PLATO - PersonaLising Anal cancer radioTherapy dOse
Research type
Research Study
Full title
PLATO - PersonaLising Anal cancer radioTherapy dOse - Incorporating Anal Cancer Trials (ACT) ACT3, ACT4 and ACT5
IRAS ID
204585
Contact name
Sue Bell
Contact email
Sponsor organisation
University of Leeds
ISRCTN Number
ISRCTN88455282
Duration of Study in the UK
8 years, 5 months, 30 days
Research summary
Anal cancer is rare, but its incidence is rising rapidly. Approximately 1000 cases are diagnosed each year in the UK. Standard treatment usually involves a combination of chemotherapy and radiotherapy (chemoradiotherapy (CRT)). Often the same radiotherapy dose is given regardless of disease stage. Recent improvements in radiotherapy means altered doses can now be given to the tumour whilst sparing normal tissues.
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). Patients with no tumour cells close to the cut edge of the removed tissue (margins >1mm) have no further treatment, and those with tumour cells close to the cut edge (margins ≤1mm) receive additional lower-dose CRT (41.4Gy in 23 fractions). 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. One of the two higher-dose experimental arms will be selected for the phase III component of the study.
REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
16/YH/0157
Date of REC Opinion
27 Apr 2016
REC opinion
Favourable Opinion