TY - JOUR
T1 - A randomized phase III trial of denosumab before curettage for giant cell tumor of bone
T2 - Japan Clinical Oncology Group Study JCOG1610
AU - Urakawa, Hiroshi
AU - Mizusawa, Junki
AU - Tanaka, Kazuhiro
AU - Eba, Junko
AU - Hiraga, Hiroaki
AU - Kawai, Akira
AU - Nishida, Yoshihiro
AU - Hosaka, Masami
AU - Iwamoto, Yukihide
AU - Fukuda, Haruhiko
AU - Ozaki, Toshifumi
N1 - Funding Information:
This study is supported by the National Cancer Center Research and Development Fund (29-A-3).
Publisher Copyright:
© The Author(s) 2019. Published by Oxford University Press. All rights reserved.
PY - 2019/3/28
Y1 - 2019/3/28
N2 - A randomized phase III trial was planned to commence in October 2017. Resectable giant cell tumor of bone (GCTB) without possible postoperative large bone defect has been treated by curettage with local adjuvant treatment, with the local recurrence rate found to be as high as 24.6-30.8%. The aim of this study is to confirm the superiority of preoperative denosumab for patients with GCTB without possible postoperative large bone defect. A total of 106 patients will be accrued from 34 Japanese institutions over 5 years. The primary endpoint is relapse-free survival (RFS). Secondary endpoints include overall survival, joint-preserved survival, local RFS, metastasis-free survival, adverse events, serious adverse events, surgical and postoperative complications, and discontinuation of denosumab. This trial is conducted by the Bone and Soft Tissue Tumor Study Group in the Japan Clinical Oncology Group and has been registered in the UMIN Clinical Trials Registry as UMIN000029451 .
AB - A randomized phase III trial was planned to commence in October 2017. Resectable giant cell tumor of bone (GCTB) without possible postoperative large bone defect has been treated by curettage with local adjuvant treatment, with the local recurrence rate found to be as high as 24.6-30.8%. The aim of this study is to confirm the superiority of preoperative denosumab for patients with GCTB without possible postoperative large bone defect. A total of 106 patients will be accrued from 34 Japanese institutions over 5 years. The primary endpoint is relapse-free survival (RFS). Secondary endpoints include overall survival, joint-preserved survival, local RFS, metastasis-free survival, adverse events, serious adverse events, surgical and postoperative complications, and discontinuation of denosumab. This trial is conducted by the Bone and Soft Tissue Tumor Study Group in the Japan Clinical Oncology Group and has been registered in the UMIN Clinical Trials Registry as UMIN000029451 .
KW - Japan
KW - curettage
KW - giant cell tumor of bone
KW - phase III
KW - preoperative denosumab
UR - http://www.scopus.com/inward/record.url?scp=85064493148&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85064493148&partnerID=8YFLogxK
U2 - 10.1093/jjco/hyz004
DO - 10.1093/jjco/hyz004
M3 - Article
C2 - 30796832
AN - SCOPUS:85064493148
SN - 0368-2811
VL - 49
SP - 379
EP - 382
JO - Japanese Journal of Clinical Oncology
JF - Japanese Journal of Clinical Oncology
IS - 4
ER -
