Patient FAQ
and right primary tumour location for effective anti-EGFR treatment
Frequently Asked Questions
Q1: What is the purpose of the trial?
A: The study is looking at a group of drugs called anti-EGFR agents. The two drugs in this group are called cetuximab and panitumumab. We are looking to see if more patients could benefit from them.
When a bowel cancer starts on the right side of the colon (in the caecal, ascending or transverse colon), we know that anti-EGFR drugs have less chance of controlling the cancer than in tumours that start elsewhere in the colon. We would like to see if, by doing some extra tests on the cancer sample used to diagnose your bowel cancer, we can find patients with right-sided bowel cancer who would still benefit from anti-EGFR drugs. If successful, these may then be given as standard practice to these patients in the future.
Q2: How will it benefit me?
A: If you receive an anti-EGFR drug in this study, the drug may help control your cancer for a longer period of time than chemotherapy alone.
Q3: Would it affect my chance of entering into another trial at the same time or shortly afterwards?
A: You won’t be able to take part in any other trial where there is a treatment component until after the main check-up at 8 weeks. However, you may be able to take part in research that does not involve a similar type of treatment. Please also be aware that if you wish to take part in other trials in the future, they may have a waiting period before they accept people who’ve recently had other treatments. Please ask your hospital doctor if you are interested or have been asked to participate in any other research, and they will be able to confirm if this will be okay.
Q4: Can I leave the trial at any time if I change my mind?
A: You can stop taking part in all or part of the study at any time and without giving a reason. However, if you’re comfortable, we would like to know your reason for leaving all or part of the study.
Before confirming to stop, you should talk to your study doctor or nurse. They may help address any concerns you have. Deciding to stop at any time will not affect the standard of care you receive. If you decide to stop the study treatment, you are likely to receive the standard treatment at your hospital (see information in Randomisation/Allocation) instead. Trial visits and assessments can still go ahead if you agree to this. If you decide to stop completing the quality of life questionnaires, we will stop asking you to complete them. You can still take part in the trial if you stop these, and you can start completing them again at a later date if you wish.
If you decide to stop study visits or assessments, we will need to keep the information we have already collected about you as this will be included in the study analysis. This is to make sure the research remains reliable.
We will continue collecting information about your health from your routine hospital visits unless you let us know that you don’t want us to. This could be via your GP or through continued visits at your hospital. This is to ensure the results of the study are valid.
Finally, we may be legally required to collect information about any side-effects you may have following your study treatment, even if you have told us you do not want to provide further data for the study.
Q5: Will I receive the trial results?
A: When the study is finished, the results will be published in a medical journal, but no individual participants will be identified. If you wish, we are able to provide these results to you in lay terms and provide you a link to the journal article. This will be sent to you by the hospital where you had your trial treatment by way of a letter or newsletter. The results will also be available on the trial website.
Q6: Why did the trial change its name from ARIEL to ARIEL-ENGIC 04?
A: ARIEL was originally run in the UK only but we recently expanded the recruitment to three other countries. These are Italy, Germany and Spain. This aspect of the trial is funded by the pharmaceutical companies Roche Diagnostics and Merck Serono under the European Network of Gastro-Intestinal Cancers (ENGIC). The ARIEL trial is the 4th trial under their group of studies, which is why the full name of the trial has changed to ARIEL-ENGIC 04. There is an additional information sheet available if you would like more information about this aspect of the trial.
Q1: What tests will I receive to determine if I can take part in the main trial?
A: Before you can be included in the main part of the trial, we will need to do some tests on your tumour sample. These will measure two cancer biomarkers called AREG and EREG. Earlier research showed that if the levels of either of these markers is high in your cancer, anti-EGFR drugs are more likely to help control the cancer for a longer period of time. On the other hand, if the marker levels are low, anti-EGFR drugs do not help control the cancer.
We will tell your hospital doctor if the marker levels in your cancer are high or low.
We may also test your cancer for a gene called RAS, to see if it is normal (known as wild type) or abnormal (known as mutant). This is a standard test which looks at your genes to see if there is a change or ‘mutation’ in your genetic code, which will affect how that gene works. This may already have been done as part of your routine testing. We will only do the RAS test if your results are not already known. To be eligible for ARIEL, you will need to have the Wild Type RAS gene.
Q2: Why do the researchers think the treatment being considered may be better than existing treatments?
A: Previous studies recruited patients with any type of bowel cancer, where all patients were able to have the new treatment that was being investigated. After these studies finished, further work was done which suggested that patients with a bowel cancer starting on the right side of the bowel gained no benefit from anti-EGFR drugs, whilst those with cancer starting on the left side of the bowel gained significant benefit. When we looked at patients with bowel cancer starting on the right using the new EREG/AREG test, we found that those with high levels of these markers appear to gain a benefit from the new drugs, even though their tumours originated on the right side of the colon. This data reinforces previous research. However, more proof is required to use these drugs for future patients outside of a trial setting. This is what we are assessing in the ARIEL trial.
Q3: What are the possible side effects of the treatment?
A: Anti-EGFR agents are already in routine use for patients with bowel cancer that began on the left side of the bowel. Therefore, your doctors and nurses are already quite familiar with them and what side effects they can cause. When they review you, they will record information about any side effects that you may suffer from as a result of treatment.
The main side effect of these drugs is a rash that is similar to acne. It may affect the face, the back, and front of the chest. It can also affect the nails, especially on the thumbs and big toes. It usually develops during the first three weeks of treatment and may result in the need to stop treatment for 1-2 weeks. It usually settles by about 12 weeks of treatment but can leave the skin rather dry. The rash can be helped with moisturisers. Steroid creams and antibiotics can also help.
Anti-EGFR drugs may also cause low levels of a mineral called magnesium in your blood. Magnesium is usually given alongside an anti-EGFR drug to combat this but you may need additional top ups.
Diarrhoea, nausea and vomiting can also occur but can be improved with medication.
Another possible side effect of anti-EGFR drugs is eye irritation. In rare cases this can be severe and require medicated eye drops. Without treatment, this condition can occasionally progress to cause damage to the cornea (the clear part of the eye).Speak to your hospital doctor immediately if you experience this side effect.
There is a rare chance that people may have an allergic anaphylactic reaction (severe immune reaction which can cause hives, swelling, a drop in blood pressure or shock) to anti-EGFR drugs. In very rare circumstances, this can be life threatening.
Q4: Can some of the treatment be given at home?
A: No, you will need to attend clinic for all treatment given as part of the trial. Whether you receive chemotherapy alone, or chemotherapy together with an anti-EGFR agent, the drugs will be given one after the other into one of your veins by an infusion (drip) on the chemotherapy day unit.
Q1: How will it be decided what treatment I get on the trial, and what are the chances of receiving the treatment being studied?
A: A computer will choose at random (as if by the roll of dice) whether or not you will receive an anti-EGFR agent in addition to chemotherapy. Half of the participants in ARIEL will receive an anti-EGFR agent and the other half will receive the usual care for this condition, known as standard of care.
Q2: What will I receive if I am given the treatment being studied?
A: If you are allocated the treatment being studied, you will receive one of the anti-EGFR agents, alongside the standard chemotherapy. Your doctor will talk to you about the two available options (cetuximab and panitumumab) and which one they think would be right for you. The standard chemotherapy would be a combination of two chemotherapy drugs: 5-fluorouracil together with either oxaliplatin (FOLFOX) or irinotecan (FOLFIRI).
Q3: What will I receive if I am not given the treatment being studied?
A: If you are given the standard treatment option then there will be no change to the usual care you would be given. You will receive the standard treatment for right-sided bowel cancer that has spread to other areas of the body. This treatment could be from a few different types of chemotherapy which includes the options described in question 2 above, along with a few other possibilities. Your doctor will talk to you about these drugs and which combination they think would be right for you.
If you would like to find out more about some of the possible chemotherapy options you may be offered, please visit the Macmillan website at the following link.
Q4: Will I know what treatment group I am in?
A: Yes, you will be informed about which treatment you have been allocated to.
Q1: How long will I be on the trial?
A: Trial treatment should last 16 weeks. At this stage your hospital doctor will discuss further treatment options if they are still needed. Trial assessments will continue beyond 16 weeks and up to 12 months after the date of your first cycle of trial treatment.
Q2: How often will I have the treatment?
A: Your doctor will discuss with you how you will receive your chemotherapy.
FOLFOX and FOLFIRI require a special tube to be inserted into a vein (blood vessel) in your arm (or sometimes just under the skin on your upper chest) so that you are able to receive some of the chemotherapy via a small pump over 2 days every 2 weeks, without needing to be admitted to hospital.
The treatment is given this way every two weeks for as long as the drugs continue to control your cancer, and as long as you find the treatment tolerable. Your doctor may suggest breaks in your treatment to give you a rest at different points and may suggest altering the doses of the drugs to reduce side effects.
Q3: How often will I need to attend the clinic?
A: You will attend clinic initially to be assessed for the trial, and then before each treatment cycle starts. You may also need to attend for a CT scan if this has not already been done recently. There will be additional assessments at the 8-week and 16-week time points. These visits may or not be on the same day as your treatment dates. After this time, you won’t need to return to clinic for any trial related assessments, but you may need to return for treatment related assessments which aren’t directly related to the trial.
Q4: How far is the treatment centre from my home?
A: The ARIEL trial is being run at several hospitals in England, Scotland and Wales. You can find the participating hospitals via the ARIEL website.
Please ask your hospital doctor to confirm which treatment centre is closest to you.
Q1: Will I be reimbursed for travel to the clinic?
A: Unfortunately we are unable to provide any reimbursement for travel to clinic for trial related visits.
Q2: What support will I receive from the clinic? Will there be support out of hours? Will I be given a named person I can speak to?
A: All centres in the UK administering chemotherapy and the anti-EGFR drug will provide 24-hour care including a 24-hour hotline for queries and concerns about treatment related effects. This will happen whether you are in the trial or not.
B: B. Your main contacts whilst on the trial will be your treating clinician and research nurse who will be able to answer any questions you may have while visiting the hospital.