LORIS, Version 1.0 14th February 2014
Research type
Research Study
Full title
A Phase III Trial of Surgery versus Active Monitoring for Low Risk Ductal Carcinoma in Situ (DCIS.
IRAS ID
125950
Contact name
Adele Francis
Contact email
Sponsor organisation
University of Birmingham
Research summary
BACKGROUND
The independent review of the UK National Health Service Breast Screening Programme (NHSBSP) recently reported on the benefits and harms of breast screening (The Lancet, Volume 380, Issue 9855, Pages 1778 - 1786, 17 November 2012). This concluded that breast screening saves lives but acknowledged the existence of overtreatment and estimated that approximately 3 unnecessary operations for screen detected breast cancer are performed for every life saved as a result of breast screening. Consequently, randomised trials were recommended to elucidate the appropriate treatment of screen-detected ductal carcinoma in situ (DCIS) and to gain a better understanding of its natural history. The LORIS Trial will address these issues in low and low-intermediate grade screen detected/asymptomatic (low risk) DCIS.TRIAL DESIGN
LORIS is a phase III, multi-centre, 2 arm study, with a built in 2 year Feasibility Study, in women confirmed by Central Histopathology Review to have low risk DCIS. Patients will be randomised between standard surgery and active monitoring with annual mammography. Follow-up will be for a minimum of 10 years.MAIN AIMS OF THE TRIAL
The LORIS Trial aims to establish whether patients with newly diagnosed low risk DCIS can safely avoid surgery without detriment to their well-being (psychological and physical) and whether those patients who do require surgery can be identified by pathological and radiological means.Primary endpoint:
Ipsilateral invasive breast cancer free survival rate at 5 years.Secondary endpoints:
Time to ipsilateral invasive breast cancer, time to invasive breast cancer, time to contralateral invasive breast cancer, overall survival, time to mastectomy, time to surgery, Quality of Life, Quality-Adjusted Life Years, an assessment of predictive biomarkers.REC name
West Midlands - Solihull Research Ethics Committee
REC reference
14/WM/0083
Date of REC Opinion
28 Apr 2014
REC opinion
Further Information Favourable Opinion