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- Title
Intensive vs. Standard Post-Operative Surveillance in High-Risk Breast Cancer Patients (INSPIRE): Japan Clinical Oncology Group Study JCOG1204.
- Authors
Takashi Hojo; Norikazu Masuda; Tomonori Mizutani; Taro Shibata; Takayuki Kinoshita; Kenji Tamura; Fumikata Hara; Tomomi Fujisawa; Kenichi Inoue; Shigehira Saji; Kenichi Nakamura; Haruhiko Fukuda; Hiroji Iwata
- Abstract
This Phase III trial aims to determine the superiority of intensive follow-up to standard follow-up in terms of overall survival in high-risk breast cancer patients, who are expected to have recurrence rates of over 30%within 5 years after surgery. Eligible patients are randomized either to the intensive follow-up group or to the standard follow-up group; the former will undergo physical examination, bone scintigraphy, chest computed tomography, abdominal computed tomography, brainmagnetic resonance imaging/computed tomography and frequent tumor marker evaluations, whereas the latter will undergo physical examination at the same frequency and tumor markers will be evaluated once a year. Mammography once a year is planned for both groups. The primary endpoint is overall survival. Patient accrual was started in November 2013. A total of 1700 patients will be enrolled for 3 years and followed up for 7 years after closure of accrual. This trial has been registered at the UMIN Clinical Trials Registry as UMIN000012429.
- Publication
Japanese Journal of Clinical Oncology, 2015, Vol 45, Issue 10, p983
- ISSN
0368-2811
- Publication type
Article
- DOI
10.1093/jjco/hyv110