Neoadjuvant Immunotherapy and Organ-sparing Treatment in Patients with Stage I-III dMMR Colon Cancer: A National, Multicentre, Personalised, Phase II Study (RESET C2)
The RESET C2 study is exploring a new treatment approach for colon cancer that is caught early and has a particular genetic feature called dMMR. This study is testing an immunotherapy drug, Keytruda, given before surgery. The main goal is to see if this treatment can completely get rid of the cancer in some patients, potentially avoiding the need for extensive surgery, or making any necessary surgery less impactful. Researchers will be carefully checking how well the treatment works, how safe it is, and how it affects patients' quality of life. This is a nationwide study aiming to offer a more personalised treatment option for people with this specific type of colon cancer.
At a glance
What is this study about?
The RESET C2 study is all about finding better and gentler ways to treat a specific type of colon cancer that's caught early. This particular type of cancer has a feature called 'dMMR', which means it responds well to a kind of treatment called immunotherapy. Immunotherapy works by boosting your body's own immune system to fight the cancer cells.
In this study, instead of going straight to surgery, patients will first receive an immunotherapy drug called Keytruda. The idea is that this medication might shrink the cancer down significantly, or even get rid of it completely, before any surgery. If the cancer disappears, it might mean some patients could avoid surgery altogether, or have a less extensive operation, which could lead to a better quality of life and fewer side effects.
The research team will be looking very closely at how well the cancer responds to this pre-surgery treatment. They'll also be carefully monitoring how patients feel during and after treatment, checking for any side effects and understanding how this new approach impacts their daily lives. By exploring this 'organ-sparing' strategy, the study hopes to offer a more targeted and less invasive treatment option for individuals with dMMR colon cancer.
Key takeaways
- Targets early colon cancer with a specific genetic marker (dMMR).
- Uses an immunotherapy drug (Keytruda) before surgery.
- Aims to potentially reduce or avoid the need for surgery.
- Monitors treatment effectiveness, safety, and quality of life.
- This is a Phase II study, exploring a new treatment approach in a smaller group of patients.
Who may be eligible?
To be considered for this study, you would typically be an adult diagnosed with early-stage colon cancer that has a specific genetic marker called dMMR. This cancer must be confined to the colon and nearby lymph nodes, meaning it hasn't spread to other parts of your body.
The study is open to both men and women, aged 18 and over. Your medical team will perform specific tests to confirm that your cancer meets the necessary dMMR criteria and that your overall health is suitable for participating in the trial.
- Am I 18 years old or older?
- Do I have early-stage colon cancer?
- Has my doctor confirmed my colon cancer has the 'dMMR' genetic marker?
- Has my cancer not spread to distant parts of my body?
- Am I generally well enough to undergo the treatments and assessments?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you join the RESET C2 study, you would first receive a series of treatments with the study medicine, Keytruda, given as an infusion (like a drip) into your vein. Doctors will regularly check your progress with exams and scans. Depending on how your cancer responds, you might then have surgery, or in some cases, your doctors might decide that close monitoring is a suitable option if the cancer appears to have completely gone.
Throughout the study, you'll have several hospital visits for treatment, check-ups, blood tests, and scans. The medical team will closely monitor you for any side effects from the medication or any procedures. The total length of your participation will vary depending on your treatment plan and follow-up, but doctors will continue to track your health and cancer status for up to 36 months after your main treatment, and even longer for quality of life assessments.
Potential risks and benefits
Locations (1)
- —Denmark
Common questions
What is 'dMMR' colon cancer?
dMMR is a specific genetic feature in some colon cancers. It means these cancers often respond particularly well to a type of treatment called immunotherapy.
What is 'immunotherapy' and how does it work?
Immunotherapy is a treatment that helps your body's own immune system find and fight cancer cells. Keytruda is one such immunotherapy drug.
Will I definitely avoid surgery if I join this study?
Not necessarily. The goal is to see if the drug can shrink the cancer enough to avoid or reduce surgery, but surgery might still be needed depending on how the cancer responds.
What are the main side effects of Keytruda?
Like all medicines, Keytruda can have side effects. These can vary but commonly include tiredness, feeling sick, skin rashes, or changes in how your immune system works. Your doctor will discuss these with you.
How long will I be involved in this study?
Your participation will involve treatment, regular check-ups, and follow-up, which could last for several years to carefully monitor your progress and long-term health.
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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