AuthorisedTherapeutic confirmatory (Phase III)Interventional

A randomized double-blind placebo-controlled study with ASA treatment in colorectal cancer patients with mutations in the PI3K signaling pathway

This important study is investigating a new way to help people with bowel cancer (colon or rectal cancer) that is in stages II or III. Researchers want to know if taking a daily aspirin-like tablet, called Trombyl 160 mg, can prevent the cancer from returning. They are focusing on patients whose cancer cells have particular changes in their genes, specifically in something called the PI3K pathway. Some people will get the active tablet, while others will get a plain dummy pill (placebo) that looks exactly the same. Neither the patients nor their doctors will know who is getting which. The main goal is to see how many people remain cancer-free after three years. We hope to learn if this treatment could offer a new option for patients with these specific gene changes.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Karolinska Institutet

Enrolment target

700

Start

01 Oct 2024

Colon and rectal cancer tumor stage II-III tumor with somatic alterationsin PIK3CA PIK3R1 or PTEN

What is this study about?

This research study is about helping people who have been diagnosed with bowel cancer, specifically colon or rectal cancer, that is in stages II or III. Many treatments exist for bowel cancer, but researchers are always looking for ways to improve outcomes and prevent the cancer from coming back. This particular study focuses on a daily tablet, similar to aspirin, called Trombyl 160 mg.

The key idea behind this study is that certain changes in a patient's cancer cells might make them more likely to respond to this aspirin-like tablet. These changes are in specific genes called PIK3CA, PIK3R1, or PTEN, which are part of a pathway in the body called the PI3K signaling pathway. If your cancer has these specific gene changes, you might be a good fit for this study. The study wants to see if taking this tablet over a long period can prevent the cancer from returning after initial treatments.

To make sure the results are fair and accurate, some patients will receive the active Trombyl tablet, while others will receive a 'dummy' tablet (a placebo) that contains no medicine but looks identical. Neither you nor your doctor will know which one you are taking until the study is over. This is a common and important way to test new medicines. The main thing the researchers will be checking is whether the cancer stays away for three years. Your participation could help doctors understand if this daily tablet could be a new and effective treatment option for future patients with similar bowel cancers.

Key takeaways

Targets bowel cancer (colon/rectal) at stages II-III.
Focuses on cancers with specific gene changes (PIK3CA, PIK3R1, PTEN).
Tests a daily aspirin-like tablet (Trombyl 160 mg) to prevent cancer recurrence.
Compares the tablet to a dummy pill (placebo).
Aims to see how many people stay cancer-free after 3 years.
Participation could help improve future bowel cancer treatments.

Who may be eligible?

To be considered for this study, you would need to meet a few important requirements. Firstly, you must be an adult, at least 18 years old. The study is open to both men and women.

Crucially, you would need to have been diagnosed with colon or rectal cancer. This cancer should be at stage II or stage III. Your medical team will be able to confirm what stage your cancer is.

Finally, and very importantly, your cancer cells must have specific changes in their genes. These are called somatic alterations in PIK3CA, PIK3R1, or PTEN. Your doctors would need to test your tumor to see if these particular gene changes are present. This helps make sure the study includes people who might benefit most from the treatment being tested.

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 been diagnosed with colon or rectal cancer?
Is your cancer considered Stage II or Stage III?
Has your doctor confirmed your cancer has specific gene changes (PIK3CA, PIK3R1, or PTEN)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be asked to take one tablet every day. This tablet will either be the active medicine, Trombyl 160 mg, or a plain dummy pill (placebo); you won't know which one you're taking, and neither will your doctor during the study. Both types of tablets will look exactly the same.

Your participation would involve regular check-ups and medical tests to monitor your health and the progress of the study. These visits are important to make sure the treatment is safe for you and to see if it's working. The total duration of your participation in the study, including taking the medication and follow-up, has not been fully detailed, but the main outcome measured is at 3 years, suggesting a significant commitment.

Potential risks and benefits

Taking part in a study like this offers potential benefits, such as contributing to medical knowledge that could help future patients with bowel cancer. You might also receive a treatment that could help prevent your cancer from returning, although there's no guarantee the active tablet will be effective for you. Potential risks include side effects from the Trombyl tablet (since it's similar to aspirin, common side effects might include stomach upset or an increased risk of bleeding, though this is not explicitly stated in the provided information). The dummy pill has very few, if any, side effects. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (4)

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

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Unverified
Finland
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Unverified
Sweden
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Unverified
Denmark
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Unverified
Norway

Common questions

What is PI3K pathway and why is it important?

The PI3K pathway is a natural process in your body's cells that helps them grow. In some cancers, changes in this pathway can make cancer cells grow more. This study looks at whether a daily tablet can affect this pathway in your cancer.

What is a 'dummy pill' or placebo?

A dummy pill, or placebo, looks exactly like the active medicine but contains no active ingredients. It's used to fairly compare the real medicine's effects. You won't know if you're taking the dummy pill or the active medicine.

Will my own doctor know what treatment I'm getting?

No, during the study, neither you nor your doctor will know if you are taking the active tablet or the dummy pill. This is standard practice in medical research to ensure the study results are fair and unbiased.

What does 'TTR at 3 years' mean?

TTR stands for 'Time to Recurrence.' At 3 years means the researchers will be checking how many patients remain cancer-free and have not had their cancer return within three years of starting the study.

What stage is 'Therapeutic Confirmatory (Phase III)'?

This means it's a large, important study comparing a new treatment against existing ones or a dummy pill. It's usually the final step before a new medicine might be considered for wider use.