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 Process | QA Activity | Required for Trial | Additional Details |
|---|---|---|---|
| Pre-Accrual | Facility Questionnaire |  | |
| Outlining Benchmark Case | | 1 case | |
| Planning Benchmark Case | | 2 cases | |
| Dummy Run | |||
| During Accrual | Individual Case Review | | Prospective: first 3 patients Retrospective: all patients |
| Data collection | | All patients | |
| Dosimetry | | ||
| QA Streamlining | | ATNEC trial RCR breast oncology course |
RTTQA contact: enh-tr.PARABLEqa@nhs.net
Chief investigator: Professor Charlotte Coles, University of Cambridge