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AuthorisedTherapeutic confirmatory (Phase III)Interventional

Randomized trial of standard chemotherapy alone or combined with atezolizumab as adjuvant therapy for patients with stage III colon cancer and deficient DNA mismatch repair (ATOMIC)

This research is for people in the UK with stage 3 bowel (colon) cancer that has a particular genetic characteristic called 'deficient DNA mismatch repair'. Doctors are testing if adding a new medicine called atezolizumab (known as Tecentriq) to standard chemotherapy is more effective than chemotherapy alone. Atezolizumab is a type of immunotherapy that helps your body's immune system fight cancer. The main goal is to see if this new combination helps patients stay cancer-free for longer. Participants will be randomly assigned to receive either standard chemotherapy or the chemotherapy plus atezolizumab. This is a Phase 3 study, meaning it's a large trial to confirm if a new treatment is better than current options.

At a glance

Status
Authorised
Phase
Therapeutic confirmatory (Phase III)
Sponsor
National Cancer Institute, AIO-Studien gGmbH
Enrolment target
28
Start
18 Sep 2024

What is this study about?

This study is investigating a new way to treat stage 3 bowel (colon) cancer. When cancer is in stage 3, it means it has spread to nearby lymph nodes but hasn't yet spread to distant parts of the body. For some people with bowel cancer, their cancer cells have a particular genetic feature called 'deficient DNA mismatch repair'. This means their cells have trouble correcting mistakes when they copy their DNA. This specific feature can sometimes make the cancer respond differently to treatments.

The main aim of this study is to find out if adding a drug called atezolizumab (also known as Tecentriq) to the usual chemotherapy treatment can improve how well people do. Atezolizumab is a type of immunotherapy, which essentially boosts your body's own immune system to recognise and fight cancer cells more effectively. Standard chemotherapy for this stage of bowel cancer usually involves drugs like fluorouracil, calcium folinate, and oxaliplatin.

Researchers want to see if the combination of chemotherapy plus atezolizumab helps people stay free of cancer for longer compared to those who only receive standard chemotherapy. This is a 'Phase 3' study, which is the final stage of testing a new treatment before it might be approved for general use. It means many people will take part to get a clear answer about the effectiveness and safety of the new treatment.

Key takeaways

  • This study is for adults with stage 3 bowel cancer with a specific genetic feature.
  • It compares standard chemotherapy with chemotherapy plus a new immunotherapy drug.
  • The main goal is to see if the new combination keeps people cancer-free for longer.
  • Participants will be randomly assigned to one of two treatment groups.
  • The study involves regular hospital visits for treatment and monitoring.
  • You can withdraw from the study at any time.

Who may be eligible?

To join this study, you would need to be an adult, aged 18 or older. Both men and women can take part.

You must have been diagnosed with stage 3 bowel (colon) cancer, and your cancer cells need to show a specific genetic feature called 'deficient DNA mismatch repair'. Your doctors will be able to test for this.

There might be other health requirements or conditions that would allow or prevent you from joining, but these are the main ones. The study team will review your full medical history to see if it's right for you.

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. Have you been diagnosed with stage 3 bowel (colon) cancer?
  3. Has your doctor confirmed your cancer has the 'deficient DNA mismatch repair' genetic feature?
  4. Are you able to travel to a study centre for treatments and check-ups?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be randomly assigned to one of two groups, like flipping a coin. One group will receive standard chemotherapy (using drugs like fluorouracil, calcium folinate, and oxaliplatin). The other group will receive the same standard chemotherapy plus the new drug, atezolizumab.

You'll have regular hospital visits for your treatment and to have check-ups, blood tests, and scans to monitor your health and how the treatment is working. The study team will explain the full schedule of visits and assessments. The actual treatment period will last for a set amount of time, and then you'll enter a follow-up period where doctors will continue to monitor your health and check if the cancer returns, which could last for several years.

Potential risks and benefits

Taking part in a clinical trial offers the chance to receive a new treatment that might be more effective than current options, and you'll receive very close medical care. However, new treatments can have side effects, and some may be serious. Standard chemotherapy also has known side effects. There's no guarantee that the new treatment will work for you, and it might not improve your condition. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (1)

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

Common questions

What is 'deficient DNA mismatch repair'?

This is a specific genetic feature in some cancer cells that doctors can test for. It means the cancer cells have trouble fixing mistakes in their DNA, which can affect how they react to treatments.

What is atezolizumab (Tecentriq)?

Atezolizumab is a type of immunotherapy. It works by helping your body's own immune system find and kill cancer cells.

Will I know which treatment I'm receiving?

No, this study uses a 'randomised' approach, which means you'll be assigned to a group by chance, and usually, neither you nor your doctors will know which treatment you are getting. This helps ensure the results are fair.

How long will I be involved in the study?

The treatment part of the study will last for a specific period, but you will be followed up for several years afterwards to see how you are doing and if your cancer returns.

Can I leave the study if I change my mind?

Yes, you are free to leave the study at any time, for any reason, without needing to explain why. Your decision will not affect your future medical care.

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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