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Study on Acetylsalicylic Acid for Colorectal Cancer Patients with PI3K Pathway Mutations

Fast replyRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a treatment for patients with colorectal cancer, specifically those with certain genetic changes known as mutations in the PI3K signaling pathway. The treatment being tested is Acetylsalicylic Acid (ASA), commonly known as aspirin, which will be given in a dose of 160 mg once daily. The study aims to find out if this treatment can help delay the return of cancer in these patients compared to a placebo.

Participants in the study will have colon or rectal cancer at stages II or III, with specific genetic changes in their tumors, such as PIK3CA, PIK3R1, or PTEN. The study will last for three years, during which time patients will take the medication or placebo orally. The main goal is to see if the treatment can improve the time it takes for the cancer to come back after surgery.

The trial is designed to be a randomized, double-blind, placebo-controlled study, meaning neither the patients nor the researchers will know who is receiving the actual medication or the placebo. This approach helps ensure that the results are reliable and unbiased. The study will help determine if ASA can be an effective additional treatment for patients with these specific types of genetic changes in their cancer.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient is randomly assigned to one of two groups: one receiving the active medication and the other receiving a placebo. This process is double-blind, meaning neither the patient nor the researchers know which group the patient is in.
Step 2
Medication administration
The patient takes one tablet daily. The active medication is acetylsalicylic acid (ASA), with a dosage of 160 mg. The placebo tablet looks the same as the active medication but does not contain the active substance.
The medication is taken orally, which means it is swallowed.
Step 3
Treatment duration
The treatment lasts for a total of three years. During this time, the patient continues to take the daily tablet as instructed.
Step 4
Monitoring and follow-up
Throughout the study, the patient's health and response to the treatment are monitored. This includes regular check-ups and assessments to track any changes in the patient's condition.
Step 5
End of study
At the end of the three-year period, the patient's participation in the study concludes. The primary goal is to determine if the treatment has improved the time to recurrence of cancer in patients with specific genetic mutations.

Who can join the trial?

9 criteria

The patient must have a tumor with **somatic alterations** in genes called **PIK3CA**, **PIK3R1**, or **PTEN**. Somatic alterations are changes in the genes that occur in the cells of the body, not inherited from parents.
The patient must have colon cancer at **stage II-III** or rectal cancer at **stage I-III**. These stages describe the size and spread of the cancer.
The patient must be between **18-80 years old**, including both ages.
The patient must have had **radical surgery**, which means surgery aimed at removing all cancer, as confirmed by a surgeon and a pathologist.
The patient must have a **Karnofsky performance status** of **60% or higher**. This is a scale that measures the patient's ability to perform daily activities, with higher numbers indicating better ability.
The patient must have **platelets** of **100 x 10⁹ / L or higher**. Platelets are cells in the blood that help with clotting.
The patient must have had a **clean colonoscopy** or **Computed Tomography (CT) colon** within 3 months before or after surgery, but before joining the study. A colonoscopy is a test to look inside the colon, and a CT colon is a special scan of the colon.
The patient must be able to **swallow tablets**.
The patient must be able to **understand and sign** a written informed consent form, which means they agree to participate in the study after understanding what it involves.

Who cannot join the trial?

7 criteria

Patients who have a different type of cancer than colon or rectal cancer.
Patients whose cancer does not have specific changes in genes called PIK3CA, PIK3R1, or PTEN. These are genes that can affect how cells grow.
Patients who are not in the age range specified for the study.
Patients who are not able to take the study medication safely.
Patients who are pregnant or breastfeeding.
Patients who have other serious health conditions that might interfere with the study.
Patients who are unable to follow the study procedures or attend the required visits.

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Verified sites

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Responsive
Region Oestergoetland
Linkoping, Sweden
Responsive
Region Vaesterbotten
Umea, Sweden
Responsive
Soedersjukhuset AB
Stockholm, Sweden

Trial locations

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Investigated drugs

Acetylsalicylic Acid (ASA) is being studied to see if it can help prevent the return of colorectal cancer in patients who have specific genetic changes in their cancer cells. In this trial, patients take ASA once a day for three years to see if it can improve the time it takes for the cancer to come back after initial treatment.

Acetylsalicylic Acid

What is already known about the treatment

Acetylsalicylic Acid (ASA) – This medication is administered orally in the form of a tablet, taken once daily. It is currently being studied in clinical trials for its potential benefits in treating colorectal cancer, specifically in patients with certain genetic mutations in the PI3K signaling pathway. The main therapeutic indication being explored is its ability to improve the time to recurrence of cancer in these patients. At the molecular level, ASA is believed to work by inhibiting the enzyme cyclooxygenase, which plays a role in inflammation and cell proliferation. It is classified pharmacologically as a non-steroidal anti-inflammatory drug (NSAID).

Investigated diseases

Colon and Rectal Cancer – This type of cancer originates in the colon or rectum, which are parts of the large intestine. It typically begins as small, noncancerous clumps of cells called polyps that form on the inside of the colon or rectum. Over time, some of these polyps can become cancerous. The disease is often classified by stages, with stage II-III indicating that the cancer has grown into or through the wall of the colon or rectum but has not spread to distant sites. Tumors with somatic alterations in genes like PIK3CA, PIK3R1, or PTEN may have specific characteristics that influence their behavior and progression. These genetic changes can affect how the cancer grows and responds to certain treatments.