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

Last updated: October 5, 2020
Sponsor: Danish Breast Cancer Cooperative Group
Overall Status: Active - Recruiting

Phase

N/A

Condition

Congestive Heart Failure

Chest Pain

Heart Failure

Treatment

N/A

Clinical Study ID

NCT04291378
DBCG Proton trial
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient operated for early breast cancer with indication for radiation therapy, wherestandard planning shows a mean heart dose 4 Gy or more and/or a V20 lung of 37% ormore.

  • Boost (breast, chest wall and nodal), breast reconstruction (any type, except implantswith metal), connective tissue disease, post-operative surgical complications, anybreast size and seromas are allowed

  • Patient with previous non-breast malignancy is accepted if the patient has beenwithout disease minimum 5 years, and the treating oncologist estimates a low risk ofrecurrence.

  • Life expectancy minimum 10 years

Exclusion

Exclusion Criteria:

  • 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 handlingthem 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 andevaluation at least a week prior to radiation start.

  • Metal implants in the radiation area, including metal in implants.

Study Design

Total Participants: 1502
Study Start date:
June 01, 2020
Estimated Completion Date:
June 01, 2037

Study 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 all breast cancer patients treated with RT have whole breast RT without nodal RT, whilst the remaining 35% are treated with loco-regional RT (target is breast / chest wall and regional nodal volumes). RT leads to fewer local and regional recurrences, a decrease in breast cancer death and improves overall survival. Since 2014, when the DBCG IMN study showed overall survival gain from internal mammary node (IMN) RT, IMN RT has been standard for all high-risk patients in Denmark. IMN RT causes a significant increase in dose to the heart and lung, thus heart and lung sparing RT techniques based on deep inspiration breath hold (DIBH), volumetric arc therapy and tomotherapy are increasingly used to lower dose to heart and lung whilst maintaining dose to breast and nodal targets. These advanced techniques are used in all DBCG departments routinely. Despite using advanced RT techniques, some patients still receive high RT dose to heart and lung.

Proton therapy (PT) has not been widely used nor investigated for adjuvant breast cancer RT, because there are only few proton centres. However, due to the properties of PT it is possible to achieve optimal dose coverage of relevant targets and at the same time ensure low dose to organs at risk compared with photon RT. In an energy-dependent manner, PT will deposit the majority of its dose in tissue depths defined by the Bragg peak. In practice, this translates into i) the ability to deliver the peak energy to target volumes of irregular 3-dimensional shape using pencil-beam scanning technology, ii) a sharp dose fall-off following deposition of energy in the target and iii) reduction of the integral dose to the patient. Within millimeters, the exit dose drops off from 90% to 10%, resulting in the virtual absence of an exit dose. The effectiveness, safety and feasibility of PT has been reported in few small cohort studies with limited follow up, and there is a lack of clinically controlled randomised trials documenting benefit from PT, evaluated either as higher tumour control and/or as fewer morbidities.

This trial tests standard photon RT versus experimental proton RT for selected early breast cancer patients.

Connect with a study center

  • Aalborg University Hospital

    Aalborg,
    Denmark

    Active - Recruiting

  • Aarhus University Hospital

    Aarhus,
    Denmark

    Active - Recruiting

  • Rigshospitalet

    Copenhagen,
    Denmark

    Active - Recruiting

  • The Danish Breast Cancer Cooperative Group

    Copenhagen, DK-2100 Ø
    Denmark

    Site Not Available

  • Herlev Hospital

    Herlev,
    Denmark

    Active - Recruiting

  • Naestved Hospital

    Naestved,
    Denmark

    Active - Recruiting

  • Odense University Hospital

    Odense,
    Denmark

    Active - Recruiting

  • Vejle Hospital

    Vejle,
    Denmark

    Active - Recruiting

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