A trial comparing chemotherapy before and after surgery with chemoradiation before surgery for cancer of the food pipe (Neo-AEGIS)
Cancer type:
Status:
Phase:
This trial compared 2 for cancer of the food pipe (oesophagus). The 2 treatments were:
- chemotherapy before and after surgery
- chemotherapy and radiotherapy together (chemoradiotherapy) before surgery
It was for people with cancer of the:
- oesophagus (food pipe)
- area where oesophagus joins the stomach (gastro oesophageal junction)
In the UK, this trial was supported by Cancer Research UK. It was open for people to join between 2013 and 2020. The team published the results in 2023.
More about this trial
This trial was for people with oesophageal cancer or gastro oesophageal junction cancer. They were all due to have surgery.
They were put into one of two treatment groups at random.
One group had chemotherapy before and after their operation. This is called peri operative chemotherapy.
The treatment they had depended on when they joined the trial. This was because new a combination of treatment became available part way through the trial.
The two chemotherapy treatments were:
- epirubicin with cisplatin or oxaliplatin, and fluorouracil or capecitabine
- fluorouracil, leucovorin, oxaliplatin, and docetaxel (known as FLOT)
They had 3 or 4 before their operation. And another 3 or 4 cycles afterwards.
The other group had radiotherapy, carboplatin and paclitaxel at the same time, before their operation. This is called chemoradiotherapy. The research team also refer to it as trimodality therapy.
Doctors weren’t sure which treatment was best to use.
The main aim of this trial was to find out if one of these treatment options is better than the other.
Summary of results
This trial showed that there wasn’t much difference between how well the 2 treatments worked.
Results
A total of 377 people joined this trial, and 362 of them went on to have treatment. There were:
- 184 people in the group who had chemotherapy before and after surgery
- 178 people in the group who had chemoradiotherapy before surgery
The research team looked at how many people were living, 3 years after they joined the trial. They found it was more 5 out of 10 and similar in each group:
- 55% of those who had chemotherapy before and after surgery
- 57% of those who had chemoradiotherapy before surgery
They looked at how many people’s cancer had come back or had spread to another part of the body. And at the of people taking part. They found all of these were similar in both groups.
The research team also looked at the number of people who had no sign of cancer when they had their operation. This is called pathological complete response.
They found more people in the chemoradiotherapy group had a pathological complete response:
- 7 people (4%) who’d had some chemotherapy before their operation and were due to have more chemotherapy afterwards
- 20 people (12%) who’d had chemoradiotherapy before their operation
The trial closed earlier than expected in December 2020. This was partly because of difficulties caused by the COVID-19 pandemic. And partly because the results were already showing there was little difference between the two groups.
Side effects
Most people taking part had at least one side effect from treatment. Around half the people in each group had a more severe side effect. The number of people who had side effects was similar in both groups.
The most common side effects from chemotherapy were:
- low
white blood cells - extreme tiredness
- diarrhoea
- feeling or being sick
The most common side effects from chemoradiotherapy were:
- extreme tiredness
- feeling sick
- constipation
We have more information on our site about:
- the side effects of chemotherapy
- the side effects of chemoradiotherapy
- having surgery for oesophageal cancer
Conclusion
The trial team concluded the results for the two groups were similar. They suggest that patients and doctors decide together which treatment option is best.
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.
Find more information about what trial results mean in our information about clinical trials.
Trimodality therapy versus perioperative chemotherapy in the management of locally advanced adenocarcinoma of the oesophagus and oesophagogastric junction (Neo-AEGIS): an open-label, randomised, phase 3 trial
J. V. Reynolds and others
The Lancet Gastroenterology and Hepatology, 2023. Volume 8, Issue 11, pages 1015-1027.
Where this information comes from
We have based this summary on the information in the article above. This has been reviewed by independent specialists () 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.
Chief Investigator
Professor Shaun Preston
Supported by
Cancer Research UK
Cancer Trials Ireland
Experimental Cancer Medicine Centre (ECMC)
French National Cancer Institute
Health Research Board Ireland
Irish Cancer Society, Oesophageal Cancer Fund
NIHR Clinical Research Network: Cancer
Southampton Clinical Trials Unit
Other information
This is Cancer Research UK trial number CRUK/14/017.
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040