Intensive vs. Standard Post-Operative Surveillance in High-Risk Breast Cancer Patients (INSPIRE): Japan Clinical Oncology Group Study JCOG1204

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 int...

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Bibliographic Details
Published in:Japanese journal of clinical oncology 2015-10, Vol.45 (10), p.983-986
Main Authors: Hojo, Takashi, Masuda, Norikazu, Mizutani, Tomonori, Shibata, Taro, Kinoshita, Takayuki, Tamura, Kenji, Hara, Fumikata, Fujisawa, Tomomi, Inoue, Kenichi, Saji, Shigehira, Nakamura, Kenichi, Fukuda, Haruhiko, Iwata, Hiroji
Format: Article
Language:English
Subjects:
Adult
Aged
Biomarkers, Tumor - analysis
Breast Neoplasms - diagnosis
Breast Neoplasms - mortality
Breast Neoplasms - prevention & control
Female
Humans
Japan
Longitudinal Studies
Magnetic Resonance Imaging
Mammography
Medical Oncology - methods
Middle Aged
Outcome and Process Assessment (Health Care)
Postoperative Period
Survival Analysis
Tomography, X-Ray Computed
Young Adult
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Summary: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, brain magnetic 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.
ISSN:0368-2811
1465-3621
DOI:10.1093/jjco/hyv110