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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Proton versus photon radiation therapy
RadiationThe intervention is proton radiation therapy versus photon radiation therapy
Treatment groups
1,502 Participants
are divided into 2 treatment groupsGroup A: Photon radiation therapyActive comparator 1 intervention
Group B: Proton radiation therapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Radiation associated ischaemic and valvular heart disease
The following incidences heart diseases according to ICD10: ischaemic heart disease codes I20-25 and valvular heart disease codes I00-09, I01.0, I09.2, I34-39
Time frame
10 years after RTSecondary outcomes
1
Radiation associated second cancer
Incidences of second cancer associated with the RT: lung, esophagus, thyroid, sarcoma, contralateral breast
Time frame
10 years after RT2
Distant failure
Incidences of distant failures, i.e. cancer recurrence outside the loco-regional region
Time frame
10 years after RT3
Acute radiation associated morbidity
According to CTC version 4.0: Incidences of radiation dermatitis, itching, pain, fatigue, dyspnea, cough, pneumonitis, dysphagia, increased sensation of tightness of the shoulder and lymphedema
Time frame
within 6 months after RT4
Late radiation associated morbidity
Incidences of fibrosis, dyspigmentation, telangiectasia, edema, arm lymph edema, range of motion of the shoulder, pain, rib fractures, pneumonitis
Time frame
10 years after RTSponsors and contacts
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Source ClinicalTrials.gov