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Management of Low-risk DCIS (LORD)

This study is currently recruiting participants.
Verified September 2017 by European Organisation for Research and Treatment of Cancer - EORTC
Sponsor:
ClinicalTrials.gov Identifier:
NCT02492607
First Posted: July 8, 2015
Last Update Posted: September 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Borstkanker Onderzoek Groep
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
  Purpose

A substantial number of DCIS lesions will never form a health hazard, particularly if it concerns slow-growing low-grade DCIS. This implies that many women might be unnecessarily going through intensive treatment resulting in a decrease in quality of life and an increase in health care costs, without any survival benefit.

The LORD (LOw Risk DCIS) study is a randomized, international, multicenter, phase III non-inferiority trial, and aims to determine whether screen-detected low-grade DCIS can safely be managed by an active surveillance strategy or that the conventional treatment, being either WLE alone, WLE + RT, or mastectomy, and possibly HT, should remain the standard of care.


Condition Intervention Phase
DCIS Other: Standard treatment Device: digital mammography Radiation: radiotherapy Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Management of Low Risk Ductal Carcinoma in Situ (Low-risk DCIS): a Randomized, Multicentre, Non-inferiority Trial, Between Standard Therapy Approach Versus Active Surveillance

Further study details as provided by European Organisation for Research and Treatment of Cancer - EORTC:

Primary Outcome Measures:
  • Ipsilateral invasive breast cancer-free rate at 10 years [ Time Frame: 10 years from randomization ]

Secondary Outcome Measures:
  • Time to ipsilateral grade II or III DCIS [ Time Frame: from randomization to the development of a new ipsilateral DCIS, up to 10 years ]
  • Time to contralateral DCIS [ Time Frame: from randomization to the development of a new contralateral DCIS, up to 10 years ]
  • Time to contralateral invasive breast cancer [ Time Frame: from randomization to the development of a contralateral invasive breast cancer, up to 10 years ]
  • Time to failure of active surveillance strategy [ Time Frame: from randomization to the time to patients received standard treatment, up to 10 years ]
  • Distant metastases free interval [ Time Frame: from randomization to the time of invasive distant metastases or death due to breast cancer, up to 10 years ]
  • Overall survival [ Time Frame: from randomization to the time of death, during 10 years at minimum ]

Estimated Enrollment: 1240
Actual Study Start Date: February 13, 2017
Estimated Study Completion Date: December 2029
Estimated Primary Completion Date: December 2029 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard treatment
Standard treatment according to local policy. This can be either wide local excision only, wide local excision and radiotherapy, or mastectomy. Hormonal therapy is also allowed.
Other: Standard treatment

wide local excision only or wide local excision and radiotherapy or mastectomy.

+/- hormonal therapy

Radiation: radiotherapy
according local policy
Experimental: Active surveillance
Active surveillance : monitoring by annual digital mammography for a period of 10 years
Device: digital mammography
annual mammography
Other Name: Active surveillance

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women of age > or = 45 years.
  • Any menopausal status.
  • Calcifications only lesions, detected by population-based or opportunistic screening mammography.
  • Representative vacuum-assisted core biopsies with pure low-grade DCIS
  • Any size DCIS.
  • Marker placement at biopsy site(s) in the breast.
  • Good correlation between pathological and radiological findings i.e. both findings confirm low-grade DCIS and no suspicion of intermediate or high-grade DCIS or invasive breast cancer
  • Prior surgery of the ipsilateral breast because of a benign lesion allowed.
  • ASA score 1 or 2
  • Before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations

Exclusion Criteria:

  • Presence of mass, increased density around calcifications, architectural distortion, stellate lesion on mammography.
  • Presence of bilateral DCIS.
  • Presence of Paget's disease, invasive breast cancer, or lobular carcinoma in situ on cytology or histology.
  • Presence of symptomatic DCIS e.g. DCIS detected by palpation or nipple discharge.
  • Presence of synchronous invasive carcinoma in the contralateral breast.
  • Prior history of invasive breast cancer or DCIS.
  • Prior history of other cancer except carcinoma in situ of the cervix or basocellular carcinoma of the skin.
  • Presence of serious disease that precludes definitive surgical treatment (e.g. cardiovascular/pulmonary/renal disease).
  • Individual from a family with a known BRCA1/2 mutation
  • Presence of pregnancy or breast-feeding.
  • Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02492607


Contacts
Contact: Bianca Colleoni, Phd +32 2 774 15 70 bianca.colleoni@eortc.be
Contact: Konstantinos Tryfonidis, MD konstantinos.tryfonidis@eortc.be

Locations
Belgium
Jan Palfijn Not yet recruiting
Antwerpen, Belgium
Principal Investigator: Vermeij         
UZ Antwerpen Not yet recruiting
Antwerpen, Belgium
Principal Investigator: Altintas         
ZNA Not yet recruiting
Antwerp, Belgium
Principal Investigator: Vermeij         
Bordet-Erasme Not yet recruiting
Brussels, Belgium
Principal Investigator: Simon         
CHU Saint-Pierre Not yet recruiting
Brussels, Belgium
Principal Investigator: Carly         
Hopital Universitaire Brugmann Not yet recruiting
Brussels, Belgium
Principal Investigator: Nazac         
UZ Leuven Not yet recruiting
Leuven, Belgium
Principal Investigator: Smeets         
Netherlands
Noordwest Ziekenhuisgroep- site Alkmaar Not yet recruiting
Alkmaar, Netherlands
Principal Investigator: Diepenhorst         
Flevoziekenhuis Not yet recruiting
Almere, Netherlands
Principal Investigator: van der Meij         
The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis Recruiting
Amsterdam, Netherlands
Principal Investigator: Wesseling         
Rijnstate Ziekenhuis Not yet recruiting
Arnhem, Netherlands
Principal Investigator: Van Eekeren         
Alexander Monro Ziekenhuis Recruiting
Bilthoven, Netherlands
Principal Investigator: Veenendaal         
Amphia Ziekenhuis Not yet recruiting
Breda, Netherlands
Principal Investigator: Luiten         
Deventer Ziekenhuis Recruiting
Deventer, Netherlands
Principal Investigator: de Noo         
Slingeland Ziekenhuis Not yet recruiting
Doetinchem, Netherlands
Principal Investigator: Reijnders         
Albert Schweitzer Ziekenhuis Not yet recruiting
Dordrecht, Netherlands
Principal Investigator: Westenend         
Catharina Ziekenhuis Not yet recruiting
Eindhoven, Netherlands
Principal Investigator: van Riet         
Maxima Medisch Centrum Recruiting
Eindhoven, Netherlands
Principal Investigator: Maaskant         
Medisch Spectrum Twente Ariensplain Not yet recruiting
Enschede, Netherlands
Principal Investigator: van Duyn         
Groene Hart Ziekenhuis Not yet recruiting
Gouda, Netherlands
Principal Investigator: Linthorst         
Kennemer Gasthuis Zuid Not yet recruiting
Haarlem, Netherlands
Principal Investigator: Vuylsteke         
Ziekenhuis St. Jansdal Recruiting
Harderwijk, Netherlands
Principal Investigator: Schouten van der Velden         
Zuyderland Medisch Centrum Not yet recruiting
Heerlen, Netherlands
Principal Investigator: Vissers         
Jeroen Bosch Ziekenhuis Not yet recruiting
Hertogenbosch, Netherlands
Principal Investigator: Bessems         
Spaarne ziekenhuis Not yet recruiting
Hoofddorp, Netherlands
Principal Investigator: De Valk         
Westfriesgasthuis Not yet recruiting
Hoorn, Netherlands
Principal Investigator: Govaert         
Diaconessenhuis Leiden Not yet recruiting
Leiden, Netherlands
Principal Investigator: Van Gijn         
Leids Universitair Medisch Centrum Not yet recruiting
Leiden, Netherlands
Principal Investigator: Liefers         
HagaZiekenhuis - Antoniushove Not yet recruiting
Leidschendam, Netherlands
Principal Investigator: Jannink         
Academisch Ziekenhuis Maastricht Not yet recruiting
Maastricht, Netherlands
Principal Investigator: Smidt         
St. Antonius Ziekenhuis Not yet recruiting
Nieuwegein, Netherlands
Principal Investigator: Koelemij         
Canisius-Wilhelmina Ziekenhuis Not yet recruiting
Nijmegen, Netherlands
Principal Investigator: Strobbe         
Waterlandziekenhuis Not yet recruiting
Purmerend, Netherlands
Principal Investigator: De Widt-Levert         
Erasmus Medisch Centrum Not yet recruiting
Rotterdam, Netherlands
Principal Investigator: Obdeijn         
St. Elisabeth Ziekenhuis Not yet recruiting
Tilburg, Netherlands
Principal Investigator: Jansen         
Diakonessenhuis Not yet recruiting
Utrecht, Netherlands
Principal Investigator: van Dalen         
Universitair Medisch Centrum Utrecht Not yet recruiting
Utrecht, Netherlands
Principal Investigator: van der Pol         
Maxima Medisch Centrum - Locatie Veldhoven Recruiting
Veldhoven, Netherlands
Principal Investigator: Maaskant         
VieCuri - Medisch Centrum voor Noord-Limburg - Locatie Venlo Recruiting
Venlo, Netherlands
Principal Investigator: Aarts         
Zaans Medisch Centrum Not yet recruiting
Zaandam, Netherlands
Principal Investigator: Muller         
Gelre ziekenhuizen Not yet recruiting
Zutphen, Netherlands
Principal Investigator: Ketel         
Isala Klinieken Not yet recruiting
Zwolle, Netherlands
Principal Investigator: Noorda         
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Borstkanker Onderzoek Groep
Investigators
Study Chair: Jelle Wesseling The Netherlands Cancer Institute
  More Information

Publications:
Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT02492607     History of Changes
Other Study ID Numbers: EORTC-1401
2014-04 ( Other Identifier: BOOG )
First Submitted: June 24, 2015
First Posted: July 8, 2015
Last Update Posted: September 8, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
Women
DCIS
Active surveillance
Standard treatment