Phase III multi‐centre parallel group randomised controlled trial comparing Proton Beam Therapy vs tailored photon Radiotherapy in patients with breast cancer: evaluating early and late effects

Trial summary:
PARABLE aims to compare proton beam therapy (PBT) with tailored photon radiotherapy (intensity‐modulated arc therapy ideally in deep‐ inspiratory breath‐hold) to assess whether PBT can reduce mean heart dose (a validated biomarker of longer term serious heart toxicity) without increasing shorter-term side effects, in patients with breast cancer who have increased risk of radiotherapy-induced heart toxicity. 192 patients will be recruited from UK sites over 2.5 years.

RT QA summary:
All QA activity will be streamlined with previous trial QA, where applicable. Please contact the RTTQA Group directly using the contact details below to discuss.

QA ProcessQA ActivityRequired for TrialAdditional Details
Pre-AccrualFacility Questionnaire
Outlining Benchmark Case1 case
Planning Benchmark Case2 cases
Dummy Run
During AccrualIndividual Case ReviewProspective: first 3 patients
Retrospective: all patients
Data collectionAll patients
QA StreamliningATNEC trial
RCR breast oncology course

RTTQA contact:

Chief investigator: Professor Charlotte Coles, University of Cambridge