A Phase III Trial of Surgery versus Active Monitoring for Low Risk Ductal Carcinoma in Situ (DCIS)

Trial Overview and Summary

 Chief Investigator:  Dr Matthew Wallis
 Sponsor:  University of Birmingham
 Funders:  Health Technology Assessment (HTA)  Programme
 Disease Site:  Breast
 Trial Type:  Surgery Trial
 Status:  Open
 UKCRN Study ID: (if applicable)  16736
 Open to new sites?  Yes
 Recruitment start date:  4th July 2014
 Anticipated Recruitment end date:  July 2020
 CRCTU Trial Management Team:  B Team
 Trial E-mail Address:  LORIS@trials.bham.ac.uk 

Trial Summary

Ductal carcinoma in situ (DCIS) is an abnormality of the milk ducts in the breast but not in any other breast tissue.  DCIS accounts for approximately 20% of breast ‘cancers’ detected by breast screening. Currently, all DCIS is treated by surgery because of concerns that it may become an invasive cancer if left untreated but many experts now believe that some cases of DCIS are unlikely to ever cause any problems in the woman’s lifetime. The LORIS Trial randomises patients with low risk DCIS to standard surgery or to active monitoring with annual mammography.  

Please note that the trials team cannot give individual’s clinical advice. Patients and their families should contact their treating physician to discuss trials for which they may be eligible.

Trial Protocol

Please Note:
Clinical trial protocols are complex technical documents which should only be used for the treatment of subjects taking part in the trial. Patients who are interested in taking part in the trial are advised to talk to their health care professional or refer to CancerHelp website (see the link below).

Investigators please ensure you have R&D approval for this specific version of the protocol before using as a reference.

More information

Patient information videos

LORIS Patient Information DVD, divided into chapters for easy viewing. 

Chapter 1 - Introduction

LORIS DVD Ch1. Introduction

Chapter 2 - What is DCIS?

LORIS DVD Ch2. What is DCIS?

Chapter 3 - Why is the LORIS trial so important?

LORIS DVD Ch3. Why is the LORIS trial so important?

Chapter 4 - Description of the study

LORIS DVD Ch4. Description of the study

Chapter 5 - Randmonisation

LORIS DVD Ch5. Randomisation

Chapter 6 - The groups

LORIS DVD Ch6. The Groups

Chapter 7 - What else can you expect from the study?

LORIS DVD Ch7. What else can you expect from the study?

Chapter 8 - Q and A


Chapter 9 - Grades of DCIS

LORIS DVD Ch9. Grades of DCIS