A trial looking at chemotherapy for neuroendocrine tumours that have spread or can't be removed with an operation (NET 01)

Cancer type:

Neuroendocrine tumour (NET)

Status:

Results

Phase:

Phase 2

This trial compared capecitabine and streptozocin with capecitabine, streptozocin and cisplatin for people with neuroendocrine tumours.

Neuroendocrine cells are cells which produce hormones that can help control different body functions. These cells are found in many parts of the body, but mostly in the lungs, brain and digestive system.

Neuroendocrine tumours (NETs) are rare cancers that can grow from neuroendocrine cells. They are most commonly found in the pancreas, small bowel and appendix.

Doctors can often treat NETs with surgery. But if it spreads to another part of the body (metastasis) then chemotherapy may be useful treatment, especially for NETs that start in the pancreas.

The chemotherapy drugs commonly used are streptozocin (Zanosar) and 5 fluorouracil (5FU) together, or cisplatin combined with these or other drugs.

In this trial, people had either capecitabine (Xeloda) and streptozocin, or capecitabine, streptozocin and cisplatin. Capecitabine is similar to 5FU but it is a tablet rather than an injection and so is more convenient.

The aims of the trial were to find out

  • How well the different treatment options worked for NETs that had started in the pancreas (or it wasn’t known where in the body the tumour had started) and couldn’t be removed with surgery
  • What the side effects were

Summary of results

The research team found that the treatments worked as well as each other for neuroendocrine tumours.

This trial recruited 86 people with neuroendocrine tumours. They all had cancer that couldn’t be removed with surgery, and had not had chemotherapy before. They were put into 1 of 2 treatment groups at random, and

  • 44 people had capecitabine and streptozocin
  • 42 people had capecitabine, streptozocin and cisplatin

The research team were able to look at how well the treatment worked for 79 of the people who took part. They found that

  • Out of 41 people who had capecitabine and streptozocin, the cancer got smaller in 5 people (12%) and stayed the same in 28 people (68%)
  • Out of 38 people who had capecitabine, streptozocin and cisplatin, the cancer got smaller in 6 people (16%) and stayed the same in 22 people (58%)

They looked at how long it was before people’s cancer started to grow. They found it was

  • 10.2 months for those who had capecitabine and streptozocin
  • 9.7 months for those who had capecitabine, streptozocin and cisplatin

They also looked at how long people lived for, and found it was

  • 26.7 months for those who had capecitabine and streptozocin
  • 27.5 months for those who had capecitabine, streptozocin and cisplatin

People in both groups had some side effects, but the people who had all 3 drugs had more severe side effects than those who had just capecitabine and streptozocin. The most common side effects were feeling or being sick, diarrhoea, a sore mouth and tiredness (fatigue).

The research team used questionnaires to measure the quality of life of those who took part. This went down a little for people having capecitabine and streptozocin, but went down a little more for those who also had cisplatin.

The researchers concluded that, overall, adding cisplatin to capecitabine and streptozocin did not benefit patients with pancreatic NETs that could not be removed with surgery.

We have based this summary on information from the team who ran the trial. The information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item) and published in a medical journal. The figures we quote above were provided by the trial team. We have not analysed the data ourselves.

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

Prof Tim Meyer
Dr Pippa Corrie

Supported by

Cambridge University Hospitals NHS Foundation Trust
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer

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

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 637

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

Last reviewed:

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