The DBCG Proton Trial: Photon Versus Proton Radiation Therapy for Early Breast Cancer
Key facts
- Where
- Aalborg, Aarhus, Copenhagen, Herlev, Næstved, Odense, and Vejle, DenmarkSee the 8 sites
Where in Denmark
- Aalborg University HospitalAalborg, DenmarkTaking people
- Aarhus University HospitalAarhus, DenmarkTaking people
- RigshospitaletCopenhagen, DenmarkTaking people
- The Danish Breast Cancer Cooperative GroupCopenhagen, DenmarkNot yet recruiting
- Herlev HospitalHerlev, DenmarkTaking people
- Naestved HospitalNæstved, DenmarkTaking people
- Odense University HospitalOdense, DenmarkTaking people
- Vejle HospitalVejle, DenmarkTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Danish Breast Cancer Cooperative Group
- Trial code
- NCT04291378
- Record updated
- 8 October 2020
- Original description
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.Read full original descriptionShow less
The DBCG Proton Trial. Adjuvant Breast Proton Radiation Therapy for Early Breast Cancer Patients: The Skagen Trial 2, a Clinically Controlled Randomised Phase III Trial
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.
Inclusion: 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: previous breast cancer/ductal carcinoma in situ,; Previous RT to the chest region; 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; Conditions indicating that the patient cannot go through the RT or follow up; Pregnant or lactating; Patients with Pacemaker or defibrillator are excluded until a guideline for handling them has been developed at the DCPT.