NCT04291378Recruiting
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
Source: ClinicalTrials.gov · Last updated 8 Oct 2020 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 1502 (estimated)
- First submitted
- 24 Feb 2020
- Start date
- 1 Jun 2020
- Primary completion date
- 1 Jun 2027
- Lead sponsor
- Danish Breast Cancer Cooperative Group
- Diseases
- Heart failure
- NCT number
- NCT04291378
What you commit to
- Study type: Interventional
- Planned participants: 1502
- From 1 Jun 2020 to the primary completion date, 1 Jun 2027
- 8 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- previous breast cancer/ductal carcinoma in situ,
- Previous RT to the chest region
- 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.
Other illness
- Conditions indicating that the patient cannot go through the RT or follow up
Other
- Pregnant or lactating
- Patients with Pacemaker or defibrillator are excluded until a guideline for handling them has been developed at the DCPT
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aalborg University Hospital Coordinator of this site? Confirm its status | Aalborg | Denmark | Recruiting |
| Aarhus University Hospital Coordinator of this site? Confirm its status | Aarhus | Denmark | Recruiting |
| Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen | Denmark | Recruiting |
| The Danish Breast Cancer Cooperative Group Coordinator of this site? Confirm its status | Copenhagen | Denmark | Not yet recruiting |
| Herlev Hospital Coordinator of this site? Confirm its status | Herlev | Denmark | Recruiting |
| Naestved Hospital Coordinator of this site? Confirm its status | Næstved | Denmark | Recruiting |
| Odense University Hospital Coordinator of this site? Confirm its status | Odense | Denmark | Recruiting |
| Vejle Hospital Coordinator of this site? Confirm its status | Vejle | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.