Surgery versus Active Monitoring for LOw RISk Ductal Carcinoma in Situ (DCI... | Recruiting
Surgery versus Active Monitoring fo... | Recruiting
Surgery versus Active Monitoring for LOw RISk Ductal Carcinoma in Situ (DCIS)
LORIS

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Medical Conditions
  • Topic: Cancer
  • Subtopic: Breast Cancer
  • Disease: Breast
Primary Contact Details
Recruitment Status
Recruiting
Trial source and source ID number
ISRCTN27544579
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Summary
http://www.cancerresearchuk.org/about-cancer/trials/a-trial-comparing-surgery-with-active-monitoring-for-low-risk-dcis-loris
Research Details
  • 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.
Phase
Phase III
Study Design
Phase III multicentre 2 arm study with a built in 2 year feasibility phase
Study Type
Interventional
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
Primary Outcome Measures
    Ipsilateral invasive breast cancer free survival rate.; Timepoint(s): 5 years
Secondary Outcome Measures
    Not provided at time of registration
Publication(s)
Sorry, this information is not available
Result Reports
Sorry, this information is not available
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Female
Age Range
Adult
Who Can Participate
Patient
Number of Participants
Planned Sample Size: 932; UK Sample Size: 932
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 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)
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Pfizer Investigational Site
Birmingham
B15 2TT
Trial Contact(s)
Primary Trial Contact
Ms Claire Gaunt
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
A Phase III Trial of Surgery versus Active Monitoring for LOw RISk Ductal Carcinoma in Situ (DCIS)
EudraCT Number
Sorry, this information is not available
Funder(s)
  • NIHR Health Technology Assessment Programme
  • Grant Codes: 11/36/16
Other Study ID Numbers
16736
Sponsor(s)
University of Birmingham (UK)
Key Dates

Recruitment Start Date

06 Jun 2014

Recruitment End Date

05 Jun 2020

Trial Start Date

06 Jun 2014

Trial End Date

05 Jun 2020

Date added to source

22 May 2014

Date updated in source

19 Sep 2014