Supporting the

Neuroendocrine Cancer Community

Neuroendocrine Cancer Research – Clinical Trials

Mar 25, 2021

RESEARCH SPOTLIGHT MARCH 2021 – CLINICAL TRIALS IN NEUROENDOCRINE CANCER. Patient and public involvement (PPI) in research is a very welcome and increasingly frequent requirement due to the potential benefits in the design of participant and researcher relevant, participant friendly, ethically sound research.

PPI is intended to benefit the research process by ensuring research is relevant, conducted in an appropriate ethical manner, that it is participant friendly and that the results of research are made accessible and provided with sensitivity to study participants and the wider public once the study is complete.

Bagley et al. (2016) A patient and public involvement (PPI) toolkit for meaningful and flexible involvement in clinical trials – a work in progress. Res Involv Engagement.

And yet, despite evidence suggesting a willingness to consider or participate in research, at all levels, too few people are recruited or involved. This maybe due to concerns about the risks/benefits of PPI:

There are both positive and negative reports about PPI.

Positive impacts of PPI have been reported for various trial stages from study design and the selection of outcomes to the dissemination and implementation of findings. Importantly, PPI may contribute to the successful delivery of trials by increasing the likelihood of recruitment to time and target together with improving participant retention.

Potential negative impacts of PPI on research have been reported, including ‘potential scientific and ethical conflict on protocol design’, potential reduction in or biases in recruitment, power issues between researchers and patient and public contributors and premature dissemination of research findings before academic publication.

Bagley et al. (2016) A patient and public involvement (PPI) toolkit for meaningful and flexible involvement in clinical trials – a work in progress. Res Involv Engagement.

. . .or simply because the matter is not discussed during consultations (due to lack of awareness or willingness – by those present – to bring up the subject).

This month’s NCUK research spotlight focus is on clinical trials in Neuroendocrine Cancer – including what is happening globally, as discussed at this year’s ENETs conference (clinical trials list) – and a look at one of the trials actively recruiting here in the UK – the NET-02 trial.

ENETs (European Neuroendocrine Tumour Society) 2021 – a bit of a misnomer – as this year’s conference was a truly global affair – with keynote speakers, presentations and posters from all across the world.

It was exciting and inspiring to see so many people truly invested in advancing knowledge, awareness and improved care and management of Neuroendocrine Cancer.

Here is a list of just some of the clinical trials currently or soon to be underway – not all are running in the UK – but there are lessons to be learned from all. nb Europe as used in this list relates to the geographical area – so does include UK.

As mentioned – our particular focus this month is on the NET-02 trial:

A multi-centre, randomised, parallel group, open-label, phase II, single-stage selection trial of liposomal irinotecan (nal-IRI) and 5-fluorouracil (5-FU)/folinic acid or docetaxel as second-line therapy in patients with progressive poorly differentiated extra-pulmonary neuroendocrine carcinoma (NEC).

The lead investigator is Dr Mairead McNamara at the Christie

Point of contact is Jayne Swain 0113 343 4108 NET02@leeds.ac.uk

Multi-centre: the trial is being run across several different Neuroendocrine Centres – these include The Beatson in Glasgow, Hammersmith in London, The Christie in Manchester and Weston Park in Sheffield.

Randomised, parallel group: A parallel study is a type of clinical study where two groups of treatments, A and B, are given so that one group receives only A while another group receives only B. Who is in Group A or Group B is based on random rather than specific selection – neither the participant nor the researcher gets to choose.

Open-label: means that whichever group you are in, you will know what drug or treatment you will be receiving. For NET-02 – this means you will be told whether you will be receiving liposomal irinotecan and 5-fluoroucal/folic acid OR docetaxel.

Second-Line: Treatment that is given when initial treatment (first-line therapy) doesn’t work, or stops working.

Poorly differentiated (PD) : refers to what the cancer cells look like, under the microscope – PD cancer cells appear abnormal and have lost most, if not all of the appearances of the cells they originally were. They tend to grow and spread faster than lower grade well or moderately  differentiated cells.

Extra-pulmonary: your primary site is was not in the lungs

The goal of NET-02 is to find out if one of the treatment options delays growth and/or spread (progression) of the disease, more than the other.

Patients will also be asked to consent to donating some blood samples during the study and a sample of tissue that was taken at the time they were diagnosed.

Samples will be used to find out what gene patterns may increase the risk of developing NEC, and to determine the relevance of these changes in terms of life-span, and whether they are linked to a better response or not to treatment.

A certain number of patients may also be asked to consent to allowing their blood samples to be used to develop an animal model of NEC, where there would be the potential to investigate new treatment options, and so develop a novel clinical trial in an effort to improve survival for patients with this devastating disease.

For further information about the NET-02 trial – please ask either your NET specialist team or use the point of contact details given above.

Please note to be considered for or enrolled into a clinical trial you will need a medical referral.

You can also find out more about this trial from the Clinical Trials database : NCT03837977

NCUK Information about Research and Trials

NCUK Information about Neuroendocrine Cancer