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Not yet recruitingPHASE2INTERVENTIONAL

5-fluorouracil Plus Panitumumab (Anti-EGFR) and Sotorasib (KRAS G12C Inhibitor) in First-line Treatment of Patients Non-eligible for a Doublet/Triplet Chemotherapy With Advanced Unresectab

This research study, called COLOSOTO, is testing a new combination of medicines for a type of advanced bowel cancer. We're focusing on patients who are older or not well enough for standard, stronger chemotherapy treatments. Specifically, we're looking at bowel cancer that has spread, can't be removed by surgery, and has a particular genetic fault called a KRAS G12C mutation. The medicines being tested are 5-fluorouracil (5-FU), Panitumumab, and Sotorasib. Earlier studies showed Panitumumab and Sotorasib might be helpful in advanced stages of this cancer. This study aims to see how safe and effective this new combination is as a very first treatment for these patients. It will involve doctors across Europe and is expected to start taking patients in September 2025.

At a glance

Status
Not yet recruiting
Phase
PHASE2
Sponsor
Federation Francophone de Cancerologie Digestive
Enrolment target
300
Start
31 Aug 2025
Estimated completion
30 Dec 2030

What is this study about?

Imagine your body as a complex machine, and sometimes, cells can start to grow out of control, leading to cancer. In this study, we're focusing on a type of bowel cancer (colorectal carcinoma) that has spread and can't be cured by surgery. We're particularly interested in cancers that have a specific change in their genes, called a KRAS G12C mutation. This mutation can make the cancer harder to treat with some standard medications.

For patients who are older or might have other health issues, standard chemotherapy treatments can sometimes be very tough to handle. This study is specially designed for these patients who might not be able to have the usual strong chemotherapy combinations. We already know that a medicine called 5-fluorouracil (5-FU) is a common treatment for these individuals. This study wants to see if adding two newer medicines, Panitumumab and Sotorasib, to 5-FU can make the treatment even better.

Panitumumab and Sotorasib have shown promise in treating this specific type of advanced bowel cancer in patients who have already tried other treatments. The main goal of this study is to find out if this new three-drug combination (5-FU, Panitumumab, and Sotorasib) is safe and effective when given as the *very first* treatment for these patients. We will be looking to see if it can stop the cancer from growing for a longer time.

Key takeaways

  • This study is for advanced bowel cancer with a specific genetic change.
  • It's for patients who are older or less healthy for strong chemotherapy.
  • A new combination of three medicines is being tested as a first treatment.
  • The aim is to see if this combination is safe and helps control the cancer for longer.
  • It will involve regular check-ups and treatment cycles at a hospital.

Who may be eligible?

To be considered for this study, you would generally need to be at least 18 years old and have bowel cancer that has been confirmed by lab tests to be advanced, has spread, and can't be removed by surgery. Crucially, your cancer must also have a specific genetic change called the KRAS G12C mutation. We are looking for patients who are generally less able to tolerate strong chemotherapy treatments, which might include those aged 75 or older, or younger patients with other health concerns that affect their physical ability.

You would not be able to join if you are fit enough for typical strong chemotherapy treatments, or if you have severe health problems with your liver, lungs, or certain other conditions. You also can't have had previous treatment specifically for cancer that has spread, though prior chemotherapy given after surgery (adjuvant chemotherapy) is generally okay if it finished more than six months ago. You would also need to have generally normal organ function (like your blood counts, kidneys, and liver).

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 or older?
  2. Do you have advanced bowel cancer that cannot be removed by surgery?
  3. Has your cancer been tested and found to have a KRAS G12C mutation?
  4. Are you generally not suitable for strong chemotherapy treatments?
  5. Have you not had previous treatment for your advanced cancer (prior treatment after surgery is usually okay if more than 6 months passed)?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the study medicines in cycles, every two weeks. This involves some medicines given through a drip into your vein (5-FU and Panitumumab) and one taken as a tablet by mouth every day (Sotorasib). These treatments would continue until the cancer starts to grow again, or if the side effects become too difficult to manage. You would have regular appointments to monitor your health, check for side effects, and have scans to see how the cancer is responding to treatment. The doctors and nurses will keep a close eye on you throughout the study. We expect to include patients for about 36 months, though your individual treatment duration would depend on how you respond to the medicines.

Potential risks and benefits

Like all medical treatments, there's a chance the study medicines could have side effects, which doctors and nurses will closely monitor and manage. The potential benefit of taking part is that this new combination might be more effective at controlling your cancer than current treatments, especially if you're not able to have stronger chemotherapy. However, there's no guarantee it will work for everyone, and it's possible it may not work better than existing options. You are free to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (80)

  • ICO site Paul Papin
    Verified postcode
    Angers, France
  • Centre Hospitalier Annecy Genevois
    Verified postcode
    Annecy, France
  • Hôpital Privé
    Verified postcode
    Antony, France
  • Centre Hospitalier
    Verified postcode
    Aurillac, France
  • Centre Hospitalier
    Verified postcode
    Bayeux, France
  • Ch Cote Basque
    Verified postcode
    Bayonne, France
  • Ch Simone Veille
    Verified postcode
    Beauvais, France
  • Chu Jean Minjoz
    Verified postcode
    Besançon, France
  • Polyclinique Courlancy
    Verified postcode
    Bezannes, France
  • Centre Hospitalier Béthune Beuvry
    Verified postcode
    Béthune, France
  • Bordeaux Nord Aquitaine
    Verified postcode
    Bordeaux, France
  • TIVOLI
    Verified postcode
    Bordeaux, France

Common questions

What is advanced bowel cancer?

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

What is a KRAS G12C mutation?

This is a specific change in the genes of the cancer cells. It helps us understand how the cancer might behave and which treatments could work best.

Why is this study for 'frail/elderly' patients?

This study is designed for patients who might find standard, stronger chemotherapy treatments too difficult to cope with, often due to age or other health conditions.

What does 'unresectable' mean?

It means the cancer cannot be completely removed by surgery.

Will I have to travel for this study?

The study involves many hospitals across Europe, so you would attend one of these sites for your treatment and check-ups.

How to find out more

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

Interested in taking part?

Register your interest

Share your details and the research team for "5-fluorouracil Plus Panitumumab (Anti-EGFR) and Sotorasib (K…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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