TY - JOUR
T1 - A randomized phase ii/iii trial of perioperative chemotherapy with adriamycin plus ifosfamide versus gemcitabine plus docetaxel for high-grade soft tissue sarcoma
T2 - Japan clinical oncology group study JCOG1306
AU - Kataoka, Kozo
AU - Tanaka, Kazuhiro
AU - Mizusawa, Junki
AU - Kimura, Aya
AU - Hiraga, Hiroaki
AU - Kawai, Akira
AU - Matsunobu, Tomoya
AU - Matsumine, Akihiko
AU - Araki, Nobuhito
AU - Oda, Yoshinao
AU - Fukuda, Haruhiko
AU - Iwamoto, Yukihide
PY - 2014/8
Y1 - 2014/8
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=84905284537&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84905284537&partnerID=8YFLogxK
U2 - 10.1093/jjco/hyu080
DO - 10.1093/jjco/hyu080
M3 - Article
C2 - 24916336
AN - SCOPUS:84905284537
SN - 0368-2811
VL - 44
SP - 1
EP - 5
JO - Japanese journal of clinical oncology
JF - Japanese journal of clinical oncology
IS - 8
M1 - hyu080
ER -
