Affordable Access

deepdyve-link deepdyve-link
Publisher Website

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.

Authors
  • 1
  • 2
  • 1
  • 1
  • 3
  • 4
  • 5
  • 6
  • 7
  • 8
  • 1
  • 9
  • 1 JCOG Data Center/Operations Office, Multi-institutional Clinical Trial Support Center, National Cancer Center, Tokyo.
  • 2 Department of Endoprosthetic Surgery, Oita University, Oita.
  • 3 Department of Orthopaedic Surgery, Hokkaido Cancer Center, Sapporo.
  • 4 Department of Orthopaedic Surgery, National Cancer Center Hospital, Tokyo.
  • 5 Department of Orthopaedic Surgery, Graduate School of Medical Sciences, Kyushu University, Fukuoka.
  • 6 Department of Orthopaedic Surgery, Mie University Graduate School of Medicine, Tsu.
  • 7 Department of Orthopaedic Surgery, Osaka Medical Center for Cancer and CVD, Osaka.
  • 8 Department of Anatomic Pathology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan. , (Japan)
  • 9 Department of Orthopaedic Surgery, Graduate School of Medical Sciences, Kyushu University, Fukuoka [email protected]
Type
Published Article
Journal
Japanese Journal of Clinical Oncology
1465-3621
Publisher
Oxford University Press
Publication Date
Volume
44
Issue
8
Pages
765–769
Identifiers
DOI: 10.1093/jjco/hyu080
PMID: 24916336
Source
Medline
Keywords
License
Unknown

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].

Statistics

Seen <100 times