093542:Gemcitabine
keywords: Phase II/III; high grade; non-round cell tumor; perioperative chemotherapy; soft-tissue sarcoma