A trial of chemotherapy for neuroendrocrine carcinoma (cancer) that started in any part of the body, except the lungs (NET-02)

Cancer type:

Neuroendocrine tumour (NET)
Secondary cancers

Status:

Results

Phase:

Phase 2

This trial compared 2 types of chemotherapy for people with a neuroendocrine carcinoma (NEC).

It was for people who had a NEC that didn’t start in the lungs and it:

  • was fast growing (grade 3)
  • couldn’t be removed with surgery or it had spread elsewhere in the body

The trial was open for people to join between 2018 and 2021. The team published the results in 2023.

More about this trial

Neuroendocrine carcinomas (NECs) are fast growing cancers of the neuroendocrine system Open a glossary item. They are rare tumours that develop in cells of the neuroendocrine system. There are a number of different types. The type you have depends on the particular cells that the tumour starts in.

The cells in a NEC look very different compared to the normal cell structure. You may hear this called a poorly differentiated carcinoma (cancer). They are fast growing and more likely to spread. 

Chemotherapy, including a platinum drug Open a glossary item, was a first treatment for neuroendocrine carcinoma when this trial was done. But this treatment can stop working. So doctors were looking for treatments to give people:

  • with fast growing NECs when platinum drugs stopped working 
  • who couldn’t tolerate platinum drugs 

In this trial they compared 2 types of chemotherapy. These were:

These weren’t new treatments. But the form of irinotecan in this trial was new. It is wrapped up in a fatty covering called a liposome. This helps the drug to stay in the bloodstream longer, so that more of the drug may reach the abnormal cells. 

The main aims of this phase 2 trial were to:

  • find out if treatment helps to delay growth of the NEC
  • learn more about the side effects
  • find out how treatment affects quality of life

Summary of results

58 people joined this trial. A computer put them into a treatment group at random:

  • 29 people had liposomal irinotecan, 5-fluorouracil (5FU) and folinic acid
  • 29 people had docetaxel 

Everyone had treatment as long as it was working and the side effects weren’t too bad. 

The trial team had hoped to find more people to take part but it was difficult. This was mainly because it was tricky to recruit people during the COVID-19 pandemic. 

They had the results for 56 people. 27 had liposomal irinotecan, 5-fluorouracil (5FU) and folinic acid and 29 who had docetaxel.

The team looked at how well treatment worked. At 6 months, they looked at whose cancer wasn’t growing or spreading. They found this was: 

  • 8 out of 27 people (29.6%) who had liposomal irinotecan, 5-fluorouracil (5FU) and folinic acid
  • 4 out of 29 people (13.8%) who had docetaxel

Based on these findings the team say that liposomal irinotecan, 5-fluorouracil (5FU) and folinic acid delayed the cancer growing at 6 months. Docetaxel didn’t work well enough to delay this happening. 

The team also looked at:

  • whose cancer went away completely or shrunk
  • how long before the cancer started to grow overall
  • how long people lived (overall survival)

They found these were similar for both groups.  

Liposomal irinotecan delayed the cancer growing at 6 months but it didn’t increase the length of time people lived. The team aren’t sure why it didn’t increase the length of time people lived. They say it might be because:

  • treatments after second treatment options don’t work very well for this group 
  • while the cancer growth slowed at 6 months in this group, this isn’t a good predictor of how long people live

Quality of life
The team looked at how treatment affected quality of life. They found it:

  • improved a bit for those having liposomal irinotecan
  • got worse in those who had docetaxel

Not everyone was able to complete the questionnaires so it was difficult to draw firm conclusions. 

Side effects
The team say the side effects were as expected.

55 people had at least 1 side effect from treatment. But some of these were mild or didn’t last long. 

Some people had more severe side effects. This was:

  • 15 out of 29 people (52%) who had liposomal irinotecan, 5-fluorouracil (5FU) and folinic acid
  • 16 out of 29 people (55%) who had docetaxel

The most common of the more severe side effects in the liposomal irinotecan group were:

  • diarrhoea
  • tiredness (fatigue)

The most common of the more severe side effects in the docetaxel group were:

  • tiredness
  • a drop in the number of a type of white blood cell called neutrophils Open a glossary item

Conclusion
This small trial provides evidence to recommend treatment to the whole body (systemic treatment Open a glossary item) for people who have a poorly differentiated NEC that started outside the lung. This is for people whose first treatment (first line treatment) has not worked.

More detailed information
There is more information about this research in the reference below. 

Please note, the information we link to here is not in plain English. It has been written for healthcare professionals and researchers.

NET-02: a randomised, non-comparative, phase II trial of nal-IRI/5-FU or docetaxel as second-line therapy in patients with progressive poorly differentiated extra-pulmonary neuroendocrine carcinoma
M McNamara and others 
eClinicalMedicine 2023. Volume 60: 102015

Where this information comes from    
We have based this summary on the information in the article above. This has been reviewed by independent specialists (peer reviewed Open a glossary item) and published in a medical journal. We have not analysed the data ourselves. As far as we are aware, the link we list above is active and the article is free and available to view.

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Dr Mairéad G McNamara

Supported by

Leeds Institute of Clinical Trials Research
NIHR Clinical Research Network 
Servier UK
The Christie NHS Foundation Trust

If you have questions about the trial please contact our cancer information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

17162

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Around 1 in 5 people take part in clinical trials

3 phases of trials

Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.

Last reviewed:

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