The DBCG Proton Trial: Photon Versus Proton Radiation Therapy for Early Breast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDanish Breast Cancer Cooperative Group
About this 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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Proton versus photon radiation therapy
Treatment groups
1,502 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov