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AuthorisedTherapeutic use (Phase IV)Interventional

A biomarker enrichment trial of anti-EGFR agents in patients with advanced colorectal cancer (aCRC) with wild-type RAS and right primary tumour location (right-PTL) - ARIEL-ENGIC trial

This study, called ARIEL-ENGIC, is for patients with advanced bowel cancer that has spread and has specific characteristics: the cancer doesn't have a change in a gene called RAS (known as 'wild-type RAS') and it started on the right side of the bowel. Researchers are testing different combinations of established cancer medicines (like CAPECITABINE, BEVACIZUMAB, OXALIPLATIN, CETUXIMAB, FOLINIC ACID, IRINOTECAN, FLUOROURACIL). The main goals are to see how many people have their tumours shrink significantly within 8 weeks, and how long people live after starting treatment. The study also looks at side effects and how treatments affect patients' quality of life.

At a glance

Status
Authorised
Phase
Therapeutic use (Phase IV)
Sponsor
Fondazione GONO G.I.
Enrolment target
120
Start
06 Oct 2025

What is this study about?

This study is designed for people living with advanced bowel cancer. "Advanced" means the cancer has spread from where it started. The study focuses on people whose cancer has two particular features: firstly, that their cancer does not have a specific genetic change in a gene called RAS (doctors call this "wild-type RAS"), and secondly, that their cancer originally started on the right side of their bowel.

The main idea behind this study is to explore if certain combinations of anti-EGFR medicines, which are already approved cancer drugs, can be more effective for this specific group of patients. These types of medicines work by targeting specific proteins on cancer cells. The team wants to find out if these combinations can help shrink tumours earlier and more effectively, and ultimately, help people live longer.

Researchers will be looking closely at a few key things. They'll measure how much tumours shrink within the first 8 weeks of treatment. They'll also track how long patients live after starting the study. Other important aspects include understanding any side effects people might experience and how the treatment affects their general well-being and daily life. This helps us understand not just if a treatment works, but also how it impacts patients' quality of life.

Key takeaways

  • This study is for advanced bowel cancer with specific genetic features.
  • It uses already-approved cancer drugs in new combinations.
  • The main goals are to shrink tumours and help people live longer.
  • It will also check how treatment affects your quality of life.
  • You'll have regular medical checks and scans if you join.
  • You can stop participating at any time.

Who may be eligible?

To be part of this study, you would need to be an adult, 18 years old or older. The study is open to both men and women.

Your advanced bowel cancer must have specific features. Doctors will check if your cancer has a normal RAS gene (they call this 'wild-type RAS'). They will also need to confirm that your cancer originally started on the right side of your large bowel.

Before you can join, the study team will carry out several tests to make sure that the treatment is suitable for you and that you meet all the health requirements to take part safely.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 18 years old or older?
  2. Do you have advanced bowel cancer?
  3. Has your doctor confirmed your cancer has 'wild-type RAS'?
  4. Did your cancer start on the right side of your large bowel?
Answer every question to see your result.

What does participation involve?

If you decide to join this study, you would receive combinations of existing cancer medications. These include drugs such as CAPECITABINE, BEVACIZUMAB, OXALIPLATIN, CETUXIMAB, FOLINIC ACID, IRINOTECAN, and FLUOROURACIL. The specific combination you receive would be decided by the study doctors.

You would have regular doctor's visits, blood tests, and scans to check on your health and how the treatment is working. The study team will also ask you to fill out questionnaires about how you are feeling and your quality of life at specific times throughout the study (at the start, at 8 and 16 weeks, and then at 12 and 24 months).

Your treatment and monitoring will continue as long as it benefits you and is safe, or until the study concludes. The study will closely monitor your progress for an extended period, with check-ups potentially lasting up to 24 months after you start treatment.

Potential risks and benefits

Taking part in a study like this might offer potential benefits, such as receiving close medical attention and access to potentially effective new ways of using existing treatments for your specific type of cancer. However, it's also important to be aware of potential risks. Like all cancer treatments, the medicines used in this study can cause side effects. The study team will carefully monitor you for these and will discuss any potential side effects with you in detail. You are always free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Unverified
    Italy
  • Unverified
    Germany
  • Unverified
    Spain

Common questions

What does 'advanced colorectal cancer' mean?

It means the bowel cancer has spread to other parts of your body from where it first started.

What is 'wild-type RAS'?

This refers to a normal version of a gene called RAS in your cancer cells. Many cancer treatments work best if the RAS gene is normal.

What are 'anti-EGFR agents'?

These are a type of medicine that targets specific proteins on cancer cells, aiming to stop them from growing and spreading.

Will I receive new, experimental drugs?

No, this study uses existing, approved cancer medicines, but in new combinations or ways to see if they work better together for your cancer type.

What is 'Early Tumour Shrinkage'?

This is a key measurement in the study to check if your tumours are shrinking significantly within the first 8 weeks of treatment.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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