Status:
RECRUITING
The DBCG Proton Trial: Photon Versus Proton Radiation Therapy for Early Breast Cancer
Lead Sponsor:
Danish Breast Cancer Cooperative Group
Conditions:
Early Breast Cancer
Radiation Associated Cardiac Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Detailed Description
Adjuvant breast cancer radiation therapy (RT) is standard for all patients operated with breast conservation and for patients diagnosed with large tumours and/or node-positive disease. Around 65% of a...
Eligibility Criteria
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
- 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.
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2037
Estimated Enrollment :
1502 Patients enrolled
Trial Details
Trial ID
NCT04291378
Start Date
June 1 2020
End Date
June 1 2037
Last Update
October 8 2020
Active Locations (8)
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1
Aalborg University Hospital
Aalborg, Denmark
2
Aarhus University Hospital
Aarhus, Denmark
3
The Danish Breast Cancer Cooperative Group
Copenhagen, Denmark, DK-2100 Ø
4
Rigshospitalet
Copenhagen, Denmark