The DBCG Proton Trial: Photon Versus Proton Radiation Therapy for Early Breast Cancer
Recruiting · NCT04291378 · Interventional (participants receive a specific treatment) · Lead sponsor: Danish Breast Cancer Cooperative Group
View the official record on ClinicalTrials.gov →Interventions studied
Proton versus photon radiation therapy
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
8 locations listed.
- Aalborg University Hospital - Aalborg, Denmark
- Aarhus University Hospital - Aarhus, Denmark
- The Danish Breast Cancer Cooperative Group - Copenhagen, Denmark
- Rigshospitalet - Copenhagen, Denmark
- Herlev Hospital - Herlev, Denmark
- Naestved Hospital - Næstved, Denmark
- Odense University Hospital - Odense, Denmark
- Vejle Hospital - Vejle, Denmark