PLATO ACT5

 Juvenile Anal Cancer / Posted 1 year ago

 A trial looking at higher doses of chemoradiotherapy for people with locally advanced anal cancer (PLATO ACT5)

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.

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.

  • Inclusion Criteria :
    • You have squamous cell cancer of the anus that is bigger than 4 cm (T2 or T3) or has spread to the lymph nodes
    • You have satisfactory blood tests results
    • Your doctor thinks you are well enough to have chemoradiotherapy
    • You are well enough to carry out your normal activities, apart from heavy physical work (performance status of 0 or 1)
    • You are at least 16 years old
    • You are willing to use reliable contraception during treatment and for 6 months afterwards if there is any possibility you or your partner could become pregnant
  • Exclusion Criteria : Your cancer has spread to other parts of the body (apart from the lymph nodes) You have had chemotherapy that reached your whole body (systemic) as a treatment for anal cancer You have had radiotherapy to the area between your hip bones (pelvis) You have had treatment for another cancer in the last 2 years (your doctor can tell you more about this) You have HIV and your CD4 blood count is low – your doctor can tell you more about this You have heart problems such as angina that isn’t controlled or you have had a heart attack in the past 6 months You have had an organ transplant You are not able to have an MRI scan for any reason, for example you have metal implants such as a pacemaker, surgical clips, implants, pins, plates, you have a fear of being in closed spaces (claustrophobia) or you are allergic to the dye (contrast medium ) given during the scan
    • You are pregnant or breastfeeding
  • Study start date : 13/01/2017
  • Study end date : 31/01/2022
  • Wales-Based Study Contact : No Welsh Recruiting Site
  • Principal Investigator : Professor David Sebag-Montefiore

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