PersonaLising Anal cancer radioTherapy dOse

Trial summary:

PLATO is an integrated protocol, comprising 3 separate trials (ACT3, ACT4 and ACT5) which aims to optimise radiotherapy dose for low-, intermediate- and high-risk disease.

ACT3: a prospective non-randomised phase II trial which will evaluate a treatment plan in patients with early, small tumours who have undergone surgery (local excision). We aim to determine whether this treatment strategy results in acceptably low rates of the cancer coming back.

ACT4: a randomised phase II trial. Compares standard-dose CRT (50.4Gy in 28 fractions) with reduced-dose CRT (41.4Gy in 23 fractions) in patients with intermediate-risk disease, to see if less radiotherapy is able to maintain the excellent success rates in treating the cancer, while reducing the side effects of treatment.

ACT5: a seamless randomised pilot, phase II and phase III trial that compares standard-dose CRT (53.2Gy in 28 fractions) with two higher doses of CRT (58.8Gy and 61.6Gy, both in 28 fractions), in patients with locally advanced anal cancer, to see if giving a higher dose of radiotherapy reduces the chance of the cancer coming back, whilst not causing too many extra side effects.

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 QuestionnaireIncluding Process Document
Outlining Benchmark Case1 case
Planning Benchmark Case1 case
Dummy Run
During AccrualIndividual Case Review
Data collectionBrief clinical history, diagnostic imaging, full planning data including; CT images, structure set, plan and dose cube and completed plan assessment form (PAF)
QA StreamliningCORINTH

RTTQA contact:

Chief investigator: David Sebag-Montefiore

Lead Investigators: Richard Adams, Mark Harrison, Maria Hawkins, Rebecca Muirhead

Sponsor: University of Leeds,

Funder: Cancer Research UK [A19121]