Early Breast CancerRadiation Associated Cardiac Failure
Investigational drug(s) / intervention(s)
Proton versus photon radiation therapy
Proton versus photon radiation therapy: The intervention is proton radiation therapy versus photon radiation therapy
Study summary
The majority of early breast cancer patients are treated with adjuvant radiation therapy (RT) as part of their multimodal therapy. The aim of the RT is to lower the risk of local, regional and distant failure and improve survival. Modern RT is been provided with photon therapy. Now, more proton therapy facilities are opened, including in Denmark. Proton RT may have the potential to cause lower dose to heart and lung during breast RT. This trial will randomise patients between standard photon RT versus experimental proton RT. The primary endpoint is 10 year risk of heart disease.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Patient operated for early breast cancer with indication for radiation therapy, where standard planning shows a mean heart dose 4 Gy or more and/or a V20 lung of 37% or more.
* Boost (breast, chest wall and nodal), breast reconstruction (any type, except implants with metal), connective tissue disease, post-operative surgical complications, any breast size and seromas are allowed
* Patient with previous non-breast malignancy is accepted if the patient has been without disease minimum 5 years, and the treating oncologist estimates a low risk of recurrence.
* Life expectancy minimum 10 years
Exclusion Criteria:
* previous breast cancer/ductal carcinoma in situ,
* Previous RT to the chest region
* Pregnant or lactating
* Conditions indicating that the patient cannot go through the RT or follow up
* Patients with Pacemaker or defibrillator are excluded until a guideline for handling them has been developed at the DCPT
* Unknown non-tissue implants upstream of the target volume. NB. all such non-tissue, non-metal objects must be delivered to the DCPT for stopping power determination and evaluation at least a week prior to radiation start.
* Metal implants in the radiation area, including metal in implants.
Primary outcome measure(s)
Radiation associated ischaemic and valvular heart disease — 10 years after RT The following incidences heart diseases according to ICD10: ischaemic heart disease codes I20-25 and valvular heart disease codes I00-09, I01.0, I09.2, I34-39
Trial sites (8)
Facility
City
Region
Status
Aalborg University Hospital
Aalborg
Denmark
Recruiting
Aarhus University Hospital
Aarhus
Denmark
Recruiting
The Danish Breast Cancer Cooperative Group
Copenhagen
Denmark
Not Yet Recruiting
Rigshospitalet
Copenhagen
Denmark
Recruiting
Herlev Hospital
Herlev
Denmark
Recruiting
Naestved Hospital
Næstved
Denmark
Recruiting
Odense University Hospital
Odense
Denmark
Recruiting
Vejle Hospital
Vejle
Denmark
Recruiting
More Danish Breast Cancer Cooperative Group trials in Denmark
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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