Condition category
Cancer
Date applied
22/05/2014
Date assigned
22/05/2014
Last edited
19/09/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Contact information

Type

Scientific

Primary contact

Ms Claire Gaunt

ORCID ID

Contact details

Institute for Cancer Studies
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
C.H.Gaunt@bham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

16736

Study information

Scientific title

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

Acronym

LORIS

Study hypothesis

The LORIS Trial aims to establish whether patients with newly diagnosed low risk DCIS can safely avoid surgery without detriment to their wellbeing (psychological and physical) and whether those patients who do require surgery can be identified by pathological and radiological means.

Ethics approval

14/WM/0083; First MREC approval date 28/04/2014

Study design

Phase III multicentre 2 arm study with a built in 2 year feasibility phase

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Cancer; Subtopic: Breast Cancer; Disease: Breast

Intervention

Comprehensive site training will be complimented by a patient friendly DVD designed to ensure consistent and appropriate use of terminology. Patients will be randomised between standard surgery and active monitoring with annual mammography. Follow-up will be for a minimum of 10 years. Active Monitoring, Patient will be actively monitored by annual mammography.; Follow Up Length: 120 month(s); Study Entry : Registration and One or More Randomisations

Intervention type

Other

Phase

Phase III

Drug names

Primary outcome measures

Ipsilateral invasive breast cancer free survival rate.; Timepoint(s): 5 years

Secondary outcome measures

Not provided at time of registration

Overall trial start date

06/06/2014

Overall trial end date

05/06/2020

Reason abandoned

Eligibility

Participant inclusion criteria

1. Female, aged 46 years or above
2. Screendetected or incidental microcalcification (unilateral or bilateral)
3. Histologically confirmed diagnosis of nonhigh grade DCIS confirmed by local pathologist on either small volume
core biopsy or VACB (in accordance with the current NHSBSP Guidelines for Pathology Reporting in Breast Cancer
Screening)
4. DCIS diagnosed =90 days before registration
5. Able to give informed consent and comply with the trial schedule and completion of Patient Reported Outcome
questionnaires
6. Patient fit to undergo surgery
7. Written informed consent obtained

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Planned Sample Size: 932; UK Sample Size: 932

Participant exclusion criteria

1. Previous diagnosis of invasive cancer or ipsilateral DCIS (previous surgically treated contralateral DCIS is permitted)
2. A mass lesion clinically on mammogram or on ultrasound scan (if performed) at the site of the microcalcification
before biopsy
3. Any serious and/or unstable preexisting medical, psychiatric, or other condition that would prevent compliance with
the trial or consent process
4. Recent onset ipsilateral bloodstained nipple discharge, unless cytology and/or Ultrasound Scan (USS) confirmed
concomitant duct ectasia
5. High risk group for developing breast cancer (as defined in current NICE guidelines for familial breast cancer, or due
to prior exposure to mantle field radiotherapy)

Recruitment start date

06/06/2014

Recruitment end date

05/06/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Institute for Cancer Studies
Birmingham
B15 2TT
United Kingdom

Sponsor information

Organisation

University of Birmingham (UK)

Sponsor details

Institute for Cancer studies
Edgbaston
Birmingham
B15 2TT
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme; Grant Codes: 11/36/16

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes