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Japanese Journal of Clinical Oncology Advance Access originally published online on January 20, 2009
Japanese Journal of Clinical Oncology 2009 39(4):271-273; doi:10.1093/jjco/hyn153
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© The Author (2009). Published by Oxford University Press. All rights reserved

Preoperative and Postoperative Chemotherapy with Ifosfamide and Adriamycin for Adult High-grade Soft-tissue Sarcomas in the Extremities: Japan Clinical Oncology Group Study JCOG0304

Kazuhiro Tanaka1, Hiroshi Kawamoto2,3, Isamu Saito2, Kenichi Yoshimura2,4, Haruhiko Fukuda2 and Yukihide Iwamoto1

1 Department of Orthopaedic Surgery, Graduate School of Medical Sciences, Kyushu University, Fukuoka
2 Clinical Trials and Practice Support Division, Center for Cancer Control and Information Services, National Cancer Center, Tokyo
3 Department of Pediatrics, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Tokyo
4 Division of Clinical Trial Management, Translational Research Center, Kyoto University Hospital, Kyoto, Japan

For reprints and all correspondence: Yukihide Iwamoto, Department of Orthopaedic Surgery, Graduate School of Medical Sciences, Kyushu University, 3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan. E-mail: yiwamoto{at}ortho.med.kyushu-u.ac.jp

Received August 19, 2008; accepted December 16, 2008

This phase II clinical trial aims to evaluate the efficacies and toxicities of pre- and postoperative chemotherapy with adriamycin plus ifosfamide on the patients with soft-tissue high-grade sarcomas. Patients who have operable, non-round cell soft-tissue sarcomas [French Federation of Cancer Center (FNCLCC) Grades 2 and 3] arising in the extremities [T2bN0M0, i.e. American Joint Committee on Cancer (AJCC) stage III] are treated by three courses of preoperative chemotherapy consisting of adriamycin and ifosfamide followed by complete resection and additional two courses of the same chemotherapy regimen. The Bone and Soft Tissue Tumor Study Group (BSTTSG) in the Japan Clinical Oncology Group (JCOG) including 26 specialized institutes will accrue 75 patients. The primary endpoint of the study is the 2-year progression-free survival rate, and secondary endpoints are response rate of the preoperative chemotherapy, 3-year progression-free survival rate, progression-free survival, overall survival and adverse events. The JCOG Clinical Trial Review Committee approved the protocol on 11 March 2004, and the study was started on 29 April 2004. Protocol amendment was approved on 18 May 2007.

Key Words: soft-tissue sarcoma • preoperative and postoperative chemotherapy • extremity • high grade • adult • non-round cell tumor


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