Actively Recruiting
The DBCG Proton Trial: Photon Versus Proton Radiation Therapy for Early Breast Cancer
Led by Danish Breast Cancer Cooperative Group · Updated on 2020-10-08
1502
Participants Needed
8
Research Sites
887 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
The DBCG Proton Trial: Photon Versus Proton Radiation Therapy for Early Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- Previous breast cancer or ductal carcinoma in situ.
- Previous radiation therapy to the chest region.
- Pregnant or lactating women.
- Conditions indicating that the patient cannot complete radiation therapy or follow-up.
- Patients with pacemaker or defibrillator until guidelines are developed.
- Unknown non-tissue implants upstream of the target volume.
- Metal implants in the radiation area, including metal in implants.
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Trial Site Locations
Total: 8 locations
1
Aalborg University Hospital
Aalborg, Denmark
Actively Recruiting
2
Aarhus University Hospital
Aarhus, Denmark
Actively Recruiting
3
The Danish Breast Cancer Cooperative Group
Copenhagen, Denmark, DK-2100 Ø
Not Yet Recruiting
4
Rigshospitalet
Copenhagen, Denmark
Actively Recruiting
5
Herlev Hospital
Herlev, Denmark
Actively Recruiting
6
Naestved Hospital
Næstved, Denmark
Actively Recruiting
7
Odense University Hospital
Odense, Denmark
Actively Recruiting
8
Vejle Hospital
Vejle, Denmark
Actively Recruiting
Research Team
B
Birgitte V Offersen, phd
CONTACT
M
Morten Høyer, phd
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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