FAST-Forward BOOST: A randomised clinical trial testing a 1-week schedule of curative simultaneous integrated boost (SIB) radiotherapy against a standard 3-week schedule in patients with early breast cancer.
Trial Summary:
The FAST-Forward Boost trial is a Phase III multicentre randomised controlled study investigating a one-week schedule of simultaneous integrated boost (SIB) radiotherapy against the standard three-week schedule in patients with early breast cancer requiring radiotherapy. The trial aims to determine whether the shorter treatment course is non-inferior in terms of local recurrence rates while evaluating its impact on acute toxicity, late effects, quality of life, and health economics. The study will enrol participants, randomised in a 1:1:1 ratio to receive either standard three-week SIB radiotherapy (48Gy in 15 fractions), or one of two one-week SIB regimens (31Gy or 30Gy in 5 fractions). Primary endpoint analysis will assess ipsilateral breast tumour recurrence at five years, while secondary outcomes include patient-reported symptoms, clinician-reported adverse events, recurrence-free survival, Breast cancer-related survival, Health economics and overall survival. An early side-effects sub-study will focus on acute toxicity, particularly skin reactions, and a health economics evaluation will assess treatment cost-effectiveness. Follow-up will continue for at least five years, with additional analysis of long-term outcomes through healthcare datasets. This trial aims to establish shorter, more convenient radiotherapy regimens while maintaining efficacy and safety.
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 | | Specific Case for all RT Centres | |
| Planning Benchmark Case | | Specific Case for all RT Centres | |
| Dummy Run | |||
| During Accrual | Individual Case Review | | Prospective: 1st IMC and 1st Non-IMC Plan for each treatment centre Retrospective: 1 in every 10 treatment plans from each centre up to a maximum of 5 plans. |
| Data collection | | ||
| Dosimetry Audit | | ||
| QA Streamlining | | PARABLE, ATNEC |
RTTQA Contact: enh-tr.ffboostqa@nhs.net
Chief Investigator: Dr Anna Kirby
RT Lead: Dr Carmel Anandadas
Sponsor: The Institute of Cancer Research (fastforwardboost-icrctsu@icr.ac.uk)
Funder: National Institute for Health and Care Research (NIHR) – Health Technology Assessment (HTA) Programme