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: Kozo Kataoka, Kazuhiro Tanaka, Junki Mizusawa, Aya Kimura, Hiroaki Hiraga, Akira Kawai, Tomoya Matsunobu, Akihiko Matsumine, Nobuhito Araki, Yoshinao Oda, Haruhiko Fukuda, Yukihide Iwamoto, Bone and Soft Tissue Tumor Study Group of the Japan Clinical Oncology Group
• Journal: Japanese journal of clinical oncology (Jpn J Clin Oncol) Vol. 44 Issue 8 Pg. 765-9 (Aug 2014) ISSN: 1465-3621 [Electronic] England
• PMID: 24916336 (Publication Type: Clinical Trial, Phase II, Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © The Author 2014. Published by Oxford University Press. All rights reserved. For Permissions, please email: [email protected].

Chemical References

• Taxoids
• Deoxycytidine
• Docetaxel
• Doxorubicin
• Ifosfamide
• Gemcitabine

Topics

• Adult
• Aged
• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Deoxycytidine (administration & dosage, analogs & derivatives)
• Disease-Free Survival
• Docetaxel
• Doxorubicin (administration & dosage)
• Female
• Follow-Up Studies
• Humans
• Ifosfamide (administration & dosage)
• Japan
• Male
• Middle Aged
• Neoplasm Staging
• Postoperative Period
• Sarcoma (drug therapy, mortality)
• Soft Tissue Neoplasms (drug therapy, mortality)
• Taxoids (administration & dosage)
• Tomography, X-Ray Computed
• Treatment Outcome
• Gemcitabine