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

Kozo Kataoka, Kazuhiro Tanaka, Junki Mizusawa, Aya Kimura, Hiroaki Hiraga, Akira Kawai, Tomoya Matsunobu, Akihiko Matsumine, Nobuhito Araki, Yoshinao Oda, Haruhiko Fukuda, Yukihide Iwamoto

研究成果: ジャーナルへの寄稿学術誌査読

10 被引用数 (Scopus)

抄録

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 noninferiority 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 preoperative 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.

本文言語英語
論文番号hyu080
ページ(範囲)1-5
ページ数5
ジャーナルJapanese journal of clinical oncology
44
8
DOI
出版ステータス出版済み - 8月 2014

!!!All Science Journal Classification (ASJC) codes

  • 腫瘍学
  • 放射線学、核医学およびイメージング
  • 癌研究

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