The DBCG Proton Trial: Photon Versus Proton Radiation Therapy for Early Breast Cancer
About this study
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.
- Condition
- Early Breast Cancer, Radiation Associated Cardiac Failure
- Tested
- Proton versus photon radiation therapy
- Sponsor
- Danish Breast Cancer Cooperative Group
Who can join
- Age
- 18 years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 6
- Minimum age: 18 years
- Study condition: Early Breast Cancer, Radiation Associated Cardiac Failure
- 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 7
- 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
8 sites, 8 recruiting
Aalborg University Hospital
Aalborg, Denmark
Aarhus University Hospital
Aarhus, Denmark
Rigshospitalet
Copenhagen, Denmark
Herlev Hospital
Herlev, Denmark
Naestved Hospital
Næstved, Denmark
Odense University Hospital
Odense, Denmark
and 2 more sites on ClinicalTrials.gov
Contact
-
Birgitte V Offersen, phd
+45 28838012 birgoffe@rm.dk
-
Morten Høyer, phd
+45 23282823 morthoey@rm.dk
Potential match only. Final eligibility is determined by the study team.