A trial comparing chemotherapy before and after surgery with chemoradiation before surgery for cancer of the food pipe (Neo-AEGIS)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Status:
Phase:
This trial is comparing chemotherapy before and after surgery with chemoradiation before surgery for cancer of the food pipe (oesophagus). The trial is open to people who have oesophageal cancer or who have cancer where the food pipe joins the stomach (gastro oesophageal cancer). This trial is supported by Cancer Research UK.
More about this trial
Doctors can treat oesophageal cancer and gastro oesophageal cancer with
- Chemotherapy before and after surgery
- Chemotherapy alongside radiotherapy (chemoradiation) before surgery
Both of these are standard treatments and have been used for several years. But doctors don’t know if one treatment is better than the other.
In this trial the researchers want to compare these 2 standard treatments. They want to find out if one treatment is better than the other, or if there is no difference between the 2 treatments.
Who can enter
You may be able to join this trial if all of the following apply
- You have cancer of the oesophagus or you have gastro oesophageal cancer that is an adenocarcinoma
- Your oesophageal cancer has grown into the muscle of the oesophagus or into the membrane covering the oesophagus (your doctor can confirm this)
- If you have gastro oesophageal cancer you have had a laparoscopy to confirm your cancer is stage 2 or 3
- Your cancer has spread to either no lymph nodes or no more than 3 lymph nodes
- Your cancer is 8cm or less in length
- You can have surgery to remove your cancer
- You have had a PET-CT scan
- You are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
- You have satisfactory blood test results
- You are willing to use reliable contraception during treatment and for 6 months afterwards if there is any chance you or your partner could become pregnant
- You are at least 18 years old
You cannot join this trial if any of these apply
- You have cancer that has spread to another part of your body
- The total length of your cancer plus any lymph nodes where the cancer has spread to is greater 10cm
- You have already had chemotherapy for any gastro intestinal cancer (your doctor can tell you about this)
- You have had radiotherapy to your chest or tummy (abdomen)
- You are having certain medications that could affect you taking part in the trial (the trial team can advise you about this)
- You have had another cancer in the past 5 years apart from successfully treated basal cell skin cancer and in situ carcinoma of the cervix
- You have certain heart problems (the trial team can advise you about this)
- You have certain breathing problems (the trial doctor will test you for this)
- You have tingling, numbness or pain in your hands or feet (peripheral neuropathy) unless it is mild
- You have an infection that needs treatment
- You have HIV, hepatitis B or hepatitis C
- You have any other medical or mental health condition that the trial team thinks could affect you taking part in this trial
- You have had an experimental drug as part of another clinical trial within the past 30 days apart from the Add Aspirin trial
- You are pregnant or breastfeeding
Trial design
This is an international phase 3 trial. The researchers need 594 people worldwide to join.
It is a randomised trial. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.
- People in one group have chemotherapy before and after surgery to remove their cancer
- People in the other group have chemoradiation before surgery to remove their cancer
People who are having chemotherapy before and after surgery will have one of the following combinations of chemotherapy drugs
- Epirubicin, cisplatin and fluorouracil (ECF)
- Epirubicin, cisplatin and capecitabine (ECX)
- Epirubicin, oxaliplatin and fluorouracil (EOF)
- Epirubicin, oxaliplatin and capecitabine (EOX)
Your doctor will talk to you about which will be the best combination for you.
You have epirubicin, cisplatin and oxaliplatin as a drip into a vein. You have them every 3 weeks. Each 3 week period is called a cycle of treatment. You have 3 cycles of treatment before surgery and another 3 cycles afterwards.
If you have fluorouracil you have it through a PICC (peripherally inserted central line). The line is attached to a portable pump. You have fluorouracil non stop for 9 weeks before your surgery and for another 9 weeks after surgery. You need to go back to the hospital every week to have the pump changed.
Capecitabine is a tablet you have twice a day for 9 weeks before surgery and 9 weeks after surgery.
People having chemoradiation will have paclitaxel and carboplatin chemotherapy alongside 4½ weeks of radiotherapy. You have radiotherapy every day Monday to Friday (not on weekends). You have paclitaxel and carboplatin as a drip into a vein every week for 5 weeks before surgery.
The trial team will ask you to fill out a questionnaire before surgery then after surgery at
- 3 months
- 6 months
- 1 year
- 2 years
- 3 years
The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.
Hospital visits
You see the doctor to have some tests before taking part. These tests include
- A physical examination
- Blood tests
- Endoscopy
- PET-CT scan
- Endoscopic ultrasound
- Laparoscopy
- A test to check how well your lungs are working
- Heart scan (MUGA or ECHO)
- Hearing test
During treatment before surgery you see the doctor regularly for a physical examination and blood tests.
Before surgery you may have a PET-CT scan or a CT scan.
If you have gastro oesophageal cancer your doctor may also want you to have a laparoscopy before surgery to see how well your cancer has responded to the chemotherapy.
You see the doctor 1 month after surgery for a physical examination and blood tests.
If you are having chemotherapy after surgery your doctor will see if you are fit enough to continue. If so you will see the doctor every 3 weeks before your chemotherapy.
Everyone then sees the doctor every 3 months for a year and then every 6 months for another 2 years.
Side effects
The most common side effects of the chemotherapy drugs used in this trial include
- A drop in blood cells causing an increased risk of infection, bruising and bleeding
- Feeling or being sick
- Tiredness (fatigue)
- Diarrhoea or constipation
- A change to the way your kidneys work
- Loss of appetite and taste changes
- Numbness, tingling or pain in your hands and feet
- Sore mouth and ulcers
- Hair loss
- Tummy (abdominal) pain
Paclitaxel can also cause your blood pressure to drop during treatment. The nurse will keep a check on this.
The side effects of chemoradiation can include
- Feeling or being sick
- Tiredness
- Swelling of your food pipe causing soreness when you swallow
The trial doctor will talk to you about the possible side effects of all the treatment, including possible complications of surgery, before you agree to take part in the trial.
We have more information on
- ECF chemotherapy
- ECX chemotherapy
- EOF chemotherapy
- EOX chemotherapy
- Paclitaxel and carboplatin
- Chemoradiation
- Surgery
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
Shaun Preston
Supported by
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
Cancer Trials Ireland
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
