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

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

Plain Language Summary

Simplified for easier understanding

This trial is comparing standard photon radiation therapy to proton beam radiation therapy in early breast cancer patients, to see if protons can better protect the heart and lungs during treatment. **You may be eligible if...** - You have had surgery for early breast cancer and need radiation therapy - Your planned standard radiation dose to the heart is 4 Gy or more, or your lung dose is high - You have a life expectancy of at least 10 years - Previous non-breast cancers are allowed if you have been cancer-free for at least 5 years **You may NOT be eligible if...** - You have a history of previous breast cancer or DCIS - You have had prior radiation to the chest - You are pregnant or breastfeeding - You have a pacemaker or defibrillator - You have metal implants in the radiation field - Your health makes it unsafe to complete radiation therapy or follow-up Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

RADIATIONProton versus photon radiation therapy

The intervention is proton radiation therapy versus photon radiation therapy


Locations(8)

Aalborg University Hospital

Aalborg, Denmark

Aarhus University Hospital

Aarhus, Denmark

The Danish Breast Cancer Cooperative Group

Copenhagen, Denmark

Rigshospitalet

Copenhagen, Denmark

Herlev Hospital

Herlev, Denmark

Naestved Hospital

Næstved, Denmark

Odense University Hospital

Odense, Denmark

Vejle Hospital

Vejle, Denmark

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04291378


Related Trials