PRODIGE 54 SAMCO : MULTICENTER RANDOMIZED PHASE II STUDY COMPARING THE EFFECTIVENESS AND TOLERANCE OF AVELUMAB VERSUS STANDARD 2nd LINE TREATMENT CHEMOTHERAPY IN PATIENTS WITH COLORECTAL METASTATIC CANCER WITH MICROSATELLITE INSTABILITY (MSI)
This research study, called PRODIGE 54 SAMCO, is looking at a new treatment called avelumab for people with advanced bowel cancer that has spread to other parts of the body. This type of cancer also has a specific genetic marker called 'microsatellite instability'. We are comparing avelumab with the usual chemotherapy treatments currently given as a second step when initial treatments haven't worked or stopped working. The main goal is to see if avelumab can keep the cancer from growing or spreading for a longer time compared to standard chemotherapy. We will also look at how long people live, how much the tumours shrink, and any side effects. This is a Phase II study, meaning we're testing its effectiveness and safety before wider use.
At a glance
What is this study about?
Imagine you or someone you know has bowel cancer that has spread, and doctors are looking for the next best step in treatment. This study, called PRODIGE 54 SAMCO, is specifically for people whose bowel cancer has spread and also has a particular genetic feature called 'microsatellite instability' (MSI). This MSI feature can sometimes mean certain treatments might work better.
The study aims to compare a new drug called avelumab with the chemotherapy treatments usually given at this stage. Think of it like comparing two different paths to see which one is more effective at slowing down the cancer. Avelumab works differently from traditional chemotherapy; it's an immunotherapy, which means it helps your body's own immune system fight the cancer. We want to find out if this newer approach can keep the cancer from growing for a longer time.
Ultimately, this research is important because it could lead to better treatment options for people with advanced bowel cancer that has the MSI feature. By carefully comparing avelumab to existing treatments, we hope to improve how patients live with and fight this type of cancer, potentially offering them more time and a better quality of life.
Key takeaways
- This study compares a new immunotherapy (avelumab) with standard chemotherapy.
- It's for advanced bowel cancer with a specific genetic marker (MSI).
- The main goal is to see if avelumab can stop cancer growth for longer.
- Participation involves regular treatments, scans, and health check-ups.
- You have the right to leave the study at any time.
- Speak with your doctor to understand if this study is right for you.
Who may be eligible?
To join this study, you would generally need to be an adult, 18 years old or older, with bowel cancer that has spread to other parts of your body. Doctors will also need to have found a specific genetic feature in your cancer called 'microsatellite instability' (MSI).
This study is for people who are considering a 'second line' treatment, which means you would have already had one type of treatment for your advanced bowel cancer, and now doctors are looking for the next best step.
There will also be other specific medical checks and tests that your doctor will need to do to make sure the study is a safe and suitable option 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.
- Are you 18 years old or older?
- Do you have bowel cancer that has spread?
- Has your doctor told you your cancer has 'microsatellite instability' (MSI)?
- Are you looking into treatments for your advanced bowel cancer after an initial treatment?
- Are you comfortable with regular hospital visits and scans?
What does participation involve?
If you decide to participate, you would be randomly assigned to receive either the new drug avelumab or one of the standard chemotherapy treatments. This is similar to flipping a coin, so it's fair. You would have regular appointments for treatment, which would likely involve infusions. Throughout the study, you'd have regular scans, like CT scans, to see how the cancer is responding to the treatment.
Your health would be closely monitored, with regular check-ups, blood tests, and discussions about any side effects you might experience. The total duration of your participation would depend on how your cancer responds to the treatment, but monitoring for side effects and progress would continue regularly. After treatment, there would still be follow-up appointments to track your long-term health and any ongoing effects of the treatment.
Potential risks and benefits
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Common questions
What is 'microsatellite instability' (MSI)?
It's a specific genetic change in some cancer cells that can help doctors decide which treatments might work best.
What is avelumab?
Avelumab is a newer type of drug called an immunotherapy, which helps your body's own immune system fight cancer.
What does 'second line treatment' mean?
It means this treatment is being considered after you've already had an initial treatment for your advanced bowel cancer.
Will I definitely get the new drug?
No, you'll be randomly assigned to either receive avelumab or one of the standard chemotherapy treatments, like drawing lots.
How will doctors know if the treatment is working?
Doctors will use regular scans, like CT scans, to measure the size of your cancer and see if it's growing, shrinking, or staying the same.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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