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

NCT04291378 | Recruiting DMC FDA Device

• 1 other identifier: DBCG Proton trial
• Study Type: interventional
• Target: 1,502
• Locations: 1 country
• Sites: 8

Brief 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

Outcome Measures

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

  10 years after RT

Secondary Outcomes (6)

• Radiation associated second cancer

  10 years after RT

• Distant failure

  10 years after RT

• Acute radiation associated morbidity

  within 6 months after RT

• Late radiation associated morbidity

  10 years after RT

• Patient reported outcome measures

  10 years after RT

Study Arms (2)

Photon radiation therapy

ACTIVE COMPARATOR

The patient is treated with standard radiation therapy based on photons

Radiation: Proton versus photon radiation therapy

Proton radiation therapy

EXPERIMENTAL

The patient is treated with experimental radiation therapy based on protons

Radiation: Proton versus photon radiation therapy

Interventions

Proton versus photon radiation therapy RADIATION

The intervention is proton radiation therapy versus photon radiation therapy

Photon radiation therapy; Proton radiation therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 handling them 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 and evaluation at least a week prior to radiation start.
• Metal implants in the radiation area, including metal in implants.

Sponsors & Collaborators

• Danish Breast Cancer Cooperative Group: lead

Study Sites (8)

Aalborg University Hospital

Aalborg, Denmark

RECRUITING

Aarhus University Hospital

Aarhus, Denmark

RECRUITING

The Danish Breast Cancer Cooperative Group

Copenhagen, DK-2100 Ø, Denmark

NOT YET RECRUITING

Rigshospitalet

Copenhagen, Denmark

RECRUITING

Herlev Hospital

Herlev, Denmark

RECRUITING

Naestved Hospital

Næstved, Denmark

RECRUITING

Odense University Hospital

Odense, Denmark

RECRUITING

Vejle Hospital

Vejle, Denmark

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Birgitte V Offersen, phd

  Danish Breast cancer Cooperation Group (DBCG)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Birgitte V Offersen, phd

CONTACT

+45 28838012; birgoffe@rm.dk

Morten Høyer, phd

CONTACT

+45 23282823; morthoey@rm.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, phd

Model Details: Patients are randomised between 2 arms with different types of radiation therapy, and patients in both arms have similar follow up

Study Record Dates

• First Submitted: February 24, 2020
• First Posted: March 2, 2020
• Study Start: June 1, 2020
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2037
• Last Updated: October 8, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will become available, when the primary and secondary endpoints have been published.
• Access Criteria: The research Group must apply the Danish Breast cancer Group (DBCG) to gain access to the anonymized trial data.

Locations

DK (8)