French prospective randomised double blind study on aspirin versus placebo in resected colon cancer with PI3K mutation stage III or II high risk (PRODIGE 50 - ASPIK)
This research, called ASPIK (PRODIGE 50), is a major study to see if a small, daily dose of aspirin can make a difference for people who have had surgery for colon cancer. Doctors are particularly interested in patients whose cancer has certain genetic changes (called PI3K mutations) and who are at a higher risk of their cancer returning. Half the participants will take a low-dose aspirin tablet each day, while the other half will take a dummy pill (placebo) that looks the same. The main goal is to see how many people remain free of cancer three years after starting the study. They will also look at how long people live, if aspirin causes any serious side effects like bleeding, and how well people stick to taking their medication. This is a "Phase III" trial, which means it's testing if a new treatment is better than existing ones.
At a glance
What is this study about?
This important study, known as ASPIK (PRODIGE 50), is exploring whether a common medication, aspirin, could play a role in preventing colon cancer from returning after surgery. It's designed for people who have already had an operation to remove their bowel cancer and whose cancer has a specific genetic feature called a PI3K mutation, which doctors think might mean they're at a higher risk of the cancer coming back.
The study aims to compare two groups of people: one group will take a low-dose aspirin tablet every day, and the other group will take a 'dummy' tablet (called a placebo) that doesn't contain any medicine but looks identical. Neither the patients nor their doctors will know who is getting aspirin and who is getting the placebo. This is to make sure the results are as fair and accurate as possible.
The main thing researchers want to find out is how many people in each group remain free of cancer for at least three years after they start the study. They will also closely monitor people for five years to see if the cancer returns, how well people live overall, and whether aspirin causes any serious side effects. The results of this study could help doctors understand if aspirin could become a useful part of after-treatment care for some people with colon cancer.
Key takeaways
- This study investigates if low-dose aspirin helps prevent colon cancer recurrence after surgery.
- It focuses on patients with specific genetic changes (PI3K mutation) and higher risk of recurrence.
- Participants will either take aspirin or a dummy pill daily.
- The main goal is to see how many people remain cancer-free after three years.
- Potential benefits include reduced recurrence risk; potential risks include bleeding from aspirin.
- You will be closely monitored for side effects and can withdraw at any time.
Who may be eligible?
This study is open to adults aged 18 and over, with no upper age limit. It's for both men and women.
To join, you must have had surgery for colon cancer that was either Stage II (high risk) or Stage III. Your cancer also needs to have a particular genetic change, known as a PI3K mutation. Your medical team will be able to tell you if your cancer fits these criteria.
There will be other, more detailed medical checks to make sure the study is right and safe for you, such as your general health and any other conditions you might have. Your doctor will discuss all these with 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?
- Have you had surgery for colon cancer?
- Was your colon cancer diagnosed as Stage II (high risk) or Stage III?
- Does your colon cancer have a PI3K genetic mutation? (Your doctor can confirm this.)
What does participation involve?
If you decide to take part in this study, you would be randomly assigned to one of two groups: one receiving a low-dose aspirin tablet daily, and the other receiving a dummy pill (placebo). You would continue taking this tablet for a set period, which your doctor will explain.
Throughout the study, you would attend regular visits with your medical team. These visits would likely involve discussions about your health, any side effects you might be experiencing, and possibly some tests or scans to monitor your health and check if the cancer has returned. The research team will monitor how well you take your medication. The main part of the study will follow your health for at least three years, with ongoing checks for up to five years. The total length of your participation would be discussed in detail by your study team.
Potential risks and benefits
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Common questions
What is a PI3K mutation?
It's a specific change in the genes within your cancer cells. Doctors are studying if this change means aspirin might be particularly helpful for you.
What does 'Stage II high risk' or 'Stage III colon cancer' mean?
These are ways doctors describe how much your colon cancer has grown or spread. Stage II high risk and Stage III generally mean there's a higher chance of the cancer coming back after surgery.
What is a placebo?
A placebo is a 'dummy' pill that looks just like the real medication but contains no active drug. It helps researchers fairly compare the effects of the active drug.
Will I know if I'm taking aspirin or the placebo?
No, neither you nor your doctor will know which tablet you're taking. This is called 'double-blind' and helps ensure the study results are unbiased.
How long will I be followed in this study?
The main part of the study will track your health for at least three years, and you might continue to be monitored for up to five years in total.
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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