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Implications of MEDIcal Low Dose RADiation Exposure - BReast Cancer Acute Coronary Events (MEDIRAD-BRACE)

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ClinicalTrials.gov Identifier: NCT03211442
Recruitment Status : Recruiting
First Posted : July 7, 2017
Last Update Posted : March 2, 2018
Sponsor:
Collaborators:
Stichting het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis
Klinikum rechts der Isar der Technischen Universität München
Institut de Radioprotection et de Sûreté Nucléaire
Information provided by (Responsible Party):
Johannes A. Langendijk, University Medical Center Groningen

Brief Summary:
MEDIRAD-BRACE aims to determine the relationship between 3D dose distributions in cardiac structures and the risk of acute coronary events (ACE) and other cardiac complications in breast cancer (BC) patients to develop and externally validate multivariable Normal Tissue Complication Probability (NTCP) models to assess the risk of ACE in individual patients based on cardiac dose metrics in the first 10 years after BC radiotherapy.

Condition or disease Intervention/treatment
Breast Cancer Female Acute Coronary Events Cardiac Complications Radiation: Radiotherapy

Study Type : Observational
Estimated Enrollment : 7000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Implications of MEDIcal Low Dose RADiation Exposure - BReast Cancer Acute Coronary Events (MEDIRAD-BRACE): A Retrospective Cohort Study
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • Radiation: Radiotherapy
    Breast cancer patients treated with radiotherapy


Primary Outcome Measures :
  1. Number of patients with an Acute Coronary Event after completion of RT treatment [ Time Frame: First 10 years after RT treatment ]

Secondary Outcome Measures :
  1. Number of patients with other cardiac complications after completion of RT treatment [ Time Frame: First 10 years after RT treatment ]
  2. Number of patients with radiotherapy-induced late non-cardiac toxicity (e.g. secondary tumors) [ Time Frame: First 10 years after RT treatment ]


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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult, female patients with stage I-III breast cancer, treated with primary surgery, either by mastectomy of breast conserving surgery, and postoperative RT in the period 2005-2013, and who were aged 40-75 years at the time of RT
Criteria

Inclusion Criteria:

  • Female breast cancer patients;
  • Treated with primary surgery for stage I-III invasive adenocarcinoma of the breast or ductal carcinoma in situ (DCIS);
  • Age between 40-75 years at time of start RT;
  • WHO performance status 0-1;
  • Planned for RT alone to the breast, the chest wall and/or the lymph node areas;
  • Start of RT is between 01-01-2015 and 31-12-2013;
  • Available planning CT scan and dose distribution;
  • Adjuvant systemic treatment, including hormonal therapy or chemotherapy is allowed;
  • Medical history of coronary artery disease and/or myocardial infarction is not an exclusion criterion;
  • Written informed consent.

Exclusion Criteria:

  • Male breast cancer patients;
  • Women with metastatic breast cancer (M1 disease);
  • Any prior malignancy other than non-melanoma skin cancer;
  • Previous thoracic or mediastinal radiation;
  • Women treated with neoadjuvant chemotherapy.

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): NCT03211442


Contacts
Contact: A.P.G. Crijns, Dr. +31503615532 a.p.g.crijns@umcg.nl

Locations
Netherlands
University Medical Center Groningen Recruiting
Groningen, Netherlands, 9700RB
Contact: A.P.G. Crijns, Dr.    +31503615532    a.p.g.crijns@umcg.nl   
Sponsors and Collaborators
University Medical Center Groningen
Stichting het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis
Klinikum rechts der Isar der Technischen Universität München
Institut de Radioprotection et de Sûreté Nucléaire

Responsible Party: Johannes A. Langendijk, Prof.Dr., University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT03211442     History of Changes
Other Study ID Numbers: RT2017-08
First Posted: July 7, 2017    Key Record Dates
Last Update Posted: March 2, 2018
Last Verified: March 2018

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

Keywords provided by Johannes A. Langendijk, University Medical Center Groningen:
Breast cancer
Radiotherapy
Cardiac complications
Acute coronary events
NTCP model

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases