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The DBCG Proton Trial: Photon Versus Proton Radiation Therapy for Early Breast Cancer

NCT04291378 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1502

Last updated 2020-10-08

No results posted yet for this study

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.

Conditions

  • Early Breast Cancer
  • Radiation Associated Cardiac Failure

Interventions

RADIATION

Proton versus photon radiation therapy

The intervention is proton radiation therapy versus photon radiation therapy

Sponsors & Collaborators

  • Danish Breast Cancer Cooperative Group

    lead OTHER

Principal Investigators

  • Birgitte V Offersen, phd · Danish Breast cancer Cooperation Group (DBCG)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-01
Primary Completion
2027-06-01
Completion
2037-06-01
FDA Device
Yes

Countries

  • Denmark

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04291378 on ClinicalTrials.gov