RecruitingNot ApplicableNCT04291378

The DBCG Proton Trial: Photon Versus Proton Radiation Therapy for Early Breast Cancer

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

Sponsor

Danish Breast Cancer Cooperative Group

Enrollment

1,502 participants

Start Date

Jun 1, 2020

Study Type

INTERVENTIONAL

Conditions

Early Breast Cancer Radiation Associated Cardiac Failure

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

Min Age: 18 Years

Inclusion Criteria4

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 Criteria7

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.